Maraviroc

Maraviroc is an HIV-1 antiviral drug [ see Microbiology ( 12.4 ) ].

• 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 ) ].ICD-10: B20

• Maraviroc tablets are contraindicated in patients with severe renal impairment or ESRD (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers [ see Warnings and Precautions ( 5.3 ) ]. • Maraviroc tablets are contraindicated in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers.contraindicated

• Prior to initiation of maraviroc tablets for treatment of HIV-1 infection, test all patients for CCR5 tropism using a highly sensitive tropism assay. ( 2.1 ) • 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. ( 2.2 ) Recommended Dosage in Adult Patients: ( 2.3 ) Concomitant Medications Dosage of Maraviroc tablets When given with potent cytochrome P450 (CYP)3A inhibitors (with or without potent CYP3A inducers) including PIs (except tipranavir/ritonavir) ( 2.3 , 7.1 ) 150 mg twice daily With NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, and other drugs that are not potent CYP3A inhibitors or CYP3A inducers ( 2.3 , 7.1 ) 300 mg twice daily With potent and moderate CYP3A inducers including efavirenz (without a potent CYP3A inhibitor) ( 2.3 , 7.1 ) 600 mg twice daily A more complete list of coadministered drugs is listed in Dosage and Administration. ( 2 ) Recommended Dosage in Pediatric Patients 2 years and older and weighing at Least 10 kg: Administer twice daily. Dosage should be based on body weight (kg) and concomitant medications and should not exceed the recommended adult dose. ( 2.4 ) Recommended Dosage in Patients with Renal Impairment: Dose adjustment may be necessary in adult patients with renal impairment. ( 2.5 ) 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.

• Hepatotoxicity accompanied by severe rash or systemic allergic reaction, including potentially life-threatening events, has been reported. Hepatic laboratory parameters including ALT, AST, and bilirubin should be obtained prior to starting maraviroc tablets and at other time points during treatment as clinically indicated. If rash or symptoms or signs of hepatitis or allergic reaction develop, hepatic laboratory parameters should be monitored and discontinuation of treatment should be considered. When administering maraviroc tablets to patients with pre-existing liver dysfunction or who are co-infected with hepatitis B and/or C virus, additional monitoring may be warranted. ( 5.1 ) • Severe and potentially life-threatening skin and hypersensitivity reactions have been reported in patients taking maraviroc. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, and toxic epidermal necrolysis. Immediately discontinue maraviroc and other suspected agents if signs or symptoms of severe skin or hypersensitivity reactions develop and monitor clinical status, including liver aminotransferases, closely. ( 5.2 ) • More cardiovascular events, including myocardial ischemia and/or infarction, were observed in treatment-experienced subjects who received maraviroc. Additional monitoring may be warranted. ( 5.3 ) • If patients with severe renal impairment or ESRD receiving maraviroc (without concomitant CYP3A inducers or inhibitors) experience postural hypotension, the dose of maraviroc should be reduced from 300 mg twice daily to 150 mg twice daily.

The following adverse reactions are discussed in other sections of the labeling: • Hepatotoxicity [ see Boxed Warning, Warnings and Precautions ( 5.1 ) ] • Severe Skin and Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] • Cardiovascular Events [ see Warnings and Precautions ( 5.3 ) ] • The most common adverse events in treatment-experienced adult subjects (greater than 8% incidence) which occurred at a higher frequency compared with placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness. ( 6.1 ) • The most common adverse events in treatment-naive adult subjects (greater than 8% incidence) which occurred at a higher frequency than the comparator arm are upper respiratory tract infections, bronchitis, flatulence, bloating and distention, upper respiratory tract signs and symptoms, and gastrointestinal atonic and hypomotility disorders. ( 6.1 ) • The most common adverse reactions in treatment-experienced pediatric subjects (greater than or equal to 3% incidence) are vomiting, abdominal pain, diarrhea, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to maraviroc during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Limited data on the use of maraviroc during pregnancy from the APR and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with maraviroc. During organogenesis in the rat and rabbit, systemic exposures (AUC) to maraviroc were approximately 20 times (rats) and 5 times (rabbits) the exposure in humans at the recommended 300-mg twice-daily dose. In the rat pre- and post-natal development study, maternal systemic exposure (AUC) to maraviroc was approximately 14 times the exposure in humans at the recommended 300-mg twice-daily dose ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Table 11. Mean Maraviroc Pharmacokinetic Parameters in Adults Patient Population Maraviroc Dose n AUC 12 (ng.h/mL) C max (ng/mL) C min (ng/mL) Healthy volunteers (Phase 1) 300 mg twice daily 64 2,908 888 43.1 Asymptomatic HIV subjects (Phase 2a) 300 mg twice daily 8 2,550 618 33.6 Treatment-experienced HIV subjects (Phase 3) a 300 mg twice daily 94 1,513 266 37.2 150 mg twice daily (+ CYP3A inhibitor) 375 2,463 332 101 Treatment-naiveHIV subjects (Phase 2b/3) a 300 mg twice daily 344 1,865 287 60 a The estimated exposure is lower compared with other trials possibly due to sparse sampling, food…

The highest single dose administered in clinical trials was 1,200 mg. The dose-limiting adverse event was postural hypotension, which was observed at 600 mg. While the recommended dose for maraviroc in patients receiving a CYP3A inducer without a CYP3A inhibitor is 600 mg twice daily, this dose is appropriate due to enhanced metabolism. Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the intended exposure of 300-mg equivalents twice daily. However, no significant QT prolongation was seen in the trials in treatment-experienced subjects with HIV using the recommended doses of maraviroc, or in a specific pharmacokinetic trial to evaluate the potential of maraviroc to prolong the QT interval [ see Clinical Pharmacology ( 12.2 ) ]. There is no specific antidote for overdose with maraviroc. Treatment of overdose should consist of general supportive measures including keeping the patient in a supine position, careful assessment of patient vital signs, blood pressure, and ECG. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.

• Aug 6, 2007NDANDA022128Viiv Hlthcare
• Nov 4, 2016NDANDA208984Viiv Hlthcare
• Feb 7, 2022ANDAANDA203347Hetero Labs Ltd Iii
• Aug 17, 2023ANDAANDA217114I 3 Pharms
• May 13, 2025ANDAANDA217880Navinta Llc

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Selzentry, Solution, 20 mg/mL Oral Solution Kit | 230 mL Oral Solution per Bottle | 1 Bottle per Carton (NDC 49702-260-55)To be discontinued
  Sponsor: ViiV Healthcare Company
  Updated Jan 20, 2026

1. 1Virologic Failure1376.1%
2. 2Viral Mutation Identified1255.5%
3. 3Pathogen Resistance1225.4%
4. 4Anxiety944.2%
5. 5Off Label Use944.2%
6. 6Pain944.2%
7. 7Drug Ineffective914.0%
8. 8Drug Interaction863.8%
9. 9Drug Resistance793.5%
10. 10Emotional Distress733.2%
11. 11Nausea733.2%
12. 12Anhedonia622.7%
13. 13Exposure During Pregnancy622.7%
14. 14Treatment Failure622.7%
15. 15Treatment Noncompliance562.5%

Recent PubMed references pinned to Maraviroc as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Maraviroc Attenuates Neuronal Apoptosis by Inhibiting CCR5-Mediated Microglial Activation After Subarachnoid Hemorrhage.
  Neurochemical research · 2026 · Ye J, Li H, Peng Z, et al.
  PMID 42159851DOI 10.1007/s11064-026-04779-7
• Maraviroc for Stroke Recovery (MASTER): protocol for a phase 2 double-blind placebo-controlled randomised clinical trial.
  BMJ open · 2026 · Broc N, Byczynski G, Dirren E, et al.
  PMID 42082248DOI 10.1136/bmjopen-2025-109554
• Maraviroc attenuates orbital remodeling, inflammation, and lipid dysregulation in a murine model of thyroid eye disease associated with Graves' disease.
  Frontiers in endocrinology · 2026 · Hashemi Arani F, Gulbins A, Horstmann M, et al.
  PMID 41837138DOI 10.3389/fendo.2026.1717212
• Intensification with a CCR5 inhibitor at antiretroviral therapy initiation modulates interleukin-18 and inflammation-driven immune pathways in people with HIV.
  International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026 · De La Torre Tarazona E, Calderón-Vicente S, Fons-Contreras M, et al.
  PMID 41360215DOI 10.1016/j.ijid.2025.108306
• Maraviroc treatment for hospitalized participants with non-severe COVID-19 at risk of progression: a randomized, proof-of-concept clinical trial.
  Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2026 · Gasca-Capote C, Lomas-Cabezas JM, Saborido-Alconchel A, et al.
  PMID 40744845DOI 10.1016/j.jmii.2025.07.007
• Impact of the initial administration of an antiretroviral drug with latency reversal properties on the HIV reservoir size.
  Scientific reports · 2025 · De La Torre Tarazona E, Moraga E, Vaquer R, et al.
  PMID 40653494DOI 10.1038/s41598-025-09474-1
• Multiomics and cellular senescence profiling of aging human skeletal muscle uncovers Maraviroc as a senotherapeutic approach for sarcopenia.
  Nature communications · 2025 · Li Y, Li C, Zhou Q, et al.
  PMID 40617829DOI 10.1038/s41467-025-61403-y
• Maraviroc Prevents Optic Nerve Injury-Induced Retinal Ganglion Cell Apoptosis by Modulating the CCL5/CCR5/CTSS Axis.
  Investigative ophthalmology & visual science · 2025 · Huang J, Chang Z, Liu L, et al.
  PMID 40557874DOI 10.1167/iovs.66.6.77

The 10 most recently updated of 169 ClinicalTrials.gov registrations naming Maraviroc as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
  Recruiting · Phase 1 · Phase 2 · Interventional · 265 enrolled · National Cancer Institute (NCI)
  NCT05470491updated 2026-06-08
• Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals
  Not yet recruiting · Phase 2 · Interventional · 70 enrolled · Federal University of São Paulo
  NCT06805656updated 2026-06-01
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 133 enrolled · Gilead Sciences
  NCT02016924updated 2026-04-21
• Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
  Completed · Phase 2 · Interventional · 60 enrolled · French National Agency for Research on AIDS and Viral Hepatitis
  NCT00944541updated 2026-04-06
• Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy
  Terminated · Phase 2 · Interventional · 48 enrolled · ANRS, Emerging Infectious Diseases
  NCT01420523updated 2026-04-02
• Antiviral Clinical Trial for Long Covid-19
  Recruiting · Phase 2 · Interventional · 90 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06511063updated 2026-03-13
• This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction
  Recruiting · Phase 2 · Interventional · 120 enrolled · University of California, San Francisco
  NCT06853223updated 2026-01-20
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
  Completed · Phase 3 · Interventional · 224 enrolled · University Hospital, Tours
  NCT02302547updated 2025-12-26
• Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes
  Terminated · Interventional · 3 enrolled · Kevin F. Gibson
  NCT02134717updated 2025-12-03
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
  Completed · Observational · 1,578 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00042289updated 2025-12-02

Frequently asked questions

How does Maraviroc work?

Maraviroc is an HIV-1 antiviral drug [ see Microbiology ( 12.4 ) ].

What is Maraviroc used for?

According to FDA labeling, Maraviroc carries indications including: 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 ) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Maraviroc?

Maraviroc is classified as Other antivirals, CCR5 Co-receptor Antagonist, Chemokine Co-receptor 5 Antagonists, Cytochrome P450 3A Inducers, Cytochrome P450 3A Inhibitors.

What are the brand names for Maraviroc?

Maraviroc is marketed under brand names including Selzentry.

What are the contraindications for Maraviroc?

Maraviroc labeling lists contraindications including: Maraviroc tablets are contraindicated in patients with severe renal impairment or ESRD (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers [ see Warnings and Precautions ( 5.3 ) ]. • Maraviroc tablets are contraindicated in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers.. Always consult the full prescribing information and a clinician.