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Selzentry Dosage

Generic name: MARAVIROC 25mg
Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Testing prior to Initiation of SELZENTRY

Prior to initiation of SELZENTRY, 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 ALT, 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.

Recommended Dosage in Adults

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

Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:

protease inhibitors (except tipranavir/ritonavir)
delavirdine
elvitegravir/ritonavir
ketoconazole, itraconazole, clarithromycin
other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
boceprevir

150 mg twice daily

Noninteracting concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all nucleoside reverse transcriptase inhibitors (NRTIs), and enfuvirtidea

300 mg twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:

efavirenz
rifampin
etravirine
carbamazepine, phenobarbital, and phenytoin

600 mg twice daily

a Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers.

Recommended Dosage in Pediatric Patients

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. Administer the oral solution using the included press-in bottle adapter and oral dosing syringe.

Table 2. Recommended Dosage in Pediatric Patients Aged 2 Years and Older Weighing at Least 10 kg (Tablets)

Concomitant Medications

Dosage of SELZENTRY Based on Weight

10 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) including:

protease inhibitors (except tipranavir/ritonavir)
delavirdine
elvitegravir/ritonavir
ketoconazole, itraconazole, clarithromycin
other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
boceprevir

50 mg
twice daily

75 mg
twice daily

100 mg
twice daily

150 mg
twice daily

Noninteracting concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtidea

Not recommended

Not recommended

300 mg
twice daily

300 mg
twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:

efavirenz
rifampin
etravirine
carbamazepine, phenobarbital, and phenytoin

Not recommended

a Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers.

Table 3. Recommended Dosage in Pediatric Patients Aged 2 Years and Older Weighing at Least 10 kg (Oral Solution)

Concomitant Medications

Dosage (Volume of Solution) of SELZENTRY Based on Weight

10 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) including:

protease inhibitors (except tipranavir/ritonavir)
delavirdine
elvitegravir/ritonavir
ketoconazole, itraconazole, clarithromycin
other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
boceprevir

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 medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtidea

Not recommended

Not recommended

300 mg
(15 mL)
twice daily

300 mg
(15 mL)
twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:

efavirenz
rifampin
etravirine
carbamazepine, phenobarbital, and phenytoin

Not recommended

a Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers.

Recommended Dosage in Patients with Renal Impairment

Adults

Table 4 provides dosing recommendations for patients based on renal function and concomitant medications.

Table 4. Recommended Dosage in Adults Based on Renal Function

Concomitant Medications

Dosage of SELZENTRY Based on Renal Function

Normal

(CrCl >80 mL/min)

Mild

(CrCl >50 and ≤80 mL/min)

Moderate

(CrCl ≥30 and ≤50 mL/min)

Severe

(CrCl <30 mL/min)

End-Stage Renal Disease

on Regular Hemodialysis

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

protease inhibitors (except tipranavir/ritonavir)
delavirdine
elvitegravir/ritonavir
ketoconazole, itraconazole, clarithromycin
other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
boceprevir

150 mg twice daily

150 mg twice daily

150 mg twice daily

Contra-
indicated

Contra-
indicated

Noninteracting concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtidea

300 mg twice daily

300 mg twice daily

300 mg twice daily

300 mg twice dailyb

300 mg twice dailyb

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:

efavirenz
rifampin
etravirine
carbamazepine, phenobarbital, and phenytoin

600 mg twice daily

600 mg twice daily

600 mg twice daily

Contra-
indicated

Contra-
indicated

a Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers.

bThe dosage of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Contraindications (4), Warnings and Precautions (5.3)].

Pediatric Patients

There are no data to recommend specific doses of SELZENTRY in pediatric patients with mild or moderate renal impairment [see Use in Specific Populations (8.6)]. Additionally, SELZENTRY is contraindicated for pediatric patients with severe renal impairment or end-stage renal disease (ESRD) on regular hemodialysis who are receiving potent CYP3A inhibitors [see Contraindications (4)].

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