Maraviroc

MARAVIROC — maraviroc tablet, film coated
Camber Pharmaceuticals, Inc.

BOXED WARNING

WARNING: HEPATOTOXICITY
Hepatotoxicity has been reported with use of maraviroc tablets. 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 maraviroc tablets should be evaluated immediately [see Warnings and Precautions ( 5.1)].

1 INDICATIONS AND USAGE

Maraviroc tablets are 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 2 years of age and older weighing at least 10 kg.

Limitations of Use:
• Maraviroc tablets are 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 Maraviroc Tablets

Prior to initiation of maraviroc tablets for treatment of HIV-1 infection, test all patients for CCR5 tropism using a highly sensitive tropism assay. Maraviroc tablets are 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 maraviroc tablets [ see Microbiology ( 12.4), Clinical Studies ( 14.1) ].

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

2.2 General Dosing Recommendations

• Maraviroc tablets are taken twice daily by mouth and may be taken with or without food.

• Maraviroc tablets must be given in combination with other antiretroviral medications. • The recommended dosage of maraviroc tablets 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 maraviroc tablets based on different concomitant medications [ see Drug Interactions ( 7.1) ].

Table 1. Recommended Dosage in Adults

Concomitant Medications Dosage of Maraviroc Tablets
Potent cytochrome P450 (CYP)3A inhibitors (with or without a potent CYP3A inducer) a 150 mg twice daily
Noninteracting concomitant medications b 300 mg twice daily
Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor) c 600 mg twice daily

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.

2.4 Recommended Dosage in Pediatric Patients with Normal Renal Function

The recommended dosage of maraviroc tablets 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 maraviroc tablets, assess children for the ability to swallow tablets. If a child is unable to reliably swallow maraviroc tablets, the oral solution formulation should be prescribed.

The recommended oral dosage of maraviroc 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)

Concomitant Medications Dosage of Maraviroc Tablets 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 mg twice daily 50 mg twice daily 75 mg twice daily 100 mg twice daily 150 mg twice daily
Noninteracting concomitant medications b 150 mg twice daily 200 mg twice daily 200 mg twice daily 300 mg twice daily 300 mg twice daily
Potent and moderate CYP3A inducers (without a potent CYP3A inhibitor) c Not recommended d

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. The recommended oral dosage of maraviroc oral solution in pediatric patients weighing at least 10 kg is presented in Table 3.

Table 3. Recommended Dosage in Pediatric Patients Weighing at Least 10 kg

Concomitant Medications Dosage (Volume of Solution) of Maraviroc Tablets 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 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 medications c 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 recommended d

a PotentCYP3A inhibitors(with or without a CYP3A inducer) including:clarithromycin, cobicistat,elvitegravir/ritonavir, itraconazole,ketoconazole,nefazodone,proteaseinhibitors (excepttipranavir/ritonavir), telithromycin.

b Insufficient data areavailable to recommend use.
c Noninteractingconcomitantmedicationsincluding all medicationsthatare not potent CYP3A inhibitorsor inducers such as: dolutegravir, enfuvirtide,nevirapine, all NRTIs,raltegravir, and tipranavir/ritonavir. d Potent and moderateCYP3A inducers (without a potent CYP3A inhibitor)including: carbamazepine,efavirenz,etravirine, phenobarbital,phenytoin, and rifampin.

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

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