Panhematin 7 mg/mL
hemin · POWDER, FOR SOLUTION · Recordati Rare Diseases, Inc.
Panhematin is a powder, for solution containing hemin at 7 mg/mL, taken intravenous. Manufactured by Recordati Rare Diseases, Inc..
Key Facts
- Brand Name
- Panhematin
- Generic Name
- hemin
- NDC Code (Product)
55292-702- Manufacturer
- Recordati Rare Diseases, Inc.
- Strength
- 7 mg/mL
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA101246
- Marketing Start
- 07/20/1983
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 repair…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous infusion only. For intravenous infusion only. Dose ( 2.1 ) 1 to 4 mg/kg/day for 3 to 14 days based on the clinical signs. The standard dose in clinical practice is 3 to 4 mg/kg/day. Repeat dose in more severe cases no earlier than every 12 hours. Do not exceed 6 mg/kg in any 24 hour period. Administration ( 2.2 ) Use sterile 0.45 micron or smaller filter to remove any undissolved particulate matter. The dose may be administered directly from the vial over a period of at least 30 minutes. After the infusion, flush the vein with 100 mL of 0.9% NaCl. 2.1 Dosing • PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias. • Before PANHEMATIN therapy is begun, the presence of acute porphyria must be diagnosed using the following criteria: 1. Presence of clinical symptoms suggestive of acute porphyric attack. 2. Quantitative measurement of porphobilinogen (PBG) in urine. The single-void urine sample should be refrigerated or frozen without additives and shielded from light for subsequent quantitative δ-aminolevulinic acid (ALA), PBG, and total porphyrin determinations. (Note: the classical …
Contraindications
4 CONTRAINDICATIONS PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug. Do not use in patients with known hypersensitivity to PANHEMATIN. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS PANHEMATIN therapy is intended to limit the rate of porphyria/heme biosynthesis possibly by inhibiting the enzyme δ-aminolevulinic acid synthetase 1 (ALAS1) [See Clinical Pharmacology ( 12.1 )] . Most of the heme synthesized in liver is used for the production of cytochrome P450 (CYP) enzymes. Therefore, avoid CYP inducing drugs (such as estrogens, barbituric acid derivatives and steroid metabolites) while on PANHEMATIN therapy, because these drugs increase the activity of ALAS leading to induction of ALAS1 through a feedback mechanism. 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. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis. Most common adverse reactions in >1% of patients are headache, pyrexia, infusion site reactions, and phlebitis. ( 6.1 ) 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. 6.1 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 co…
Frequently Asked Questions
What is Panhematin used for?
Panhematin contains hemin. It is a powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Panhematin a controlled substance?
Panhematin is not classified as a controlled substance by the DEA.
What is the generic name for Panhematin?
The generic name for Panhematin is hemin. There are no other listed brand versions of hemin.
What is the NDC code for Panhematin 7 mg/mL?
The NDC (National Drug Code) for Panhematin 7 mg/mL is 55292-702, listed by Recordati Rare Diseases, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)