Diovan (valsartan) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June and December 2011, February and August 2012

 

August 2012

Summary View

 

• Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics…

Hyperkalemia

• Some patients with heart failure have developed increases in potassium…

ADVERSE REACTIONS

Heart Failure

• The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients…

Post-Myocardial Infarction

• Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients.

Post-Marketing Experience

• Hypersensitivity: There are rare reports of angioedema. Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should not be re-administered to patients who have had angioedema.
• Renal: renal failure

USE IN SPECIFIC POPULATIONS

Renal Impairment

• Safety and effectiveness of Diovan in patients with severe renal impairment (CrCl ≤ 30mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60-90 mL/min) or moderate (CrCl 30-60) renal impairment.

Hepatic Impairment

• No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.

PATIENT COUNSELING INFORMATION

Tell your doctor about all your medical conditions including whether you:

• have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing.
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

 

February 2012

Summary View

 

ADVERSE REACTIONS

Clinical Studies Experience, Pediatric Hypertension

• Headache and hyperkalemia were the most common adverse events suspected to be study drug-related in older children (6 to 17 years old) and younger children (6 months to 5 years old), respectively. Hyperkalemia was mainly observed in children with underlying renal disease.
• Diovan is not recommended for pediatric patients under 6 years of age

 

DRUG INTERACTIONS

Transporters

• Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine.

 

USE IN SPECIFIC POPULATIONS

Pediatric Use

• In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.
• No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2.
• There is limited clinical experience with Diovan in pediatric patients with mild to moderate hepatic impairment.

 

December 2011

Summary View

 

PATIENT PACKAGE INSERT

High Blood Pressure (Hypertension)

• Medicines that lower your blood pressure lower your chance of having a stroke or heart attack

 

June 2011

Summary View

 

*NSAID interaction

 

DRUG INTERACTIONS

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

• In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.
• The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

PATIENT INFORMATION

What should I tell my doctor before taking Diovan

• Nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)