Tenofovir Dosage

This dosage information may not include all the information needed to use Tenofovir safely and effectively. See additional information for Tenofovir.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

300 mg orally once a day

Usual Adult Dose for Chronic Hepatitis B

300 mg orally once a day
The optimum duration of treatment is not known.

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

Centers for Disease Control and Prevention (CDC) recommendations: 300 mg orally once a day plus efavirenz plus (emtricitabine or lamivudine)

Duration: 28 days

Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection

2 to less than 12 years: 8 mg/kg orally once a day
Maximum: 300 mg/dose

Dosage based on body weight for pediatric patients 2 years or older:
Using oral powder:
10 to less than 12 kg: 80 mg (2 scoops of powder) orally once a day
12 to less than 14 kg: 100 mg (2.5 scoops of powder) orally once a day
14 to less than 17 kg: 120 mg (3 scoops of powder) orally once a day
17 to less than 19 kg: 140 mg (3.5 scoops of powder) orally once a day
19 to less than 22 kg: 160 mg (4 scoops of powder) orally once a day
22 to less than 24 kg: 180 mg (4.5 scoops of powder) orally once a day
24 to less than 27 kg: 200 mg (5 scoops of powder) orally once a day
27 to less than 29 kg: 220 mg (5.5 scoops of powder) orally once a day
29 to less than 32 kg: 240 mg (6 scoops of powder) orally once a day
32 to less than 34 kg: 260 mg (6.5 scoops of powder) orally once a day
34 to less than 35 kg: 280 mg (7 scoops of powder) orally once a day
35 kg or greater: 300 mg (7.5 scoops of powder) orally once a day

Using tablets:
17 to less than 22 kg: 150 mg orally once a day
22 to less than 28 kg: 200 mg orally once a day
28 to less than 35 kg: 250 mg orally once a day
35 kg or greater: 300 mg orally once a day

Weight should be monitored periodically and the tenofovir dose should be adjusted accordingly.

12 years or older (35 kg or more): 300 mg orally once a day

Usual Pediatric Dose for Chronic Hepatitis B

12 years or older (35 kg or more): 300 mg orally once a day
The optimum duration of treatment is not known.

Renal Dose Adjustments

Adults:
300 mg tablets:
CrCl 30 to 49 mL/min: 300 mg orally every 48 hours
CrCl 10 to 29 mL/min: 300 mg orally every 72 to 96 hours
CrCl less than 10 mL/min (non-hemodialysis): Data not available

Safety and efficacy of these dosing guidelines have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients.

150 mg tablets, 200 mg tablets, 250 mg tablets, and oral powder: Data not available

Pediatric patients: Data not available

Liver Dose Adjustments

No adjustment recommended.

Precautions

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs, including tenofovir, in combination with other antiretroviral agents. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment should be suspended in any patient who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued antihepatitis B treatment, including tenofovir. HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after discontinuation of tenofovir. If appropriate, resumption of antihepatitis B therapy may be necessary.

Patients coinfected with HIV-1 and HBV should use tenofovir in combination with other antiretroviral agents due to the risk of developing HIV-1 resistance. HIV-1 antibody testing should be offered to all patients before starting HBV treatment with tenofovir. It is also recommended that all patients with HIV-1 be tested for chronic HBV before starting tenofovir therapy.

Renal impairment, including acute renal failure and Fanconi syndrome, has been reported with tenofovir. Creatinine clearance should be calculated in all patients before starting tenofovir treatment and during treatment when clinically appropriate. Routine monitoring of calculated creatinine clearance and serum phosphorus is recommended for patients at risk of or with a history of renal dysfunction, including patients with previous renal events while using adefovir. Tenofovir should be avoided in patients who are currently using or have recently used nephrotoxic drugs.

Tenofovir has been associated with decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism in HIV-1 infected patients. Assessment of BMD should be considered for patients who have a history of pathological bone fracture or other risk factors for osteoporosis or bone loss. Consultation is recommended if bone abnormalities are suspected or observed.

Immune reconstitution syndrome has occurred in HIV-infected patients during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Clinical studies of tenofovir did not contain sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Tenofovir should always be used in combination with other antiretroviral agents in HIV-1-infected patients.

Related drugs not for coadministration with tenofovir include emtricitabine-tenofovir, efavirenz/emtricitabine/tenofovir, cobicistat/elvitegravir/emtricitabine/tenofovir, and emtricitabine/rilpivirine/tenofovir, in which tenofovir is one of the active components. Tenofovir should not be administered in combination with adefovir dipivoxil.

The potential for HIV-1 and HBV cross-resistance among reverse transcriptase inhibitors exists but has not been fully explored. It is unknown what effect therapy will have on the activity of subsequently administered nucleoside reverse transcriptase inhibitors (NRTIs). Selection of antiretroviral agents for a patient's medication regimen should be done carefully and in consultation with an infectious disease specialist.

During clinical trials, regimens containing only 3 NRTIs have generally been less successful than 3-drug regimens containing 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor or an HIV-1 protease inhibitor. Early virological failure and high rates of resistance substitutions have been reported. Triple nucleoside therapy should be used with caution. Careful monitoring and treatment modification should be considered for patients using such a regimen.

Safety and effectiveness of tenofovir for treatment of HIV-1 have not been established in pediatric patients less than 2 years of age. Safety and effectiveness of tenofovir for treatment of chronic HBV have not been established in pediatric patients less than 12 years of age or less than 35 kg.

Dialysis

Adults:
300 mg tablets:
Hemodialysis: 300 mg orally every 7 days or after a total of about 12 hours of dialysis; generally once a week assuming three hemodialysis sessions a week of about 4 hours duration

Tenofovir should be given after a hemodialysis session.

Peritoneal dialysis: Data not available

150 mg tablets, 200 mg tablets, 250 mg tablets, and oral powder: Data not available

Pediatric patients: Data not available

Other Comments

Tenofovir is indicated for combination use with other antiretroviral agents in HIV-1-infected patients.

The dosage is expressed in terms of tenofovir disoproxil fumarate (DF).

Tenofovir may be given without regard to food.

Patients who are unable to reliably swallow intact tablets may use the oral powder formulation.

Tenofovir oral powder should be measured only with the provided dosing scoop. One level scoop (1 g of powder) contains 40 mg of tenofovir DF. The oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing (e.g., applesauce, baby food, yogurt). The entire mixture should be ingested at once to avoid a bitter taste. Tenofovir oral powder should not be administered in a liquid as the powder may float on top of the liquid even after stirring.

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