SELZENTRY

SELZENTRY- maraviroc tablet, film coated
A-S Medication Solutions

WARNING: HEPATOTOXICITY

Hepatotoxicity has been reported with use of SELZENTRY. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg.

Limitations of Use

SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Testing prior to Initiation of SELZENTRY

Prior to initiation of SELZENTRY for treatment of HIV-1 infection, test all patients for CCR5 tropism using a highly sensitive tropism assay. SELZENTRY is recommended for patients with only CCR5-tropic HIV-1 infection. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on SELZENTRY [see Microbiology (12.4), Clinical Studies (14.1)].

Monitor patients for alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of SELZENTRY and at other time points during treatment as clinically indicated [see Warnings and Precautions (5.1)].

2.2 General Dosing Recommendations

SELZENTRY tablets and oral solution are taken twice daily by mouth and may be taken with or without food.
SELZENTRY must be given in combination with other antiretroviral medications.
The recommended dosage of SELZENTRY differs based on concomitant medications due to drug interactions.

2.3 Recommended Dosage in Adult Patients with Normal Renal Function

Table 1 displays oral dosage of SELZENTRY based on different concomitant medications [see Drug Interactions (7.1)].

Table 1. Recommended Dosage in Adults
Concomitant Medications Dosage of SELZENTRY
a Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including: clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, protease inhibitors (except tipranavir/ritonavir), telithromycin.b Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers such as: dolutegravir, enfuvirtide, nevirapine, all nucleoside reverse transcriptase inhibitors (NRTIs), raltegravir, and tipranavir/ritonavir.c Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor) including: carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin.

Potent cytochrome P450 (CYP)3A inhibitors (with or without a potent CYP3A inducer)a

150 mg twice daily

Noninteracting concomitant medicationsb

300 mg twice daily

Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor)c

600 mg twice daily

2.4 Recommended Dosage in Pediatric Patients with Normal Renal Function

The recommended dosage of SELZENTRY should be based on body weight (kg) and should not exceed the recommended adult dose. The recommended dosage also differs based on concomitant medications due to drug interactions (Table 2 and Table 3) [see Drug Interactions (7.1), Use in Specific Populations (8.4)].

Before prescribing SELZENTRY tablets, assess children for the ability to swallow tablets. If a child is unable to reliably swallow SELZENTRY tablets, the oral solution formulation should be prescribed.

The recommended oral dosage of SELZENTRY tablets in pediatric patients aged 2 years and older weighing at least 10 kg is presented in Table 2.

Table 2. Recommended Dosage in Pediatric Patients Aged 2 Years and Older Weighing at Least 10 kg (Tablets)
a Potent CYP3A inhibitors (with or without a CYP3A inducer) including: clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, protease inhibitors (except tipranavir/ritonavir), telithromycin.b Noninteracting concomitant medications including all medications that are not potent CYP3A inhibitors or inducers such as: dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir.c Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor) including: carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin.d Insufficient data are available to recommend use.

Concomitant Medications

Dosage of SELZENTRY Based on Weight

10 kg to <14 kg

14 kg to <20 kg

20 kg to <30 kg

30 kg to <40 kg

≥40 kg

Potent CYP3A inhibitors (with or without a CYP3A inducer)a

50 mgtwice daily

50 mgtwice daily

75 mgtwice daily

100 mgtwice daily

150 mgtwice daily

Noninteracting concomitant medicationsb

150 mg twice daily

200 mgtwice daily

200 mgtwice daily

300 mgtwice daily

300 mgtwice daily

Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor)c

Not recommendedd

The recommended oral dosage of SELZENTRY oral solution in pediatric patients weighing at least 2 kg is presented in Table 3.

Table 3. Recommended Dosage in Pediatric Patients Weighing at Least 2 kg (Oral Solution)
a Potent CYP3A inhibitors (with or without a CYP3A inducer) including: clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, protease inhibitors (except tipranavir/ritonavir), telithromycin.b Insufficient data are available to recommend use.c Noninteracting concomitant medications including all medications that are not potent CYP3A inhibitors or inducers such as: dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir.d Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor) including: carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin.

Concomitant Medications

Dosage (Volume of Solution) of SELZENTRY Based on Weight

2 kg to <4 kg

4 kg to <6 kg

6 kg to

<10 kg

10 kg to

<14 kg

14 kg to <20 kg

20 kg to <30 kg

30 kg to <40 kg

≥40 kg

Potent CYP3A inhibitors (with or without a CYP3A inducer)a

Not recommendedb

50 mg(2.5 mL)twice daily

50 mg(2.5 mL)twice daily

80 mg(4 mL)twice daily

100 mg(5 mL)twice daily

150 mg(7.5 mL)twice daily

Noninteracting concomitant medicationsc

30 mg(1.5 mL)twice daily

40 mg(2 mL)twice daily

100 mg(5 mL)twice daily

150 mg(7.5 mL)twice daily

200 mg(10 mL)twice daily

200 mg(10 mL)twice daily

300 mg(15 mL)twice daily

300 mg(15 mL)twice daily

Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor)d

Not recommendedb

Administer the oral solution using the included press-in bottle adapter and the appropriate oral dosing syringe: for doses of 2.5 mL or less, use the 3-mL syringe; for doses greater than 2.5 mL, use the 10-mL syringe.

Care should be taken when measuring neonate doses due to the small volumes of oral solution required.

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