Adult Dosing
CCR5-tropic HIV-1 infection
Concomitant therapy with potent CYP3A inhibitors (with or without a potent CYP3A inducer)
- 150 mg PO bid; potent CYP3A inhibitors include drugs such as protease inhibitors (except tipranavir/ritonavir), delavirdine, ketoconazole, itraconazole, clarithromycin, or other strong CYP3A inhibitors (e.g., nefazodone, telithromycin), or boceprevir, telaprevir
Other concomitant medications
- 300 mg PO bid; other concomitant medications include drugs such as NRTIs, tipranavir/ritonavir, nevirapine, enfuvirtide, and other drugs that are not strong inhibitors/inducers of CYP3A
Concomitant therapy with potent CYP3A inducers (without a potent CYP3A inhibitor)
- 600 mg PO bid; potent CYP3A inducers include drugs such as efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, or phenytoin
Pediatric Dosing
- Safety and effectiveness in pediatric patients <16 yrs of age have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl )
- Mild to moderate renal impairment (
80 mL/min to
30 mL/min): No dose adjustments - Severe renal impairment/end stage renal disease (<30 mL/min):
- Other concomitant medications: 300 mg PO bid; if these patients experience any symptoms of postural hypotension, reduce the dose to 150 mg PO bid
- Co-administration with potent CYP3A inhibitors (with or without a CYP3A inducer): Contraindicated
- Co-administration with potent CYP3A inducers (without a potent CYP3A inhibitor): Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: In combination with no potent CYP3A inhibitors, use with caution
- Moderate hepatic impairment: In combination with CYP3A inhibitor, no dose adjustments; monitor closely
- Severe hepatic impairment: Dose adjustments not defined; use with caution
See Supplemental Patient Information
- Hepatotoxicity with allergic features has been reported with maraviroc. Discontinue therapy on appearance of signs or symptoms of hepatitis or with increased liver transaminases combined with rash or other systemic symptoms [US Black Box Warning]
- Use with caution in patients with preexisting liver dysfunction or who are co-infected with viral hepatitis B or C
- Use with caution in patients with a history of postural hypotension or on concomitant medication known to lower blood pressure
- Cardiovascular events including myocardial ischemia and/or infarction have been reported in patients receiving maraviroc. Use cautiously in patients at increased risk for cardiovascular events
- Patients with impaired renal function may have cardiovascular co-morbidities and could be at increased risk of cardiovascular adverse events triggered by postural hypotension
- Use with caution in patients with severe renal insufficiency or ESRD, as they are at increased risk of postural hypotension. Should be used when no alternate therapy is available and in patients not receiving any concomitant potent CYP3A inhibitor or inducer
- Reduce the dose of maraviroc from 300 mg bid to 150 mg bid in patients with severe renal impairment or ESRD, experiencing any symptoms of postural hypotension
- Immune reconstitution syndrome requiring further evaluation and treatment has occurred in patients treated with combination antiretroviral therapy
- Autoimmune disorders including Graves disease, polymyositis, and Guillain-Barré syndrome may occur in the setting of immune reconstitution
- Maraviroc antagonizes the CCR5 co-receptor located on some immune cells, which potentially increases the risk of developing infections. Monitor the patient closely for the evidence of infection while receiving maraviroc
- Even though no increase in malignancy has been observed with maraviroc, due to its mechanism of action it could affect immune surveillance and may lead to an increased risk of malignancy
- Risk of developing hypersensitivity reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug associated rash with eosinophilia and systemic symptoms (DRESS) have been reported with maraviroc. Discontinue therapy and other suspected agents immediately if signs and symptoms of hypersensitivity reaction develops
Caution: Use cautiously in
Supplemental Patient Information
- Advise patients to promptly inform their physicians if they develop signs or symptoms of hepatitis or allergic reactions during therapy
- Inform patients that maraviroc is not a cure for HIV infection and that he/she may still develop illnesses associated with HIV infection, including opportunistic infections
- Advise patients to refrain from driving or operating machinery if they experience dizziness during therapy
Pregnancy Category:B
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. Exclusive breastfeeding for 6 months is recommended for HIV-infected mothers, in countries where no acceptable, feasible, sustainable and safe replacement feeding is available, to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral drugs appears to reduce the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Due to limited data available about the use of maraviroc during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 February 2011). As per manufacturers data, the Centers for Disease Control and Prevention recommend that HIV-infected mothers should not breastfeed their infants to avoid risking postnatal transmission of HIV infection. Excretion of maraviroc in human milk is unknown. Because of the potential for both HIV transmission and serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving maraviroc.
Pricing data from www.DrugStore.com in U.S.A.
- Selzentry 300 MG TABS [Bottle] (VIIV HEALTHCARE)
30 mg = $570.98
90 mg = $1671.95 - Selzentry 150 MG TABS [Bottle] (VIIV HEALTHCARE)
30 mg = $530
90 mg = $1529.94
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Selzentry 150 MG Oral Tablet
Ingredient(s): Maraviroc
Imprint: Pfizer;MVC150
Color(s): Blue
Shape: Oval
Size (mm): 12.00
Score: 1
Inactive Ingredient(s): cellulose, microcrystalline / anhydrous dibasic calcium phosphate / sodium starch glycolate type a potato / magnesium stearate / fd&c blue no. 2 / aluminum oxide / lecithin, soybean / polyethylene glycol / polyvinyl alcohol / talc / titanium dioxide
Drug Label Author:
Pfizer Laboratories Div Pfizer Inc
DEA Schedule:
Non-Scheduled
Drug Name: Selzentry 300 MG Oral Tablet
Ingredient(s): Maraviroc
Imprint: Pfizer;MVC300
Color(s): Blue
Shape: Oval
Size (mm): 12.00
Score: 1
Inactive Ingredient(s): cellulose, microcrystalline / anhydrous dibasic calcium phosphate / sodium starch glycolate type a potato / magnesium stearate / fd&c blue no. 2 / aluminum oxide / lecithin, soybean / polyethylene glycol / polyvinyl alcohol / talc / titanium dioxide
Drug Label Author:
Pfizer Laboratories Div Pfizer Inc
DEA Schedule:
Non-Scheduled