Indications for VIREAD ORAL POWDER:
HIV-1 infection, in combination with other antiretroviral agents. Chronic hepatitis B virus (HBV) in adults.
May use tabs or oral pwd (if unable to swallow). Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV or HBV: ≥12yrs (≥35kg): 300mg once daily. Renal impairment: CrCl 30–49mL/min: 300mg every 48hrs; CrCl 10–29mL/min: 300mg every 72–96hrs; hemodialysis: 300mg every 7 days or after a total of 12hrs of dialysis; CrCl <10mL/min: not recommended.
Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV: <2yrs: not established. ≥2yrs: 8mg/kg once daily; max 300mg/day. ≥17kg: may use tabs if able to swallow. 17–<22kg: 150mg once daily. 22–<28kg: 200mg once daily. 28–<35kg: 250mg once daily. ≥35kg: 300mg once daily. See full labeling for additional dosing based on body wt. HBV: <12yrs or <35kg: not established.
Post-treatment severe acute exacerbation of hepatitis B.
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. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Pregnancy (Cat.B). Nursing mothers: not recommended.
Nucleotide analogue (HIV-1 and HBV reverse transcriptase inhibitor).
Avoid concomitant drugs that contain tenofovir DF, tenofovir alafenamide or adefovir dipivoxil. Avoid concomitant or recent use of nephrotoxic agents. 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, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Concomitant atazanavir: must give with ritonavir. Potentiated by concomitant lopinavir/ritonavir, ritonavir-boosted atazanavir or darunavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir; monitor for toxicity. Caution with triple nucleoside-only regimen (high rate of early virologic failure); monitor and consider alternative therapy. See full labeling for dosing on concomitant didanosine or ritonavir.
Rash, diarrhea, headache, pain, depression, asthenia, nausea, insomnia, dizziness, pyrexia, abdominal pain, vomiting, pruritus; decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome.
Register pregnant patients exposed to tenofovir DF by calling (800) 258-4263.
Tabs—30; Oral pwd—60g (w. dosing scoop)