NDC 61958-0403-1

Viread®
(tenofovir disoproxil fumarate)
Oral Powder, 40 mg/scoop

Each level dosing scoop provides approximately
1g of the oral powder which contains 40 mg of
tenofovir disoproxil fumarate, which is
equivalent to 33 mg of tenofovir disoproxil.

60 g per bottle

Rx only

GILEAD





 

Generic Name for VIREAD ORAL POWDER
Tenofovir disoproxil fumarate 40mg per 1g pwd.

Legal Classification:
Rx

Pharmacological Class for VIREAD ORAL POWDER
Nucleotide analogue (reverse transcriptase and polymerase inhibitor).

Manufacturer of VIREAD ORAL POWDER
Gilead Sciences, Inc.
 

Indications for VIREAD ORAL POWDER
HIV-1 infection. Chronic hepatitis B virus (HBV) in adults.

Adult dose for VIREAD ORAL POWDER
Use tabs or oral pwd. Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV or HBV: 300mg once daily. Renal impairment: CrCl 30–49mL/min: 300mg every 48 hours; CrCl 10–29mL/min: 300mg every 72–96 hours; hemodialysis: 300mg once per week or after a total of 12 hours of dialysis; CrCl <10mL/min: not recommended.

Children's dosing for VIREAD ORAL POWDER
<2yrs: not recommended. HIV: Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). ≥2yrs: 8mg/kg once daily; max 300mg/day. ≥17kg: may use tablets if able to swallow. 17–<22kg: 150mg once daily. 22–<28kg: 200mg once daily. 28–<35kg: 250mg once daily. ≥35kg: 300mg once daily.

Also:
VIREAD

Warnings/Precautions for VIREAD ORAL POWDER
Suspend if lactic acidosis or hepatotoxicity occurs. Calculate CrCl prior to initiating therapy. Monitor CrCl and serum phosphorus in patients at risk for renal impairment. Decompensated liver disease. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Monitor hepatic function during and for several months after stopping anti-HBV treatment (discontinuing therapy may exacerbate HBV infection). HIV-1 and HBV coinfection: do HIV-1 antibody testing for HBV-infected patients, and test for presence of HBV in HIV-1 infected patients before starting therapy. 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.

Interactions for VIREAD ORAL POWDER
Avoid concomitant drugs that contain tenofovir or adefovir dipivoxil. 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, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). Potentiated by lopinavir/ritonavir, atazanavir; monitor for toxicity. Concomitant atazanavir: must give with ritonavir. Caution with triple nucleoside-only regimens (high rate of early viral non-response); monitor and consider alternative therapy. See literature for dosing of concomitant didanosine or ritonavir.

Adverse Reactions for VIREAD ORAL POWDER
Rash, GI upset, headache, pain, depression, asthenia; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, worsening renal impairment, decreased BMD, severe acute exacerbation of hepatitis.

Notes for VIREAD ORAL POWDER
Note: Register pregnant patients exposed to tenofovir DF by calling (800) 258-4263.

How is VIREAD ORAL POWDER supplied?
Tabs—30
Oral pwd—60g (w. dosing scoop)

Related Disease:
Hepatitis~antivirals
HIV~antivirals