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 GuidePANHEMATIN® is an FDA-approved medication that has been providing relief from attacks of AIP for over 40 years.1
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.1
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
Watch how AIP Disrupts the Heme Cycle
and How Panhematin Works
•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 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
•Study included 90 patients with AIP
reported receiving hemin during acute attacks
of these patients reported PANHEMATIN as being very successful in treating abdominal pain and other symptoms of AIP
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.
Monday-Thursday 6:30 PM CT
Friday 6:00 PM CT
Saturday Delivery
UPS Next Day Air for 10:30am delivery
UPS Next Day Air for MONDAY 10:30am delivery
Saturday delivery must be requested when order is placed
Include any specific delivery instructions when ordering. 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
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
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.
You are about to leave the PANHEMATIN.com website and enter a website operated by an independent third party. The links to third-party websites contained on PANHEMATIN.com are provided solely for your convenience. Recordati Rare Diseases does not control the opinions, claims or comments contained on any third-party website linked to PANHEMATIN.com, and your activities at those websites will be governed by the policies and practices of those third parties.
