Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
VIREAD |
| Manufacturer |
|
Gilead Sciences, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Nucleotide analogue (reverse transcriptase inhibitor). |
| Generic Name |
|
Tenofovir disoproxil fumarate 300mg; tabs. |
| Indications |
|
HIV-1 infection. |
| Children |
|
<18yrs: not recommended. |
| Adults |
|
≥18yrs: 300mg once daily. Renal impairment: CrCl 30–49mL/min: 300mg every 48 hours; CrCl 10–29mL/min: 300mg twice weekly; hemodialysis: 300mg once per week or after a total of 12 hours of dialysis; CrCl <10mL/min: not recommended. |
| 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 closely 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 |
|
Avoid concomitant drugs that contain tenofovir. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue 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 |
|
Rash, GI upset, headache, pain, depression, asthenia; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, worsening renal impairment, reduced bone mineral density, exacerbation of hepatitis B. |
| Extra Text |
|
Note: Register pregnant patients exposed to tenofovir DF by calling (800) 258-4263. |
| How Supplied |
|
Tabs—30 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|