Acriptega Dosage/Direction for Use

Therapy should be prescribed by a physician experienced in the management of HIV-1 infection.
Posology: Adults and adolescents (from 12 years of age and weighing ≥ 40 kg): The recommended dose of Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets in adults and adolescents is one tablet once daily.
Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced.
Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments. Separate preparations of Lamivudine, Tenofovir Disoproxil Fumarate and Dolutegravir are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases the physician should refer to the individual product information for these medicinal products.
Pregnancy Testing before Initiation of Dolutegravir: Perform pregnancy testing before initiation of dolutegravir in adolescents and adults of childbearing potential.
Method of administration: It is recommended that Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets be swallowed whole with water.
Children: Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets is not recommended for use in children below 12 years of age due to a lack of data on safety and efficacy.
Elderly: There are limited data available on the use of Dolutegravir in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see Pharmacology: Pharmacokinetics under Actions). Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets should be administered with caution to elderly patients (see Precautions).
Dose adjustments: Where discontinuation of therapy with one of the components of Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets is indicated or where dose modification is necessary, separate preparations of tenofovir disoproxil fumarate, lamivudine and Dolutegravir are available. Please refer to the Summary of Product Characteristics for these medicinal products.
Renal impairment: Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/min). Patients with moderate or severe renal impairment require dose interval adjustment of lamivudine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The pharmacokinetics of Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets have not been studied in patients with hepatic impairment. Patients should be monitored carefully for adverse reactions.
If Dolutegravir (as sodium)/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see Precautions).