Adult Dosing
Treatment of HIV-1 infection or chronic hepatitis B
- 300 mg PO qd, without regard to food
Notes- Oral powder formulation (7.5 scoops) must be considered if patients are unable to swallow tablets
Pediatric Dosing
Treatment of HIV-1
2 years: 8 mg/kg PO qd as oral powder or tablets. Max: 300mg/day- 17 kgs : 1 tab PO qd. Max: 300mg/day
Notes- Powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing
- Refer to package insert for dosing recommendation based on body weight using tablet and oral powder
Chronic hepatitis B
- 300 mg PO qd, without regard to food
- Safety and efficacy in pediatric patients <12 years of age and weighing <35 kg have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
Adults 18 yrs
- 50 mL/min: 300 mg PO qd
- 30-49 mL/min: 300 mg PO q48 hrs
- 10-29 mL/min: 300 mg PO q72-96 hrs
- <10 mL/min: Dose adjustments not defined
- Hemodialysis: 300 mg PO q7 days (assuming 3 dialysis sessions per week of approximately q4 hrs duration, or after approximately 12 hrs of dialysis). Administered following completion of dialysis
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of nucleoside analogues alone or in combination with other antiretrovirals [US Black Box Warning]. Female gender, obesity and prolonged nucleoside exposure are risk factors
- Exercise caution while administering to any patient with known risk factors for liver disease
- Consider suspension of therapy if clinical or laboratory findings suggest symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Permanently discontinue therapy for patients with confirmed lactic acidosis
- Severe acute exacerbations of hepatitis B have occurred in patients after discontinuation of anti-hepatitis B therapy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months after a patient discontinues therapy. Anti-hepatitis B therapy may be resumed if warranted [US Black Box Warning]
- New onset or worsening renal impairment has occurred. Renal impairment, including cases of acute renal failure and fanconi syndrome (renal tubular injury with severe hypophosphatemia) have occurred with the use of tenofovir
- Calculate creatinine clearance in all patients prior to initiating therapy and as clinically appropriate during therapy. Routinely monitor calculated creatinine clearance and perform serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events. Avoid concurrent use with nephrotoxic agents or in patients recently using nephrotoxic agents
- Adjust dosing interval and closely monitor renal function in all patients with creatinine clearance <50 mL/min. Safety or efficacy data is not established in patients with renal impairment who received this drug using dosing guidelines. Assess potential benefit of therapy against the potential risk of renal toxicity. Avoid administering in patients with creatinine clearance <30 mL/min or patients requiring hemodialysis
- Avoid using in combination with the fixed-dose combination of truvada or atripla. Avoid administering in combination with hepsera
- Avoid use in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen. Test all patients with HIV-1 for the presence of chronic hepatitis B before initiating treatment
- Monitor bone mineral density (BMD) for HIV-1 infected subjects having a history of pathologic bone fracture or having risk for osteopenia. Tenofovir is associated with significant increases in biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C-telopeptide, and urinary N-telopeptide)
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have occurred in patients receiving antiretroviral therapy
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- Early virological failure and high rates of resistance substitutions have occurred
Cautions: Use cautiously in:
- Renal impairment
- Risk of renal disease
- Concurrent use of nephrotoxic agents
- Hepatic impairment
- Risk of hepatic disease
- HIV or HBV co-infection
- Prolonged therapy with nucleoside
- Obesity
- Osteopenia/osteoporosis
- History of pathologic fracture
- Women
Pregnancy Category:B
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Extended antiretroviral prophylaxis has been successfully used as part of a regimen that decreases mother-to-child transmission to half but the optimal regimen and duration of prophylaxis has not yet been defined. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 February 2011). Centers for disease control and prevention recommends mothers avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Viread 300 MG TABS [Bottle] (GILEAD SCIENCES)
30 mg = $836.95
90 mg = $2387.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Viread 300 MG Oral Tablet
Ingredient(s): Tenofovir disoproxil
Imprint: GILEAD;4331;300
Color(s): Blue
Shape: Freeform
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): N/A
Drug Label Author:
Gilead Sciences, Inc.
DEA Schedule:
Non-Scheduled
Drug Name: Viread 300 MG Oral Tablet
Ingredient(s): Tenofovir disoproxil
Imprint: GILEAD;4331;300
Color(s): Blue
Shape: Freeform
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): N/A
Drug Label Author:
State of Florida DOH Central Pharmacy
DEA Schedule:
Non-Scheduled
