Celsentri

Maraviroc

In combination w/ other antiretroviral agents for the treatment of adult patients infected w/ only CCR5-tropic HIV-1.

Dosing based on concomitant medications due to drug interactions. Must be given in combination w/ other antiretroviral medications. Concomitantly taking potent CYP3A inhibitors (w/ or w/o a potent CYP3A inducer) including PIs (except tipranavir/ritonavir), delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, other potent CYP3A inhibitors (eg, nefazodone, telithromycin), boceprevir 150 mg bd. Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, & enfuvirtide 300 mg bd. Concomitantly taking potent CYP3A inducers (w/o potent CYP3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, pheonbarb, phenytoin 600 mg bd.

May be taken with or without food.

Patients w/ severe renal impairment or end-stage renal disease (CrCl <30 mL/min) on potent CYP3A inducer/inhibitor.

Discontinue immediately if signs or symptoms of severe skin or hypersensitivity reactions develop. Use w/ caution in patients w/ pre-existing liver dysfunction or co-infection w/ HBV &/or HCV; increased risk of CV events; hepatic impairment; elderly. Perform appropriate laboratory testing including ALT, AST & bilirubin, prior to treatment initiation & at other time points during treatment as clinically indicated. Consider discontinuation in any patient w/ signs or symptoms of hepatitis, or w/ increased liver transaminases combined w/ rash or other systemic symptoms. Increased risk of postural hypotension in patients w/ severe renal insufficiency or w/ end-stage renal disease. Reports of immune reconstitution syndrome. Potential risk of infection or malignancy. Pregnancy. Mothers should not breastfeed if taking Celsentri. Should not be used in ped patients. Not recommended in subjects w/ dual/mixed- or CXCR4-tropic HIV-1.

Upper resp tract infections, cough, pyrexia, rash, dizziness.

Decreased maraviroc conc w/ St. John's wort. Pharmacokinetics of maraviroc are likely to be modulated by inhibitors & inducers of CYP3A & P-gp.

Antivirals

J05AX09 - maraviroc ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.

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