Composition:

Tenofovir disoproxil fumarate tablets
Each film-coated tablet contains:Tenofovir Disoproxil Fumarate 300 mg equivalent to Tenofovir Disoproxil ….. 245 mg

Indication:

For the treatment of HIV-1 infection (in combination with other antiretroviral agents).


Dosage and Administration:

The dose of Tenofovir is 300 mg once daily taken orally, without regard to food. Dose recommended in renal impairment: Creatinine clearance 30-49 mL/min: 300 mg every 48 hours Creatinine clearance 10-29 mL/min: 300 mg twice a week Hemodialysis: 300 mg every 7 days or after approximately 12 hours of dialysis


Contraindications:

Hypersensitivity to any of the components of the product.


Adverse Reactions:

Common: Rash, diarrhea, flatulence, nausea, vomiting, asthenia.
Serious: lactic acidosis, hepatitis B, hepatomegaly, with steatosis, immune hypersensitivity reaction, acute renal failure, fanconi syndrome, interstitial nephritis, nephrogenic diabetes insipidus, renal impairment, tubular necrosis.


Warnings & Precautions:

Lactic acidosis and severe hepatomegaly with steatosis have been reported with nucleoside analogues. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. Hepatitis B virus coinfection: risk for severe, acute exacerbations of HBV infection after discontinuation of tenofovir disoproxil fumarate. Tenofovir DF is not indicated for the treatment of chronic HBV infection, and the safety and efficacy of tenofovir DF have not been established in patients coinfected with HBV and HIV. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue tenofovir DF and are coinfected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Combination of didanosine and tenofovir is not recommended for initial therapy; early virologic failure, rapid selection of resistant mutations, and potential for non-response. Concurrent use of nephrotoxic drug therapy may increase risk of renal impairment. Triple NRTI therapy has been associated with early virologic non-response; the use of lamivudine and abacavir in combination with tenofovir, and the use of lamivudine and didanosine in combination with tenofovir is not recommended due to high rates of early virologic non-response. Decrease in bone mineral density and osteomalacia have been reported with tenofovir therapy.


Drug Interactions:

Coadministration of tenofovir DF and didanosine should be undertaken with caution, and patients receiving this combination should be monitored closely for didanosine-associated adverse events. Didanosine should be discontinued in patients who develop didanosine-associated adverse events. Patients receiving atazanavir or lopinavir/ritonavir and tenofovir DF should be monitored for tenofovir-associated adverse events. Tenofovir DF should be discontinued in patients who develop tenofovir-associated adverse events. Tenofovir DF decreases the AUC and Cmin of atazanavir. Atazanavir without ritonavir should not be coadministered with this product.


Pregnancy:

Category B.


Lactation:

It is recommended that HIV-infected women do not breast feed their infants to avoid risking postnatal transmission of HIV.


Overdosage:

If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir DF, a 4-hour haemodialysis session removed approximately 10% of the administered tenofovir dose.