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SELZENTRY ORAL SOLUTION
Viral infections
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Drug Name:

SELZENTRY ORAL SOLUTION Rx

Generic Name and Formulations:
Maraviroc 20mg/mL; strawberry flavor.

Company:
ViiV Healthcare

Therapeutic Use:

Indications for SELZENTRY ORAL SOLUTION:

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 tabs 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 tabs whole; if unable to swallow, use oral soln. ≥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 or 2.5mL twice daily; (20–<30kg): 75mg or 4mL twice daily; (30–<40kg): 100mg or 5mL twice daily; (≥40kg): 150mg or 7.5mL twice daily. Noninteracting concomitant drugs, including tipranavir/ritonavir, nevirapine, raltegravir, NRTIs, enfuvirtide: (10–<30kg): not recommended; (≥30kg): 300mg or 15mL 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) in 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 infections, malignancies. Pregnancy. Nursing mothers: not recommended.

Interactions:

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

See Also:

SELZENTRY

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 and hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis; discontinue immediately if develop), immune reconstitution syndrome; also Peds: vomiting, abdominal pain, diarrhea, nausea.

Note:

Register pregnant patients exposed to maraviroc by calling (800) 258-4263.

Metabolism:

Hepatic (CYP3A).

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs 25mg, 75mg—120; 150mg, 300mg—60; Soln (w. oral syringe)—230mL

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