Mirvetuximab soravtansine-gynx
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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Black Box Warning
|
OCULAR TOXICITY/span>
See full prescribing information for complete Boxed Warning.
Condition Name: (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)) |
Overview
Mirvetuximab soravtansine-gynx is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor that is FDA approved for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian,fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
- The recommended dosage of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity. Dosing based on AIBW reduces exposure variability for patients who are either under or overweight.
The total dose of ELAHERE is calculated based on each patient’s AIBW using the following formula:
AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW)
Female IBW [kg] = 0.9*height[cm] – 92
- Injection: 100 mg/20 mL (5 mg/mL) clear to slightly opalescent, colorless solution in a single-dose vial.
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
None.
Warnings
|
OCULAR TOXICITY/span>
See full prescribing information for complete Boxed Warning.
Condition Name: (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)) |
5.1 Ocular Disorders ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.
Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%). [see Adverse Reactions (6.1)].
The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.
Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended [see Dosage and Administration (2.3)]. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.
Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.
Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions. [see Dosage and Administration (2.4)].
5.2 Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.
Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology.
Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.
Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis [see Dosage and Administration (2.4)]. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.
5.3 Peripheral Neuropathy Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%).
The median time to onset of peripheral neuropathy was 5.9 weeks (range 0.1 to 126.7). Of the patients who experienced peripheral neuropathy, 23% had complete resolution and 12% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Peripheral neuropathy led to discontinuation of ELAHERE in 0.7% of patients.
Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening peripheral neuropathy, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of peripheral neuropathy [see Dosage and Administration (2.4)].
5.4 Embryo-Fetal Toxicity Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose
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
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Package and Label Display Panel
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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
ELAHERE
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.