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Exjade (deferasirox) Tablets for Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Severe Skin Reactions
- Severe skin reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme, have been reported during Exjade therapy. If SJS or erythema multiforme is suspected, discontinue Exjade and evaluate.
- Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS)
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Transfusional Iron Overload
- Six hundred twenty-seven patients with MDS were enrolled across 5 uncontrolled trials. These studies varied in duration from 1 to 5 years. The discontinuation rate across studies in the first year was 46% (AEs 20%, withdrawal of consent 10%, death 8%, other 4%, lab abnormalities 3%, and lack of efficacy 1%). Among 47 patients enrolled in the study of 5-year duration, 10 remained on Exjade at the completion of the study.
Table 1 displays adverse reactions.....
- In the MDS pool, in the first year, a total of 229 (37%) patients treated with Exjade had increases in serum creatinine >33% above baseline on 2 consecutive occasions (Table 2) and 8 (3.5%) patients permanently discontinued [see Warnings and Precautions (5.1)]. A total of 5 (0.8%) patients developed SGPT/ALT levels >5 times the upper limit of normal at 2 consecutive visits. The most frequent .....
8 USE IN SPECIFIC POPULATIONS
8.6 Renal Impairment
- For patients with renal impairment (CLcr 40-60 mL/min), reduce the starting dose by 50% [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Exjade is contraindicated in patients with a creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal [see Contraindications (4)].
BOXED WARNING (section rewritten and revised)
4 CONTRAINDICATIONS (section rewritten, revised)
5 WARNING AND PRECAUTIONS (all sections rewritten, revised)
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- Renal and urinary disorders: ..... tubulointerstitial nephritis
- Hepatobiliary disorders: ....hepatic failure
- Gastrointestinal disorders: .....gastrointestinal hemorrhage
7 DRUG INTERACTIONS
7.4 Interaction with Theophilline and...
- multiple changes in first paragraph
- ...Use caution when.....and zolmitriptan