Tenofovir Disoproxil Fumarate: Brands, Price & Uses in Bangladesh

Tenofovir Disoproxil Fumarate is a nucleotide reverse transcriptase inhibitor (NtRTI) used in the following clinical settings:

Established / FDA-approved uses

• Treatment of HIV-1 infection: Tenofovir Disoproxil Fumarate is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 10 kg.
• HIV pre-exposure prophylaxis (PrEP): Tenofovir Disoproxil Fumarate, combined with emtricitabine in a fixed-dose combination product, is indicated to reduce the risk of sexually acquired HIV-1 infection in HIV-negative adults and adolescents (weighing at least 35 kg) at high risk. Tenofovir Disoproxil Fumarate is not approved and is not effective for PrEP when used alone, without its combination partner.
• Chronic hepatitis B virus (HBV) infection: Tenofovir Disoproxil Fumarate is indicated for treatment of chronic hepatitis B in adults and pediatric patients with evidence of active viral replication and evidence of liver disease.

Uses requiring combination therapy

For the HIV-1 treatment and HIV PrEP indications, Tenofovir Disoproxil Fumarate must always be given as part of a complete antiretroviral regimen together with other agents; it must never be used as HIV monotherapy, since this risks development of viral resistance.

Off-label use

Tenofovir Disoproxil Fumarate is used off-label in some prevention-of-mother-to-child-transmission (PMTCT) protocols for pregnant women living with HIV, under specialist guidance, and in some settings as part of post-exposure prophylaxis (PEP) regimens.

Tenofovir Disoproxil Fumarate is administered orally, generally once daily, with or without food (though absorption is improved when taken with food, especially a high-fat meal). The dose depends on the indication, age, body weight, and renal function.

Adult dosing

Pediatric dosing

For HIV-1 treatment, Tenofovir Disoproxil Fumarate may be used in pediatric patients weighing at least 10 kg, with weight-band-based tablet or oral-powder dosing determined by a specialist. For chronic hepatitis B, use in pediatric patients is generally reserved for those aged 12 years and older weighing at least 35 kg, dosed at 300 mg once daily; safety and efficacy in younger children for the hepatitis B indication have not been fully established in all age groups. See Use in Special Populations and Pediatric Uses for further detail.

Renal impairment dose adjustment

Renal function should be assessed before starting Tenofovir Disoproxil Fumarate and monitored periodically during treatment; see Precautions and Warnings.

Missed dose

If a dose of Tenofovir Disoproxil Fumarate is missed, it should be taken as soon as remembered on the same day; if it is almost time for the next dose, the missed dose should be skipped rather than doubling up. Maintaining consistent, uninterrupted dosing is important for treatment effectiveness and to reduce the risk of viral resistance.

Common and clinically important side effects of Tenofovir Disoproxil Fumarate include:

• Renal effects: Renal impairment, including acute kidney injury, Fanconi syndrome (renal tubular dysfunction), and, rarely, acute tubular necrosis, have been reported with Tenofovir Disoproxil Fumarate. This is a notable and somewhat distinguishing safety concern requiring periodic monitoring of renal function (see Precautions and Warnings).
• Decreased bone mineral density: Long-term use of Tenofovir Disoproxil Fumarate has been associated with decreases in bone mineral density; monitoring may be considered in patients with a history of pathologic fracture or risk factors for osteoporosis.
• Gastrointestinal effects: Nausea, diarrhea, vomiting, and flatulence.
• Other common effects: Headache, dizziness, asthenia (weakness), and rash.
• Serious but rare effects: Lactic acidosis and severe hepatomegaly with steatosis, and immune reconstitution syndrome in HIV patients starting combination therapy (see Precautions and Warnings for details).

Patients should seek medical attention promptly for symptoms such as unusual muscle pain, difficulty breathing, marked fatigue, decreased urination, or swelling of the legs/ankles while taking Tenofovir Disoproxil Fumarate.