General Information

Byvalson (nebivolol and valsartan 5 mg/ 80 mg tablet) is a fixed-dose combination of nebivolol - a beta-adrenergic receptor blocking agent that is preferentially beta-1 selective, and valsartan - an angiotensin II receptor blocker.

Byvalson is specifically indicated for the treatment of hypertension, to lower blood pressure.

Byvalson is supplied as a tablet for oral administration. The recommended dose is as follows: as initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose is 5 mg/ 80 mg taken orally once daily. Maximum antihypertensive effects are attained within 2 to 4 weeks. Byvalson may be substituted for its components in patients already receiving 5 mg nebivolol and 80 mg valsartan.

Clinical Results

FDA Approval

The FDA approval of Byvalson was based on a Phase III, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study, which randomized approximately 4,100 patients with Stage 1 or 2 hypertension. Treatment with Byvalson 5 mg/ 80 mg for 4 weeks resulted in placebo-adjusted reductions from baseline in systolic (SBP) and diastolic (DBP) blood pressure of -8.3 and -7.2 mmHg, respectively. Treatment with Byvalson 5 mg/ 80 mg resulted in greater reductions in SBP and DBP than did treatment with nebivolol 5 mg alone (p<0.0001 for both SBP and DBP) or valsartan 80 mg, alone (p=0.0007 for SBP and p<0.0001 for DBP). The overall rate of adverse events was similar across treatment groups and placebo during this 4 week period.

Side Effects

Adverse effects associated with the use of Byvalson may include, but are not limited to, the following:

skull hypoplasia

anuria

hypotension

renal failure

death

Byvalson comes with a Black Box warning of fetal toxicity. When pregnancy is detected, discontinue Byvalson as soon as possible. Drugs, including Byvalson, that act directly on the reninangiotensin system can cause injury and death to the developing fetus.

Mechanism of Action

Byvalson (nebivolol and valsartan 5 mg/ 80 mg tablet) is a fixed-dose combination that combines two FDA approved, once daily, blood pressure lowering agents with different mechanisms of action. Nebivolol is a beta-adrenergic receptor blocking agent that is preferentially beta-1 selective. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects.