Emtrycytabina i tenofowir dizoproksylu

Truvada

Poniższe sekcje przytoczono z anglojęzycznej charakterystyki, ponieważ to ten dokument nosi rejestrację. Tam, gdzie europejski urząd publikuje tę samą informację po polsku, link znajduje się w źródłach. Sami nie tłumaczymy tekstów urzędowych: błąd tłumaczenia w przeciwwskazaniu byłby groźniejszy niż linijka w obcym języku.

01Zarejestrowane wskazania

• TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.

02Postacie i dawki

• TRUVADA tablets are available in four dose strengths. 100 mg/150 mg Tablets: 100 mg of emtricitabine (FTC) and 150 mg of tenofovir disoproxil fumarate (TDF) (equivalent to 123 mg of tenofovir disoproxil): blue, oval shaped, film coated, debossed with "GSI" on one side and with "703" on the other side.
• Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate, respectively.

03Jak się przyjmuje

• Testing: Prior to or when initiating TRUVADA test for hepatitis B virus infection. Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus.
• HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA, and upon diagnosis of any other sexually transmitted infections (STIs).
• Treatment of HIV-1 Infection Recommended dosage in adults and pediatric patients weighing at least 35 kg: One TRUVADA tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
• Recommended dosage in pediatric patients weighing at least 17 kg: One TRUVADA low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food.
• Recommended dosage in renally impaired HIV-1 infected adult patients: Creatinine clearance (CrCl) 30−49 mL/min: 1 tablet every 48 hours.
• CrCl below 30 mL/min or hemodialysis: TRUVADA is not recommended.

04Nie wolno stosować, gdy

• TRUVADA for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.

05Interakcje

• Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted.
• Coadministration decreases atazanavir concentrations. When coadministered with TRUVADA, use atazanavir given with ritonavir.
• Coadministration of TRUVADA with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.
• Consult Full Prescribing Information prior to and during treatment for important drug interactions.

06Ostrzeżenia i środki ostrożności

• Comprehensive management to reduce the risk of acquiring HIV-1 when TRUVADA is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.
• Management to reduce the risk of acquiring HIV-1 drug resistance when TRUVADA is used for HIV-1 PrEP: refer to full prescribing information for additional detail.
• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs.
• Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment.
• Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.
• Lactic acidosis/severe hepatomegaly with steatosis: Discontinue TRUVADA in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

07Częste działania niepożądane

• Most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

08Ciąża

Data on the use of TRUVADA during pregnancy from observational studies have shown no increased risk of major birth defects. Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S.

09Mechanizm działania

TRUVADA is a fixed-dose combination of antiviral drugs FTC and TDF.

Ta sekcja przytacza zatwierdzoną charakterystykę produktu leczniczego. Tekst jest skrócony na podstawie streszczenia sporządzonego przez sam urząd, a pełny dokument znajduje się w źródłach.