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TRUVADA
Viral infections
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Drug Name:

TRUVADA Rx

Generic Name and Formulations:
Emtricitabine, tenofovir disoproxil fumarate; 100mg/150mg, 133mg/200mg, 167mg/250mg, 200mg/300mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

Indications for TRUVADA:

HIV-1 infection, in combination with other antiretroviral agents. Pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 in high-risk uninfected adults and adolescents in combination with safer sex practices.

Adult:

HIV-1 infection: ≥35kg: 200mg/300mg once daily. Renal impairment: CrCl 30–49mL/min: 200mg/300mg every 48hrs; CrCl <30mL/min, hemodialysis: not recommended. PrEP: confirm negative HIV-1 test immediately prior to initiating, repeat at least every 3mos. ≥35kg: 200mg/300mg once daily. CrCl<60mL/min: not recommended.

Children:

HIV-1 infection: <17kg: not established. 17–<22kg: 100mg/150mg once daily. 22–<28kg: 133mg/200mg once daily. 28–<35kg: 167mg/250mg once daily. ≥35kg: 200mg/300mg once daily.

Contraindications:

PrEP in individuals with unknown or positive HIV-1 status.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B. Risk of drug resistance with Truvada use for preexposure prophylaxis (PrEP) in undiagnosed early HIV-1 infection.

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). PrEP: do not initiate if symptoms consistent with acute viral infection are present and recent exposures suspected; delay PrEP for ≥1 month and reconfirm negative HIV-1 status. Counsel patients about safer sex practices. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl, serum creatinine, serum phosphorus (in CKD patients), urine glucose, urine protein prior to and during therapy in all patients. History of pathologic fracture or risk factors for osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).

Interactions:

Potentiates didanosine toxicity (>60kg: reduce dose of didanosine); discontinue didanosine if toxicity develops. Avoid concomitant or recent use of nephrotoxic agents. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Potentiated by lopinavir/ritonavir, ritonavir-boosted atazanavir or darunavir; monitor for toxicity; discontinue if occurs. Concomitant atazanavir: must give with ritonavir. Tenofovir levels increased by concomitant ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir; monitor for toxicity. See full labeling for dosing of concomitant didanosine or ritonavir.

Adverse Reactions:

Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, weight decreased; decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome.

Note:

Register pregnant patients exposed to Truvada by calling (800) 258-4263.

Metabolism:

Emtricitabine: hepatic; tenofovir DF: remains largely unchanged.

Elimination:

Renal.

REMS:

YES

Generic Availability:

YES (200mg/300mg)

How Supplied:

Tabs—30


Data provided by MPR.

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