USATENVIR 300

COMPOSITION: Each film-coated tablet contains:

Tenofovir disoproxil fumarat……………………..300 mg

Excipients: Lactose, Microcrystalline cellulose, Pregelatinised starch, Croscarmellose sodium, Magnesi stearat, Opadry II white, Brilliant blue lake q.s one tablet.

INDICATIONS

• USATENVIR 300 is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
• USATENVIR 300 is indicated in combination with other antiretroviral agents for postexposure prophylaxis of HIV infection (occupational / non-occupational exposure) in individuals associated with a risk for transmission of the virus.
• USATENVIR 300 is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

DOSAGE AND ADMINISTRATION

Take USATENVIR 300 with a full glass of water.

Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (≥ 35 kg)

• For the treatment of HIV-1 or chronic hepatitis B: 300mg USATENVIR 300 tablet once daily taken orally, without regard to food.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.

• Postexposure prophylaxis following occupational or nonoccupational exposure to HIV: 1 tablet once daily in combination with other antiretroviral agents. 

Postexposure prophylaxis should be started as soon as possible following exposure (preferably within hours rather than days) and continued for 4 weeks, if tolerated.

Recommended Dose in Pediatric Patients 2 Years to Less Than 12 Years of Age

For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of USATENVIR 300 is 8mg/kg (up to a maximum of 300 mg) once daily, without regard to food. Weight should be monitored periodically and the USATENVIR 300 dose adjusted accordingly.

Dosing recommendations for pediatric patients ≥ 2 years of age and weighing ≥ 17 kg using USATENVIR 300tablet

Safety and efficacy of Tenofovir disoproxil fumarate in chronic hepatitis B patients younger than 12 years of age have not been established.

Dose Adjustment for Renal Impairment in Adults

The dosing interval of USATENVIR 300 tablets 300 mg should be adjusted in renal impairment patients with baseline creatinine clearance (CC) as follows:

• CC ≥ 50 ml/minute: usual once-daily dosage
• CC 30 to 49 ml/minute: every 48 hours
• CC 10 to 29 ml/minute: every 72 to 96 hours

Haemodialysis patients: a dose every 7 days or after a cumulative total of 12 hours of dialysis.

The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients.

No dose adjustment of USATENVIR 300 is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment.

No dosing recommendation is available for non-hemodialysis patients with creatinine clearance below 10 mL/min.

Dose Adjustment for Hepatic Impairment in Adults

No change in USATENVIR 300 dosing is required in patients with hepatic impairment.

CONTRAINDICATIONS

Hypersensitivity to tenofovir disoproxil fumarate or to any of the excipients listed in the composition.

WARNINGS AND PRECAUTIONS

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) were reported with the use of nucleoside analogs in combination with other antiretrovirals. Monitor patient for signs and symptoms of lactic acidosis.

Severe acute exacerbations of HBV have been reported in HBV-infected patients who have discontinued anti–hepatitis B therapy, including tenofovir. Monitor hepatic function closely with clinical and laboratory follow-up for at least several months in patients who discontinue tenofovirand are coinfected with HIV and HBV. If appropriate, resumption of anti–hepatitis B therapy may be warranted. Test HIV patients for chronic HBV before starting antiretroviral therapy. Test HBV patients for HIV-1 before starting therapy.

Monitor renal function and serum phosphorous in patients at risk of or with a history of renal dysfunction and in patients receiving nephrotoxic agents.

Reduction in bone mineral density and fractures has been reported. Ensure that supplementation with calcium and vitamin D has been considered in patients with HIV-associated osteopenia or osteoporosis. Monitor bone density in HIV-infected patients with history of pathologic bone fracture or who are at risk of osteoporosis or bone loss.

Accumulation and redistribution of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, may occur.

Immune reconstitution syndrome:During the initial phase of therapy, a patient whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections. Autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution syndrome.

Pregnancy:There are no adequate and well-controlled studies in pregnant women.

HIV-1-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1. Tenofovir is secreted in human milk.

PRESENTATION: Blister of 10 film-coated tablets; box of 3 blisters. 

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203