AIP Medical Emergency Letter - panhematin-hcp

AIP Medical Emergency Letter

The AIP Medical Emergency Letter is a tool designed to help patients communicate the treatment plan recommended by their physician to healthcare providers during an AIP attack.

Fill out the details below to generate a personalized emergency letter that includes the patient’s diagnosis, physician contact information, and physician-recommended treatment considerations during an AIP attack.

No patient or physician identifiable information will be transmitted to Recordati Rare Diseases in the creation of this Medical Emergency letter. All completed form fields and letter(s) are stored locally and will only be transmitted by you to your patient(s).

Advise your patients to carry the completed letter with them at all times so they can share it with healthcare providers who may be unfamiliar with AIP.

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AIP Medical Emergency Letter

The AIP Medical Emergency Letter provides a framework that you can modify to explain your patient’s AIP diagnosis. There is also space to provide your recommended treatment plan if the patient presents with symptoms of an AIP attack and also for your contact information. You may want to encourage your patient to carry the completed wallet item with them at all times so that they can give it to physicians who may not be familiar with AIP.

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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.

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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.