Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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;
5 WARNINGS AND PRECAUTIONS • Phlebitis is possible.
Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.
( 5.1 ) • Elevated iron and serum ferritin may occur.
Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
( 5.2 ) • PANHEMATIN has transient and mild anticoagulant effect.
Like all medications, Panhematin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: