"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported. In 1 case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. Single doses up to 80 mg per kg per day in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy volunteers, single doses of up to 40 mg per kg per day were tolerated. There is no specific antidote for Exjade. In case of overdose, induce vomiting and employ gastric lavage.
Exjade is contraindicated in patients with:
- Serum creatinine greater than 2 times the age-appropriate upper limit of normal or creatinine clearance less than 40 mL/min [see WARNINGS AND PRECAUTIONS];
- Poor performance status;
- High-risk myelodysplastic syndromes;
- Advanced malignancies;
- Platelet counts < 50 x 109/L;
- Known hypersensitivity to deferasirox or any component of Exjade [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Last reviewed on RxList: 8/21/2015
Additional Exjade Information
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