Vitekta

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Vitekta must be administered in combination with a ritonavir-boosted protease inhibitor. The Summary of Product Characteristics for the co-administered ritonavir-boosted protease inhibitor should be consulted.

The recommended dose of Vitekta is one 85 mg tablet or one 150 mg tablet taken orally once daily with food. 5). For use of the 150 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 150 mg tablets.

Medicinal product no longer authorised 3 Table 1:

Recommended dosing regimens Dose of Vitekta Dose of co-administered ritonavir-boosted protease inhibitor 85 mg once daily atazanavir 300 mg and ritonavir 100 mg once daily lopinavir 400 mg and ritonavir 100 mg twice daily 150 mg once daily darunavir 600 mg and ritonavir 100 mg twice daily fosamprenavir 700 mg and ritonavir 100 mg twice daily There are no data to recommend the use of Vitekta with dosing frequencies or HIV-1 protease inhibitors other than those presented in Table 1.

Missed dose If the patient misses a dose of Vitekta within 18 hours of the time it is usually taken, the patient should take Vitekta with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Vitekta by more than 18 hours, and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 1 hour of taking Vitekta another tablet should be taken. 2). 2). Hepatic impairment No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).

2). 1). No data are available. 2). The film-coated tablet should not be chewed or crushed.

Summary of the safety profile Assessment of adverse reactions is based on data from a controlled clinical study (GS-US-183-0145) in which 712 HIV-1 infected, antiretroviral treatment-experienced adults received elvitegravir (n = 354) or raltegravir (n = 358) each administered with a background regimen consisting of a fully active ritonavir-boosted protease inhibitor and other antiretroviral agents.

Of these 712 patients, 543 (269 elvitegravir and 274 raltegravir) and 439 (224 elvitegravir and 215 raltegravir) received at least 48 and 96 weeks of treatment, respectively. 0%) (see Table 3). Tabulated summary of adverse reactions Adverse reactions to elvitegravir from clinical study experience are listed in Table 3 below, by body system organ class and frequency.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4). Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.

4). Osteonecrosis Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). 3% of subjects in the raltegravir group. In these subjects, diarrhoea was mild to moderate in severity and did not result in discontinuation of study drug.

Paediatric population No data are available for children below 18 years of age. 2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

General While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.

The use of Vitekta with HIV-1 protease inhibitors or dosing frequencies other than those presented in Table 1 may result in inadequate or elevated plasma levels of elvitegravir and/or the co-administered medicinal products. 1). Elvitegravir has a relatively low genetic barrier to resistance.

1). Co-administration of other medicinal products Elvitegravir is primarily metabolised by CYP3A. Co-administration of Vitekta with strong CYP3A inducers (including St. 5). 5). Due to the need for co-administration of Vitekta with a ritonavir-boosted protease inhibitor, prescribers should consult the Summary of Product Characteristics of the co-administered protease inhibitor and ritonavir for a description of contraindicated medicinal products and other significant drug-drug interactions that may cause potentially life-threatening adverse reactions or loss of therapeutic effect and possible development of resistance.

5). 2).

Co-administration of Vitekta and related active substances:

Vitekta must be used in combination with a ritonavir-boosted protease inhibitor. Vitekta should not be used with a protease inhibitor boosted by another agent as dosing recommendations for such combinations have not been established.

Boosting elvitegravir with an agent other than ritonavir may result in suboptimal plasma concentrations of elvitegravir and/or the protease inhibitor leading to loss of therapeutic effect and possible development of resistance. Vitekta should not be used in combination with products containing elvitegravir or pharmacokinetic boosting agents other than ritonavir.

1. 5): • anticonvulsants: carbamazepine, phenobarbital, phenytoin • antimycobacterials: rifampicin • herbal products: St. John’s wort (Hypericum perforatum)Medicinal product no longer authorised 4