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Tenofovir Dosage

Applies to the following strength(s): 300 mg40 mg/g150 mg200 mg250 mg

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

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Chronic Hepatitis B

300 mg orally once a day
Duration of therapy: Optimum duration unknown

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 300 mg orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-This drug and emtricitabine (as emtricitabine-tenofovir disoproxil fumarate [DF]) plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug is also recommended as a component in various alternative regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the institution protocol.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 300 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug and emtricitabine (as emtricitabine-tenofovir DF) plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adults (including pregnant women) with CrCl at least 60 mL/min; this drug and emtricitabine (as emtricitabine-tenofovir DF) plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

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

12 years or older and at least 35 kg: 300 mg orally once a day

Dose based on body weight for pediatric patients 2 years or older:
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
At least 35 kg: 300 mg (7.5 scoops of powder) orally once a day

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
At least 35 kg: 300 mg orally once a day

Comments:
-Weight should be monitored periodically and the dose should be adjusted accordingly.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Chronic Hepatitis B

12 years or older and at least 35 kg: 300 mg orally once a day
Duration of therapy: Optimum duration unknown

Usual Pediatric Dose for Nonoccupational Exposure

US CDC recommendations:
2 years or older:
Oral powder: 8 mg/kg orally once a day
Maximum dose: 300 mg/dose

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
At least 35 kg: 300 mg orally once a day

Duration of therapy: 28 days

Comments:
-This drug is recommended as a component of a preferred (or alternative) 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection in children (aged 2 to 12 years).
-This drug and emtricitabine (as emtricitabine-tenofovir DF) plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents (13 years or older) with CrCl at least 60 mL/min; this drug and emtricitabine (as emtricitabine-tenofovir DF) plus darunavir/ritonavir is recommended as an alternative regimen for such patients.
-If other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Adults:
300 mg tablets:
-CrCl at least 50 mL/min: No adjustment recommended.
-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

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

Pediatric patients: Data not available

Comments:
-Safety and efficacy of these dosing guidelines have not been clinically evaluated in patients with moderate or severe renal dysfunction; clinical response to therapy and renal function should be closely monitored in these patients.
-According to US CDC recommendations, this drug is considered contraindicated as nonoccupational postexposure prophylaxis in patients with estimated CrCl less than 60 mL/min.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT EXACERBATION OF HEPATITIS B: Severe acute exacerbations of hepatitis reported in HBV-infected patients after stopping this drug. Hepatic function of HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Safety and efficacy have not been established in HIV-1-infected patients younger than 2 years or in HBV-infected patients younger than 12 years or less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Adults:
300 mg tablets:
-Hemodialysis: 300 mg orally every 7 days or after a total of about 12 hours of dialysis
-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

Comments:
-Generally used once a week, assuming three 4-hour hemodialysis sessions a week
-This drug should be administered after hemodialysis completed.
-Safety and efficacy of these dosing guidelines have not been clinically evaluated; clinical response to therapy and renal function should be closely monitored in these patients.

Other Comments

Dose expressed as tenofovir disoproxil fumarate (DF).

Administration advice:
-May administer without regard to food
-May use the oral powder formulation for patients unable to reliably swallow intact tablets
-Ingest the entire oral powder mixture at once to avoid a bitter taste.
-Do not administer the oral powder in a liquid as the powder may float on top of the liquid even after stirring.

Storage requirements:
-Keep in the original container.
-Keep bottle tightly closed.

Reconstitution/preparation techniques:
-The oral powder should be measured only with the provided dosing scoop; 1 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 manufacturer product information should be consulted for additional instructions.

General:
The following should be considered when starting this drug:
-For treatment of HBV infection:
---Adult indication based primarily on safety and efficacy data from treatment of nucleoside-therapy-naive subjects and therapy-experienced subjects with documented resistance to lamivudine; subjects were adults with hepatitis B e antigen (HBeAg)-positive and HBeAg-negative chronic HBV with compensated liver disease.
---This drug was evaluated in few subjects with chronic HBV and decompensated liver disease.
---Efficacy was not established in subjects who had adefovir resistance-associated substitutions at baseline; too few subjects in clinical trials.
-For treatment of HIV infection:
---This drug should not be used with other tenofovir DF-containing products.

Monitoring:
-General: For HIV-1 antibody in all HBV-infected patients (should be offered before therapy); weight in HIV-infected pediatric patients 2 to less than 12 years of age
-Hepatic: Hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Infections/Infestations: For chronic HBV in HIV-1-infected patients (before therapy)
-Metabolic: Serum phosphorus in patients at risk of renal dysfunction (before starting and periodically during therapy) or with mild renal dysfunction (routinely)
-Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: Estimated CrCl in all patients (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in patients at risk of renal dysfunction (before starting and periodically during therapy) or who have mild renal dysfunction (routinely); renal function in patients with CrCl less than 50 mL/min

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).

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