DIOVAN

What it is

DIOVAN (valsartan) is an orally active, potent and specific angiotensin II receptor antagonist that acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. DIOVAN is available as film-coated tablets containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan as the active ingredient.

Approved indications

— Treatment of hypertension. — Treatment of heart failure (NYHA class II–IV) in patients receiving usual therapy (such as diuretics or digitalis) who are intolerant to ACE inhibitors. — To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction.

Dosing overview

No initial dosage adjustment is required in the elderly. For patients with severe renal impairment, a maximum daily dose of 80 mg per day is recommended.

Key safety warnings

In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with DIOVAN. Sodium and/or volume depletion should be corrected before starting treatment, for example by reducing the diuretic dose or treatment should be commenced under close medical supervision. Angioedema, including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported in patients treated with valsartan. DIOVAN should be immediately discontinued in patients who develop angioedema, and should not be re-administered. An increase in the mortality rate among patients who received a combination of valsartan, ACE inhibitors and beta-blockers has been observed in clinical trials. Concurrent administration of ACE inhibitors, beta-blockers and valsartan is not recommended. The concomitant use of angiotensin receptor blockers, including valsartan, with other agents acting on the renin-angiotensin system is associated with an increased incidence of hypotension, hyperkalaemia, and changes in renal function compared to monotherapy. It is recommended to monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the renin-angiotensin system.

Contraindications

DIOVAN is contraindicated in cases of hypersensitivity to any of the components of DIOVAN or pregnancy. DIOVAN is also contraindicated in severe hepatic impairment, biliary cirrhosis and cholestasis, and in concomitant use with aliskiren in patients with Type 2 diabetes mellitus.

Regulatory history

DIOVAN was first registered on the Australian Register of Therapeutic Goods in 2001, with the 80 mg and 160 mg film-coated tablet blister packs listed on 13 November 2001. The 40 mg strength was added on 24 March 2003, and the 320 mg strength on 23 November 2006. The current formulation was approved on 26 August 2014.