Viread Access

VIREAD ACCESS- tenofovir disoproxil fumarate tablet, coated
Gilead Sciences, 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 12 years of age and older.

1.2 Chronic Hepatitis B

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

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 12 Years of Age and Older (35 kg or more)

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.

Safety and efficacy in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established.

2.3 Dosage Adjustment in Patients with Renal Impairment

Significant increase in drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment (creatinine clearance below 50 mL/min). Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment 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 1 Dosage Interval Adjustment for Adult Patients with Altered Creatinine Clearance
Creatinine Clearance(mL/min)* Hemodialysis Patients
50 or greater 30–49 10–29
*
Calculated using ideal (lean) body weight.
Generally once weekly assuming 3 hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis.
Recommended 300 mg Dosing Interval Every 24 hours Every 48 hours Every 72 to96 hours Every 7 days or after a total of approximately 12 hours 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 12 years of age and older with renal impairment.

3 DOSAGE FORMS AND STRENGTHS

VIREAD is available as tablets. Each tablet contains 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil. The tablets are almond shaped, white, film coated, and debossed with “GILEAD” and “4331” on one 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 VIREAD [see Dosage and Administration (2.1)].

Discontinuation of anti-HBV therapy, including VIREAD, may be associated with severe acute exacerbations of hepatitis B. Patients infected with HBV who discontinue VIREAD 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.

5.2 New Onset or Worsening Renal Impairment

Tenofovir is principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of VIREAD [see Adverse Reactions (6.2)].

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.

Dosing interval adjustment of VIREAD and close monitoring of renal function are recommended in all patients with creatinine clearance below 50 mL/min [see Dosage and Administration (2.3)]. No safety or efficacy data are available in patients with renal impairment who received VIREAD using these dosing guidelines, so the potential benefit of VIREAD therapy should be assessed against the potential risk of renal toxicity.

VIREAD should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs]) [see Drug Interactions (7.1)]. Cases of acute renal failure after initiation of high dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on TDF. Some patients required hospitalization and renal replacement therapy. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.

Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in patients at risk of renal dysfunction.

5.3 Patients Coinfected with HIV-1 and HBV

Due to the risk of development of HIV-1 resistance, VIREAD should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.

HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy with VIREAD. It is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating treatment with VIREAD.

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