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
Contact a Recordati Rare Diseases Representative
Support Icon

Contact a Recordati Rare
Diseases Representative
For U.S. Healthcare Professionals For U.S. Patients

Contact a Recordati Rare Diseases Representative

Contact Information

*Required

By submitting this form, I give permission for a Recordati Rare Diseases (RRD) representative to contact me by phone, email, or text message. I acknowledge that I have read this authorization, or had it read to me, in its entirety. I authorize the use and disclosure of my professional information as described in the RRD Privacy Policy and Permissions.


Read the RRD Privacy Policy and Permissions.

I affirm that I am a US healthcare professional

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

+ 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

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

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.

OK to proceed to third-party website CANCEL to return to PANHEMATIN.com