indicated for:

HIV-1 Infection:

• VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.

VIREAD alone should not be used in patients with HIV-1 infection.

Chronic Hepatitis B:

• For the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.

Due to the risk of development of HIV-1 resistance, VIREAD should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.

All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating VIREAD.

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue anti-hepatitis B therapy, including VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Significantly increased drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment.

There are no data to recommend use of VIREAD tablets 150 mg, 200 mg, or 250 mg or VIREAD oral powder in patients with renal impairment.

Tenofovir is principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of VIREAD.

In clinical trials in HIV-1 infected adults, VIREAD was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving VIREAD.

Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of VIREAD.

Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including VIREAD. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir DF, alone or in combination with other antiretrovirals.

VIREAD should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs).Cases of acute renal failure after initiation of high dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on tenofovir DF.

Co-administration of VIREAD with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the coadministered drug. Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs.

In the treatment of chronic hepatitis B, VIREAD should not be administered in combination with HEPSERA (adefovir dipivoxil).

Patients receiving VIREAD and didanosine should be monitored closely for didanosine-associated adverse reactions.

When co-administered with VIREAD, atazanavir 300 mg should be given with ritonavir 100 mg.

In patients receiving VIREAD concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative HCV or antiretroviral therapy, as the safety of increased tenofovir concentrations in this setting has not been established.

There are no adequate and well-controlled studies in pregnant women.  Reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir.

The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Samples of breast milk obtained from five HIV-1 infected mothers in the first postpartum week show that tenofovir is secreted in human milk.

GoToSource

• Use in patients under the age 2 of for treatment of HIV-1 infection. GoToSource

• Use in patients under the age 12 for the treatment of chronic hepatitis B. GoToSource

• Postexposure prophylaxis for simian immunodeficiency virus and prevention of HIV infection transmission in pregnant women. GoToSource

Asthenia (loss of strength, weakness, or lack of energy), depression, nasopharyngitis (swelling of nasal passages and back of the throat), increase in ALT (indicating liver damage), aspartate aminotransferase (indicating liver or heart damage), serum amylase (indicating pancreatic disorders), and glycosuria (indicates elevated blood glucose levels), osteomalacia (softening of bones), hepatitis flares, hypophosphatemia (low level of phosphate in blood) acute kidney failure and fanconi syndrome (disorder of kidney tubule function). GoToSource

Lactic acidosis. GoToSource

Pancreatitis. GoToSource

Decreased bone mineral density. GoToSource

Lawsuits filed for bone loss and kidney injuries.