Celsentri 150mg 60film tablets 

Pfizer 

1,387.85 

1,374.11 

1,067.58 

Each film-coated tablet contains 150 mg of maraviroc. Excipients Each 150 mg film-coated tablet contains 0.84 mg of soya lecithin 

CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatmentexperienced adult patients infected with only CCR5-tropic HIV-1 detectable. This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients. 

Hypersensitivity to the active substance or to peanut or soya or to any of the excipients. 

Therapy should be initiated by a physician experienced in the management of HIV infection. Before taking CELSENTRI it has to be confirmed that only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample. The Monogram Trofile assay was used in the clinical studies of CELSENTRI.Other phenotypic and genotypic assays are currently being evaluated. The viral tropism cannot be safely predicted by treatment history and assessment of stored samples. There are currently no data regarding the reuse of CELSENTRI in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on CELSENTRI (or other CCR5 antagonists) with a CXCR4 or dual/mixed tropic virus. There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients. Alternative treatment options should be considered. Adults: the recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice daily depending on interactions with co-administered antiretroviral therapy and other medicinal products. CELSENTRI can be taken with or without food. Children: CELSENTRI is not recommended for use in children due to lack of data on safety, efficacy and pharmacokinetics. Elderly: there is limited experience in patients >65 years of age, therefore CELSENTRI should be used with caution in this population. Renal impairment: dosage adjustment is only recommended in patients with renal impairment who are receiving potent CYP3A4 inhibitors such as: • protease inhibitors (except tipranavir/ritonavir) • ketoconazole, itraconazole, clarithromycin, telithromycin. CELSENTRI should be used with caution in patients with renal impairment (CLcr < 80ml/min) who are taking potent CYP3A4 inhibitors.