Tasigna Capsules, 200 mg

SECTION 2: Hazards identification

EMERGENCY OVERVIEW *************************************************************************************************** FINISHED PHARMACEUTICAL PRODUCT REFER TO PHYSICIANS' DESK REFERENCE OR PACKAGE INSERT MAY CAUSE NAUSEA, VOMITING AND DIARRHEA MAY CAUSE HEADACHE, FATIGUE MAY CAUSE SKIN RASH MAY ADVERSELY AFFECT THE DEVELOPING FETUS ***************************************************************************************************

Principle Routes of Exposure

Oral EFFECTS OF OVEREXPOSURE: Finished pharmaceutical product. Potential for exposure is reduced in this form. Skin: No hazard is expected from normal clinical use. Eye: No hazard is expected from normal clinical use. Inhalation: No hazard is expected from normal clinical use. Ingestion: No hazard is expected from normal clinical use. THERAPEUTIC SIDE EFFECTS: Nausea, vomiting, diarrhea, skin rash, pruritis, headache, fatigue, dizziness, palpitations and constipation. Common serious drug-related adverse reactions include thrombocytopenia and neutropenia. Sudden deaths and QT prolongation have been reported. TARGET ORGAN EFFECTS: Prolonged or repeated exposure may cause liver toxicity, elevated serum lipase, electrolyte abnormalities and myelosuppresion. REPRODUCTIVE HAZARDS: FDA Pregnancy Category D (see section 11). CARCINOGENICITY: Carcinogenicity studies have not been performed for nilotinib.. MUTAGENICITY: Nilotinib was not mutagenic and/or clastogenic in three in vitro assays and one in vivo assay (see Section 11).

Medical Conditions Generally Aggravated by Exposure

Pre-existing hypokalemia, hypomagnesemia, or long QT syndrome; known hypersensitivity to nilotanib or any other components of the formulation.