Mirvetuximab soravtansine-gynx: Difference between revisions
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|blackBoxWarningTitle='''<span style="color:#FF0000;"> | |blackBoxWarningTitle='''<span style="color:#FF0000;"> OCULAR TOXICITY/span>''' | ||
|blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' ( | |blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' (WARNING: OCULAR TOXICITY | ||
See full prescribing information for complete boxed warning. | |||
ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. (5.1, 6.1) | |||
Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. (2.3) | |||
Administer prophylactic artificial tears and ophthalmic topical steroids. (2.3, 5.1) | |||
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. (2.4, 5.1) | |||
Discontinue ELAHERE for Grade 4 ocular toxicities. (2.4, 5.1)) | |||
|offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Mirvetuximab soravtansine-gynx in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Mirvetuximab soravtansine-gynx in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Mirvetuximab soravtansine-gynx in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Mirvetuximab soravtansine-gynx in adult patients. | ||
Revision as of 17:40, 14 April 2025
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Mirvetuximab soravtansine-gynx is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Mirvetuximab soravtansine-gynx 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 Mirvetuximab soravtansine-gynx in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mirvetuximab soravtansine-gynx in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Mirvetuximab soravtansine-gynx FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Mirvetuximab soravtansine-gynx in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mirvetuximab soravtansine-gynx in pediatric patients.
Contraindications
There is limited information regarding Mirvetuximab soravtansine-gynx Contraindications in the drug label.
Warnings
There is limited information regarding Mirvetuximab soravtansine-gynx Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Mirvetuximab soravtansine-gynx Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Mirvetuximab soravtansine-gynx Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Mirvetuximab soravtansine-gynx Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Mirvetuximab soravtansine-gynx in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mirvetuximab soravtansine-gynx in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Mirvetuximab soravtansine-gynx during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in geriatric settings.
Gender
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx with respect to specific gender populations.
Race
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Mirvetuximab soravtansine-gynx in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Mirvetuximab soravtansine-gynx in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Mirvetuximab soravtansine-gynx Administration in the drug label.
Monitoring
There is limited information regarding Mirvetuximab soravtansine-gynx Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Mirvetuximab soravtansine-gynx and IV administrations.
Overdosage
There is limited information regarding Mirvetuximab soravtansine-gynx 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 Mirvetuximab soravtansine-gynx Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Mirvetuximab soravtansine-gynx Mechanism of Action in the drug label.
Structure
There is limited information regarding Mirvetuximab soravtansine-gynx Structure in the drug label.
Pharmacodynamics
There is limited information regarding Mirvetuximab soravtansine-gynx Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Mirvetuximab soravtansine-gynx Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Mirvetuximab soravtansine-gynx Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Mirvetuximab soravtansine-gynx Clinical Studies in the drug label.
How Supplied
There is limited information regarding Mirvetuximab soravtansine-gynx How Supplied in the drug label.
Storage
There is limited information regarding Mirvetuximab soravtansine-gynx Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Mirvetuximab soravtansine-gynx |?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::Mirvetuximab soravtansine-gynx |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Mirvetuximab soravtansine-gynx Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Mirvetuximab soravtansine-gynx interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Mirvetuximab soravtansine-gynx Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Mirvetuximab soravtansine-gynx 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.