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Selzentry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Tabs—60; Soln (w. oral syringe)—230mL
Manufacturer
Generic Availability
Mechanism of Action
Selzentry Indications
Indications
In combination with other antiretrovirals, in patients weighing ≥2kg infected with only CCR5-tropic HIV-1.
Limitations of Use
Selzentry 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], clarithromycin, cobicistat, elvitegravir/ritonavir, ketoconazole, itraconazole, nefazodone, telithromycin) (with or without a potent CYP3A inducer): 150mg twice daily. Noninteracting concomitant drugs, including dolutegravir, enfuvirtide, nevirapine, NRTIs, raltegravir, tipranavir/ritonavir: 300mg twice daily. Concomitant potent and moderate CYP3A inducers (eg, efavirenz, etravirine, carbamazepine, phenobarbital, phenytoin, rifampin) (without a potent CYP3A inhibitor): 600mg twice daily. Renal impairment: see full labeling.
Children
<2yrs or <2kg: not recommended. 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], clarithromycin, cobicistat, elvitegravir/ritonavir, ketoconazole, itraconazole, nefazodone, telithromycin) (with or without a potent CYP3A inducer): (10–<20kg): 50mg or 2.5mL twice daily; (20–<30kg): 75mg or 4mL (80mg soln) twice daily; (30–<40kg): 100mg or 5mL twice daily; (≥40kg): 150mg or 7.5mL twice daily. Noninteracting concomitant drugs, including dolutegravir, enfuvirtide, nevirapine, NRTIs, raltegravir, tipranavir/ritonavir (2–<4kg): 30mg or 1.5mL twice daily; (4–<6kg): 40mg or 2mL twice daily; (6–<10kg): 100mg or 5mL twice daily; (10–<14kg): 150mg or 7.5mL twice daily; (14–<30kg): 200mg or 10mL twice daily; (≥30kg): 300mg or 15mL twice daily. Concomitant potent and moderate CYP3A inducers (eg, efavirenz, etravirine, carbamazepine, phenobarbital, phenytoin, rifampin) (without a potent CYP3A inhibitor): not recommended.
Administration
Nursing Considerations
Selzentry Contraindications
Contraindications
Selzentry Boxed Warnings
Boxed Warning
Selzentry 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. Significant underlying liver disorders, severe hepatic impairment or pediatric patients with any degree of hepatic impairment: not studied. 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. Elderly. Pregnancy. Nursing mothers: not recommended.
Selzentry Pharmacokinetics
Absorption
Peak plasma concentrations are obtained 0.5–4 hours. Absolute bioavailability: 23–33%.
Distribution
Volume of distribution: ~194 L. Plasma protein bound: ~76%.
Elimination
Fecal (76%), renal (~20%). Half-life: 14–18 hours.
Selzentry Interactions
Interactions
Selzentry 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, SJS, TEN, DRESS; discontinue immediately if develop), immune reconstitution syndrome; also Peds: vomiting, abdominal pain, diarrhea, nausea.
Selzentry Clinical Trials
See Literature
Selzentry Note
Notes
Selzentry Patient Counseling
See Literature
