EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA

Emtricitabine/Tenofovir disoproxil Teva should be initiated by a physician experienced in the management of HIV infection. Posology Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.

Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily. Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Emtricitabine/Tenofovir disoproxil Teva.

Please refer to the Summary of Product Characteristics for these medicinal products. If a dose of Emtricitabine/Tenofovir disoproxil Teva is missed within 12 hours of the time it is usually taken, Emtricitabine/Tenofovir disoproxil Teva should be taken as soon as possible and the normal dosing schedule should be resumed.

If a dose of Emtricitabine/Tenofovir disoproxil Teva is missed by more than 12 hours and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed. If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Teva, another tablet should be taken.

If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Teva a second dose should not be taken. 2). 2).

Adults with renal impairment:

Emtricitabine/Tenofovir disoproxil Teva should only be used in individuals with creatinine clearance (CrCl) < 80 mL/min if the potential benefits are considered to outweigh the potential risks. See Table 1. 4). Limited data from clinical studies support once daily dosing of emtricitabine and tenofovir in HIV-1 uninfected individuals with CrCl 60-80 mL/min.

2). 4). Emtricitabine/Tenofovir disoproxil Teva is not recommended for use in this population. Severe renal impairment (CrCl < 30mL/min) and haemodialysis patients Emtricitabine/Tenofovir disoproxil Teva is not recommended because appropriate dose reductions cannot be achieved with the combination tablet.

Emtricitabine/Tenofovir disoproxil Teva is not recommended for use in this population. 4). 2). 2). Method of administration Oral administration. It is preferable that Emtricitabine/Tenofovir disoproxil Teva is taken with food. Emtricitabine/Tenofovir disoproxil Teva can be disintegrated in approximately 100 mL of water, orange juice or grape juice and taken immediately.

1). Overall HIV-1 infection prevention strategy The combination of emtricitabine and tenofovir disoproxil is not always effective in preventing the acquisition of HIV-1. The time to onset of protection after commencing the combination of emtricitabine and tenofovir is unknown.

g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections). 3). g. at least every 3 months) using a combined antigen/antibody test while taking Emtricitabine/Tenofovir disoproxil Teva for pre-exposure prophylaxis.

Emtricitabine/Tenofovir disoproxil Teva alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking the combination of emtricitabine and tenofovir.

If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Teva should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Teva for pre-exposure prophylaxis.

Importance of adherence:

HIV-1 uninfected individuals should be counselled to strictly adhere to the recommended Emtricitabine/Tenofovir disoproxil Teva dosing schedule. The effectiveness of the combination of emtricitabine and tenofovir in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood.

Patients with hepatitis B or C virus infection HIV-1 infected patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).

The safety and efficacy of the combination of emtricitabine and tenofovir for PrEP in patients with HBV or HCV infection has not been established. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.

See also under Use with ledipasvir and sofosbuvir or sofosbuvir and velpatasvir below. Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of the combination of emtricitabine and tenofovir have not been specifically established in patients with chronic HBV infection.

Discontinuation of Emtricitabine/Tenofovir disoproxil Teva therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue Emtricitabine/Tenofovir disoproxil Teva should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

If appropriate, resumption of hepatitis B therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.

Liver disease The safety and efficacy of the combination of emtricitabine and tenofovir disoproxil have not been established in patients with significant underlying liver disorders. The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose adjustment is required.

The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment. 2). HIV-1infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.

If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. Renal and bone effects in adults Renal effects Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.

8). Renal monitoring Prior to initiating Emtricitabine/Tenofovir disoproxil Teva for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis, it is recommended that creatinine clearance is calculated in all individuals.

In individuals without risk factors for renal disease, it is recommended that renal function (creatinine clearance and serum phosphate) is monitored after two to four weeks of use, after three months of use and every three to six months thereafter.

In individuals at risk for renal disease more frequent monitoring of renal function is required. See also under Co-administration […]

1. Use of Emtricitabine/Tenofovir disoproxil Teva for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status.