Tenofovir Disproxil Fumarate

TENOFOVIR DISPROXIL FUMARATE- tenofovir disoproxil fumarate tablet
Major Pharmaceuticals

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 antihepatitis B therapy, including tenofovir disoproxil fumarate. 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 tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].

1 INDICATIONS & USAGE

1.1 HIV-1 Infection

Tenofovir disoproxil fumarate tablets are 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

Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older.

Pediatric use information is approved for Gilead Sciences, Inc.’s VIREAD® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE & ADMINISTRATION

2.1 Testing Prior to Initiation of tenofovir disoproxil fumarate tablet for Treatment of HIV-1 Infection or Chronic Hepatitis B

Prior to or when initiating tenofovir disoproxil fumarate tablets, test patients for HBV infection and HIV-1 infection. Tenofovir disoproxil fumarate tablets alone should not be used in patients with HIV-1 infection [see Warnings and Precautions ( 5.3 )] .
Prior to initiation and during use of tenofovir disoproxil fumarate , 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 tenofovir disoproxil fumarate tablets 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 tenofovir disoproxil fumarate tablet is the same for both HIV and HBV indications.

The recommended dosage of tenofovir disoproxil fumarate 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 tenofovir disoproxil fumarate dose adjusted accordingly.

Table 1 Recommended Dosing for Patients 2 Years and Older and Weighing at Least 17 kg Using Tenofovir Disoproxil Fumarate Tablets

Body Weight (kg)

Dosing of Tenofovir Disoproxil Fumarate 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

2.4 Dosage Adjustment in Patients with Renal Impairment

Significant increase in drug exposures occurred when tenofovir disoproxil fumarate tablets was administered to subjects with moderate to severe renal impairment (creatinine clearance below 50 mL/min). Table 3 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment of tenofovir disoproxil fumarate tablets 300 mg is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min) [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )]. Table 3 Dosage Interval Adjustment for Adult Patients with Altered Creatinine Clearance

Creatinine Clearance (mL/min)a

Hemodialysis Patients

50 or greater

30–49

10–29

Every 7 days or after a total of approximately 12 hours of dialysisb

Recommended 300 mg Dosing Interval

Every 24 hours

Every 48 hours

Every 72 to 96 hours

a. Calculated using ideal (lean) body weight.
b. Generally once weekly assuming 3 hemodialysis sessions a week of approximately 4 hours’ duration. Tenofovir disoproxil fumarate should be administered following completion of dialysis.
No data are available to make dosage recommendations in patients with creatinine clearance below 10 mL/min who are not on hemodialysis.
No data are available to make dosage recommendations in pediatric patients with renal impairment.

3 DOSAGE FORMS & STRENGTHS

Tenofovir disoproxil fumarate is available as tablets.

300 mg Tablets: 300mg of TDF, which is (equivalent to 245 mg of tenofovir disoproxil). The tablets are blue coloured, oval shaped, biconvex, film coated tablets debossed with ‘CL 77’ on one side and plain on other side.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection

All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating tenofovir disoproxil fumarate [see Dosage and Administration ( 2.1 )] .
Discontinuation of anti-HBV therapy, including tenofovir disoproxil fumarate, may be associated with severe acute exacerbations of hepatitis B. Patients infected with HBV who discontinue tenofovir disoproxil fumarate should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.

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