Drug Detail:Viread (Tenofovir disoproxil)
Generic Name: TENOFOVIR DISOPROXIL FUMARATE 150mg
Drug Class: Nucleoside reverse transcriptase inhibitors (NRTIs)
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)].
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.
| 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 |
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).
| 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 |
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 3 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment of VIREAD 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)].
| Creatinine Clearance (mL/min)* | Hemodialysis Patients | |||
|---|---|---|---|---|
| 50 or greater | 30–49 | 10–29 | ||
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| 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 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.
