Maraviroc Dosage

This dosage information may not include all the information needed to use Maraviroc safely and effectively. See additional information for Maraviroc.

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

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, ketoconazole, itraconazole, clarithromycin, and other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin): 150 mg orally twice a day

With other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide: 300 mg orally twice a day

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, and phenytoin: 600 mg orally twice a day

Usual Pediatric Dose for HIV Infection

16 years or older:
With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, ketoconazole, itraconazole, clarithromycin, and other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin): 150 mg orally twice a day

With other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide: 300 mg orally twice a day

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, and phenytoin: 600 mg orally twice a day

Renal Dose Adjustments

CrCl less than 30 mL/min:
With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, ketoconazole, itraconazole, clarithromycin, and other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin): Not recommended.

With other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide: 300 mg orally twice a day; however, dosage should be reduced to 150 mg orally twice a day if there are any symptoms of postural hypotension

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, and phenytoin: Not recommended.

Liver Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with liver dysfunction.

Precautions

Hepatotoxicity with allergic features (including life-threatening events) has occurred during maraviroc therapy. Severe rash or indication of a systemic allergic reaction (including drug-related rash with fever, eosinophilia, elevated IgE, or other systemic symptoms) may precede hepatotoxicity. Such events have been reported in conjunction with hepatotoxicity about 1 month after starting treatment. Some cases of hepatitis were observed without allergic features or with no preexisting liver disease. Appropriate laboratory tests (including ALT, AST, and bilirubin) are recommended prior to starting maraviroc therapy and during therapy as clinically indicated. Patients with signs or symptoms of hepatitis or allergic reaction should be evaluated at once. Hepatic laboratory parameters should be obtained in any patient who develops rash, signs or symptoms of hepatitis, or allergic reaction. Maraviroc discontinuation should be considered in any patient with signs or symptoms of hepatitis, or with increased liver enzymes combined with rash or other systemic symptoms.

Safety and effectiveness of maraviroc treatment have not been specifically evaluated in patients with significant preexisting liver disorders. Increased concentrations of maraviroc are possible in patients with hepatic dysfunction. It is unknown if patients coinfected with hepatitis B or C are at a greater risk of hepatic adverse events during maraviroc therapy. Caution is recommended when maraviroc is used in patients with underlying liver dysfunction or coinfected with hepatitis B or C.

Patients with moderate hepatic dysfunction receiving maraviroc 150 mg with a potent CYP450 3A inhibitor should be monitored closely for maraviroc-associated adverse effects due to increased maraviroc concentrations.

Maraviroc is contraindicated in patients with severe renal impairment or end-stage renal disease (CrCl less than 30 mL/min) who are taking potent CYP450 3A inhibitors or inducers.

Patients with impaired renal function may have cardiovascular comorbidities and could be at greater risk of cardiovascular side effects triggered by postural hypotension. An increased risk of postural hypotension may occur in patients with severe renal dysfunction or end-stage renal disease (ESRD) due to increased maraviroc exposure in some patients. Maraviroc should be used in patients with severe renal dysfunction or ESRD only if they are not receiving a concomitant potent CYP450 3A inhibitor or inducer; however, maraviroc use in such patients should only be considered when no alternative treatment options are available. If any symptoms of postural hypotension occur in patients with severe renal dysfunction or ESRD while taking the usual dosage of maraviroc, the dosage should be reduced.

Cardiovascular events, including myocardial ischemia and/or infarction, have been reported with maraviroc during Phase 3 treatment-experienced studies, generally in patients with preexisting cardiac disease or cardiac risk factors. The relative contribution of maraviroc to these events is unknown. Three treatment-naive subjects receiving maraviroc during the Phase 2b/3 study had events related to ischemic heart disease. At increased doses, higher than recommended, a greater incidence of symptomatic postural hypotension was observed in healthy volunteers. At the usual dosage, the rate of postural hypotension was similar to placebo. Caution is recommended when maraviroc is used in patients with greater risk of cardiovascular events, history of postural hypotension, or using medication that lowers blood pressure.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Maraviroc may increase the risk of infection. Certain upper respiratory tract infections and herpes virus infections were observed at a higher rate in patients receiving maraviroc during Phase 3 treatment-experienced studies. Patients should be carefully monitored for infections during maraviroc therapy.

Maraviroc must be administered as part of a combination antiretroviral regimen.

Tropism testing must be performed with a highly sensitive tropism assay that has demonstrated the ability to detect patients appropriate maraviroc use. Maraviroc is not recommended in patients with CXCR4- or dual/mixed-tropic HIV-1.

Safety and efficacy have not been established in pediatric patients under the age of 16 years.

Dialysis

End-stage renal disease on regular hemodialysis:
With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, ketoconazole, itraconazole, clarithromycin, and other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin): Not recommended.

With other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide: 300 mg orally twice a day; however, dosage should be reduced to 150 mg orally twice a day if there are any symptoms of postural hypotension

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, and phenytoin: Not recommended.

Other Comments

Maraviroc may be administered with or without food.

Maraviroc should not be chewed; the tablets should be swallowed whole.

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