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brand selzentry 300 mg tablet

In stock Manufacturer VIIV HEALTHCARE 49702022418
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Uses

Treatment of HIV Infection

Maraviroc is used in conjunction with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral-naive (have not previously received antiretroviral therapy) or antiretroviral-experienced (previously treated) adults infected with CCR5-tropic HIV-1.

Coreceptor tropism testing (assay detects CCR5- and CXCR4-using virus; results reported as CCR5-tropic, CXCR4-tropic, or dual/mixed-tropic HIV-1) is required for appropriate use of maraviroc.

The manufacturer advises that the following factors be considered when initiating therapy with maraviroc. Only adults infected with CCR5-tropic HIV-1 should receive maraviroc. Tropism testing must be conducted on a current sample using a highly sensitive assay that can identify patients who are appropriate candidates for maraviroc; low levels of CXCR4-tropic or dual/mixed-tropic HIV-1 not detected at screening are associated with virologic failure. Maraviroc is not recommended for use in patients with CXCR4-tropic or dual/mixed HIV-1 infection; data from a phase 2 study indicate the virologic response to the drug was minimal in those who had dual/mixed HIV-1 infection at the time of study enrollment.

Safety and efficacy of maraviroc have not been established in pediatric patients.

The most appropriate antiretroviral regimen cannot be defined for each clinical scenario, and selection of specific antiretroviral agents for use in multiple-drug regimens should be individualized based on information regarding antiretroviral potency, potential rate of development of resistance, known toxicities, and potential for pharmacokinetic interactions as well as virologic, immunologic, and clinical characteristics of the patient. For information on the general principles and guidelines for use of antiretroviral therapy, including specific recommendations for initial therapy in antiretroviral-naive patients and recommendations for changing antiretroviral regimens,

Antiretroviral-naive Adults and Adolescents

The US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents states that maraviroc is not recommended for initial treatment regimens in antiretroviral-naive adults or adolescents because a coreceptor tropism assay should be performed before the drug is initiated, there is no virologic benefit compared with recommended regimens, and a twice-daily dosing regimen is required.

Clinical Experience

Safety and efficacy of maraviroc in antiretroviral-naive adults with CCR5-tropic HIV-1 infection is being evaluated in an ongoing randomized, double-blind, multicenter study (study A4001026; NCT00098293; MERIT study). Adults enrolled in this study had baseline HIV-1 RNA levels of 2000 copies/mL or greater, had received no antiretroviral therapy for at least 14 days, did not have a recent or active opportunistic infection, did not have primary HIV-1 infection, and did not have phenotypic or genotypic resistance to zidovudine, lamivudine, or efavirenz. Over 600 patients (mean age 36-37 years [range 18-77 years], 71-72% male, 55-57% white, 34-37% black, median baseline plasma HIV-1 RNA level 4.9 log10 copies/mL, median baseline CD4 T-cell count 241-254 cells/mm) were randomized to received maraviroc 300 mg once daily, maraviroc 300 mg twice daily, or efavirenz 600 mg once daily in conjunction with lamivudine and zidovudine. At 16 weeks, the maraviroc 300 mg once daily regimen did not meet the criteria to demonstrate non-inferiority and the regimen was discontinued.

At 96 weeks, 59% of those receiving maraviroc 300 mg twice daily in conjunction with lamivudine and zidovudine and 63% of those receiving efavirenz in conjunction with lamivudine and zidovudine had plasma HIV-1 RNA levels less than 50 copies/mL; 64% of those receiving either regimen had plasma HIV-1 RNA levels less than 400 copies/mL. The median increase from baseline CD4 T-cell count was 184 cells/mm in those receiving maraviroc compared with 155 cells/mm in those receiving efavirenz. Virologic failure (plasma HIV-1 RNA did not remain suppressed) was reported in 13-14 or 7-8% of those receiving maraviroc in conjunction with lamivudine and zidovudine or efavirenz in conjunction with lamivudine and zidovudine, respectively.

Antiretroviral-experienced Adults and Adolescents

Clinical Experience

Maraviroc is being evaluated in 2 randomized, double-blind, multicenter phase 3 studies (studies A4001027, A4001028; NCT0098306, NCT00098722; MOTIVATE 1 and 2) in antiretroviral-experienced adults infected with CCR5-tropic HIV-1. Adults enrolled in these studies had baseline HIV-1 RNA levels greater than 5000 copies/mL despite at least 6 months prior treatment with antiretroviral regimens that included at least one agent from 3 classes of antiretroviral agents (at least 1 NRTI, 1 NNRTI, 2 PIs, and/or enfuvirtide) or had documented resistance to at least one drug in each class of antiretroviral agents. Over 600 patients (mean age 46 years [range 21-73 years]; 89-90% male; 85% white; 12% black; mean baseline plasma HIV-1 RNA level 4.85-4.86 log10 copies/mL; median baseline CD4 T-cell count 167-171 cells/mm) received an optimized background antiretroviral regimen (OBR; consists of 3-6 antiretroviral agents selected on the basis of the individual's prior antiretroviral treatment and results of baseline genotypic and phenotypic viral resistance testing) and were randomized to receive maraviroc twice daily in conjunction with the OBR or the OBR alone. Analysis at 48 weeks indicated that maraviroc (300 mg twice daily) added to an OBR resulted in greater decreases in plasma HIV-1 RNA levels (-1.84 log10 copies/mL) than the OBR alone (-0.78 log10 copies/mL). At 48 weeks, 56 or 46% of those receiving maraviroc twice daily in conjunction with the OBR and 22 or 17% of those receiving the OBR alone had plasma HIV-1 RNA levels less than 400 or 50 copies/mL, respectively. In addition, the mean increase from baseline CD4 T-cell count at 48 weeks was greater in patients receiving maraviroc twice daily in conjunction with an OBR (increase of 124 cells/mm) than in those receiving the OBR alone (increase of 60 cells/mm).

Maraviroc also was evaluated in a randomized, double-blind, phase 2 study (A4001029; NCT00098748) in antiretroviral-experienced adults infected with dual/mixed tropic HIV-1. All patients received an OBR (3-6 antiretrovirals with or without low-dose ritonavir) and were randomized to receive maraviroc in conjunction with the OBR or the OBR alone. At week 24, the mean increase in CD4 T-cell counts was greater in those receiving maraviroc and the OBR compared with those receiving the OBR alone; however, the mean decrease in plasma HIV-1 RNA levels was similar in both groups.

Postexposure Prophylaxis following Occupational Exposure to HIV

Maraviroc is used in conjunction with other antiretrovirals for postexposure prophylaxis of HIV infection following occupational exposure (PEP) in health-care personnel and other individuals exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV.

The US Public Health Service (USPHS) states that the preferred regimen for PEP following an occupational exposure to HIV is a 3-drug regimen of raltegravir used in conjunction with emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) (may be administered as the fixed combination emtricitabine/tenofovir DF; Truvada). These experts state that maraviroc is one of several alternative agents that may be used in conjunction with other antiretrovirals in PEP regimens, but should be used only with expert consultation.

Because management of occupational exposures to HIV is complex and evolving, consultation with an infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians' Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) is recommended whenever possible. However, initiation of PEP should not be delayed while waiting for expert consultation.

For information on types of occupational exposure to HIV and associated risk of infection, management of occupational exposure to HIV, efficacy and safety of postexposure prophylaxis, and recommendations regarding PEP,

Dosage and Administration

Administration

Maraviroc is administered orally twice daily.

The drug may be administered without regard to food.

Dosage

Dosage of maraviroc depends on whether the drug is administered concomitantly with drugs affecting hepatic metabolism or the P-glycoprotein transport system.

Adult Dosage

Treatment of HIV Infection in Adults Receiving a Potent CYP3A Inhibitor (with or without a CYP3A Inducer)

For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults receiving concomitant therapy with a drug that is a potent inhibitor of cytochrome P-450 (CYP) isoenzyme 3A, such as a PI (except ritonavir-boosted tipranavir), delavirdine, ketoconazole, itraconazole, clarithromycin, or other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) with or without a potent CYP3A inducer, the recommended dosage of maraviroc is 150 mg twice daily.

Treatment of HIV Infection in Adults Receiving Drugs that are not CYP3A Inhibitors or Inducers

For the treatment of HIV-1 infection in adults receiving concomitant therapy with ritonavir-boosted tipranavir, nevirapine, NRTIs, enfuvirtide, raltegravir, or other drugs that are not potent CYP3A inhibitors or inducers, the recommended dosage of maraviroc is 300 mg twice daily.

Treatment of HIV Infection in Adults Receiving a Potent CYP3A Inducer (without a Potent CYP3A Inhibitor)

For the treatment of HIV-1 infection in adults receiving concomitant therapy with a drug that is a potent CYP3A inducer, such as efavirenz, etravirine, rifampin, carbamazepine, phenobarbital, or phenytoin and is not receiving a potent CYP3A inhibitor, the recommended dosage of maraviroc is 600 mg twice daily.

Postexposure Prophylaxis following Occupational Exposure to HIV

For postexposure prophylaxis of HIV infection following occupational exposure (PEP) in health-care personnel or other individuals, the recommended dosage of maraviroc is 300 mg twice daily, provided the patient is not receiving a potent CYP3A inducer. Maraviroc is used in conjunction with other antiretrovirals.(See Uses: Postexposure Prophylaxis following Occupational Exposure to HIV.)

The PEP regimen should be initiated as soon as possible following occupational exposure to HIV (preferably within hours) and continued for 4 weeks, if tolerated.

Special Populations

Hepatic Impairment

Dosage recommendations for adults with hepatic impairment are not available. Maraviroc plasma concentrations may be increased; the drug should be used with caution.(See Hepatic Impairment under Cautions: Specific Populations.)

Renal Impairment

Dosage adjustments are not necessary in patients with mild or moderate renal impairment (creatinine clearance greater than 30 mL/minute).

In adults with severe renal impairment (creatinine clearance less than 30 mL/minute) or with end-stage renal disease (ESRD) on regular hemodialysis who are receiving concomitant therapy with ritonavir-boosted tipranavir, nevirapine, NRTIs, enfuvirtide, and/or raltegravir and are not receiving concomitant therapy with a potent CYP3A inhibitor or inducer, the recommended dosage of maraviroc is 300 mg twice daily. Maraviroc dosage should be reduced to 150 mg twice daily in such patients if they have any symptoms of postural hypotension.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Maraviroc is not recommended in adults with severe renal impairment who are receiving concomitant therapy with a potent CYP3A inhibitor, such as a PI (except ritonavir-boosted tipranavir), delavirdine, ketoconazole, itraconazole, clarithromycin, or other potent CYP3A inhibitor (e.g., nefazodone, telithromycin).

Maraviroc is not recommended in adults with severe renal impairment who are receiving concomitant therapy with a potent CYP3A inducer, such as efavirenz, etravirine, rifampin, carbamazepine, phenobarbital, or phenytoin.

Cautions

Contraindications

Patients with severe renal impairment (creatine clearance less than 30 mL/minute) or end-stage renal disease (ESRD) who are receiving concomitant therapy with a potent cytochrome P-450 (CYP) isoenzyme 3A inhibitor or inducer.

Warnings/Precautions

Sensitivity Reactions

Severe Dermatologic and Hypersensitivity Reactions

Severe, potentially life-threatening skin and hypersensitivity reactions have been reported in those receiving maraviroc, usually in those receiving concomitant therapy with other drugs associated with such reactions. Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported; these cases usually involved rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

Maraviroc and other suspected agents should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions occur (e.g., severe rash or rash accompanied by fever, malaise, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, lip swelling, and/or eosinophilia). Life-threatening reactions could occur if discontinuance of maraviroc or other suspect agents is delayed after the onset of rash.

Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated.

Hepatic Effects

Hepatotoxicity with allergic features, including life-threatening events, has been reported in patients receiving maraviroc. Hepatotoxicity may be preceded by severe rash or signs of a systemic allergic reaction (e.g., fever, eosinophilia, elevated IgE antibody levels). These effects have occurred approximately 1 month after initiation of maraviroc. Hepatitis has been reported in the absence of allergic features and in patients without preexisting hepatic disease.

Maraviroc should be used with caution in patients with preexisting liver dysfunction and in those coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV).(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Appropriate laboratory testing (e.g., ALT, AST, bilirubin) should be performed prior to initiation of maraviroc therapy and as clinically indicated during therapy with the drug. Hepatic function should be assessed in any patient who develops rash or signs or symptoms of hepatitis or allergic reaction. Discontinuance of maraviroc should be considered in any patient with manifestations of hepatitis or with increased liver transaminases with rash or other systemic symptoms.

Cardiovascular Effects

Cardiovascular events (i.e., myocardial ischemia and/or myocardial infarction) have been reported in patients receiving maraviroc during clinical studies. Patients who experienced these events generally had cardiac disease or risk factors for cardiac disease prior to initiation of maraviroc; the contribution of maraviroc to these events is not known.

Maraviroc should be used with caution in patients at increased risk for cardiovascular events.

Symptomatic postural hypotension was observed in healthy individuals receiving higher than recommended dosages of maraviroc in early studies. In clinical studies in patients with HIV-1 infection, the incidence of postural hypotension in those receiving the recommended dosage of maraviroc was similar to that in patients receiving placebo.

Maraviroc should be used with caution in patients with a history of or risk factors for postural hypotension and in those who have cardiovascular comorbidities or are receiving concomitant therapy with an agent known to lower blood pressure. Patients with cardiovascular comorbidities could be at increased risk of adverse cardiovascular events triggered by postural hypotension. In addition, patients with severe renal insufficiency or with ESRD may be at increased risk of postural hypotension because of increased maraviroc concentrations, and patients with renal impairment may have cardiovascular co-morbidities and be at increased risk of adverse cardiovascular events that are triggered by postural hypotension.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium, M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii], herpes simplex virus, varicella-zoster virus [VZV]); this may necessitate further evaluation and treatment.

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome) have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of antiretroviral therapy.

Infectious Complications

Because some immune cells have CCR5 receptors, the possibility exists that agents that bind to CCR5 receptors, including maraviroc, can increase the risk of infection. In phase 3 clinical studies, the overall incidence and severity of infection (including AIDS-defining category C infections) in antiretroviral-experienced patients receiving maraviroc was similar to that in patients receiving placebo. AIDS-defining category C events also were reported in antiretroviral-naive patients. In studies that evaluated maraviroc in antiretroviral-experienced patients, upper respiratory tract infections or pneumonia occurred in 23 or 2%, respectively, of those receiving maraviroc and in 13 or 5%, respectively, of those receiving placebo. Herpes infections were reported more frequently in those receiving maraviroc than in those receiving placebo.

Patients receiving maraviroc should be monitored for infection.

Malignancies

Because some immune cells have CCR5 receptors, the possibility exists that agents that bind to CCR5 receptors, including maraviroc, can increase the risk of malignancy. No increase in the incidence of malignancy in maraviroc-treated patients has been observed to date. Long-term studies are needed to fully access this risk.

Coreceptor Tropism Assay

Coreceptor tropism testing with a highly sensitive tropism assay is required for appropriate use of maraviroc. Some experts also recommend that such testing be considered in patients who exhibit virologic failure while receiving a CCR5 antagonist.

Specific Populations

Pregnancy

Category B.

Antiretroviral Pregnancy Registry at 800-258-4263 or http://www.apregistry.com.

The US Department of Health and Human Services (HHS) Panel on Treatment of HIV-infected Pregnant Women and Prevention of Perinatal Transmission states that safety and pharmacokinetic data are insufficient to recommend routine use of maraviroc in initial antiretroviral regimens in antiretroviral-naive pregnant women.

Lactation

Maraviroc is distributed into milk in rats; not known whether the drug is distributed into human milk.

Because of the risk of adverse effects in the infant and the risk of HIV transmission, HIV-infected women should not breast-feed infants.

Pediatric Use

Safety, efficacy, and pharmacokinetics of maraviroc have not been established in pediatric patients younger than 16 years of age; the drug is not recommended in this age group.

Geriatric Use

Experience in those 65 years of age and older is insufficient to determine whether they respond differently than younger adults. Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.

Hepatic Impairment

Peak plasma concentrations and area under the plasma concentration-time curve (AUC) are higher in individuals with mild or moderate hepatic impairment compared with individuals with normal hepatic function. The pharmacokinetics of maraviroc have not been investigated in patients with severe hepatic impairment.

Maraviroc should be used with caution in patients with hepatic impairment and in those coinfected with HBV or HCV. Safety and efficacy of maraviroc have not been specifically studied in patients with clinically significant underlying liver disorders. In clinical studies in antiretroviral-experienced HIV-infected patients, approximately 6% were coinfected with HBV and 6% were coinfected with HCV. Because of this small number of patients, no conclusions can be made regarding whether coinfection with HBV or HCV increases the risk for maraviroc-associated adverse hepatic effects.

Individuals with moderate hepatic impairment receiving maraviroc 150 mg twice daily and a drug that strongly inhibits CYP3A should be monitored closely for maraviroc-associated adverse effects.

Renal Impairment

Maraviroc should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) or with ESRD who are receiving concomitant therapy with a drug that is a potent inhibitor or inducer of cytochrome P-450 (CYP) isoenzyme 3A.

Increased maraviroc plasma concentrations are expected in patients with renal impairment, especially in those receiving concomitant therapy with a drug that inhibits CYP3A.

Patients with severe renal insufficiency or ESRD may be at increased risk of postural hypotension because of increased maraviroc plasma concentrations. In addition, patients with renal impairment may have cardiovascular co-morbidities and be at increased risk of adverse cardiovascular events that are triggered by postural hypotension.

Maraviroc should be used in patients with severe renal impairment or ESRD only if they are not receiving concomitant therapy with a potent CYP3A inhibitor or inducer and only when no alternative treatment options are available. If patients with severe renal impairment or ESRD experience any symptoms of postural hypotension while receiving maraviroc, dosage of the drug should be reduced.(See Renal Impairment under Dosage and Administration: Special Populations.)

Common Adverse Effects

The most common adverse effects reported in antiretroviral-experienced patients receiving maraviroc in conjunction with other antiretrovirals are cough (14%), pyrexia (13%), upper respiratory tract infections (23%), rash (11%), and dizziness (9%).

Drug Interactions

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Maraviroc is metabolized by the cytochrome P-450 (CYP) isoenzyme 3A, and the possibility exists that drugs that inhibit or induce this isoenzyme may alter the pharmacokinetics of maraviroc.

In vitro studies indicate that maraviroc does not inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 3A. Pharmacokinetic interaction unlikely with drugs that are substrates for these isoenzymes.

Maraviroc does not induce CYP1A2. Maraviroc may inhibit CYP2D6 at higher than recommended dosage.

Drugs Affecting or Affected by P-glycoprotein Transport

Maraviroc is a substrate of the P-glycoprotein (P-gp) transport system, and the possibility exists that drugs that are inhibitors or inducers of this system may alter the pharmacokinetics of maraviroc.

Although in vitro studies suggest that maraviroc could inhibit P-gp in the gut, in vivo studies using digoxin indicate that maraviroc may not inhibit or induce P-gp to any clinically important extent.

Anticonvulsants

Possible pharmacokinetic interaction with carbamazepine, phenobarbital, or phenytoin (decreased maraviroc plasma concentrations). Recommended dosage of maraviroc is 600 mg twice daily in patients receiving these anticonvulsants, provided the regimen does notinclude a potent CYP3A inhibitor. Some experts suggest that alternative anticonvulsants be considered in patients receiving maraviroc.

Antifungal Agents

Itraconazole

Possible pharmacokinetic interaction with itraconazole (increased maraviroc plasma concentrations). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving itraconazole.

Ketoconazole

Pharmacokinetic interaction with ketoconazole (substantially increased maraviroc plasma concentrations). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving ketoconazole.

Voriconazole

Possible pharmacokinetic interaction with voriconazole (increased maraviroc plasma concentrations). Consider using maraviroc dosage of 150 mg twice daily in patients receiving voriconazole.

Antimycobacterial Agents

Rifabutin

Possible pharmacokinetic interaction with rifabutin (decreased maraviroc plasma concentrations). If rifabutin is used concomitantly with maraviroc in a regimen that does not include a drug that is a potent inducer or inhibitor of CYP3A, the recommended dosage of maraviroc is 300 mg twice daily. If rifabutin is used concomitantly with maraviroc and the regimen includes a drug that is a potent inhibitor of CYP3A, the recommended dosage of maraviroc is 150 mg twice daily.

Rifampin

Pharmacokinetic interaction with rifampin (decreased maraviroc plasma concentrations). Concomitant use of rifampin and maraviroc is not recommended. If concomitant use with rifampin is considered necessary, the recommended dosage of maraviroc is 600 mg twice daily, provided the regimen does not include a potent CYP3A inhibitor. If rifampin is used concomitantly with maraviroc and the regimen includes a drug that is a potent inhibitor of CYP3A, the recommended dosage of maraviroc is 300 mg twice daily.

Rifapentine

Possible pharmacokinetic interaction with rifapentine (decreased maraviroc concentrations). Concomitant use of maraviroc and rifapentine is not recommended. HIV-infected tuberculosis patients treated with rifapentine have a higher rate of tuberculosis relapse than those treated with other rifamycin-based tuberculosis regimens; an alternative antimycobacterial agent is recommended in HIV patients.

Antiretroviral Agents

HIV Entry and Fusion Inhibitors

Enfuvirtide

When maraviroc is used in conjunction with enfuvirtide in a regimen that does not include a potent CYP3A inhibitor or inducer, the recommended dosage of maraviroc is 300 mg twice daily.

No in vitro evidence of antagonistic antiretroviral effects between maraviroc and enfuvirtide.

HIV Integrase Inhibitors (INSTIs)

Dolutegravir

No in vitro evidence of antagonistic antiretroviral effects with dolutegravir.

Elvitegravir and Cobicistat

Possible pharmacokinetic interaction with the fixed combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/TDF/FTC) (increased maraviroc concentrations). Concomitant use of EVG/COBI/TDF/FTC and maraviroc is not recommended.

Raltegravir

Pharmacokinetic interaction with raltegravir (decreased raltegravir plasma concentrations and AUC; decreased maraviroc concentrations and AUC); not considered clinically important.

When maraviroc is used in conjunction with raltegravir in a regimen that does not include a potent CYP3A inhibitor or inducer, the recommended maraviroc dosage is 300 mg twice daily.

HIV Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

No in vitro evidence of antagonistic antiretroviral effects between maraviroc and HIV NNRTIs (delavirdine, efavirenz, etravirine, nevirapine, rilpivirine).

Delavirdine

Recommended dosage of maraviroc is 150 mg twice daily in patients receiving delavirdine.

Efavirenz

Pharmacokinetic interaction with efavirenz (decreased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 600 mg twice daily in patients receiving efavirenz, provided the regimen does notinclude a potent CYP3A inhibitor.

Pharmacokinetic interaction when maraviroc is used with efavirenz and with lopinavir/ritonavir (increased maraviroc plasma concentrations and AUC). Pharmacokinetic interaction when maraviroc is used with efavirenz and with ritonavir-boosted saquinavir (increased maraviroc plasma concentrations and AUC).

Etravirine

Pharmacokinetic interaction with etravirine (decreased maraviroc plasma concentrations and AUC; no clinically important effect on etravirine plasma concentrations or AUC).

If maraviroc and etravirine are used concomitantly, the recommended maraviroc dosage is 600 mg twice daily with the usual etravirine dosage, provided the regimen does not include a potent CYP3A inhibitor (e.g., a ritonavir-boosted PI).

Nevirapine

Pharmacokinetic interaction with nevirapine (increased maraviroc plasma concentrations but no effect on maraviroc AUC). If nevirapine is used with maraviroc in a regimen that does not include an HIV PI or other potent CYP3A inhibitor, the recommended maraviroc dosage is 300 mg twice daily. If nevirapine is used with maraviroc in a regimen that includes an HIV PI (except ritonavir-boosted tipranavir), the recommended maraviroc dosage is 150 mg twice daily.

Rilpivirine

Clinically important pharmacokinetic interactions unlikely.

HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTIs)

Maraviroc has no clinically important effect on the pharmacokinetics of lamivudine or zidovudine.

Tenofovir does not affect the pharmacokinetics of maraviroc.

When maraviroc is used concomitantly with HIV NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zidovudine), the recommended dosage of maraviroc is 300 mg twice daily, provided the regimen does not include a potent CYP3A inhibitor or inducer.

No in vitro evidence of antagonistic antiretroviral effects between maraviroc and NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zidovudine).

HIV Protease Inhibitors (PIs)

No in vitro evidence of antagonistic antiretroviral effects between maraviroc and HIV PIs (amprenavir, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir).

Atazanavir

Pharmacokinetic interaction with atazanavir (with or without low-dose ritonavir) (increased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving atazanavir or ritonavir-boosted atazanavir.

Darunavir

Pharmacokinetic interaction with ritonavir-boosted darunavir (increased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving ritonavir-boosted darunavir.

Pharmacokinetic interaction when maraviroc is used with ritonavir-boosted darunavir and etravirine (increased maraviroc AUC).

Fosamprenavir

Pharmacokinetic interaction with maraviroc (increased plasma concentrations and AUC of maraviroc; decreased plasma concentrations and AUC of amprenavir [active metabolite of fosamprenavir]). A maraviroc dosage of 150 mg twice daily should be used concomitantly with the usual dosage of ritonavir-boosted fosamprenavir. Fosamprenavir without low-dose ritonavir should not be used concomitantly with maraviroc.

Indinavir

Recommended dosage of maraviroc is 150 mg twice daily in patients receiving indinavir.

Lopinavir

Pharmacokinetic interaction with the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir) (substantially increased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving lopinavir/ritonavir.

Nelfinavir

Recommended dosage of maraviroc is 150 mg twice daily in patients receiving nelfinavir.

Ritonavir

Pharmacokinetic interaction with low-dose ritonavir (ritonavir 100 mg twice daily) (increased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving low-dose ritonavir (except ritonavir-boosted tipranavir).

Saquinavir

Pharmacokinetic interaction with ritonavir-boosted saquinavir (saquinavir 1 g twice daily with ritonavir 100 mg twice daily) (substantially increased maraviroc plasma concentrations and AUC). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving ritonavir-boosted saquinavir.

Pharmacokinetic interaction when maraviroc is used with ritonavir-boosted saquinavir and efavirenz (increased maraviroc plasma concentrations and AUC).

Tipranavir

No clinically important effect on maraviroc pharmacokinetics with ritonavir-boosted tipranavir. Recommended dosage of maraviroc is 300 mg twice daily in patients receiving ritonavir-boosted tipranavir, provided the regimen does not include a potent CYP3A inhibitor or inducer.

Co-trimoxazole

Co-trimoxazole does not affect the pharmacokinetics of maraviroc.

Estrogens/Progestins

No clinically important effect on pharmacokinetics of oral contraceptives containing ethinyl estradiol and levonorgestrel. Oral contraceptives can be used safely in patients receiving maraviroc.

HCV Antivirals

HCV Protease Inhibitors

Boceprevir

Pharmacokinetic interaction with boceprevir (increased maraviroc plasma concentrations and AUC; no clinically important effect on boceprevir pharmacokinetics). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving boceprevir.

Simeprevir

No clinically important interactions are expected if simeprevir is used concomitantly with maraviroc.

Telaprevir

Pharmacokinetic interaction with telaprevir (increased maraviroc plasma concentrations and AUC; no clinically important effect on telaprevir pharmacokinetics). Concomitant use of telaprevir and maraviroc is not recommended.

Macrolide Antibiotics

Possible pharmacokinetic interaction with clarithromycin (increased maraviroc plasma concentrations). Recommended dosage of maraviroc is 150 mg twice daily in patients receiving clarithromycin.

Midazolam

Pharmacokinetic interaction unlikely with midazolam.

Nefazodone

Possible pharmacokinetic interaction with nefazodone. Recommended dosage of maraviroc is 150 mg twice daily in patients receiving nefazodone.

St. John's Wort

Potential pharmacokinetic interaction with St. John's wort (Hypericum perforatum) (decreased maraviroc concentrations); potential for loss of virologic response. Concomitant use is not recommended.

Telithromycin

Possible pharmacokinetic interaction with telithromycin. Recommended dosage of maraviroc is 150 mg twice daily in patients receiving telithromycin.

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