Femara Tablets, 2.5 mg

SECTION 2: Hazards identification

EMERGENCY OVERVIEW *************************************************************************************************** FINISHED PHARMACEUTICAL PRODUCT REFER TO PHYSICIANS' DESK REFERENCE OR PACKAGE INSERT MAY CAUSE NAUSEA, BONE PAIN AND ARTHRALGIA EXPERIMENTAL TERATOGEN 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: Bone pain, hot flushes, back pain, nausea, fatigue, dizziness, arthralgia and dyspnea. TARGET ORGAN EFFECTS: Letrozole has been found to accumulate in the skin, as well as produce changes in the liver and bone. REPRODUCTIVE HAZARDS: FDA Pregnancy Category D (see section 11). Given its inhibitory effect on estrogen synthesis, the potential exists for Letrozole to inhibit uterine implantation of the fertilized egg, produce menstrual irregularities, and adversely affect the developing fetus. CARCINOGENICITY: See section 11. MUTAGENICITY: Letrozole was clastogenic in two in vitro assays, and non-mutagenic in two in vitro assays and one in vivo assay (see Section 11).

Medical Conditions Generally Aggravated by Exposure

Pregnancy; known hypersensitivity to letrozole or any other components of the formulation; pre-existing liver or kidney impairment.