hemin
Drug Details
- Generic Name
- hemin
- Brand Names
- Panhematin
- Application Number
- BLA101246
- Sponsor
- Recordati Rare Diseases, Inc.
- NDC Codes
- 1
- Dosage Forms
- POWDER, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- HEMIN
Indications and Usage
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 • Before administering PANHEMATIN, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days) [ See Dosage and Administration ( 2.1 ) ]. • 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. PANHEMATIN is a hemin for injection indicated for 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 ) Limitations of Use • Before administering PANHEMATIN, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days). ( 1 ) • PANHEMATIN is not effective in repairing neuronal damage due to progression of porphyria attacks. ( 1 )