| 12/26/12 |
| PrEP indication and information added. |
Indications for TRUVADA:
HIV-1 infection. Pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 in high-risk adults in combination with safer sex practices.
Adult Dose for TRUVADA:
HIV-1 infection: ≥12yrs (≥35kg): 1 tab once daily. Renal impairment: CrCl 30–49mL/min: 1 tab every 48 hrs; CrCl <30mL/min, hemodialysis: not recommended. PrEP: Confirm negative HIV-1 test immediately prior to initiating, repeat at least every 3 months. 1 tab once daily. CrCl<60mL/min: do not use.
Children's Dose for TRUVADA:
<12yrs: not recommended.
Pharmacological Class:
Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).
Contraindications:
PrEP in individuals with unknown or positive HIV-1 status.
Warnings/Precautions:
Suspend if lactic acidosis or hepatotoxicity occurs. Renal impairment: monitor CrCl and serum phosphorus. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Not for treating chronic hepatitis B; test for HBV before starting therapy and monitor patients co-infected with HIV-1 and HBV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). History or risk of fractures or osteopenia: monitor bone mineral density (BMD); consider Vit. D and calcium supplementation. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. PrEP: counsel patients about safe sex practices and evaluate for symptoms consistent with acute viral infection.
Interactions:
Avoid concomitant drugs that contain emtricitabine, tenofovir, lamivudine, or adefovir dipivoxil. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue didanosine if toxicity develops. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). Avoid concomitant or recent use of nephrotoxic agents. Potentiated by lopinavir/ritonavir, atazanavir; monitor for toxicity. Concomitant atazanavir: must give with ritonavir. Caution with triple nucleoside-only regimen (high rate of early viral non-response); monitor and consider alternative therapy. See literature for dosing of concomitant didanosine or ritonavir.
Adverse Reactions:
GI upset, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash, infections; fat redistribution, immune reconstitution syndrome, autoimmune disorders, lactic acidosis, severe hepatomegaly w. steatosis, new or worsening renal impairment, decreased BMD, severe acute exacerbations of hepatitis B.
Note:
Register pregnant patients exposed to Truvada by calling (800) 258-4263.
Metabolism:
Emtricitabine: hepatic; tenofovir DF: remains largely unchanged.
Elimination:
Renal.
Generic Availability:
NO
How Supplied:
Tabs—30
