Tenofovir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

300 mg orally once a day

Approved indication: 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: The optimum duration is not known.

Usual Adult Dose for Occupational Exposure

(Not approved by FDA)

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

Comments:
-Tenofovir plus emtricitabine plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; tenofovir 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's protocol.
-The most current therapeutic guidelines should be consulted for more information.

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

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

Comments:
-Tenofovir should be used in combination with efavirenz plus (emtricitabine or lamivudine).
-Prophylaxis should be started 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 dose: 300 mg per 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

Comments:
-Weight should be monitored periodically and the tenofovir dose should be adjusted accordingly.
-Safety and efficacy for treatment of HIV-1 have not been established in patients younger than 2 years.

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

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

Usual Pediatric Dose for Chronic Hepatitis B

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

Comments:
-Safety and efficacy for treatment of chronic HBV have not been established in patients younger than 12 years or less than 35 kg.

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 (nonhemodialysis): Data not available

Comments:
-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.

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

Consult WARNINGS section for dosing related precautions.

Dialysis

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

Comments:
-Generally used once a week, assuming 3 hemodialysis sessions a week of about 4 hours duration.
-Tenofovir should be used 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

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

Administration advice:
-May be taken without regard to food
-Patients who are unable to reliably swallow intact tablets may use the oral powder formulation.
-The entire oral powder mixture should be ingested at once to avoid a bitter taste.

Storage requirements:
-Tenofovir should be kept in the original container.
-The bottle should be kept tightly closed.

Reconstitution/preparation techniques:
-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).
-Tenofovir oral powder should not be administered in a liquid as the powder may float on top of the liquid even after stirring.
-The manufacturer's product information should be consulted for additional instructions.

General:
The following should be considered when starting tenofovir 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 HBeAg-positive and HBeAg-negative chronic HBV with compensated liver disease.
-Tenofovir 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.

Monitoring:
-General: HIV-1 antibody testing in all HBV-infected patients (should be offered before therapy)
-Hepatic: For chronic HBV in HIV-1-infected patients (before therapy); hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping 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 with mild renal dysfunction (routinely); renal function in patients with CrCl less than 50 mL/min

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