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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About PANHEMATIN

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QUICK REFERENCE GUIDE FOR HEALTHCARE PROFESSIONALS

An acute intermittent porphyria (AIP) attack requires immediate attention. This guide provides quick access to information needed to treat an AIP patient during an acute attack.

View Quick Reference Guide

PANHEMATIN® is an FDA-approved medication that has been providing relief from attacks of AIP for over 30 years.1

PANHEMATIN is a hemin for injection indicated for the amelioration of recurrent in 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.1


How PANHEMATIN treats AIP attacks

During AIP attacks, the body's heme pool is depleted.2 PANHEMATIN helps replenish the heme pool, which represses the body's signaling to produce more heme. This allows heme production to slow and the accumulated neurotoxic porphyrin precursors to decline.3

AIP Attack Cycle

Limitations of Use1

  • 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 and chemical responses after PANHEMATIN infusions

•5 open-label studies involving 72 patients and 127 courses of treatment supported the approval of PANHEMATIN3,4,5
•85.5% of treatment courses had a positive clinical response and 100% of treatment courses had a positive chemical response1

clinical and chemical response chart *Clinical response defined as improvement of symptoms and reduction in pain. **Chemical response defined as reductions in δ-aminolevulinic acid (ALA) and/or porphobilinogen (PBG) levels

Results from an Observational Patient Reported Outcomes Study1

•Study included 90 patients with AIP

55%

reported receiving hemin during acute attacks

74%

of these patients reported PANHEMATIN as being very successful in treating abdominal pain and other symptoms of AIP

50% reported having received treatment with opiates during an acute attack

44% of these patients reported that opiates were effective

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Safety Summary1

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 intravenously for 1 to 9 doses. For prophylaxis patients, the most common doses were weekly or biweekly infusions. The table below 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

adverse reactions graph

How to order PANHEMATIN

Contact your primary wholesaler or
ASD Healthcare

Same day, earlier in the day, or weekend delivery available on request with an additional shipping cost

How to Order Panhematin

ORDERS PLACED BY

Monday-Thursday 6:30 PM CT

Friday 6:00 PM CT

DELIVERED

UPS Next Day Air Saver for mid-afternoon delivery

UPS Next Day Air Saver for MONDAY mid-afternoon delivery
For next day delivery, Saturday delivery must be requested

Include any specific delivery instructions when ordering.
If new to ordering PANHEMATIN, ask for expedited account setup.

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).1

Clinical benefit from PANHEMATIN depends on prompt administration1

Resources for Patients Help Your Patients Access Support
Dosing and 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

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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

  • 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 1-800-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 PANHEMATIN Full Prescribing Information at www.recordatirarediseases.com.

References

  1. PANHEMATIN® package insert. Recordati Rare Diseases Inc., Lebanon, NJ 08833 USA; 2020.
  2. Khanderia U, Bhattacharya A. Acute intermittent porphyria: Pathophysiology and treatment. Pharmacotherapy.1984;4(3):144-150.
  3. Anderson KE, Bloomer JR, Bonkovsky HL, Kushner JP, Pierach CA, Pimstone NR, Desnick RJ. Recommendations for the diagnosis and treatment of the acute porphyrias. Ann Intern Med. 2005;142:439-450.
  4. McColl KEL, Moore MR, Thompson GG, Goldberg A. Treatment with haematin in acute hepatic porphyria. Q J Med. 1981;50(198):161-174.
  5. Watson CJ, Pierach CA, Bossenmaier I, Cardinal R. Use of hematin in the acute attack of the "inducible" hepatic porphyrias. Adv Intern Med. 1978;23:265-286.

Important Safety Information

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