Pomalidomide: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{KS}} | |authorTag={{KS}} | ||
|aOrAn= | |genericName=pomalidomide | ||
|aOrAn=an | |||
|drugClass=antineoplastic agent | |||
|indicationType=treatment | |||
|hasBlackBoxWarning=Yes | |hasBlackBoxWarning=Yes | ||
|adverseReactions=<!--Black Box Warning--> | |adverseReactions=<!--Black Box Warning--> | ||
|blackBoxWarningTitle= | |blackBoxWarningTitle=WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM | ||
|blackBoxWarningBody= | |blackBoxWarningBody='''Embryo-Fetal Toxicity''' | ||
* | * POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment. | ||
* Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment. | |||
* POMALYST is only available through a restricted distribution program called POMALYST REMS™. | |||
'''Venous Thromboembolism''' | |||
* Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients with multiple myeloma treated with POMALYST. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures after assessing an individual patient’s underlying risk factors. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
|contraindications=* | |||
|warnings=* | |||
|contraindications=* | |||
|warnings=* | |||
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
|drugInteractions=* | |||
|drugInteractions=* | |||
|useInPregnancyFDA=* '''Pregnancy Category''' | |useInPregnancyFDA=* '''Pregnancy Category''' | ||
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | ||
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|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | ||
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | ||
|administration=* Oral | |administration=* Oral | ||
* Intravenous | * Intravenous | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | ||
|mechAction=* | |mechAction=* | ||
Revision as of 17:14, 4 February 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [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: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
See full prescribing information for complete Boxed Warning.
Embryo-Fetal Toxicity
Venous Thromboembolism
|
Overview
Pomalidomide is an antineoplastic agent that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pomalidomide FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pomalidomide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pomalidomide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Pomalidomide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pomalidomide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pomalidomide in pediatric patients.
Contraindications
Warnings
WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
See full prescribing information for complete Boxed Warning.
Embryo-Fetal Toxicity
Venous Thromboembolism
|
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Pomalidomide in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Pomalidomide in the drug label.
Drug Interactions
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pomalidomide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pomalidomide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pomalidomide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Pomalidomide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Pomalidomide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Pomalidomide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pomalidomide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pomalidomide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pomalidomide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pomalidomide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pomalidomide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Pomalidomide in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Pomalidomide in the drug label.
Overdosage
There is limited information regarding Pomalidomide 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 Pomalidomide Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Pomalidomide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Pomalidomide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Pomalidomide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Pomalidomide in the drug label.
How Supplied
Storage
There is limited information regarding Pomalidomide Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Pomalidomide |?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::Pomalidomide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Pomalidomide in the drug label.
Precautions with Alcohol
- Alcohol-Pomalidomide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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