PANHEMATIN® (hemin for injection)

Relief When Minutes Matter1,2:

Act Fast with PANHEMATIN3,4

The first and only FDA-approved medication indicated for the relief of recurrent AIP attacks in women.3

How PANHEMATIN Works

Patient portrayal.

Magnifying glass icon Identify Acute Intermittent Porphyria

Recognizing AIP can be challenging, since its symptoms often mimic other conditions.5 Learn how to spot the signs of an acute attack.

IV icon How to Dose, Prepare and Administer

PANHEMATIN is an IV infusion that must be reconstituted and used immediately. Learn how to dose and administer safely.

Two hands holding icon AIP Resources and Support

Living with AIP can be overwhelming for patients and caregivers. Connect them to personalized support and resources.

A portrayal of a doctor and a patient
Doctor and patient portrayal.

PANHEMATIN is an FDA-approved medication with over 40 years of real world use3

Clinical and chemical responses after PANHEMATIN infusions have been examined in five open-label studies, as well as an observational patient reported outcomes study.

A portrait of a woman looking at the camera
Patient portrayal.

Gain insights into diverse and often non-specific symptoms associated with AIP

Learning to recognize characteristic patterns that might otherwise be overlooked can help with diagnostic challenges of AIP.

References: 1. Besur S, Hou W, Schmeltzer P, Bonkovsky HL. Clinically important features of porphyrin and heme metabolism and the porphyrias. Metabolites. 2014; 4:977‍-10‍06. 2. Stein P, Badminton M, Barth J, Rees D, Stewart MF. Best practices guidelines on clinical management of acute attacks of porphyria and their complications. Ann Clin Biochem. 2013;50:217-223. 3. PANHEMATIN® package insert. Recordati Rare Diseases Inc., Bridgewater, NJ 08807 USA; 2025. 4. Whatley SD, Badminton MN. Acute Intermittent Porphyria. 2005 Sep 27 [Updated 2013 Feb 7]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2019. 5. Anderson KE, Bloomer JR, Bonkovsky HL, et al. Recommendations for the diagnosis and treatment of the acute porphyrias. Ann Intern Med. 2005;142:439-450.


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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION 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.

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 full Prescribing Information.