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 following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [ see Warnings and Precautions (5.1,5.6)] Hepatic Toxicity and Failure [ see Warnings and Precautions (5.2,5.6)] GI Hemorrhage [ see Warnings and Precautions (5.3 )] Bone Marrow Suppression [ see Warnings and Precautions (5.4)] Hypersensitivity [see Warnings and Precautions (5.7) ] Severe Skin Reactions [see Warnings and Precautions (5.8) ] Skin Rash [see Warnings and Precautions (5.9)] Auditory and Ocular Abnormalities [see Warnings and Precautions (5.10) ] In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine.In deferasirox-treated patients with NTDT syndromes, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, rash, and nausea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MSN Pharmaceuticals Inc.
at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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.
Deferasirox was evaluated in healthy volunteer trials.
Currently, there are no clinical data in patients with deferasirox tablets.
Deferasirox contains the same active ingredient as deferasirox tablets for oral suspension.
The following adverse reactions have been reported with deferasirox tablets for oral suspension.
Transfusional Iron Overload A total of 700 adult and pediatric patients were treated with deferasirox for 48 weeks in premarketing studies.
These included 469 patients with beta-thalassemia, 99 with rare anemias, and 132 with sickle cell disease.
5 WARNINGS AND PRECAUTIONS Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy.
Monitor renal function during deferasirox therapy and reduce dose or interrupt therapy for toxicity.
( 2.1 , 2.4 , 5.1 ) Hepatic Toxicity: Monitor hepatic function.
Reduce dose or interrupt therapy for toxicity.
( 5.2 ) Fatal and Nonfatal Gastrointestinal (GI) Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking deferasirox in combination with drugs that have known ulcerogenic or hemorrhagic potential.
Like all medications, Deferasirox 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: