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Valsartan) Tablets, for Oral Use Diovan in Patients with Diabetes (4) Initial U.S

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Valsartan) Tablets, for Oral Use Diovan in Patients with Diabetes (4) Initial U.S HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS---------------------­ These highlights do not include all the information needed to use Tablets (mg): 40 (scored), 80, 160, 320 DIOVAN safely and effectively. See full prescribing information for ------------------------------ CONTRAINDICATIONS -----------------------------­ DIOVAN. Known hypersensitivity to any component; Do not coadminister aliskiren with DIOVAN® (valsartan) tablets, for oral use Diovan in patients with diabetes (4) Initial U.S. Approval: 1996 ----------------------- WARNINGS AND PRECAUTIONS ----------------------­ WARNING: FETAL TOXICITY • Observe for signs and symptoms of hypotension (5.2) See full prescribing information for complete boxed warning. • Monitor renal function and potassium in susceptible patients (5.3, 5.4) • When pregnancy is detected, discontinue Diovan as soon as possible. ------------------------------ ADVERSE REACTIONS -----------------------------­ (5.1) Hypertension: Most common adverse reactions are headache, dizziness, viral • Drugs that act directly on the renin-angiotensin system can cause infection, fatigue and abdominal pain (6.1) injury and death to the developing fetus. (5.1) Heart Failure: Most common adverse reactions are dizziness, hypotension, --------------------------- INDICATIONS AND USAGE ---------------------------- diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1) Post-Myocardial Infarction: Most common adverse reactions which caused Diovan is an angiotensin II receptor blocker (ARB) indicated for: patients to discontinue therapy are hypotension, cough and increased blood • Treatment of hypertension, to lower blood pressure. Lowering blood creatinine (6.1) pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis • Treatment of heart failure (NYHA class II-IV); Diovan significantly Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA­ reduced hospitalization for heart failure (1.2) 1088 or www.fda.gov/medwatch. • Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following ------------------------------ DRUG INTERACTIONS------------------------------­ myocardial infarction (1.3) • Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, ----------------------- DOSAGE AND ADMINISTRATION ----------------------­ increases in serum creatinine (7) • NSAID use may lead to increased risk of renal impairment and loss of Indication Starting Dose Dose Range Target antihypertensive effect (7) Maintenance • Dual inhibition of the renin-angiotensin system: Increased risk of renal Dose* impairment, hypotension, and hyperkalemia (7) Adult 80 or 160 mg 80-320 mg once --­ • Lithium: Increases in serum lithium concentrations and lithium toxicity Hypertension (2.1) once daily daily (7) Pediatric 1.3 mg/kg 1.3-2.7 mg/kg --­ ----------------------- USE IN SPECIFIC POPULATIONS ----------------------­ Hypertension (6­ once daily (up once daily (up to Nursing Mothers: Nursing or drug should be discontinued (8.3); Pediatrics: 16 years) (2.2) to 40 mg total) 40-160 mg total) Efficacy and safety data support use in 6-16 year old patients; use is not recommended in patients <6 years old (6.1, 8.4) Heart Failure (2.3) 40 mg twice 40-160 mg twice 160 mg twice daily daily daily See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling Post-Myocardial 20 mg twice 20-160 mg twice 160 mg twice Revised: 01/2017 Infarction (2.4) daily daily daily * as tolerated by patient FULL PRESCRIBING INFORMATION: CONTENTS* 8.1 Pregnancy 8.3 Nursing Mothers WARNING: FETAL TOXICITY 8.4 Pediatric Use 1 INDICATIONS AND USAGE 8.5 Geriatric Use 1.1 Hypertension 8.6 Renal Impairment 1.2 Heart Failure 8.7 Hepatic Impairment 1.3 Post-Myocardial Infarction 10 OVERDOSAGE 2 DOSAGE AND ADMINISTRATION 11 DESCRIPTION 2.1 Adult Hypertension 12 CLINICAL PHARMACOLOGY 2.2 Pediatric Hypertension 6 to 16 Years of Age 12.1 Mechanism of Action 2.3 Heart Failure 12.2 Pharmacodynamics 2.4 Post-Myocardial Infarction 12.3 Pharmacokinetics 3 DOSAGE FORMS AND STRENGTHS 13 NONCLINICAL TOXICOLOGY 4 CONTRAINDICATIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5 WARNINGS AND PRECAUTIONS 13.2 Animal Toxicology and/or Pharmacology 5.1 Fetal Toxicity 14 CLINICAL STUDIES 5.2 Hypotension 14.1 Hypertension 5.3 Impaired Renal Function 14.2 Heart Failure 5.4 Hyperkalemia 14.3 Post-Myocardial Infarction 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Studies Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience 7 DRUG INTERACTIONS * Sections or subsections omitted from the full prescribing information are not 7.1 Clinical Laboratory Test Findings listed 8 USE IN SPECIFIC POPULATIONS Reference ID: 4050060 FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Diovan as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) 1 INDICATIONS AND USAGE 1.1 Hypertension Diovan® (valsartan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor [see Clinical Studies (14.2)]. 1.3 Post-Myocardial Infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality [see Clinical Studies (14.3)]. 2 DOSAGE AND ADMINISTRATION 2.1 Adult Hypertension The recommended starting dose of Diovan (valsartan) is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once a day. Reference ID: 4050060 The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment. Diovan may be administered with
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