ATACAND for Heart Failure

ATACAND is indicated for the treatment of heart failure (NYHA Class II-IV) in patients with left-ventricular systolic dysfunction (ejection fraction ≤40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.

ATACAND is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

• ATACAND is contraindicated in patients who are hypersensitive to any component of this product

USE IN PREGNANCY: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, ATACAND should be discontinued as soon as possible. See full PI WARNINGS, Fetal/Neonatal Morbidity and Mortality.

• In heart failure patients receiving ATACAND, hypotension, increases in serum creatinine, and hyperkalemia have occurred. Caution should be observed for hypotension when initiating therapy. Evaluation of patients with heart failure should always include assessment of renal function and volume status. Monitoring of blood pressure, serum creatinine, and serum potassium is recommended during drug dose escalation and periodically thereafter

• Greater sensitivity of some older individuals (eg, >75 years) with heart failure must be considered

• During concomitant use of ATACAND and lithium, careful monitoring of serum lithium levels is recommended

• The adverse-event profile of ATACAND in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing ATACAND in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued ATACAND for adverse events vs 16.1% of placebo patients

• In hypertension, volume and/or salt depletion should be corrected in patients prior to administering ATACAND or symptomatic hypotension may occur

• In hypertension, the AEs that occurred more frequently (>1% and greater than placebo) with ATACAND were upper respiratory tract infection (URI) (6% vs 4%), dizziness (4% vs 3%), back pain (3% vs 2%), pharyngitis (2% vs 1%), and rhinitis (2% vs 1%)

• The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient

• In hypertension, the usual recommended starting dose is 16 mg once daily as monotherapy in patients who are not volume depleted. Administration can be once or twice daily with total daily doses ranging from 8 to 32 mg. Blood pressure response is dose related over the range of 2-32 mg

Please see full Prescribing Information, including boxed WARNING regarding use in pregnancy.