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Viread (Tenofovir Disoproxil Fumarate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

HIV-1 Infection

VIREAD® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection:

  • VIREAD should not be used in combination with TRUVADA® or ATRIPLA® [ See Warnings and Precautions ].

Chronic Hepatitis B

VIREAD is indicated for the treatment of chronic hepatitis B in adults.

The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

  • This indication is based on data from one year of treatment in primarily nucleoside-treatment-naive adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Efficacy in Patients with Chronic Hepatitis B].
  • The numbers of patients in clinical trials who were nucleoside-experienced or who had lamivudine-associated mutations at baseline were too small to reach conclusions of efficacy [See Clinical Efficacy in Patients with Chronic Hepatitis B].
  • VIREAD has not been evaluated in patients with decompensated liver disease.

DOSAGE AND ADMINISTRATION

Recommended Dose

For the treatment of HIV-1 or chronic hepatitis B: The dose of VIREAD is 300 mg once daily taken orally, without regard to food.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown.

Dose Adjustment for Renal Impairment

Significantly increased drug exposures occurred when VIREAD was administered to patients with moderate to severe renal impairment [See Clinical Pharmacology]. Therefore, the dosing interval of VIREAD should be adjusted in patients with baseline creatinine clearance <50 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions].

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50—80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment [See Warnings and Precautions].

Table 1 Dosage Adjustment for Patients with Altered Creatinine Clearance
Creatinine Clearance
(mL/min)Calculated using ideal (lean) body weight.
≥50 30—49 10—29 Hemodialysis Patients
Recommended 300 mg Dosing Interval Every 24 hours Every 48 hours Every 72 to 96 hours Every 7 days or after a total of approximately 12 hours of dialysisGenerally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis.

The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients.

DOSAGE FORMS AND STRENGTHS

VIREAD is available as tablets. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. The tablets are almond-shaped, light blue, film-coated, and debossed with "GILEAD" and "4331" on one side and with "300" on the other side.

HOW SUPPLIED/STORAGE AND HANDLING

The almond-shaped, light blue, film-coated tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with "GILEAD" and "4331" on one side and with "300" on the other side, and are available in unit of use bottles (containing a desiccant [silica gel canister or sachet] and closed with a child-resistant closure) of:

  • 30 tablets (NDC 61958—0401—1)

Store at 25 C (77 F), excursions permitted to 15—30 C (59—86 F) (see USP Controlled Room Temperature).

Do not use if seal over bottle opening is broken or missing.

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