PrPANHEMATIN® (hemin for injection) is 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.
Pediatrics (< 16 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PANHEMATIN in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥ 65 years of age): Clinical data for subjects aged 65 and over was not sufficient to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
PANHEMATIN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Relevant warnings and precautions:
- Do not use in patients with known hypersensitivity to PANHEMATIN.
- Risk of phlebitis.
- Risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) agent, and theoretically the Creutzfeldt-Jacob disease (CJD) agent.
- Transient, mild anticoagulant effects may occur. Avoid concurrent anticoagulant therapy.
- Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
- Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion. Recommended dosage guidelines should be strictly followed.
- Should be given to a pregnant woman only if clearly needed. Avoid administering hematin in severe pre-eclampsia.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PANHEMATIN and any potential adverse effects on the breastfed child from PANHEMATIN or from the underlying maternal condition.
- Avoid CYP inducing drugs (such as estrogens, barbituric acid derivatives and steroid metabolites) while on PANHEMATIN therapy.
For more information:
Please consult the Product Monograph at http://www.recordatirarediseases.com/sites/www.recordatirarediseases.com/files/inline-files/panhematin-product-monograph-ENG.pdf for important information related to adverse reactions, interactions and dosing information which has not been discussed on this website. The Product Monograph is also available by calling McKesson Specialized Distribution at 1-877-827-1306 or email email@example.com.
AIP = Acute intermittent porphyria
Recordati Rare Diseases Canada Inc. PANHEMATIN® Product Monograph. July 13, 2018.