Important Safety Information | Prescribing Information | Indications and Usage | Medical Information | Report An Adverse Event
Important Safety Information
Prescribing Information | Indications & Usage
Medical Information | Report An Adverse Event
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PANHEMATIN® (HEMIN FOR INJECTION)

The only FDA-approved medication indicated for the relief of recurrent AIP attacks in women

PANHEMATIN® is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

  • Before administering PANHEMATIN, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days).
  • 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.
Quick Reference Guide for Healthcare Professionals
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The only FDA-approved medication indicated for the relief of recurrent AIP attacks in women

PANHEMATIN® is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

Quick Reference Guide for Healthcare Professionals

INDICATION(S) AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

PANHEMATIN is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

Limitations of Use

  • Before administering PANHEMATIN, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days).
  • 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.

Indication(s) and Important
Safety Information

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Indications And Usage

PANHEMATIN is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

IMPORTANT SAFETY INFORMATION

PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.

Risk of Phlebitis: Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.

Iron and Serum Ferritin: Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.

Anticoagulant Effects: PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy.

Renal Effects: Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines.

Transmissible Infectious Agents: PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product.

The most common adverse reactions (>1% of patients) are headache, pyrexia, infusion site reactions, and phlebitis.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions: Avoid CYP inducing drugs such as estrogens, barbituric acid derivatives and steroid metabolites which induce δ-aminolevulinic acid synthetase 1 (ALAS1) through a feedback mechanism.

PANHEMATIN® (hemin for injection), for intravenous infusion only, is available as powder for reconstitution in 350 mg vials.

Please see the accompanying full Prescribing Information.

Important Safety Information

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