Hemin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Black Box Warning
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WARNING
See full prescribing information for complete Boxed Warning.
* PANHEMATIN (hemin for injection) should only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available.
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Overview
Hemin is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of acute intermittent porphyria. There is a Black Box Warning for this drug as shown here. Common adverse reactions include phlebitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- PANHEMATIN (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women.
- Manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder.
- Similar findings have been reported in other patients with acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. PANHEMATIN is not indicated in porphyria cutanea tarda.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hemin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hemin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Hemin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hemin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hemin in pediatric patients.
Contraindications
- PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.
Warnings
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WARNING
See full prescribing information for complete Boxed Warning.
* PANHEMATIN (hemin for injection) should only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available.
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- PANHEMATIN is made from human blood. Products made from human blood may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening blood donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Recordati Rare Diseases, (1-888-575-8344). The physician should discuss the risks and benefits of this product with the patient.
- Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- PANHEMATIN therapy is intended to limit the rate of porphyria/heme biosynthesis possibly by inhibiting the enzyme δ-aminolevulinic acid synthetase. For this reason, drugs such as estrogens, barbituric acid derivatives and steroid metabolites which increase the activity of δ-aminolevulinic acid synthetase should be avoided.
- Also, because hemin for injection has exhibited transient, mild anticoagulant effects during clinical studies, concurrent anticoagulant therapy should be avoided.[9] The extent and duration of the hypocoagulable state induced by PANHEMATIN has not been established.
PRECAUTIONS
General
- Clinical benefit from PANHEMATIN depends on prompt administration. Attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. PANHEMATIN is not effective in repairing neuronal damage.
- Recommended dosage guidelines should be strictly followed. Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion. Oliguria and increased nitrogen retention occurred although the patient remained asymptomatic.[4] No worsening of renal function has been seen with administration of recommended dosages of hematin.[9]
- A large arm vein or a central venous catheter should be utilized for the administration of PANHEMATIN to avoid the possibility of phlebitis.
- Since reconstituted PANHEMATIN is not transparent, any undissolved particulate matter is difficult to see when inspected visually. Therefore, terminal filtration through a sterile 0.45 micron or smaller filter is recommended.
- Because increased levels of iron and serum ferritin have been reported in post-marketing experience, physicians should monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Hemin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Hemin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Hemin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Animal reproduction studies have not been conducted with hematin. It is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. For this reason PANHEMATIN should not be given to a pregnant woman unless the expected benefits are sufficiently important to the health and welfare of the patient to outweigh the unknown hazard to the fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hemin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Hemin during labor and delivery.
Nursing Mothers
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PANHEMATIN is administered to a nursing woman.
Pediatric Use
- Safety and effectiveness in pediatric patients under 16 years of age have not been established.
Geriatic Use
- Clinical studies in PANHEMATIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Gender
There is no FDA guidance on the use of Hemin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Hemin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Hemin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Hemin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hemin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Hemin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Hemin Administration in the drug label.
Monitoring
There is limited information regarding Hemin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Hemin and IV administrations.
Overdosage
There is limited information regarding Hemin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Hemin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Hemin Mechanism of Action in the drug label.
Structure
- PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed red blood cells. Hemin for injection was known previously as hematin. The term hematin has been used to describe the chemical reaction product of hemin and sodium carbonate solution. Hemin is an iron containing metalloporphyrin. Chemically hemin is represented as chloro [7,12-diethenyl-3,8,13,17-tetramethyl-21H,23H-porphine-2,18-dipropanoato(2-)-N21,N22,N23,N24] iron. The structural formula for hemin is:
Pharmacodynamics
There is limited information regarding Hemin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Hemin Pharmacokinetics in the drug label.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- PANHEMATIN was not mutagenic in bacteria systems in vitro and was not clastogenic in mammalian systems in vitro and in vivo. No data are available on potential for carcinogenicity or impairment of fertility in animals or humans.
Clinical Studies
There is limited information regarding Hemin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Hemin How Supplied in the drug label.
Storage
There is limited information regarding Hemin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Hemin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Hemin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Panhematin
Look-Alike Drug Names
There is limited information regarding Hemin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.