Viread

VIREAD- tenofovir disoproxil fumarate tablet, coated
REMEDYREPACK INC.

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue anti-hepatitis B therapy, including VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)] .

1 INDICATIONS AND USAGE

1.1 HIV-1 Infection

VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.

1.2 Chronic Hepatitis B

VIREAD is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg .

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation of VIREAD for Treatment of HIV-1 Infection or Chronic Hepatitis B

Prior to or when initiating VIREAD, test patients for HBV infection and HIV-1 infection. VIREAD alone should not be used in patients with HIV-1 infection [see Warnings and Precautions (5.3)] .

Prior to initiation and during use of VIREAD, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.2)] .

2.2 Recommended Tablet Dosage in Adults and Pediatric Patients 2 Years and Older Weighing at Least 17 kg

The recommended dosage of VIREAD in adults and pediatric patients weighing at least 35 kg is one 300 mg tablet taken orally once daily without regard to food . The dosage for VIREAD is the same for both HIV and HBV indications.

The recommended dosage of VIREAD tablet in adults and pediatric patients 2 years and older weighing at least 17 kg is 8 mg of tenofovir disoproxil fumarate (TDF) per kg of body weight (up to a maximum of 300 mg) once daily. Dosage for pediatric patients 2 years and older weighing between 17 kg and 35 kg and able to swallow an intact tablet is provided in Table 1. Weight should be monitored periodically and the VIREAD dose adjusted accordingly.

Table 1 Recommended Dosing for Patients 2 Years and Older and Weighing at Least 17 kg Using VIREAD Tablets
Body Weight (kg) Dosing of VIREAD Tablets
17 to less than 22 one 150 mg tablet once daily
22 to less than 28 one 200 mg tablet once daily
28 to less than 35 one 250 mg tablet once daily
at least 35 one 300 mg tablet once daily

2.3 Recommended Oral Powder Dosage in Adults and Pediatric Patients 2 Years and Older Weighing at Least 10 kg

The recommended dosage of VIREAD oral powder in adults and pediatric patients 2 years and older weighing at least 10 kg who are unable to swallow a tablet is 8 mg of TDF per kg of body weight (up to a maximum of 300 mg) once daily administered as oral powder (see Table 2). Weight should be monitored periodically and the VIREAD dose adjusted accordingly.

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 TDF. 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 oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder, which contains 40 mg of TDF. 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).

Table 2 Dosing for Patients 2 Years and Older Weighing at least 10 kg Using VIREAD Oral Powder
Body Weight (kg) Dosing of VIREAD Oral Powder Total Daily Dosage (40 mg per scoop)
10 to less than 12 2 scoops once daily 80 mg
12 to less than 14 2.5 scoops once daily 100 mg
14 to less than 17 3 scoops once daily 120 mg
17 to less than 19 3.5 scoops once daily 140 mg
19 to less than 22 4 scoops once daily 160 mg
22 to less than 24 4.5 scoops once daily 180 mg
24 to less than 27 5 scoops once daily 200 mg
27 to less than 29 5.5 scoops once daily 220 mg
29 to less than 32 6 scoops once daily 240 mg
32 to less than 34 6.5 scoops once daily 260 mg
34 to less than 35 7 scoops once daily 280 mg
at least 35 7.5 scoops once daily 300 mg

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