Select therapeutic use:
Indications for VIREAD ORAL POWDER:
HIV-1 infection, in combination with other antiretroviral agents. Chronic hepatitis B virus (HBV).
Test for HBV and HIV-1 infection prior to initiation. 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 (≥35kg): 300mg once daiy. 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.
Test for HBV and HIV-1 infection prior to initiation. <2yrs (<10kg): not established. Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV or HBV: Oral pwd (≥2yrs [≥10kg] or Tabs ≥2yrs [≥17kg]): 8mg/kg once daily; max 300mg/day. For additional oral pwd dosing based on body wt: see full labeling. Tabs (if able to swallow): ≥2yrs (17–<22kg): 150mg once daily; (22–<28kg): 200mg once daily; (28–<35kg): 250mg once daily; (≥35kg): 300mg once daily.
Post-treatment severe acute exacerbation of hepatitis B.
Discontinuation of anti-HBV therapy may be associated with severe acute exacerbations of hepatitis B. Closely monitor HBV-infected patients for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy. 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. Nursing mothers: not recommended in HIV-1.
Nucleotide analogue (HIV-1 and HBV reverse transcriptase inhibitor).
Concomitant adefovir dipivoxil for chronic HBV: not recommended. Avoid concomitant or recent use of nephrotoxic agents. Potentiates didanosine levels; monitor closely. 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 (see full labeling).
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)