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Viread

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Viread

INDICATIONS

HIV-1 Infection

VIREAD® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.

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 ATRIPLA®, COMPLERA® , STRIBILD®, or TRUVADA® [See WARNINGS AND PRECAUTIONS].

Chronic Hepatitis B

VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

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

  • The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-na´ve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies].
  • VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease [See ADVERSE REACTIONS, Clinical Studies].
  • The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology, Clinical Studies].

DOSAGE AND ADMINISTRATION

Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)

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

For patients unable to swallow VIREAD tablets, the oral powder formulation (7.5 scoops) may be used.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.

Recommended Dose in Pediatric Patients 2 Years to Less Than 12 Years of Age

HIV-1 Infection

For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of VIREAD is 8 mg of tenofovir disoproxil fumarate per kilogram of body weight (up to a maximum of 300 mg) once daily administered as oral powder or tablets.

VIREAD oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder which contains 40 mg of tenofovir disoproxil fumarate. VIREAD 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 immediately to avoid a bitter taste. Do not administer VIREAD oral powder in a liquid as the powder may float on top of the liquid even after stirring. Further patient instructions on how to administer VIREAD oral powder with the supplied dosing scoop are provided in the FDA-approved patient labeling (Patient Information).

VIREAD is also available as tablets in 150, 200, 250 and 300 mg strengths for pediatric patients who weigh greater than or equal to 17 kg and who are able to reliably swallow intact tablets. The dose is one tablet once daily taken orally, without regard to food.

Tables 1 and 2 contain dosing recommendations for VIREAD oral powder and tablets based on body weight. Weight should be monitored periodically and the VIREAD dose adjusted accordingly.

Table 1 : Dosing Recommendations for Pediatric Patients ≥ 2 Years of Age Using

Body Weight Kilogram (kg) Oral Powder Once Daily Scoops of Powder
10 to < 12 2
12 to < 14 2.5
14 to < 17 3
17 to < 19 3.5
19 to < 22 4
22 to < 24 4.5
24 to < 27 5
27 to < 29 5.5
29 to < 32 6
32 to < 34 6.5
34 to < 35 7
≥ 35 7.5

Table 2 : Dosing Recommendations for Pediatric Patients ≥ 2 Years of Age and Weighing ≥ 17 kg Using VIREAD Tablets

Body Weight Kilogram (kg) Tablets Once Daily
17 to < 22 150 mg
22 to < 28 200 mg
28 to < 35 250 mg
≥ 35 300 mg

Chronic Hepatitis B

Safety and efficacy of VIREAD in patients younger than 12 years of age have not been established.

Dose Adjustment for Renal Impairment in Adults

Significantly increased drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment [See CLINICAL PHARMACOLOGY]. Therefore, the dosing interval of VIREAD tablets 300 mg should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 3. 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]. There are no data to recommend use of VIREAD tablets 150, 200 or 250 mg or VIREAD oral powder in patients with renal impairment.

No dose adjustment of VIREAD tablets 300 mg is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See WARNINGS AND PRECAUTIONS].

Table 3 : Dosage Adjustment for Patients with Altered Creatinine Clearance

  Creatinine Clearance (mL/min)a Hemodialysis Patients
≥ 50 30–49 10–29
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 dialysisb
a Calculated using ideal (lean) body weight.
b Generally 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 below 10 mL/min; therefore, no dosing recommendation is available for these patients.

No data are available to make dose recommendations in pediatric patients with renal impairment.

HOW SUPPLIED

Dosage Forms And Strengths

VIREAD is available as tablets or as an oral powder.

VIREAD tablets 150 mg contain 150 mg of tenofovir disoproxil fumarate, which is equivalent to 123 mg of tenofovir disoproxil. The tablets are triangle-shaped, white, film-coated, and debossed with “GSI” on one side and “150” on the other side.

VIREAD tablets 200 mg contain 200 mg of tenofovir disoproxil fumarate, which is equivalent to 163 mg of tenofovir disoproxil. The tablets are round-shaped, white, film-coated, and debossed with “GSI” on one side and “200” on the other side.

VIREAD tablets 250 mg contain 250 mg of tenofovir disoproxil fumarate, which is equivalent to 204 mg of tenofovir disoproxil. The tablets are capsule-shaped, white, film-coated, and debossed with “GSI” on one side and “250” on the other side.

VIREAD tablets 300 mg contain 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.

The oral powder consists of white, taste-masked, coated granules containing 40 mg of tenofovir disoproxil fumarate, which is equivalent to 33 mg of tenofovir disoproxil, per level scoop. Each level scoop contains 1 gram of oral powder.

Storage And Handling

Tablets

VIREAD tablets, 150 mg, are triangle-shaped, white, film-coated tablets containing 150 mg of tenofovir disoproxil fumarate, which is equivalent to 123 mg of tenofovir disoproxil, are debossed with “GSI” on one side and with “150” on the other side. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0404-1)

VIREAD tablets, 200 mg, are round-shaped, white, film-coated tablets containing 200 mg of tenofovir disoproxil fumarate, which is equivalent to 163 mg of tenofovir disoproxil, are debossed with “GSI” on one side and with “200” on the other side. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0405-1)

VIREAD tablets, 250 mg, are capsule-shaped, white, film-coated tablets containing 250 mg of tenofovir disoproxil fumarate, which is equivalent to 204 mg of tenofovir disoproxil, are debossed with “GSI” on one side and with “250” on the other side. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0406-1)

VIREAD tablets, 300 mg, are almond-shaped, light blue, film-coated tablets containing 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. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0401-1)

Oral Powder

VIREAD oral powder consists of white, coated granules containing 40 mg of tenofovir disoproxil fumarate, which is equivalent to 33 mg of tenofovir disoproxil, per gram of powder and is available in multi-use bottles containing 60 grams of oral powder, closed with a child-resistant closure, and co-packaged with a dosing scoop. (NDC 619580403-1)

Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15– 30 °C (59–86 °F) (see USP Controlled Room Temperature).

Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.

Manufactured for and distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Revised October 2013.

Last reviewed on RxList: 11/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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