Important Safety Information
Prescribing Information
Indications and Usage
For Patients For U.S. Healthcare Professionals Only

About PANHEMATIN for
the Treatment of AIP

Panhematin® is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria (AIP) 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.

Clinical benefit with PANHEMATIN depends on prompt administration.

Recommended dosing guidelines should be strictly followed.

How PANHEMATIN Works

AIP is caused by a partial deficiency of the enzyme porphobilinogen (PBG) deaminase in the heme biosynthetic pathway.1

  • This complex biological process, represented graphically, and the role of Panhematin in the disease process have not been fully elucidated.
  • The enzyme deficiency disrupts normal heme production, which leads to overproduction of porphyrin precursors in response to synthetic pathway blockages.2
  • The accumulation of heme intermediates in the liver, plus precipitating factors, can lead to AIP attacks.1
  • Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway.
  • The exact mechanism by which hematin produces symptomatic improvement in individuals with acute episodes of the hepatic porphyrias has not been elucidated.3

PANHEMATIN is the only
FDA-approved therapy for AIP attacks.

PANHEMATIN Treatment for AIP Attacks

Biochemical and clinical response to the treatment of AIP attacks in 72 patients

Summary of open-label studies which supported the approval of PANHEMATIN

Clinical and chemical response after hemin therapy

Data from open-label studies which supported approval of PANHEMATIN3

Observational study with patient-reported outcomes

  • Study included 90 AIP patients
  • 55% reported receiving hemin during acute attacks
  • 74% reported PANHEMATIN as being very successful in treatment of abdominal pain and other symptoms
  • 50% reported having received treatment with opiates during an acute attack, and 44% of these patients reported that opiates were effective3

PANHEMATIN Safety Summary

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

Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PANHEMATIN use was evaluated in a compassionate use study. A total of 130 patients were treated with hemin for acute attacks, prophylaxis or both. Of those, 111 patients were administered hemin for treatment of 305 acute porphyria attacks and to 40 patients for prophylaxis. The majority (92%) of patients were Caucasian. Most (72%) were female; all adult patients had a mean age ± SD of 40.3 ± 12.3 years. Proportionally more females (15 out of 19) received prophylaxis or a combination of acute treatment and prophylaxis (19 out of 21). For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN IV for 1 to 9 doses. For prophylaxis patients, the most common doses were weekly or biweekly infusions. Table 1 summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.

Adverse Reactions in >1% of Patients Treated with PANHEMATIN

Post-Marketing Experience

The following adverse reactions associated with the use of PANHEMATIN were identified in open-label clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: thrombocytopenia, coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time), and hemolysis

Immune System Disorders: hypersensitivity reactions including a report of infusionrelated anaphylactoid reaction presenting as circulatory collapse

Vascular Disorders: injection site venous thrombosis including some that occurred in large veins such as venae cavae

General Disorders and Administration Site Conditions: infusion site reactions (such as erythema, pain, bleeding and extravasation)

Metabolism and Nutrition Disorders: iron overload and serum ferritin increased [See Warnings and Precautions (5.2)]

Ordering PANHEMATIN

How to order PANHEMATIN

To order PANHEMATIN in the US, contact either:

ASD Healthcare: phone: 1-800-746-6273    fax: 1-800-547-9413
email: asd.customerservice@asdhealthcare.com

Or your primary wholesaler

How supplied

PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 55292-702-54) in a carton (NDC 55292-702-55).

The vial stopper contains natural rubber latex.

Store lyophilized powder at 20-25°C (68-77°F).

Diagnosing and Managing AIP Review diagnostic testing guidance
Dosing & Administration Get step-by-step instructions

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.

Indications and Important
Safety Information

+ See More

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

  • Do not use in patients with known hypersensitivity to PANHEMATIN.
  • Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.
  • Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
  • PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy.
  • Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines.
  • PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Most common adverse reactions in >1% of patients are headache, pyrexia, infusion site reactions, and phlebitis.
  • To report SUSPECTED ADVERSE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.
  • 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.

For more information, please see Full Prescribing Information at www.recordatirarediseases.com.


References

  1. Watson CJ, Pierach CA, Bossenmaier I, Cardinal R. Use of hematin in the acute attack of the “inducible” hepatic prophyrias. Adv Intern Med. 1978;23:265-286.
  2. Pierach CA, Bossenmaier I, Cardinal R, Weimer M, Watson CJ. Hematin therapy in porphyric attacks. Klin Wochenschr. 1980;58:829-832.
  3. Lamon JM, Frykholm BC, Hess RA, Tschudy DP. Hematin therapy for acute porphyria. Medicine (Baltimore). 1979;58:252-269.
  4. McColl KE, Moore MR, Thompson GG, Goldberg A. Treatment with haematin in acute hepatic porphyria. Q J Med. 1981;50:161-174.
  5. Anderson KE, Collins S. Open-label study of hemin for acute porphyria: clinical practice implications. Am J Med. September 2006;119:801.e19-801.e24.
  6. PANHEMATIN [Package Insert]. Lebanon, NJ: Recordati Rare Diseases; 2013.

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