SELZENTRY ORAL SOLUTION Dosage & Rx Info

Selzentry Oral Solution Generic Name & Formulations

Legal Class

General Description

Maraviroc 20mg/mL; strawberry flavor.

Pharmacological Class

CCR5 co-receptor antagonist.

How Supplied

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

Manufacturer

ViiV Healthcare

Generic Availability

Selzentry Oral Solution Indications

Indications

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.

Selzentry Oral Solution Dosage and Administration

Adult

Test all patients for CCR5 tropism prior to initiation. 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. Test all patients for CCR5 tropism prior to initiation. 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.

Selzentry Oral Solution Contraindications

Contraindications

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

Selzentry Oral Solution Boxed Warnings

Boxed Warning

Hepatotoxicity.

Selzentry Oral Solution Warnings/Precautions

Warnings/Precautions

Hepatotoxicity (may be preceded by systemic allergic reaction; immediately 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.

Selzentry Oral Solution Pharmacokinetics

See Literature

Selzentry Oral Solution Interactions

Interactions

See Adult, Children. Concomitant St. John's wort: not recommended. May affect, or be affected by, inhibitors or inducers of CYP3A and P-gp (eg, potentiated by ketoconazole, boceprevir, lopinavir/ritonavir, ritonavir, darunavir/ritonavir, saquinavir/ritonavir, atazanavir; antagonized by rifampin, etravirine, efavirenz). May be affected by inhibitors of OATP1B1 and MRP2. Caution with antihypertensives.

Selzentry Oral Solution Adverse Reactions

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.

Selzentry Oral Solution

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