Glatopa

MS Agents
Other Immunostimulating Agents

Administer by subcutaneous injection only. Do not administer intravenously.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.

Syringes containing glatiramer may be used with a compatible autoinjector that is available by prescription. Refer to the specific autoinjector labeling and "Instructions for Use" to determine if a device is compatible with a specific glatiramer product. The use of an incompatible autoinjector has resulted in missed and partial doses. Compatible autoinjector devices for each product are as follows:
Autoject 2 (Copaxone)
Glatopaject (Glatopa), and
WhisperJECT (glatiramer injection from Viatris or Mylan)
Patients and/or their caregivers should be trained regarding proper administration. Review the provided detailed "Instructions for Use" for each product.
 
Subcutaneous injection:
If refrigerated, remove the prefilled syringe from the refrigerator and allow the solution to warm for 20 minutes at room temperature. Visually inspect the product before use.
There may be small air bubbles in the syringe. Do not try to push the air bubble from the syringe before administering the injection.
Sites for injection include upper arms, abdomen, hips, and thighs.
Pinch about a 2-inch fold of skin at the chosen site. Insert the needle at a 90-degree angle straight into the skin. Slowly inject the entire dose. Pull the needle straight out when finished.
Rotate injection sites with each dose. Do not use any injection site more than once a week.
The prefilled syringe is for single use only and does not contain preservatives; use immediately and discard unused portions. Discard of used needles and syringes in an appropriate sharps container.

laryngospasm / Rapid / 2.0-2.0
pancytopenia / Delayed / 0.1-1.0
optic neuritis / Delayed / 0.1-1.0
esophageal ulceration / Delayed / 0.1-1.0
pancreatitis / Delayed / 0.1-1.0
cholecystitis / Delayed / 0.1-1.0
serum sickness / Delayed / 0.1-1.0
seizures / Delayed / 0.1-1.0
coma / Early / 0.1-1.0
skin atrophy / Delayed / 0.1-1.0
skin necrosis / Early / 0-1.0
cyanosis / Early / 0.1-1.0
hematemesis / Delayed / 0.1-1.0
bradycardia / Rapid / 0.1-1.0
atrial fibrillation / Early / 0.1-1.0
angioedema / Rapid / 0.1-1.0
erythema nodosum / Delayed / 0.1-1.0
visual impairment / Early / 1.0
new primary malignancy / Delayed / Incidence not known
hepatic failure / Delayed / Incidence not known
cirrhosis / Delayed / Incidence not known
hepatotoxicity / Delayed / Incidence not known
cerebral edema / Early / Incidence not known
myelitis / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
pleural effusion / Delayed / Incidence not known
pulmonary embolism / Delayed / Incidence not known
arrhythmia exacerbation / Early / Incidence not known
pericardial effusion / Delayed / Incidence not known
thrombosis / Delayed / Incidence not known
heart failure / Delayed / Incidence not known
cardiomyopathy / Delayed / Incidence not known
myocardial infarction / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

erythema / Early / 2.0-43.0
peripheral vasodilation / Rapid / 3.0-20.0
dyspnea / Early / 3.0-14.0
chest pain (unspecified) / Early / 2.0-13.0
palpitations / Early / 9.0-9.0
edema / Delayed / 0.1-8.0
lymphadenopathy / Delayed / 7.0-7.0
sinus tachycardia / Rapid / 5.0-5.0
candidiasis / Delayed / 4.0-4.0
migraine / Early / 4.0-4.0
peripheral edema / Delayed / 3.0-3.0
dysphagia / Delayed / 2.0-2.0
lipodystrophy / Delayed / 0.5-2.0
leukopenia / Delayed / 0.1-1.0
cataracts / Delayed / 0.1-1.0
photophobia / Early / 0.1-1.0
hepatomegaly / Delayed / 0.1-1.0
esophagitis / Delayed / 0.1-1.0
oral ulceration / Delayed / 0.1-1.0
colitis / Delayed / 0.1-1.0
melena / Delayed / 0.1-1.0
gout / Delayed / 0.1-1.0
myopathy / Delayed / 0.1-1.0
bone pain / Delayed / 0.1-1.0
depression / Delayed / 0.1-1.0
hostility / Early / 0.1-1.0
ataxia / Delayed / 0.1-1.0
memory impairment / Delayed / 0.1-1.0
myoclonia / Delayed / 0.1-1.0
aphasia / Delayed / 0.1-1.0
hallucinations / Early / 0.1-1.0
vaginitis / Delayed / 0.1-1.0
flank pain / Delayed / 0.1-1.0
priapism / Early / 0.1-1.0
bleeding / Early / 0.1-1.0
splenomegaly / Delayed / 0.1-1.0
hematoma / Early / 0.1-1.0
anemia / Delayed / 0.1-1.0
hyperthyroidism / Delayed / 0.1-1.0
goiter / Delayed / 0.1-1.0
hypothyroidism / Delayed / 0.1-1.0
hypotension / Rapid / 0.1-1.0
eosinophilia / Delayed / 0.1-1.0
contact dermatitis / Delayed / 0.1-1.0
furunculosis / Delayed / 0.1-1.0
impaired wound healing / Delayed / 0.1-1.0
psoriasis / Delayed / 0.1-1.0
bullous rash / Early / 0.1-1.0
Cushing's syndrome / Delayed / 0.1-1.0
stomatitis / Delayed / 1.0
impotence (erectile dysfunction) / Delayed / 1.0
hematuria / Delayed / 1.0
vaginal bleeding / Delayed / 1.0
hypertension / Early / 1.0
meningitis / Delayed / Incidence not known
cholelithiasis / Delayed / Incidence not known
hepatitis / Delayed / Incidence not known
jaundice / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
hypoventilation / Rapid / Incidence not known
hypercholesterolemia / Delayed / Incidence not known
phlebitis / Rapid / Incidence not known
angina / Early / Incidence not known

infection / Delayed / 30.0-30.0
pruritus / Rapid / 5.0-27.0
asthenia / Delayed / 22.0-22.0
rash / Early / 2.0-19.0
nausea / Early / 2.0-15.0
influenza / Delayed / 3.0-14.0
anxiety / Delayed / 13.0-13.0
back pain / Delayed / 12.0-12.0
pharyngitis / Delayed / 11.0-11.0
injection site reaction / Rapid / 8.0-8.0
rhinitis / Early / 7.0-7.0
vomiting / Early / 7.0-7.0
hyperhidrosis / Delayed / 7.0-7.0
cough / Delayed / 6.0-6.0
fever / Early / 3.0-6.0
urinary urgency / Early / 5.0-5.0
tremor / Early / 4.0-4.0
urticaria / Rapid / 3.0-3.0
chills / Rapid / 2.0-3.0
diplopia / Early / 3.0-3.0
weight gain / Delayed / 3.0-3.0
syncope / Early / 3.0-3.0
ptosis / Delayed / 0.1-1.0
mydriasis / Early / 0.1-1.0
xerophthalmia / Early / 0.1-1.0
tongue discoloration / Delayed / 0.1-1.0
xerostomia / Early / 0.1-1.0
appetite stimulation / Delayed / 0.1-1.0
weight loss / Delayed / 0.1-1.0
tenesmus / Delayed / 0.1-1.0
libido decrease / Delayed / 0.1-1.0
paresthesias / Delayed / 0.1-1.0
paranoia / Early / 0.1-1.0
photosensitivity / Delayed / 0.1-1.0
breast enlargement / Delayed / 0.1-1.0
nocturia / Early / 0.1-1.0
epistaxis / Delayed / 0.1-1.0
striae / Delayed / 0.1-1.0
xerosis / Delayed / 0.1-1.0
maculopapular rash / Early / 0.1-1.0
vesicular rash / Delayed / 0.1-1.0
fecal urgency / Early / 1.0
emotional lability / Early / 1.0
increased urinary frequency / Early / 1.0
menorrhagia / Delayed / 1.0
flushing / Rapid / Incidence not known
eructation / Early / Incidence not known
arthralgia / Delayed / Incidence not known
amenorrhea / Delayed / Incidence not known
hyperventilation / Early / Incidence not known

Copaxone, Glatopa

Rx

Synthetic random peptide given subcutaneously; formerly known as copolymer-1
Used in adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; also used off-label in pediatric patients
Immediate post-injection reactions (flushing, chest pain, dyspnea, and urticaria) have been reported and may be serious, and often present several months after treatment initiation

20 mg subcutaneous once daily. Glatiramer 20 mg/mL and 40 mg/mL solutions for injection are NOT interchangeable.

40 mg subcutaneous 3 times per week. Administer doses at least 48 hours apart. Glatiramer 20 mg/mL and 40 mg/mL solutions for injection are NOT interchangeable.

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.

Alemtuzumab: (Major) Concomitant use of glatiramer with alemtuzumab may increase the risk of immunosuppression. Avoid the use of these drugs together.
Ocrelizumab: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as glatiramer. Concomitant use of ocrelizumab with glatiramer may increase the risk of immunosuppression. Avoid the use of these drugs together.
Ofatumumab: (Moderate) Concomitant use of ofatumumab with glatiramer may increase the risk of immunosuppression. Ofatumumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as glatiramer. Consider the duration and mechanism of action of drugs with immunosuppressive effects when switching therapies for multiple sclerosis patients.
Ozanimod: (Moderate) Concomitant use of ozanimod with glatiramer may increase the risk of immunosuppression. Ozanimod has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis. Ozanimod can generally be started immediately after discontinuation of glatiramer.

Copaxone/Glatiramer/Glatiramer Acetate/Glatopa Subcutaneous Inj Sol: 1mL, 20mg, 40mg

Once daily dose schedule: 20 mg/day subcutaneously using the 20 mg/mL solution.
Three times weekly dose schedule: 40 mg/dose subcutaneously using the 40 mg/mL solution.

Once daily dose schedule: 20 mg/day subcutaneously using the 20 mg/mL solution.
Three times weekly dose schedule: 40 mg/dose subcutaneously using the 40 mg/mL solution.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Glatiramer acetate modifies immune processes that are responsible for the pathogenesis of multiple sclerosis (MS). The exact mechanism of action in treating MS is unclear at this time. It is proposed that the drug serves as a decoy to locally-generated autoantibodies. These antibodies, along with certain T-cells, are thereby neutralized before they can cause tissue damage. Studies in animals and in vitro systems suggest that glatiramer-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer modifies immune functions, concerns exist about its potential to alter naturally occurring immune responses. Results of limited tests reveal no risk of this concern; however, there is no way to absolutely exclude this possibility.

Glatiramer acetate is administered subcutaneously.

It is assumed that a substantial fraction of glatiramer acetate is hydrolyzed locally after subcutaneous injection. Nevertheless, larger fragments of glatiramer acetate can be recognized by glatiramer-reactive antibodies. Some fraction of the injected material, either intact or partially hydrolyzed, is presumed to enter the lymphatic circulation thereby enabling it to reach regional lymph nodes, and some of the injected material may enter the systemic circulation intact.

There are no adequate and well-controlled studies of glatiramer use during pregnancy. No adverse effects were noted in animal reproduction studies. Because animal reproduction studies are not always predictive of human response, glatiramer acetate should be used during pregnancy only if necessary. If a patient does become pregnant while receiving glatiramer therapy, she should be educated regarding the benefits or risks of continuing treatment for multiple sclerosis (MS).[44361] Data are limited but provide no evidence that glatiramer acetate poses a substantial teratogenic risk; data are insufficient to demonstrate safety or the absence of later-onset problems in an exposed infant.[61642] [49556] In many cases, disease-modifying drugs for MS are discontinued during pregnancy. Data from a large, multicenter trial of pregnant patients with MS suggest that patients have a decrease in the number and severity of MS relapses during pregnancy, despite discontinuation or lack of receipt of disease-modifying medications.[49551] Experts generally recommend the discontinuation of glatiramer when trying to conceive and throughout gestation. However, in pregnant women with severe or highly active MS, the benefit of treating the mother with glatiramer acetate may outweigh the possible risk to the fetus.[61642]

Breast-feeding is not expected to result in clinically relevant exposure of the infant to glatiramer as data support that a substantial fraction of a dose is hydrolyzed locally following subcutaneous administration. There are no data on the effects of glatiramer on milk production.[44361] Glatiramer is rated as "probably compatible" with breast-feeding by expert groups.[61643] Interferon beta-1a and beta-1b are considered alternative therapies.[61643]