VEMLIDY

Vemlidy Generic Name & Formulations

Legal Class

General Description

Tenofovir alafenamide 25mg; tabs.

Pharmacological Class

Nucleoside analogue (reverse transcriptase inhibitor).

How Supplied

Tabs—30

Manufacturer

Gilead Sciences, Inc.

Generic Availability

Vemlidy Indications

Indications

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

Vemlidy Dosage and Administration

Adult

Test for HIV-1 infection prior to initiation. Take with food. 1 tab once daily. Concomitant carbamazepine: 2 tabs once daily. Hemodialysis: give after session.

Children

<12yrs: not established.

Vemlidy Contraindications

Not Applicable

Vemlidy Boxed Warnings

Boxed Warning

Post-treatment severe acute exacerbation of hepatitis B.

Vemlidy Warnings/Precautions

Warnings/Precautions

Discontinuation of anti-HBV therapy may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted. HBV and HIV-1 coinfection: not recommended as monotherapy for treatment of HIV-1 infection (risk of developing HIV-1 resistance). Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome develops. Decompensated hepatic impairment (Child-Pugh B or C) or ESRD (CrCl <15mL/min) not on hemodialysis: not recommended. Elderly. Pregnancy. Nursing mothers.

Vemlidy Pharmacokinetics

Metabolism

CES1 (hepatocytes), cathepsin A (PBMCs), CYP3A (minimal).

Elimination

Fecal (31.7%), renal (<1%). Half-life: 0.51 hour.

Vemlidy Interactions

Interactions

Concomitant oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort: not recommended. Antagonized by carbamazepine (see Adults). Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. Caution with concomitant nephrotoxic agents. 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).

Vemlidy Adverse Reactions

Adverse Reactions

Headache, abdominal pain, cough, fatigue, nausea, back pain; new onset or worsening renal impairment.

Vemlidy Clinical Trials

See Literature

Vemlidy Note

Notes

Vemlidy Patient Counseling