SELZENTRY Rx

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SELZENTRY

Viral infections
Only 4 drugs may be compared at once

Generic Name and Formulations:

Maraviroc 25mg, 75mg, 150mg, 300mg; tabs.

Company:

ViiV Healthcare

Select therapeutic use:

Indications for SELZENTRY:

In combination with other antiretrovirals, in patients ≥2yrs and weighing ≥10kg infected with only CCR5-tropic HIV-1.

Limitations Of use:

Not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.

Adult:

Swallow whole. Concomitant potent CYP3A inhibitors (eg, PIs [except tipranavir/ritonavir], delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, boceprevir) (with or without a potent CYP3A inducer): 150mg twice daily. Noninteracting concomitant drugs, including tipranavir/ritonavir, nevirapine, raltegravir, NRTIs, enfuvirtide: 300mg twice daily. Concomitant potent CYP3A inducers (eg, efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, phenytoin) (without a potent CYP3A inhibitor): 600mg twice daily. Severe renal impairment (CrCl <30mL/min) or ESRD (without potent CYP3A inhibitors or inducers): reduce dose from 300mg twice daily to 150mg twice daily if postural hypotension occurs; others: see full labeling.

Children:

<2yrs: not established. Swallow whole. ≥2yrs: Concomitant potent CYP3A inhibitors (eg, PIs [except tipranavir/ritonavir], delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, boceprevir) (with or without a potent CYP3A inducer): (10–<20kg): 50mg twice daily; (20–<30kg): 75mg twice daily; (30–<40kg): 100mg twice daily; (≥40kg): 150mg twice daily. Noninteracting concomitant drugs, including tipranavir/ritonavir, nevirapine, raltegravir, NRTIs, enfuvirtide: (10–<30kg): not recommended; (30–<40kg or ≥40kg): 300mg twice daily. Concomitant potent CYP3A inducers (eg, efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, phenytoin) (without a potent CYP3A inhibitor): not recommended.

Contraindications:

Severe renal impairment or ESRD (CrCl <30mL/min) patients taking concomitant potent CYP3A inhibitors or inducers.

Warnings/Precautions:

Do CCR5 tropism testing prior to initiation. Hepatotoxicity (may be preceded by systemic allergic reaction; evaluate if occurs); obtain ALT, AST, and bilirubin prior to initiating and during therapy; consider discontinuing if hepatitis or elevated liver transaminases with rash or other systemic symptoms develop. Pre-existing liver dysfunction or co-infected with hepatitis B and/or C virus; monitor more frequently. Increased risk of cardiovascular events (eg, myocardial ischemia and/or infarction); monitor more frequently. Postural hypotension (esp. with severe renal insufficiency or ESRD). Monitor for immune reconstitution syndrome, infections, malignancies. Pregnancy. Nursing mothers: not recommended.

Interactions:

Concomitant St. John's wort: not recommended. May affect, or be affected by, CYP3A inhibitors or inducers and drugs affected by P-glycoprotein (eg, potentiated by ketoconazole, boceprevir, lopinavir/ritonavir, ritonavir, darunavir/ritonavir, saquinavir/ritonavir, atazanavir; antagonized by rifampin, etravirine, efavirenz). Caution with antihypertensives.

Pharmacological Class:

CCR5 co-receptor antagonist.

Adverse Reactions:

Upper respiratory tract infections, cough, pyrexia, rash, dizziness, constipation, bronchitis, flatulence, bloating, distention, GI atonic, hypomotility disorders; severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) and hypersensitivity reactions (discontinue immediately if signs/symptoms develop); others (see full labeling); also Peds: vomiting, abdominal pain, diarrhea, nausea.

Metabolism:

Hepatic (CYP3A).

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs 25mg, 75mg—120; 150mg, 300mg—60

SELZENTRY 300mg tablets (Qty:30)

appx. price $723.00