Thalomid

Agents for Leprosy
Immunomodulators, Angiogenesis Inhibitors

All prescribers, patients, and pharmacists must comply with the conditions of the THALOMID REMS program when prescribing, dispensing, or receiving thalidomide. Information about the drug and the program can be found at www.celgeneriskmanagement.com or by calling 1-888-423-5436.
Hazardous Drugs Classification
NIOSH 2016 List: Group 2
NIOSH (Draft) 2020 List: Table 1
Observe and exercise appropriate precautions for handling, preparation, administration, and disposal of hazardous drugs.
Use gloves to handle. Cutting, crushing, or otherwise manipulating tablets/capsules will increase exposure.
Maintain storage of capsules in blister packs until taken. Wash the exposed area immediately and thoroughly with soap and water if powder from thalidomide capsules come into contact with skin; flush thoroughly with water if thalidomide comes into contact with mucous membranes.
Emetic Risk
Minimal/Low
Administer prn antiemetics as necessary.

Take thalidomide once daily at least 1 hour after the evening meal, preferably at bedtime.
Swallow capsules whole; do not crush, break, or chew.
If a dose is missed, take within 12 hours of missing the dose. If more than 12 hours have passed, skip the dose of the day and take the dose the next day at the scheduled time.
No more than a 28-day supply should be dispensed at one time.

thrombosis / Delayed / 13.0-22.5
thromboembolism / Delayed / 0-22.5
fatigue / Early / 0-17.0
dyspnea / Early / 0-13.0
hypocalcemia / Delayed / 0-11.0
neutropenia / Delayed / 0-10.0
confusion / Early / 0-9.0
peripheral neuropathy / Delayed / 3.0-8.0
constipation / Delayed / 3.0-8.0
pulmonary embolism / Delayed / 7.0-7.0
infection / Delayed / 0-7.0
leukopenia / Delayed / 0-6.0
edema / Delayed / 0-6.0
weakness / Early / 0-6.0
asthenia / Delayed / 0-5.0
nausea / Early / 0-5.0
atrial fibrillation / Early / 5.0-5.0
anorexia / Delayed / 0-4.0
rash / Early / 0-4.0
weight loss / Delayed / 0-3.0
stroke / Early / 2.6-2.6
tremor / Early / 0-2.0
hyperbilirubinemia / Delayed / 0-2.0
anxiety / Delayed / 0-2.0
vertigo / Early / 0-2.0
myocardial infarction / Delayed / 1.3-1.3
fever / Early / 0-1.0
xerostomia / Early / 0-1.0
dizziness / Early / 0-1.0
agitation / Early / 0-1.0
weight gain / Delayed / 0-1.0
teratogenesis / Delayed / 10.0
fetal death / Delayed / Incidence not known
GI obstruction / Delayed / Incidence not known
GI perforation / Delayed / Incidence not known
peptic ulcer / Delayed / Incidence not known
erythema nodosum / Delayed / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
myocarditis / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
pericarditis / Delayed / Incidence not known
skin necrosis / Early / Incidence not known
erythema multiforme / Delayed / Incidence not known
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) / Delayed / Incidence not known
exfoliative dermatitis / Delayed / Incidence not known
pancytopenia / Delayed / Incidence not known
GI bleeding / Delayed / Incidence not known
seizures / Delayed / Incidence not known
tumor lysis syndrome (TLS) / Delayed / Incidence not known
hyperkalemia / Delayed / Incidence not known
pulmonary hypertension / Delayed / Incidence not known
progressive multifocal leukoencephalopathy / Delayed / Incidence not known
hepatitis B exacerbation / Delayed / Incidence not known
leukemia / Delayed / Incidence not known
new primary malignancy / Delayed / Incidence not known
lymphoma / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
suicidal ideation / Delayed / Incidence not known
pleural effusion / Delayed / Incidence not known
SIADH / Delayed / Incidence not known
cyanosis / Early / Incidence not known
hearing loss / Delayed / Incidence not known
oliguria / Early / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
organ transplant rejection / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

peripheral edema / Delayed / 0-34.0
hyperglycemia / Delayed / 0-15.0
depression / Delayed / 0-10.0
hypokalemia / Delayed / 3.0-3.0
hyperesthesia / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
stomatitis / Delayed / Incidence not known
hepatitis / Delayed / Incidence not known
bullous rash / Early / Incidence not known
lymphadenopathy / Delayed / Incidence not known
pneumonitis / Delayed / Incidence not known
anemia / Delayed / Incidence not known
lymphopenia / Delayed / Incidence not known
bleeding / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known
eosinophilia / Delayed / Incidence not known
splenomegaly / Delayed / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypertension / Early / Incidence not known
peripheral vasodilation / Rapid / Incidence not known
hypotension / Rapid / Incidence not known
orthostatic hypotension / Delayed / Incidence not known
hypomagnesemia / Delayed / Incidence not known
hyponatremia / Delayed / Incidence not known
hyperuricemia / Delayed / Incidence not known
hypophosphatemia / Delayed / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known
hypothyroidism / Delayed / Incidence not known
impotence (erectile dysfunction) / Delayed / Incidence not known
galactorrhea / Delayed / Incidence not known
amnesia / Delayed / Incidence not known
psychosis / Early / Incidence not known
euphoria / Early / Incidence not known
diabetes mellitus / Delayed / Incidence not known
interstitial lung disease / Delayed / Incidence not known
hypertonia / Delayed / Incidence not known
myasthenia / Delayed / Incidence not known
amblyopia / Delayed / Incidence not known
nystagmus / Delayed / Incidence not known
blurred vision / Early / Incidence not known
pyuria / Delayed / Incidence not known
hematuria / Delayed / Incidence not known
proteinuria / Delayed / Incidence not known

xerosis / Delayed / 0-21.0
myalgia / Early / 0-17.0
arthralgia / Delayed / 0-13.0
headache / Early / 12.5-12.5
paresthesias / Delayed / 0-12.0
dyspepsia / Early / 0-11.0
pruritus / Rapid / 0-8.0
malaise / Early / 0-8.0
chills / Rapid / 0-4.0
abdominal pain / Early / 0-4.0
diarrhea / Early / 0-4.0
maculopapular rash / Early / 0-4.0
rhinitis / Early / 0-4.0
sinusitis / Delayed / 0-4.0
pharyngitis / Delayed / 0-4.0
back pain / Delayed / 0-4.0
syncope / Early / 3.0-3.0
hypoesthesia / Delayed / Incidence not known
vomiting / Early / Incidence not known
eructation / Early / Incidence not known
flatulence / Early / Incidence not known
alopecia / Delayed / Incidence not known
hyperhidrosis / Delayed / Incidence not known
purpura / Delayed / Incidence not known
seborrhea / Delayed / Incidence not known
acne vulgaris / Delayed / Incidence not known
ichthyosis / Delayed / Incidence not known
leukocytosis / Delayed / Incidence not known
petechiae / Delayed / Incidence not known
epistaxis / Delayed / Incidence not known
carpal tunnel syndrome / Delayed / Incidence not known
gynecomastia / Delayed / Incidence not known
amenorrhea / Delayed / Incidence not known
insomnia / Early / Incidence not known
cough / Delayed / Incidence not known
muscle cramps / Delayed / Incidence not known
photosensitivity / Delayed / Incidence not known
ocular pain / Early / Incidence not known
diplopia / Early / Incidence not known
xerophthalmia / Early / Incidence not known
tinnitus / Delayed / Incidence not known
increased urinary frequency / Early / Incidence not known
urticaria / Rapid / Incidence not known

Venous (e.g., pulmonary embolism, deep vein thrombosis) and arterial (e.g., stroke, myocardial infarction (MI)) thromboembolism has been reported in patients with multiple myeloma who received thalidomide. Using thalidomide in combination with chemotherapy agents, including dexamethasone, may increase the risk of thromboembolism (TE); use caution when administering thalidomide with chemotherapy agents or other agents that may increase the risk of TE (e.g., estrogen-containing contraceptives). Monitor patients for signs and symptoms of a blood clot such as dyspnea, chest pain, and arm or leg swelling; a stroke such as sudden numbness or weakness (especially on one side of the body), severe headache or confusion, or problems with vision, speech, or balance; and a MI such as feeling sweaty, shortness of breath, feeling sick or vomiting, and/or chest pain that may spread to the arms, neck, jaw, back, or stomach. Consider thromboprophylaxis based on an assessment of individual patients’ underlying risk factors.

Thalidomide is contraindicated for use during pregnancy. Thalidomide is a known human teratogen and even a single dose taken by a pregnant woman may cause severe birth defects. Severe and life-threatening birth defects such as amelia; phocomelia; hypoplasticity of the bones; absence of bones; external ear abnormalities; facial palsy; eye abnormalities; congenital heart defects; alimentary tract, urinary tract, and genital malformations; and death at or shortly after birth have been reported in human infants. It may cause birth defects or intrauterine fetal death if administered during pregnancy. In order to prevent fetal exposure, thalidomide is only available through a restricted distribution program, the THALOMID REMS program. This program requires prescribers, pharmacists, and patients to comply with certain conditions prior to prescribing, dispensing, or receiving thalidomide. It can be prescribed only by licensed prescribers who are registered in the THALOMID REMS program and understand the potential risk of teratogenicity if used during pregnancy. If pregnancy does occur during treatment, immediately discontinue thalidomide. Prescribers are encouraged to report all cases of suspected fetal exposure to Celgene Corporation at 1-888-423-5436 or to the FDA MedWatch program at 1-800-332-1088. Refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.[60079]

Counsel patients about the reproductive risk and contraception requirements during thalidomide treatment. Do not initiate therapy in females of reproductive potential until pregnancy testing is performed twice with confirmed negative results. Administer the first test within 10 to 14 days and the second test 24 hours prior to prescribing thalidomide. Once treatment is started, continue pregnancy testing weekly during the first 4 weeks of treatment, then every 4 weeks in females with regular menstrual cycles and every 2 weeks in females with irregular menstrual cycles. Effective contraception must be used by all females of reproductive potential for at least 4 weeks before beginning treatment, during therapy and dosage interruptions, and for 4 weeks following discontinuation of therapy. Women must commit to abstain continuously from heterosexual sexual intercourse or use 2 methods of reliable birth control, including at least 1 highly effective method (e.g., intrauterine device (IUD), hormonal contraception, tubal ligation, or partner's vasectomy) and 1 additional effective method (e.g., latex condom, diaphragm, or cervical cap). Follow these contraceptive requirements even in patients with a history of fertility problems, unless a hysterectomy has been performed. Discontinue treatment, test for pregnancy, and counsel any woman of reproductive potential who experiences menstrual irregularity (e.g., dysfunctional uterine bleeding) or misses her period. Advise patients that if her doctor is not available, she can call 1-888-423-5436 for information. Thalidomide passes into semen and there is potential for male-mediated teratogenicity. Male patients must use barrier contraception (latex condom) during sexual intercourse with a woman of reproductive potential while on therapy, during interruptions, and for 4 weeks after discontinuing therapy, even if he has undergone a successful vasectomy. Male patients should be warned against sperm donation during thalidomide therapy and for 4 weeks after stopping therapy. Infertility may occur in males based on data from animal studies.[60079]

Thalomid

Rx

Biologic response modifier with immunomodulatory, antiangiogenic, and antitumor properties
Used for patients with erythema nodosum leprosum; also used in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma
Known teratogen that may cause birth defects or embryo-fetal death; routine testing required; prescribers, pharmacies, and patients must register in the THALOMID REMS program (1-888-423-5436)

100 to 300 mg orally once daily is the usual initial dosage range; administration at bedtime and at least 1 hour after the evening meal is recommended. Concomitant corticosteroid therapy should be given in patients with moderate to severe neuritis associated with a severe ENL reaction; taper steroids after the neuritis resolves. Start thalidomide at the lower end of the dosing range in patients weighing less than 50 kg. Patients who have a severe cutaneous ENL reaction or who have previously required higher doses to control the reaction may start thalidomide at 400 mg/day orally; the daily dose may be taken at bedtime or in divided doses. Therapy is usually continued at least 2 weeks or until signs and symptoms of active reaction resolve. After treatment, taper therapy by decreasing the thalidomide dose by 50 mg every 2 to 4 weeks. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.

Use the minimum dose necessary to control the cutaneous ENL reaction in patients who require maintenance therapy or who flare when thalidomide was tapered after an acute cutaneous reaction. Every 3 to 6 months, attempt to taper therapy by decreasing the thalidomide dose by 50 mg every 2 to 4 weeks. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.

200 mg orally once daily in combination with dexamethasone 40 mg orally on days 1 to 4, 9 to 12, and 17 to 20; administration at bedtime and at least 1 hour after the evening meal is recommended. Treatment cycles are repeated every 28 days. Consider therapy interruption, a dose reduction, or therapy discontinuation in patients who develop grade 3 or 4 adverse reactions.

400 mg/day PO during induction chemotherapy (withheld on day 5 of cycle 3 during peripheral blood stem-cell collection), thalidomide 100 mg/day PO after each transplant (when platelet count greater than 50,000/mm3), thalidomide 200 mg/day during consolidation therapy, and maintenance therapy with thalidomide 100 mg/day for 1 year and then thalidomide 50 mg every other day until relapse or unacceptable toxicity. Concurrent thalidomide administration was studied as part of the Total Therapy 2 regimen in combination with 4 cycles of induction chemotherapy, 2 (tandem) autologous stem-cell transplants, and 4 cycles of consolidation therapy. Supportive medications included filgrastim, prophylactic antibiotics, histamine H2 blockers, and erythropoietin (as necessary); low molecular weight heparin was given as thromboprophylaxis.

Multiple regimens have been studied. Thalidomide 100 mg/day PO plus dexamethasone 40 mg/day PO on days 1 to 4 repeated monthly (median time to max response, 4 months; duration of therapy range, 4 to 36 months); and, thalidomide 200 mg/day PO at bedtime (increased by 100 mg every 7 days to a max dose of 600 mg/day) plus dexamethasone 20 mg/m2/day PO for 5 days repeated every 15 days followed by thalidomide 100 to 150 mg/day continuously plus dexamethasone for 5 consecutive days/month were administered in responding patients (median time to remission, 2 months; mean dose at 2 months, 270 mg/day) have been studied in clinical trials.

The optimal dosage of thalidomide plus melphalan and prednisone has not been clearly established and dosages have varied in randomized controlled trials. Thalidomide 200 mg/day PO for 2 to 4 weeks escalated up to a maximum dose of 400 mg/day if no severe adverse events occurred (median therapy duration of 11 months) plus melphalan 0.25 mg/kg daily for 4 days and prednisone 2 mg/kg daily for 4 days repeated every 6 weeks for 12 cycles was studied in previously untreated patients with multiple myeloma who were between 65 and 75 years of age in one study. Thalidomide was stopped after day 4 of the last cycle. Most patients in this study took a thalidomide dose of 200 mg/day or less. In another study, patients aged 75 years and older received thalidomide 100 mg/day PO at bedtime (median therapy duration of 13.5 months) plus melphalan 0.2 mg/kg daily for 4 days and prednisone 2 mg/kg daily for 4 days repeated every 6 weeks for 12 cycles.

100 mg PO daily for the first 14 days (cycle 1 only) then 200 mg PO daily thereafter plus bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone 40 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 (VTD regimen) repeated every 21 days for 3 cycles prior to a double (tandem) autologous stem-cell transplant (ASCT) was studied in a multicenter, randomized, phase III study. Patients randomized to induction therapy with VTD also received two 35-day consolidation cycles with VTD (bortezomib 1.3 mg/m2 IV on days 1, 8, 15, and 22 plus thalidomide 100 mg PO daily and dexamethasone 40 mg on days 1, 2, 8, 9, 15, 16, 22, and 23) following the second transplantation. Patients also received maintenance therapy with dexamethasone 40 mg PO on days 1 to 4 every 28 days until relapse or disease progression. Additionally, thalidomide 200 mg PO daily (dose escalation as follows in the first cycle: 50 mg/day on days 1 to 14 and 100 mg/day on days 15 to 28) plus bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone 40 mg on days 1 to 4 and 9 to 12 repeated every 4 weeks for 6 cycles prior to an ASCT was studied in another randomized, phase III study. In this study, patients who received up to 3 years of maintenance therapy (starting 3 months after ASCT) with thalidomide (100 mg/day) plus bortezomib (1.3 mg/m2 IV on days 1, 4, 8, and 11 repeated every 3 months) had significantly improved 2-year progression-free survival compared with thalidomide or interferon alfa-2b maintenance therapy.

100 mg orally daily as continuous therapy in combination with daratumumab, bortezomib, and dexamethasone was evaluated in a multicenter, randomized, phase 3 trial (n = 1,085; the CASSIOPEIA trial). In this trial, thalidomide was administered with up to four 28-day induction therapy cycles and two 28-day consolidation therapy cycles of daratumumab (16 mg/kg IV weekly in induction cycles 1 and 2; 16 mg/kg IV every 2 weeks in induction cycles 3 and 4 and for both consolidation cycles), bortezomib (1.3 mg/m2 subcutaneously on days 1, 4, 8, and 11 in each induction and consolidation cycle), and dexamethasone (40 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in induction cycles 1 and 2; 40 mg PO/IV on days 1 and 2 and 20 mg PO/IV on days 8, 9, 15, and 16 in induction cycles 3 and 4; and 20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 for both consolidation cycles). Consolidation therapy was begun after hematopoietic reconstitution but not earlier than 30 days after transplant.

Thalidomide 100 mg PO once daily at bedtime is the typical dose with a range of 50 to 200 mg/day PO. In patients with AIDS-associated wasting syndrome, thalidomide has shown to increase lean body mass 10.5% from baseline after 24 weeks of treatment. Weight gain has continued with continued treatment with thalidomide.

Thalidomide 100 to 200 mg PO once daily at bedtime has been studied. If the patient does not respond to lower doses, thalidomide may be increased to 400 to 600 mg/day PO. In patients with HIV-related aphthous ulcers, more than 90% of patients experienced healing of ulcers, decreased pain, improved appetite and increased sense of well-being following 7 to 28 days of treatment with thalidomide. Once the ulcers have healed thalidomide is usually discontinued. Retreatment with thalidomide if the ulcers recur is effective.

Dosage for this indication not established. 200 mg PO once daily, gradually increased to a target dose of 200 mg PO 4 times daily has been studied. Drug discontinuation due to intolerance in the thalidomide group was high (>90%). Thalidomide has been given in combination with prednisone and a calcineurin inhibitor (cyclosporine or tacrolimus).

Dosage for this indication not established. 3 mg/kg PO once daily (if patient less than 67 kg), gradually increased to a target dose of 3 mg/kg PO 4 times daily has been studied. Drug discontinuation due to intolerance in the thalidomide group was high (>90%). Thalidomide has been given in combination with prednisone and a calcineurin inhibitor (cyclosporine or tacrolimus).

200 mg/day PO escalated by 200 mg/day every 2 weeks as tolerated to a maximum of 1,000 mg/day was given to patients for 52 weeks in a phase II study of 20 male patients; the overall response rate was 47%.

800 to 1,200 mg PO per day has been studied. In a phase II study of single-agent thalidomide in recurrent high-grade gliomas, results showed an ORR of 6%, median TTP = 10 weeks and median OS = 28 weeks, leading authors to conclude that single-agent thalidomide was not effective. Toxicities included seizures, constipation, neuropathy and somnolence.

Thalidomide has been used in combination with various chemotherapy agents and/or radiation therapy. In a phase II trial, thalidomide 800 to 1,200 mg PO per day was given with carmustine 200 mg/m2 intravenously every 6 weeks. Alternately, a starting dose of thalidomide 100 mg PO per day (escalated by 100 mg PO per day up to a dose of 400 mg PO per day) was given with irinotecan 350 to 700 mg/m2 (depending on anti-epileptic regimen). Additionally, temozolomide 150 to 200 mg/m2/day PO on days 1 to 5 every 28 days plus radiation therapy (6 weeks) was given in combination with thalidomide 200 mg PO per day (beginning on day 7) dose escalated by 100 to 200 mg PO per day every 7 to 14 days to a maximum dose of 1,200 mg PO per day.

As a single agent, thalidomide 100 mg/day PO escalated to 400 mg/day PO was used in one trial. Of the 51 evaluable patients, 31% responded to therapy including some patients becoming transfusion independent. No cytogenetic or complete responses were seen, but some patients showed hematologic improvement. Patients who responded had lower baseline blast counts, shorter duration of pretherapy platelet transfusions, and higher platelet counts.

In patients who are refractory to previous treatment, initial doses of thalidomide of 50 to 400 mg/day PO until clinical response is achieved have been given. Doses are gradually tapered and maintained at 25 to 100 mg PO once daily. Retreatment for relapse with thalidomide 25 to 100 mg/day PO is usually effective.

Thalidomide 100 to 400 mg/day PO daily for up to 38 months has been effective in improving arthritis, ocular manifestations and skin lesions associated with Behcet's syndrome.

Thalidomide 50 to 300 mg/day PO for an average duration of 12 months produced immediate and pronounced relief of intense pruritus and a significant decrease in the number of skin lesions.

Safety and efficacy not established. Various treatment regimens have been described in the literature, in the range of 50 mg to 300 mg/day PO. Reserve for induction therapy in patients refractory to guideline recommended therapies. Due to side effects and teratogenic potential, as well as lack of evidence for maintenance of remission, thalidomide is not included in current guidelines for the induction or maintenance management of Crohn's disease in adults.

200 mg orally daily in combination with gemcitabine (800 mg/m2 IV over 30 minutes on days 1 and 8), cisplatin (25 mg/m2 IV on days 1, 2, and 3), and prednisone (60 mg/m2 PO on days 1, 2, 3, 4, and 5) was evaluated in patients with previously untreated PTCL in a randomized trial. Cycles of therapy were repeated every 21 days until disease progression or for up to 6 cycles. Thalidomide was initiated at 50 mg/day and increased in 50-mg increments daily until 200 mg/day. Patients received aspirin 100 mg/day PO during thalidomide therapy. The use of granulocyte colony-stimulation factor was permitted as indicated.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Acebutolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Acetaminophen; Dichloralphenazone; Isometheptene: (Moderate) Thalidomide frequently causes drowsiness and somnolence and may enhance the sedative activity of dichloralphenazone.
Alpha-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Amiodarone: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as amiodarone should be used cautiously due to the potential for additive effects.
Amitriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Atorvastatin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Benazepril: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Celecoxib: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Olmesartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Valsartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Anxiolytics; Sedatives; and Hypnotics: (Major) The use of anxiolytics, sedatives, or hypnotics concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Atenolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Atenolol; Chlorthalidone: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Azelastine: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Azelastine; Fluticasone: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Barbiturates: (Major) The use of barbiturate anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Benzodiazepines: (Major) The use of benzodiazepine anxiolytics, sedatives, or hypnotics with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Beta-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Betaxolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Bisoprolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Bortezomib: (Moderate) Monitor patients for the development of peripheral neuropathy when receiving bortezomib in combination with other drugs that can cause peripheral neuropathy like thalidomide; the risk of peripheral neuropathy may be additive.
Brimonidine; Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Buspirone: (Major) Avoid the concomitant use of thalidomide with anxiolytics, sedatives, and hypnotics due to the potential for additive sedative effects.
Butorphanol: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as butorphanol due to the potential for additive sedative effects.
Butyrophenone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Calcium-channel blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Cannabidiol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cannabidiol and thalidomide. CNS depressants can potentiate the effects of cannabidiol.
Carbidopa; Levodopa; Entacapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Carteolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Carvedilol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Cenobamate: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cenobamate and thalidomide. Concurrent use may result in additive CNS depression.
Cetirizine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Cetirizine; Pseudoephedrine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Chlordiazepoxide; Amitriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Cimetidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Cisplatin: (Moderate) Monitor for peripheral neuropathy if coadministration of thalidomide and cisplatin is necessary. Both drugs can cause peripheral neuropathy, which may be additive.
Clevidipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Clomipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Clozapine: (Major) It is unclear if concurrent use of other drugs known to cause neutropenia (e.g., antineoplastic agents) increases the risk or severity of clozapine-induced neutropenia. Because there is no strong rationale for avoiding clozapine in patients treated with these drugs, consider increased absolute neutrophil count (ANC) monitoring and consult the treating oncologist.
COMT inhibitors: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Darbepoetin Alfa: (Moderate) Thalidomide and darbepoetin alfa should be used cautiously due an increased risk of thromboembolism.
Denosumab: (Moderate) The safety and efficacy of denosumab use in patients with immunosuppression have not been evaluated. Patients receiving immunosuppressives along with denosumab may be at a greater risk of developing an infection and/or osteonecrosis of the jaw, a rare condition that has been reported during denosumab therapy.
Desipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Desogestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Deutetrabenazine: (Moderate) Concurrent use of deutetrabenazine and drugs that can cause CNS depression, such as thalidomide, may have additive effects and worsen drowsiness or sedation. Advise patients about worsened somnolence and not to drive or perform other tasks requiring mental alertness until they know how deutetrabenazine affects them.
Dexamethasone: (Moderate) Coadministration of dexamethasone with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
Dienogest; Estradiol valerate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Difelikefalin: (Moderate) Monitor for dizziness, somnolence, mental status changes, and gait disturbances if concomitant use of difelikefalin with CNS depressants is necessary. Concomitant use may increase the risk for these adverse reactions.
Digoxin: (Moderate) Thalidomide and digoxin should be used cautiously due to the potential for additive bradycardia. The pharmacokinetic parameters of thalidomide and digoxin were not affected when a single dose of digoxin 0.5 mg was administered in 16 healthy men who were receiving thalidomide 200 mg/day (at steady state levels).
Diltiazem: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Disulfiram: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as disulfiram should be used cautiously due to the potential for additive effects.
Docetaxel: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as docetaxel should be used cautiously due to the potential for additive effects.
Dorzolamide; Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Doxazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Doxepin: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Drospirenone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Estetrol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Elagolix; Estradiol; Norethindrone acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Entacapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Epoetin Alfa: (Moderate) Thalidomide and epoetin alfa should be used cautiously due an increased risk of thromboembolism.
Esketamine: (Major) Closely monitor patients receiving esketamine and thalidomide for sedation and other CNS depressant effects. Instruct patients who receive a dose of esketamine not to drive or engage in other activities requiring alertness until the next day after a restful sleep.
Esmolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Estradiol; Levonorgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Estradiol; Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Estradiol; Norgestimate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethanol: (Major) Avoid the concomitant use of thalidomide with alcohol due to the potential for additive sedative effects. Additionally, using thalidomide and alcohol together may potentiate the adverse effect of peripheral neuropathy. (Moderate) Avoid the concomitant use of thalidomide with alcohol due to the potential for additive sedative effects. Additionally, using thalidomide and alcohol together may potentiate the adverse effect of peripheral neuropathy.
Ethinyl Estradiol; Norelgestromin: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethinyl Estradiol; Norethindrone Acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethinyl Estradiol; Norgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Etonogestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Etonogestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Famotidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Felodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Fenfluramine: (Major) Avoid coadministration of fenfluramine with thalidomide due to the risk of additive CNS depression.
Fenofibric Acid: (Minor) At therapeutic concentrations, fenofibric acid is a weak inhibitor of CYP2C19. Concomitant use of fenofibric acid with CYP2C19 substrates, such as thalidomide, has not been formally studied. Fenofibric acid may theoretically increase plasma concentrations of CYP2C19 substrates and could lead to toxicity for drugs that have a narrow therapeutic range. Monitor the therapeutic effect of thalidomide during coadministration with fenofibric acid.
Food: (Major) Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions.
Fosphenytoin: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as phenytoin or fosphenytoin due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and agents that cause peripheral neuropathy such as phenytoin may increase the potential for additive neuropathy.
Gabapentin: (Major) Avoid coadministration of thalidomide with gabapentin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate gabapentin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression.
H2-blockers: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Ibuprofen; Famotidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Imipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Isradipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Labetalol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Lasmiditan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lasmiditan and thalidomide. Concurrent use may result in additive CNS depression.
Lemborexant: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lemborexant and thalidomide. Dosage adjustments of lemborexant and thalidomide may be necessary when administered together because of potentially additive CNS effects. The risk of next-day impairment, including impaired driving, is increased if lemborexant is taken with other CNS depressants.
Leuprolide; Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levamlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Levobunolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Levocetirizine: (Moderate) Concurrent use of cetirizine/levocetirizine with thalidomide should generally be avoided. Coadministration may increase the risk of CNS depressant-related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence.
Levonorgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Lithium: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as lithium due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as lithium may increase the potential for additive bradycardia.
Lofexidine: (Moderate) Monitor for additive hypotension, bradycardia, and sedation during coadministration of lofexidine and thalidomide. Lofexidine can potentiate the effects of CNS depressants. Patients should be advised to avoid driving or performing any other tasks requiring mental alertness until the effects of the combination are known.
Loxapine: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Lumateperone: (Moderate) Avoid the concurrent use of thalidomide and lumateperone if possible due to the potential for additive CNS depression. If coadministration is required, monitor for excessive sedation and somnolence.
Lurasidone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Methocarbamol: (Moderate) Thalidomide frequently causes drowsiness and somnolence and may enhance the sedative activity of methocarbamol.
Metoprolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Metronidazole: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as metronidazole should be used cautiously due to the potential for additive effects.
Molindone: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Nabilone: (Major) The use of CNS depressants concomitantly with thalidomide may cause an additive sedative effect and should be avoided.
Nadolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nalbuphine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as nalbuphine due to the potential for additive sedative effects.
Nebivolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nebivolol; Valsartan: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Nefazodone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as nefazodone due to the potential for additive sedative effects.
Nicardipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nifedipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nimodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nisoldipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Nizatidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Non-oral combination contraceptives: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norgestimate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Norgestrel: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Nortriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Opiate Agonists: (Major) Avoid coadministration of opioid agonists with thalidomide due to the risk of additive CNS depression.
Opicapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Oral Contraceptives: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Oritavancin: (Moderate) Thalidomide is metabolized by CYP2C19; oritavancin is a weak CYP2C19 inhibitor. Coadministration may result in elevated thalidomide plasma concentrations. If these drugs are administered concurrently, monitor patients for signs of thalidomide toxicity, such as increased fatigue, drowsiness, or neuropathy.
Paclitaxel: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as paclitaxel should be used cautiously due to the potential for additive effects.
Pamidronate: (Moderate) In patients with multiple myeloma, the risk of renal dysfunction may be higher in patients taking both pamidronate and thalidomide.
Pentazocine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as pentazocine due to the potential for additive sedative effects.
Pentazocine; Naloxone: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as pentazocine due to the potential for additive sedative effects.
Perindopril; Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Perphenazine; Amitriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Phenothiazines: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Phenoxybenzamine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Phentolamine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Phenytoin: (Moderate) Avoid the concomitant use of thalidomide with other central nervous system depressants such as phenytoin due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and agents that cause peripheral neuropathy such as phenytoin may increase the potential for additive neuropathy.
Pimozide: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Pindolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Pramipexole: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as pramipexole due to the potential for additive sedative effects.
Prazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Pregabalin: (Major) Avoid coadministration of thalidomide with pregabalin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression.
Propranolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Propranolol; Hydrochlorothiazide, HCTZ: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Protriptyline: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Ramelteon: (Major) Avoid the concomitant use of thalidomide with anxiolytics, sedatives, and hypnotics due to the potential for additive sedative effects.
Ranitidine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as H2-blockers should be used cautiously due to the potential for additive bradycardia.
Relugolix; Estradiol; Norethindrone acetate: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Ropinirole: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as ropinirole due to the potential for additive sedative effects.
Sedating H1-blockers: (Major) Avoid the concomitant use of thalidomide with opiate agonists; antihistamines; antipsychotics; anxiolytics, sedatives, and hypnotics; and other central nervous system depressants due to the potential for additive sedative effects.
Segesterone Acetate; Ethinyl Estradiol: (Moderate) Thalidomide and hormone contraceptives should be used cautiously due an increased risk of thromboembolism. The pharmacokinetic parameters of norethindrone/estradiol were not affected when a single dose of norethindrone 1 mg/estradiol 75 micrograms was administered in 10 healthy women who were receiving thalidomide 200 mg/day (at steady state levels).
Skeletal Muscle Relaxants: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as skeletal muscle relaxants due to the potential for additive sedative effects.
Sotalol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Stiripentol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of stiripentol and thalidomide. CNS depressants can potentiate the effects of stiripentol.
Succinylcholine: (Moderate) Use succinylcholine with caution in patients taking thalidomide due the risk of additive bradycardia.
Telmisartan; Amlodipine: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Terazosin: (Moderate) Thalidomide and other agents that slow cardiac conduction such as alpha-blockers should be used cautiously due to the potential for additive bradycardia.
Thiothixene: (Major) Avoid the concomitant use of thalidomide with antipsychotics due to the potential for additive sedative effects.
Timolol: (Moderate) Thalidomide and other agents that slow cardiac conduction such as beta-blockers should be used cautiously due to the potential for additive bradycardia.
Tizanidine: (Moderate) Thalidomide frequently causes drowsiness and somnolence and may enhance the sedative activity of tizanidine.
Tolcapone: (Major) The use of thalidomide and COMT inhibitors may cause an additive sedative effect and should be avoided if possible. If concurrent treatment is needed, prescribers should monitor patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them.
Trandolapril; Verapamil: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Trazodone: (Major) The use of CNS depressants, such as trazodone, concomitantly with thalidomide may cause an additive sedative effect and should be avoided. Thalidomide frequently causes drowsiness and somnolence. Dose reductions may be required. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Advise patients as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.
Trimipramine: (Major) Avoid the concomitant use of thalidomide with other central nervous system depressants such as tricyclic antidepressants (TCAs) due to the potential for additive sedative effects. Additionally, co-administration of thalidomide and other agents that slow cardiac conduction such as TCAs may increase the potential for additive bradycardia.
Verapamil: (Moderate) Thalidomide and other agents that slow cardiac conduction such as calcium-channel blockers should be used cautiously due to the potential for additive bradycardia.
Vincristine Liposomal: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as vincristine should be used cautiously due to the potential for additive effects.
Vincristine: (Moderate) Thalidomide and other agents that cause peripheral neuropathy such as vincristine should be used cautiously due to the potential for additive effects.
Zoledronic Acid: (Moderate) In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.

Thalomid Oral Cap: 50mg, 100mg, 150mg, 200mg

Multiple myeloma: 200 mg/day PO.Erythema nodosum leprosum: 400 mg/day PO.

Multiple myeloma: 200 mg/day PO.Erythema nodosum leprosum: 400 mg/day PO.

Erythema nodosum leprosum: 400 mg/day PO.

12 years of age: Erythema nodosum leprosum, 400 mg/day PO.
1 to 11 years: Safety and efficacy not established.

The complete mechanism of action of thalidomide is not completely understood. In vitro and in vivo studies show that thalidomide selectively reduces levels of tumor necrosis factor alpha (TNF-alpha) by accelerating the degradation of TNF-alpha messenger RNA (mRNA) encoding protein. Thalidomide reduces the half-life of the TNF-alpha mRNA encoding protein from 30 minutes to about 17 minutes. Thalidomide does not affect mRNA levels of interleukin (IL)—1 or IL—6. TNF-alpha has been associated with the pathology and symptoms of many different diseases including ENL, AIDS, cancers, graft-versus-host disease, tuberculosis and malaria. Symptoms associated with TNF-alpha include fever, weight loss and characteristics of septic shock resulting in endothelial damage, disturbances of lipid metabolism and release of IL—1. The mechanism of thalidomide is different from the proposed mechanism of pentoxifylline or corticosteroids, which suppress lipopolysaccharide-induced TNF-alpha RNA transcription and translation, respectively. Thalidomide also increases levels of IL—2 and interferon-gamma, augment NK-like activity, and inhibit IL—12 production. Recently, thalidomide has been recognized as an inhibitor of angiogenesis due to inhibition of basic fibroblast growth factor (bFGF). bFGF has been shown to stimulate limb growth and its inhibition may be the basis for the limb defects associated with thalidomide.

Thalidomide is administered orally. It is 55—66% protein bound. Thalidomide appears to undergo non-enzymatic hydrolysis in the plasma followed by urinary excretion. Approximately 94% of the radioactivity was recovered at day 8 following a single 400-mg oral dose of 14C-thalidomide; most of the radioactivity was excreted within 48 hours. About 92% of the radioactive dose was excreted in the urine, primarily as hydrolytic metabolites; less than 3.5% of the dose was excreted as unchanged thalidomide. Fecal excretion accounted for less than 2% of the radioactive dose. The half-life ranged from 5.5—7.3 hours in healthy subjects (n = 14) and patients with Hansen's disease (n = 6) who received a single dose of thalidomide (50—400 mg).
 
Affected cytochrome P450 isoenzymes: none at therapeutic concentrations
Thalidomide undergoes insignificant metabolism by human CYP450 isoenzymes at therapeutic concentrations. Therefore, clinically important interactions with other CYP450 substrates, inhibitors, or inducers are not expected.

Thalidomide is slowly absorbed from the GI tract. The exact bioavailability has not been determined due to the poor aqueous solubility of thalidomide. Following a single dose of thalidomide 50 mg, 200 mg, or 400 mg, the AUC values ranged from 4.9—36.4 micrograms (mcg) X hr/mL in 14 healthy subjects; the AUC value was 46.4 mcg X hr/mL in 6 patients with Hansen's disease (leprosy) who received a single 400-mg dose of thalidomide. Additionally, the Cmax and Tmax values ranged from 0.62—2.82 mcg/mL and 2.9—4.3 hours, respectively, in healthy subjects; the Cmax and Tmax values were 3.44 mcg/mL and 5.7 hours, respectively, in patients with Hansen's disease. Administering thalidomide with a high-fat meal increased the Tmax to about 6 hours; however, the AUC and Cmax values changed by less than 10%.

It is not known if thalidomide is secreted in human milk or if it has effects on the breast-fed infant or on milk production. Due to the risk of serious adverse reactions in nursing infants, women should discontinue breast-feeding during thalidomide therapy.