CELSENTRI FILM-COATED TABLET 150MG [SIN13640P]

Product Info

CELSENTRI FILM-COATED TABLET 150MG

[SIN13640P]

Indications

Maraviroc, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The following points should be considered when initiating therapy with maraviroc:

• Treatment history should guide the use of CELSENTRI. Tropism testing is required for the appropriate use of maraviroc (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Use of maraviroc is not recommended in patients with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group.

• The safety and efficacy of maraviroc have not been established in treatment-naïve adult patients or pediatric patients.

Dosage and Administration

Pharmaceutical form: Film-coated tablets

Therapy should be initiated by a physician experienced in the management of HIV infection.

Before taking maraviroc 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 maraviroc. 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 maraviroc in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on maraviroc (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 maraviroc in virologically suppressed patients. Alternative treatment options should be considered.

Adults: the recommended dose of maraviroc is 150 mg, 300 mg or 600 mg twice daily depending on interactions with concomitant antiretroviral therapy and other medicinal products (see Table 1 and Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Maraviroc can be taken with or without food.

Children: the safety and efficacy for the use of maraviroc in children younger than 18 years of age have not been established, therefore use in children is not recommended (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly: there is limited experience in patients above 65 years of age. Therefore caution should be exercised when administering maraviroc in elderly patients (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment: dosage adjustment is only recommended in patients with renal impairment who are receiving potent CYP3A inhibitors such as:

• protease inhibitors (except tipranavir/ritonavir and fosamprenavir/ritonavir) (see Table 2).

• boceprevir, telaprevir

• delavirdine, boosted elvitegravir

• ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin.

Maraviroc should be used with caution in patients with severe renal impairment (creatinine clearance < 30 mL/min) who are receiving potent CYP3A inhibitors (see Warnings and Precautions and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Maraviroc should be dosed every 24 hours in renally impaired patients (creatinine clearance < 80 mL/min), including patients with end stage renal disease (ESRD) requiring dialysis, who are receiving maraviroc in combination with potent CYP3A inhibitors (see Warnings and Precautions, Interactions and Pharmacokinetics). These dosing recommendations are based on data from a renal impairment study (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) in addition to modelling of pharmacokinetic data in subjects with varying degrees of renal impairment.

No dose adjustment is necessary for renally impaired patients, including patients with ESRD, requiring dialysis, not receiving a potent CYP3A inhibitor in combination with maraviroc. Table 2 below provides dosing interval adjustment guidelines.

Hepatic impairment: limited data in patients with mild and moderate hepatic impairment demonstrated a small increase in the mean C_max of maraviroc, suggesting no dose adjustment is required. However, maraviroc should be used with caution in patients with hepatic impairment (see Warnings and Precautions and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).