New Drug Reviews
Nebivolol/Valsartan (Byvalson) for Hypertension
Am Fam Physician. 2018 Jan 15;97(2):124-125.
Nebivolol/valsartan (Byvalson) is a combination of a beta1 adrenergic blocker/nitric oxide producer and an angiotensin receptor blocker (ARB) labeled for the treatment of patients with hypertension.1–5
Adverse effects of nebivolol/valsartan therapy comprise those of the individual drug components. Valsartan may induce changes in renal function, including acute renal failure, especially when combined with other medications that have been shown to affect renal function. Valsartan rarely causes angioedema or hypersensitivity reactions.6 Nebivolol may cause or worsen bradycardia, heart block, and heart failure. Use of combination nebivolol/valsartan should be avoided in patients with a history of hypersensitivity reaction to either component.1,3–5
No dosage adjustment is required for patients with mild hepatic impairment; however, nebivolol/valsartan is not recommended as an initial therapy in patients with moderate hepatic impairment. It is contraindicated in patients with severe hepatic impairment.1,3–5
Nebivolol/valsartan inhibits the cytochrome P450 (CYP450) 2D6 enzyme and should be avoided in combination with other CYP2D6 inhibitors. Use of nebivolol/valsartan with other antihypertensive medications such as beta blockers, angiotensin-converting enzyme (ACE) inhibitors, and ARBs can increase the risk of hypotension, bradycardia, hyperkalemia, and changes in renal function. Concomitant medications affected by changes in renal function such as oral or intravenous antibiotics, lithium, and immunosuppressants should be monitored. Nebivolol/valsartan should not be used with aliskiren (Tekturna) because of the increased risk of hyperkalemia, renal impairment, and hypotension.1,3–5
The safety and effectiveness of the valsartan component have not been established in patients with severe renal impairment.1–5 The nebivolol component has been shown to cause severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias in patients following the abrupt discontinuation of beta-blocker therapy.1,3–5 Nebivolol/valsartan should be discontinued in women who become pregnant because risk to the fetus is unknown, and it should not be used by breastfeeding women.1,3–5
In clinical trials of carefully selected patients, nebivolol/valsartan was generally well-tolerated at the starting dosage, with about 2% of patients discontinuing treatment because of adverse effects. Bra
Referencesshow all references
1. Byvalson (nebivolol/valsartan) prescribing information. Irvine, Calif.: Allergan USA, Inc.; 2016. https://www.allergan.com/assets/pdf/byvalson_pi. Accessed June 12, 2017....
2. Maffei A, Di Pardo A, Carangi R, et al. Nebivolol induces nitric oxide release in the heart through inducible nitric oxide synthase activation. Hypertension. 2007;50(4):652–656.
3. Daily Med. Byvalson—nebivolol hydrochloride and valsartan tablet, film coated. Updated June 16, 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4ad6a5b-e69d-4b39-9fe3-58569a964978. Accessed June 12, 2017.
4. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Medical Review: Byvalson NDA 206302. September 29, 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206302Orig1s000MedR.pdf. Accessed June 11, 2017.
5. U.S. Food and Drug Administration. Drug approval package: Byvalson (nebivolol/valsartan). Approved June 3, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206302Orig1ByvalsonTOC.cfm. Accessed June 11, 2017.
6. Knecht SE, Dunn SP, Macaulay TE. Angioedema related to angiotensin inhibitors. J Pharm Pract. 2014;27(5):461–465.
7. Giles TD, Weber MA, Basile J, et al.; NAC-MD-01 Study Investigators. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study [published correction appears in Lancet 2016;388(10051):1280]. Lancet. 2014;383(9932):1889–1898.
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This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.
A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.
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