Maraviroc
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Black Box Warning
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WARNING: HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
Hepatotoxicity has been reported with use of SELZENTRY®. 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 SELZENTRY should be evaluated immediately
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Overview
Maraviroc is an antiretroviral agent that is FDA approved for the treatment of adults infected with only CCR5-tropic HIV-1. There is a Black Box Warning for this drug as shown here. Common adverse reactions include upper respiratory tract infections, cough, pyrexia, rash, and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Maraviroc in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1. The recommended dose of maraviroc differs based on concomitant medications due to drug interactions:
- Potent CYP3A inhibitors (with or without a potent CYP3A inducer): 150 mg twice daily
- Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide: 300 mg twice daily
- Potent CYP3A inducers (without a potent CYP3A inhibitor): 600 mg twice daily
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Maraviroc in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Maraviroc in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and efficacy not established in patients younger than 18 years
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Maraviroc in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Maraviroc in pediatric patients.
Contraindications
There is limited information regarding Maraviroc Contraindications in the drug label.
Warnings
|
WARNING: HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
Hepatotoxicity has been reported with use of SELZENTRY®. 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 SELZENTRY should be evaluated immediately
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There is limited information regarding Maraviroc Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Maraviroc Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Maraviroc Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Maraviroc Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): B
There is no FDA guidance on usage of Maraviroc in women who are pregnant.
Pregnancy Category (AUS): B1
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Maraviroc in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Maraviroc during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Maraviroc in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Maraviroc in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Maraviroc in geriatric settings.
Gender
There is no FDA guidance on the use of Maraviroc with respect to specific gender populations.
Race
There is no FDA guidance on the use of Maraviroc with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Maraviroc in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Maraviroc in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Maraviroc in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Maraviroc in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Maraviroc Administration in the drug label.
Monitoring
There is limited information regarding Maraviroc Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Maraviroc and IV administrations.
Overdosage
There is limited information regarding Maraviroc overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Maraviroc Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Maraviroc Mechanism of Action in the drug label.
Structure
There is limited information regarding Maraviroc Structure in the drug label.
Pharmacodynamics
There is limited information regarding Maraviroc Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Maraviroc Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Maraviroc Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Maraviroc Clinical Studies in the drug label.
How Supplied
There is limited information regarding Maraviroc How Supplied in the drug label.
Storage
There is limited information regarding Maraviroc Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Maraviroc Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Maraviroc interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Selzentry [1]
Look-Alike Drug Names
There is limited information regarding Maraviroc Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]
Overview
Maraviroc (brand-named Selzentry in U.S.) is an antiretroviral drug in the CCR5 receptor antagonist class used in the treatment of HIV infection. It is also classed as an entry inhibitor. It also appeared to reduce graft-versus-host disease in patients treated with allogeneic bone marrow transplantation for leukemia, in a phase 1/2 study.[1][2]
Category
Antiretroviral
US Brand Names
Selzentry®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages
Mechanism of Action
References
- ↑ http://www.uphs.upenn.edu/news/News_Releases/2012/07/hiv/
- ↑ Blocade of lymphocyte chemotaxis in visceral graft-versus-host disease, Ran Reshef et al., New England Journal of Medicine, 367:135 (July 12, 2012)