Panhematin
Generic: HEMIN
Basic Information
Manufacturer
Recordati Rare Diseases, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9984267a-4d57-4444-9bb5-16bca7dea691
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 repairing neuronal damage due to progression of porphyria attacks.
( 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) [ 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 )
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 combination of acute treatment and prophylaxis (19 out of 21).
For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses.
For prophylaxis patients, the most common doses were weekly or biweekly infusions.
Table 1 summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.
Table 1: Adverse Reactions in >1% of Patients Treated with PANHEMATIN System Organ Class Preferred Term Adverse Events N (% of Total Adverse Events) Description Total Possibly or Probably Related to Treatment Infections and infestations Cellulitis 3 (1.5%) 2 (1.0%) Nervous System Disorders Headache 18 (9.2%) 5 (2.6%) Vascular Disorders Phlebitis / Injection site phlebitis 7 (3.6%) 6 (3.1%) Skin and subcutaneous tissue disorders Rash 3 (1.5%) 3 (1.5%) General Disorders and Administration Site Conditions Pyrexia 9 (4.6%) 6 (3.1%) Catheter-related Complication 7 (3.6%) 3 (1.5%) 6.2 Postmarketing Experience The following adverse reactions associated with the use of PANHEMATIN were identified in open-label clinical trials or postmarketing reports.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: thrombocytopenia, coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time), and hemolysis Immune System Disorders: hypersensitivity reactions including a report of infusion-related anaphylactoid reaction presenting as circulatory collapse Vascular Disorders: injection site venous thrombosis including some that occurred in large veins such as venae cavae General Disorders and Administration Site Conditions: infusion site reactions (such as erythema, pain, bleeding and extravasation) Metabolism and Nutrition Disorders: iron overload and serum ferritin increased [See Warnings and Precautions ( 5.2 )]
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 combination of acute treatment and prophylaxis (19 out of 21).
For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses.
For prophylaxis patients, the most common doses were weekly or biweekly infusions.
Table 1 summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.
Table 1: Adverse Reactions in >1% of Patients Treated with PANHEMATIN System Organ Class Preferred Term Adverse Events N (% of Total Adverse Events) Description Total Possibly or Probably Related to Treatment Infections and infestations Cellulitis 3 (1.5%) 2 (1.0%) Nervous System Disorders Headache 18 (9.2%) 5 (2.6%) Vascular Disorders Phlebitis / Injection site phlebitis 7 (3.6%) 6 (3.1%) Skin and subcutaneous tissue disorders Rash 3 (1.5%) 3 (1.5%) General Disorders and Administration Site Conditions Pyrexia 9 (4.6%) 6 (3.1%) Catheter-related Complication 7 (3.6%) 3 (1.5%) 6.2 Postmarketing Experience The following adverse reactions associated with the use of PANHEMATIN were identified in open-label clinical trials or postmarketing reports.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: thrombocytopenia, coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time), and hemolysis Immune System Disorders: hypersensitivity reactions including a report of infusion-related anaphylactoid reaction presenting as circulatory collapse Vascular Disorders: injection site venous thrombosis including some that occurred in large veins such as venae cavae General Disorders and Administration Site Conditions: infusion site reactions (such as erythema, pain, bleeding and extravasation) Metabolism and Nutrition Disorders: iron overload and serum ferritin increased [See Warnings and Precautions ( 5.2 )]