Monograph Details
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Infections & Infestations
> Viral infections
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TRUVADA |
| Manufacturer |
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Gilead Sciences, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside/nucleotide analogue (reverse transcriptase inhibitors). |
| Generic Name |
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Emtricitabine 200mg, tenofovir disoproxil fumarate 300mg; tabs. |
| Indications |
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HIV-1 infection. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs (CrCl ≥50mL/min): 1 tab once daily. Renal impairment: CrCl 30–49mL/min: 1 tab every 48 hrs; CrCl <30mL/min, hemodialysis: not recommended. |
| Precautions |
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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 HBV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Risk of osteopenia or osteoporosis: consider Vit. D and calcium supplementation. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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Avoid concomitant drugs that contain emtricitabine, tenofovir, or lamivudine. 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). Potentiated by lopinavir/ritonavir, atazanavir; monitor for toxicity. Concomitant atazanavir: must give with ritonavir. See literature for dosing of concomitant didanosine or ritonavir. |
| Adverse Reactions |
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GI upset, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash; fat redistribution, lactic acidosis, severe hepatomegaly w. steatosis, worsening renal impairment, decreased bone mineral density, immune reconstitution syndrome, exacerbations of hepatitis B. |
| Extra Text |
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Note: Register pregnant patients exposed to Truvada by calling (800) 258-4263. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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