Posted from: Sunday, December 11, 2016 - 04:08 PM - Present

Vemlidy Approved for Hepatitis B

November 10, 2016 – The US FDA approved Vemlidy® (tenofovir alafenamide) manufactured by Gilead Sciences, Inc. Vemlidy is indicated to treat patients who have chronic hepatitis B and compensated (not yet progressed to cirrhosis) liver disease. Vemlidy maintains relatively constant blood levels, therefore it is effective at a lower dose (25mg/day) than Gilead’s previous hepatitis B drug, Viread® (tenofovir disoproxil fumarate), which is dosed at 300mg/day. As a result, Vemlidy does not cause as many side effects, particularly on bones and in kidneys, as Viread does. Labeling for Vemlidy does include a boxed warning that taking it may be associated with two potentially serious conditions -- lactic acidosis (excessive lactate accumulation) and hepatomegaly with steatosis (enlargement of the liver with fat deposits). In addition, hepatitis B may reactivate after treatment with Vemlidy ends. Recommended dosing is one tablet daily along with a meal or snack. Vemlidy will be launched through open distribution on Nov. 11, 2016, with a wholesale price of approximately $1,000 for a 30-day supply, which is comparable to Viread.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

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Last Updated Monday, April 24, 2017 - 06:47 PM.