Maraviroc: Difference between revisions

Jump to navigation Jump to search
No edit summary
No edit summary
Line 1: Line 1:
{{DrugProjectFormSinglePage
|authorTag={{GP}}
|genericName=Maraviroc
|aOrAn=an
|drugClass=antiretroviral agent
|indicationType=treatment
|indication=adults infected with only CCR5-tropic HIV-1
|hasBlackBoxWarning=Yes
|adverseReactions=upper respiratory tract infections, cough, pyrexia, rash, and dizziness
|blackBoxWarningTitle=WARNING: HEPATOTOXICITY
|blackBoxWarningBody=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
|fdaLIADAdult=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
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Maraviroc in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Maraviroc in adult patients.
|fdaLIADPed=Safety and efficacy not established in patients younger than 18 years
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Maraviroc in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Maraviroc in pediatric patients.
|FDAPregCat=B
|AUSPregCat=B1
|alcohol=Alcohol-Maraviroc interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* Selzentry <ref>{{cite web|url=http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46f30ac5-c96b-429e-976d-8c5ee1c0761b|title=FDA LABEL: SELZENTRY- maraviroc tablet, film coated}}</ref>
}}
__NOTOC__
__NOTOC__
{{Maraviroc}}
{{Maraviroc}}

Revision as of 21:28, 26 January 2015

Maraviroc
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

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

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

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

{{#ask: Page Name::Maraviroc |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Maraviroc |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

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.

  1. "FDA LABEL: SELZENTRY- maraviroc tablet, film coated".


Maraviroc
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

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

  1. http://www.uphs.upenn.edu/news/News_Releases/2012/07/hiv/
  2. Blocade of lymphocyte chemotaxis in visceral graft-versus-host disease, Ran Reshef et al., New England Journal of Medicine, 367:135 (July 12, 2012)