Panhematin

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Panhematin

Classes

Other Hematological Agents

Administration
Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Reconstitution:
Because hemin products contain no preservatives and undergo rapid chemical decomposition in solution, reconstitute immediately before use.
Add 48 mL of Sterile Water for Injection to the dispensing vial.
Shake well for 2 to 3 minutes to aid dissolution.
After reconstitution, the concentration is approximately 7 mg/mL.
Storage: After the first withdrawal from the vial, any remaining solution must be discarded.
 
Intravenous infusion:
The reconstituted drug may be administered directly from the vial.
Inspection of reconstituted hemin injection solutions for undissolved particulate matter prior to administration is difficult since the solutions are not transparent. Terminal filtration through a sterile 0.45 micron or smaller filter is recommended.
Do not add other drug or chemical agent to a hemin fluid admixture.
A large arm vein or a central venous catheter should be utilized for administration to minimize the risk of phlebitis.
Infuse over at least 30 minutes via a separate line.
After infusion, flush the vein with 100 mL of 0.9% Sodium Chloride Injection.

Adverse Reactions
Severe

coagulopathy / Delayed / Incidence not known
oliguria / Early / Incidence not known
azotemia / Delayed / Incidence not known

Moderate

phlebitis / Rapid / Incidence not known
thrombocytopenia / Delayed / Incidence not known

Mild

leukocytosis / Delayed / Incidence not known
fever / Early / Incidence not known
infection / Delayed / Incidence not known

Common Brand Names

Panhematin

Dea Class

Rx

Description

Also known as hematin; parenteral enzyme inhibitor used for acute intermittent porphyria (AIP); made from processed red blood cells.

Dosage And Indications
For the treatment of recurrent attacks of acute intermittent porphyria related to the menstrual cycle or other patients† with acute intermittent porphyria, porphyria variegata†, or hereditary coproporphyria†.
NOTE: Clinical benefits from hemin depend on prompt administration. Control of pain, hypertension, tachycardia, abnormal mental status, and mild to progressive neurologic signs may be achieved in patients with acute intermittent porphyria, porphyria variegata, or hereditary coproporphyria. Attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. Hemin therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration; it does not repair neuronal damage.
NOTE: Recommended dosage guidelines should be strictly followed.
Intravenous infusion dosage Adults

1 to 4 mg/kg/day IV over 10 to 15 minutes. Treatment usually continues for 3 to 14 days based on clinical signs. In more severe cases, the dose may be repeated no earlier than every 12 hours. Do not exceed 6 mg/kg/day. May consider hemin after an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days). Monitor hemin therapy by a decrease in urinary concentrations of 1 or more of the following compounds: (delta)-aminolevulinic acid (ALA), uroporphyrinogen (UPG), porphobilinogen (PBG), or coproporphyrin.

Adolescents 16 years and older

1 to 4 mg/kg/day IV over 10 to 15 minutes. Treatment usually continues for 3 to 14 days based on clinical signs. In more severe cases, the dose may be repeated no earlier than every 12 hours. Do not exceed 6 mg/kg/day. May consider hemin after an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days). Monitor hemin therapy by a decrease in urinary concentrations of 1 or more of the following compounds: (delta)-aminolevulinic acid (ALA), uroporphyrinogen (UPG), porphobilinogen (PBG), or coproporphyrin.

Dosing Considerations
Hepatic Impairment

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

Renal Impairment

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

Drug Interactions

Amobarbital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Anticoagulants: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Antithrombin III: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Apixaban: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Argatroban: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Aspirin, ASA; Butalbital; Caffeine: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Barbiturates: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Betrixaban: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Bivalirudin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Butabarbital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Butalbital; Acetaminophen: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Butalbital; Acetaminophen; Caffeine: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Butalbital; Acetaminophen; Caffeine; Codeine: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Butalbital; Aspirin; Caffeine; Codeine: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Conjugated Estrogens: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Conjugated Estrogens; Bazedoxifene: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Conjugated Estrogens; Medroxyprogesterone: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Corticosteroids: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Corticosteroids increase the activity of this enzyme should not be used with hemin.
Dabigatran: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Dalteparin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Desirudin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Desogestrel; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Dienogest; Estradiol valerate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Diethylstilbestrol, DES: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Drospirenone; Estetrol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Drospirenone; Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Drospirenone; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Edoxaban: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Elagolix; Estradiol; Norethindrone acetate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Enoxaparin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Esterified Estrogens: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Esterified Estrogens; Methyltestosterone: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estradiol; Levonorgestrel: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estradiol; Norethindrone: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estradiol; Norgestimate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estradiol; Progesterone: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estrogens: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Estropipate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Ethinyl Estradiol; Norelgestromin: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Ethinyl Estradiol; Norethindrone Acetate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Ethinyl Estradiol; Norgestrel: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Etonogestrel; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Fondaparinux: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Heparin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Levonorgestrel; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Methohexital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Norethindrone; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Norgestimate; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Pentobarbital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Pentosan: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Phenobarbital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Primidone: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Relugolix; Estradiol; Norethindrone acetate: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Rivaroxaban: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.
Secobarbital: (Major) Hemin works by inhibiting the enzyme (delta)-aminolevulinic acid synthetase. Drugs which increase the activity of this enzyme, such as barbiturates should not be used with hemin.
Segesterone Acetate; Ethinyl Estradiol: (Moderate) Hemin works by inhibiting aminolevulinic acid synthetase. Estrogens increase the activity of this enzyme should not be used with hemin.
Warfarin: (Major) Because hemin has exhibited transient, mild anticoagulant effects during clinical studies, concurrent use of anticoagulants should be avoided. The extent and duration of the hypocoagulable state induced by hemin has not been established.

How Supplied

Panhematin Intravenous Inj Pwd F/Sol: 350mg

Maximum Dosage
Adults

6 mg/kg/day IV.

Elderly

6 mg/kg/day IV.

Adolescents

 >= 16 years: 6 mg/kg/day IV.
 < 16 years: Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Mechanism Of Action

Hemin inhibits the enzyme (delta)-aminolevulinic acid synthetase. In normal patients, heme inhibits this enzyme and limits the rate of the porphyrin/heme biosynthetic pathway. Administration of hemin results in effects similar to heme and limits the hepatic and/or marrow synthesis of porphyrin. The exact mechanism by which hemin improves symptoms in patients with acute episodes of the hepatic porphyrias has not been determined. Hemin therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration; it is not effective in repairing neuronal damage nor is hemin therapy curative. After stopping therapy, symptoms generally return although in some cases remission is prolonged. Some neurological symptoms have improved weeks to months after therapy although little or no response was noted at the time of treatment.

Pharmacokinetics

Hemin is administered by intravenous infusion. Data on the pharmacokinetics of hemin in humans are limited. After intravenous infusion of hemin in non-jaundiced patients, an increase in fecal urobilinogen can be observed which is roughly proportional to the amount of hemin administered. Therefore, an enterohepatic pathway is considered to be a route of elimination. Bilirubin metabolites are also excreted in the urine. Other aspects of human pharmacokinetics have not been defined.

Pregnancy And Lactation
Pregnancy

It is not known whether hemin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Although anecdotal evidence suggests safe use of hemin during pregnancy, the available human data is not sufficient to establish the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with hemin. Use hemin during pregnancy only if clearly needed.

It is not known if hemin is excreted in human breast milk. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for hemin and any potential adverse effects on the breast-fed child from hemin or the underlying maternal condition.