Usual Adult Dose for HIV Infection

Tenofovir disoproxil fumarate (DF): 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

Tenofovir alafenamide: 25 mg orally once a day
Tenofovir DF: 300 mg orally once a day

Comments:

• Tenofovir DF: Optimum duration of therapy is unknown.

Uses:

• Tenofovir alafenamide: For the treatment of chronic HBV infection in patients with compensated liver disease
• Tenofovir DF: For the treatment of chronic HBV

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:
Tenofovir DF: 300 mg orally once a day
Duration of therapy: 28 days, if tolerated

Comments:

• This drug and emtricitabine (as emtricitabine-tenofovir 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:
Tenofovir DF: 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.
• Dolutegravir is not recommended in nonpregnant females of reproductive potential who are not using effective contraception or in pregnant women who are not at least 8 weeks from last menstrual period.
• 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

Tenofovir DF:
2 years or older:

• Weight at least 10 to 35 kg: 8 mg/kg orally once a day
• Maximum dose: 300 mg/dose
• Weight at least 35 kg: 300 mg orally once a day

Dose based on body weight for pediatric patients 2 years or older:
ORAL POWDER:

• Weight 10 to less than 12 kg: 80 mg (2 scoops of powder) orally once a day
• Weight 12 to less than 14 kg: 100 mg (2.5 scoops of powder) orally once a day
• Weight 14 to less than 17 kg: 120 mg (3 scoops of powder) orally once a day
• Weight 17 to less than 19 kg: 140 mg (3.5 scoops of powder) orally once a day
• Weight 19 to less than 22 kg: 160 mg (4 scoops of powder) orally once a day
• Weight 22 to less than 24 kg: 180 mg (4.5 scoops of powder) orally once a day
• Weight 24 to less than 27 kg: 200 mg (5 scoops of powder) orally once a day
• Weight 27 to less than 29 kg: 220 mg (5.5 scoops of powder) orally once a day
• Weight 29 to less than 32 kg: 240 mg (6 scoops of powder) orally once a day
• Weight 32 to less than 34 kg: 260 mg (6.5 scoops of powder) orally once a day
• Weight 34 to less than 35 kg: 280 mg (7 scoops of powder) orally once a day
• Weight at least 35 kg: 300 mg (7.5 scoops of powder) orally once a day

TABLETS:

• Weight 17 to less than 22 kg: 150 mg orally once a day
• Weight 22 to less than 28 kg: 200 mg orally once a day
• Weight 28 to less than 35 kg: 250 mg orally once a day
• Weight at least 35 kg: 300 mg orally once a day

Comments:

• Weight should be monitored periodically and the dose should be adjusted accordingly.
• The optimum duration of chronic HBV therapy is unknown.

Uses:

• For the treatment of chronic HBV
• In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Chronic Hepatitis B

Tenofovir DF:
2 years or older:

• Weight at least 10 to 35 kg: 8 mg/kg orally once a day
• Maximum dose: 300 mg/dose
• Weight at least 35 kg: 300 mg orally once a day

Dose based on body weight for pediatric patients 2 years or older:
ORAL POWDER:

• Weight 10 to less than 12 kg: 80 mg (2 scoops of powder) orally once a day
• Weight 12 to less than 14 kg: 100 mg (2.5 scoops of powder) orally once a day
• Weight 14 to less than 17 kg: 120 mg (3 scoops of powder) orally once a day
• Weight 17 to less than 19 kg: 140 mg (3.5 scoops of powder) orally once a day
• Weight 19 to less than 22 kg: 160 mg (4 scoops of powder) orally once a day
• Weight 22 to less than 24 kg: 180 mg (4.5 scoops of powder) orally once a day
• Weight 24 to less than 27 kg: 200 mg (5 scoops of powder) orally once a day
• Weight 27 to less than 29 kg: 220 mg (5.5 scoops of powder) orally once a day
• Weight 29 to less than 32 kg: 240 mg (6 scoops of powder) orally once a day
• Weight 32 to less than 34 kg: 260 mg (6.5 scoops of powder) orally once a day
• Weight 34 to less than 35 kg: 280 mg (7 scoops of powder) orally once a day
• Weight at least 35 kg: 300 mg (7.5 scoops of powder) orally once a day

TABLETS:

• Weight 17 to less than 22 kg: 150 mg orally once a day
• Weight 22 to less than 28 kg: 200 mg orally once a day
• Weight 28 to less than 35 kg: 250 mg orally once a day
• Weight at least 35 kg: 300 mg orally once a day

Comments:

• Weight should be monitored periodically and the dose should be adjusted accordingly.
• The optimum duration of chronic HBV therapy is unknown.

Uses:

• For the treatment of chronic HBV
• In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure

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

Tablets:

• Weight 17 to less than 22 kg: 150 mg orally once a day
• Weight 22 to less than 28 kg: 200 mg orally once a day
• Weight 28 to less than 35 kg: 250 mg orally once a day
• Weight 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.
• Dolutegravir is not recommended in nonpregnant females of reproductive potential who are not using effective contraception or in pregnant women who are not at least 8 weeks from last menstrual period.
• 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

Tenofovir alafenamide:

• Estimated CrCl at least 15 mL/min: No adjustment recommended.
• ESRD (estimated CrCl less than 15 mL/min) not receiving chronic hemodialysis: Not recommended.

Tenofovir DF:
Adults:

• 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

Pediatric patients: Data not available

Comments (tenofovir DF):

• No safety or efficacy data available in patients with renal dysfunction who received this drug using these dosing guidelines; potential benefit of therapy should be weighed against potential risk of renal toxicity.
• 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

Tenofovir alafenamide:

• Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
• Decompensated (Child-Pugh B or C) liver dysfunction: Not recommended.

Tenofovir DF: No adjustment recommended.

Precautions

US BOXED WARNINGS:

• POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B (TENOFOVIR ALAFENAMIDE): Severe acute exacerbations of hepatitis B may occur when antihepatitis B therapy, including this drug, is stopped. 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, resumption of antihepatitis B therapy may be necessary.
• POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B (TENOFOVIR DF): Severe acute exacerbations of HBV reported in HBV-infected patients after stopping antihepatitis B therapy, including 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.

CONTRAINDICATIONS: None

Tenofovir alafenamide: Safety and efficacy have not been established in patients younger than 18 years.
Tenofovir DF: Safety and efficacy have not been established in patients younger than 2 years or less than 10 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Tenofovir alafenamide:

• ESRD (estimated CrCl less than 15 mL/min) receiving chronic hemodialysis: No adjustment recommended.

Tenofovir DF:
Adults:

• Hemodialysis: 300 mg orally every 7 days or after a total of about 12 hours of dialysis
• Peritoneal dialysis: Data not available

Pediatric patients: Data not available

Comments:

• On days of hemodialysis, this drug should be administered after hemodialysis completed.
• Tenofovir DF: Generally used once a week, assuming three 4-hour hemodialysis sessions a week
• Tenofovir DF: No safety or efficacy data available in patients with renal dysfunction who received this drug using these dosing guidelines; potential benefit of therapy should be weighed against potential risk of renal toxicity.

Other Comments

Administration advice:

• Tenofovir alafenamide: Test patients for HIV-1 infection before starting this drug; do not use this drug alone in patients with HIV-1 infection.
• Tenofovir alafenamide: In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before/when starting this drug and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
• Tenofovir alafenamide: Administer with food.
• Tenofovir DF: Test patients for HBV infection and HIV-1 infection before/when starting this drug; do not use this drug alone in patients with HIV-1 infection.
• Tenofovir DF: In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before starting and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
• Tenofovir DF: May administer without regard to food
• Tenofovir DF: May use the oral powder formulation for patients unable to reliably swallow intact tablets
• Tenofovir DF: After mixing the oral powder with soft food, ingest the entire 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:

• Dispense only in original container; keep bottle tightly closed.
• Tenofovir alafenamide: Store below 30C (86F).
• Tenofovir DF: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

Reconstitution/preparation techniques (tenofovir DF):

• 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.

Monitoring:

• General: Weight in pediatric patients (periodically)
• Hepatic: Hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
• Infections/Infestations: For HIV-1 infection (before starting tenofovir alafenamide); for HBV infection and HIV-1 infection (before/when starting tenofovir DF)
• Metabolic: Serum phosphorus in patients with chronic kidney disease (before/when starting therapy and as clinically appropriate during therapy)
• Musculoskeletal: Bone mineral density in patients using tenofovir DF with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
• Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before/when starting therapy and as clinically appropriate during therapy); renal function in patients with CrCl less than 50 mL/min using tenofovir DF

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information [tenofovir alafenamide]; Patient Information and Instructions for Use [tenofovir DF]).
• If you have HBV (with or without HIV), do not stop this drug without consulting healthcare provider.
• Avoid taking tenofovir DF with concurrent/recent use of nephrotoxic agents.
• Contact healthcare provider at once and stop this drug if symptoms suggesting lactic acidosis or pronounced hepatotoxicity develop.
• Notify healthcare provider at once of any symptoms of infection.
• Take this drug on a regular dosing schedule; do not miss or skip doses as resistance may develop.