Candesartan Cilexetil

1 INDICATIONS AND USAGE Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) . Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2). 1.1 Hypertension Candesartan cilexetil is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

6 ADVERSE REACTIONS Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ). Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) ( 5.5 ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Candesartan cilexetil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue candesartan cilexetil as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension (5.3) . Monitor renal function (5.4) and potassium levels (5.5) . 5.1 Fetal Toxicity Candesartan cilexetil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure and death. When pregnancy is detected, discontinue candesartan cilexetil as soon as possible [see Use in Specific Populations (8.1) ]. 4 CONTRAINDICATIONS Candesartan cilexetil is contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes [see Drug Interactions (7.4) ] . Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes (4) .