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Celsentri

Celsentri

maraviroc

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Maraviroc
Indications/Uses
In combination w/ other antiretroviral agents for the treatment of adult patients infected w/ only CCR5-tropic HIV-1.
Dosage/Direction for Use
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. Noninteracting 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.
Administration
May be taken with or without food.
Contraindications
Patients w/ severe renal impairment or ESRD (CrCl <30 mL/min) on potent CYP3A inducer/inhibitor.
Special Precautions
Discontinue immediately if signs or symptoms of severe skin or hypersensitivity reactions develop. Additional monitoring in patients w/ pre-existing liver dysfunction or co-infection w/ HBV &/or HCV; increased risk of CV events. Caution in patients w/ 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/ ESRD. 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 patients w/ dual/mixed- or CXCR4-tropic HIV-1.
Adverse Reactions
Upper resp tract infections, cough, pyrexia, rash, dizziness.
Drug Interactions
Decreased maraviroc conc w/ St. John's wort. Pharmacokinetics of maraviroc are likely to be modulated by inhibitors & inducers of CYP3A & P-gp.
MIMS Class
Antivirals
ATC Classification
J05AX09 - maraviroc ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Celsentri FC tab 150 mg
Packing/Price
60's
Form
Celsentri FC tab 300 mg
Packing/Price
60's
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