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VEMLIDY
Viral infections
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Drug Name:

VEMLIDY Rx

Generic Name and Formulations:
Tenofovir alafenamide 25mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

Indications for VEMLIDY:

Chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

Adult:

Take with food. ≥18yrs: 1 tab once daily. Concomitant carbamazepine: 2 tabs once daily.

Children:

<18yrs: not established.

Boxed Warning:

Post-treatment severe acute exacerbation of hepatitis B.

Warnings/Precautions:

Discontinuing anti-hepatitis B therapy may ­result in severe acute exacerbations of hepatitis B; closely monitor for several months after stopping; if appropriate, resumption of anti-hepatitis B therapy may be warranted. HBV and HIV-1 coinfection: risk of developing HIV-1 resistance; not recommended as monotherapy for treatment of HIV-1 infection. Perform HIV antibody testing prior to initiating therapy in all HBV-infected patients. Monitor serum creatinine, CrCl, urine glucose, urine protein prior to and during treatment in all patients; also serum phosphorus in those with chronic kidney disease. Discontinue if significant renal dysfunction or Fanconi syndrome develops. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Decompensated hepatic impairment (Child-Pugh B or C) or ESRD (CrCl <15mL/min): not recommended. Pregnancy. Nursing mothers.

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Interactions:

Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. Caution with concomitant nephrotoxic agents. Antagonized by carbamazepine (see Adults). Concomitant oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort: not recommended. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs).

Adverse Reactions:

Headache, abdominal pain, fatigue, cough, nausea, back pain.

Note:

Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—30

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