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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:

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

Children:

<18yrs: not established.

Warnings/Precautions:

Discontinuing anti-hepatitis B treatment may ­exacerbate severe HBV infection; monitor hepatic function closely for several months after stopping; treatment resumption may be warranted. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. 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 CrCl, urine glucose, urine protein, serum creatinine, serum phosphorus before and during treatment. Discontinue if significant renal dysfunction or Fanconi syndrome develops. Decompensated hepatic impairment (Child-Pugh B or C) or ESRD (CrCl <15mL/min): not recommended. Pregnancy. Nursing mothers.

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).

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

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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