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Other brands with the same active ingredient
These brands contain the same active ingredient (Tenofovir Alafenamide). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Tenofovir Alafenamide is a nucleoside analog reverse transcriptase inhibitor that works against the hepatitis B virus (HBV). Doctors use it to treat chronic hepatitis B virus infection in adults whose liver disease is compensated.
Pharmacology
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (a 2'-deoxyadenosine monophosphate analog). It is lipophilic and can cross cell membranes, so it enters primary hepatocytes by passive diffusion and also through the hepatic uptake transporters OATP1B1 and OATP1B3. Inside the cell, tenofovir alafenamide is hydrolysed to tenofovir, mainly by carboxylesterase 1 (CES1) in primary hepatocytes. Cellular kinases then phosphorylate the tenofovir to its pharmacologically active metabolite, tenofovir diphosphate.
Tenofovir diphosphate stops HBV replication because the HBV reverse transcriptase incorporates it into viral DNA, and this ends the DNA chain. It is a weak inhibitor of mammalian DNA polymerases, including mitochondrial DNA polymerase γ, and in cell culture there is no evidence of toxicity to mitochondria.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Prior testing and initiation
Before initiation of Tenofovir alafenamide, patients should be tested for HIV-1 infection. Tenofovir alafenamide alone should not be used in patients who have HIV-1 infection.
Recommended dosage in adults
The recommended dosage of Tenofovir alafenamide is 25 mg (one tablet), taken orally once daily with food.
Dosage in renal impairment
No dosage adjustment is needed in patients with estimated creatinine clearance greater than or equal to 15 ml per minute. The same applies to patients with end stage renal disease (ESRD, estimated creatinine clearance below 15 ml per minute) who are receiving chronic hemodialysis. On days of hemodialysis, give Tenofovir alafenamide after the hemodialysis treatment is completed. It is not recommended in patients with ESRD who are not receiving chronic hemodialysis.
Dosage in hepatic impairment
No dosage adjustment is needed in patients with mild hepatic impairment (Child-Pugh A). Tenofovir alafenamide is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
Pediatric use
Safety and effectiveness of Tenofovir alafenamide in pediatric patients less than 18 years of age have not been established.
Geriatric use
In clinical trials, Tenofovir alafenamide was given to 89 subjects aged 65 and over. No clinically significant differences in safety or efficacy were seen between these elderly subjects and subjects between 18 and less than 65 years of age.
Side Effects
Other sections of the labeling discuss these adverse reactions with Tenofovir Alafenamide: lactic acidosis or severe hepatomegaly with steatosis, severe acute exacerbation of hepatitis B, and new onset or worsening of renal impairment. The most common side effects are headache, stomach pain, tiredness, cough, nausea and back pain.
Cautions & Contraindications
Warnings & Precautions
Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment Discontinuation of anti-hepatitis B therapy, including Tenofovir Alafenamide, may result in severe acute exacerbations of hepatitis B. Patients who stop Tenofovir Alafenamide should be watched closely, with both clinical and laboratory follow-up, for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may need to be started again. Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1 Because of the risk of development of HIV-1 resistance, Tenofovir Alafenamide alone is not recommended for the treatment of HIV-1 infection. Its safety and efficacy have not been established in patients coinfected with HBV and HIV-1. HIV antibody testing should be offered to all HBV-infected patients before therapy with Tenofovir Alafenamide begins. If the result is positive, use an appropriate antiretroviral combination regimen that is recommended for patients coinfected with HIV-1. New Onset or Worsening Renal Impairment Postmarketing cases of renal impairment have been reported with TAF-containing products. These include acute renal failure, proximal renal tubulopathy (PRT) and Fanconi syndrome. Most of these cases had potential confounders that may have contributed to the renal events, but it's also possible these factors made patients more open to tenofovir-related adverse events. Patients who take tenofovir prodrugs and have impaired renal function are at increased risk of renal-related adverse reactions, and so are those taking nephrotoxic agents, including non-steroidal anti-inflammatory drugs. Before or when starting Tenofovir Alafenamide, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue Tenofovir Alafenamide in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs. This includes tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, used alone or in combination with other antiretrovirals. Treatment with Tenofovir Alafenamide should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. These findings may include hepatomegaly and steatosis, even when transaminase levels are not markedly raised.
Pregnancy & Breastfeeding
Pregnancy: Based on prospective reports to the APR, over 660 exposures to TAF-containing regimens during pregnancy ended in live births (over 520 exposed in the first trimester and over 130 exposed in the second/third trimester). Birth defects were seen in 4.2% of live births (95% CI: 2.6% to 6.3%) after first trimester exposure and in 3.0% (95% CI: 0.8% to 7.5%) after second/third trimester exposure to TAF-containing regimens. One methodologic limitation of the APR is its use of MACDP as the external comparator group. MACDP is not disease-specific, it evaluates women and infants from a limited geographic area, and it does not include outcomes for births that occurred at less than 20 weeks gestation.
Lactation: It is not known whether Tenofovir alafenamide and its metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant. Tenofovir has been shown to be present in the milk of lactating rats and rhesus monkeys after administration of TDF. It is not known if tenofovir alafenamide can be present in animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Tenofovir alafenamide and any potential adverse effects on the breastfed infant from Tenofovir alafenamide or from the underlying maternal condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
If someone takes an overdose of Tenofovir Alafenamide, watch the patient for any signs of toxicity. Treatment is general supportive care, which means monitoring vital signs and observing the patient's clinical status. Tenofovir Alafenamide is removed efficiently by hemodialysis, with an extraction coefficient of approximately 54%.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Tenofovir Alafenamide below 30°C. Keep it in its original container and protect it from light. Keep it out of children's reach.
Drug Interactions
Common questions about Telabee 25 25 mg
What is Telabee 25 25 mg Tablet?
Telabee 25 25 mg Tablet is a medicine that contains Tenofovir Alafenamide. It is made by Jenphar Bangladesh Ltd. It belongs to the Hepatic viral infections (Hepatitis B) group of medicines.
What is Telabee 25 used for?
Tenofovir Alafenamide is a nucleoside analog reverse transcriptase inhibitor that works against the hepatitis B virus (HBV). Doctors use it to treat chronic hepatitis B virus infection in adults whose liver disease is compensated.
What are the side effects of Telabee 25?
Other sections of the labeling discuss these adverse reactions with Tenofovir Alafenamide: lactic acidosis or severe hepatomegaly with steatosis, severe acute exacerbation of hepatitis B, and new onset or worsening of renal impairment. The most common side effects are headache, stomach pain, tiredness, cough, nausea and back pain.
Can I take Telabee 25 during pregnancy or while breastfeeding?
Pregnancy: Based on prospective reports to the APR, over 660 exposures to TAF-containing regimens during pregnancy ended in live births (over 520 exposed in the first trimester and over 130 exposed in the second/third trimester). Birth defects were seen in 4.2% of live births (95% CI: 2.6% to 6.3%) after first trimester exposure and in 3.0% (95% CI: 0.8% to 7.5%) after second/third trimester exposure to TAF-containing regimens. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Telabee 25?
If someone takes an overdose of Tenofovir Alafenamide, watch the patient for any signs of toxicity. Treatment is general supportive care, which means monitoring vital signs and observing the patient's clinical status. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Telabee 25?
Store Tenofovir Alafenamide below 30°C. Keep it in its original container and protect it from light.
Can I take other medicines with Telabee 25?
Some medicines can interact with Tenofovir Alafenamide, for example: Gentamicin, Valacyclovir, Ganciclovir, Acyclovir. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Telabee 25?
Telabee 25 is a prescription (Rx) medicine. Take it as your doctor advises.