Mirvetuximab soravtansine
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 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 [see Dosage and Administration ( 2.3 )] . Administer prophylactic artificial tears and ophthalmic topical steroids [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.1 )] .
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . Discontinue ELAHERE for Grade 4 ocular toxicities [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . 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 )
Dosing in kidney impairment
Renal Impairment No dosage adjustment of ELAHERE is recommended for patients with mild to moderate renal impairment (CLcr 30 to 89 mL/min). The effect of severe renal impairment (CLcr 15 to < 30 mL/min) or end-stage renal disease on ELAHERE is unknown [see Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >
Preparation and administration
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Instructions for Preparation and Administration Preparation ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Calculate the dose (mg) (based on the patient’s AIBW), total volume (mL) of solution required, and the number of vials of ELAHERE needed [see Recommended Dosage and Dose Modifications] .
More than one vial will be needed for a full dose. Remove the vials of ELAHERE from the refrigerator and allow to warm to room temperature. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ELAHERE is a clear to slightly opalescent, colorless solution.
Gently swirl and inspect each vial prior to withdrawing the calculated dose volume of ELAHERE. Do not shake the vial. Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent dilution. ELAHERE contains no preservatives and is intended for single-dose only. Discard any unused drug remaining in the vial.
Dilution ELAHERE must be diluted prior to administration with 5% Dextrose Injection, USP to a final concentration of 1 mg/mL to 2 mg/mL. ELAHERE is incompatible with 0.9% Sodium Chloride Injection. ELAHERE must not be mixed with any other drugs or intravenous fluids. Determine the volume of 5% Dextrose Injection, USP required to achieve the final diluted drug concentration.
Either remove excess 5% Dextrose Injection, USP from a prefilled intravenous bag or add the calculated volume of 5% Dextrose Injection, USP to a sterile empty intravenous bag. Then add the calculated dose volume of ELAHERE to the intravenous bag. Gently mix the diluted drug solution by slowly inverting the bag several times to assure uniform mixing.
Do not shake or agitate.
If the diluted infusion solution is not used immediately, store solution either at ambient temperature [(18°C to 25°C (64.4°F to 77°F)] for no more than 8 hours (including infusion time), or under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. If refrigerated, allow the infusion bag to reach room temperature prior to administration.
After refrigeration, administer diluted infusion solutions within 8 hours (including infusion time). Do not freeze prepared infusion solution. Administration Inspect the ELAHERE intravenous infusion bag visually for particulate matter and discoloration prior to administration. Administer pre-medications prior to ELAHERE administration [see Premedication and Prophylactic Regimen] .
Administer ELAHERE as an intravenous infusion only, using a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter. Do not substitute other membrane materials. Administer the initial dose as an intravenous infusion at the rate of 1 mg/min. If well tolerated after 30 minutes at 1 mg/min, the infusion rate can be increased to 3 mg/min.
If well tolerated after 30 minutes at 3 mg/min, the infusion rate can be increased to 5 mg/min. If no infusion-related reactions occur with the previous dose, subsequent infusions should be started at the maximally tolerated rate and may be increased up to a maximum infusion rate of 5 mg/min, as tolerated. Following the infusion, flush the intravenous line with 5% Dextrose Injection, USP to ensure delivery of the full dose.
Do not use any other intravenous fluids for flushing.
| Premedication | Route of Administration | Examples (or equivalent) | Administration Time Prior to ELAHERE Infusion |
| Corticosteroid | intravenous | dexamethasone 10 mg | |
| Antihistamine | oral or intravenous | diphenhydramine 25 mg to 50 mg | At least 30 minutes prior |
| Antipyretic | oral or intravenous | acetaminophen 325 mg to 650 mg | |
| Antiemetic | oral or intravenous | 5-HT3 serotonin receptor antagonist or appropriate alternatives | Before each dose and thereafter as needed |
| Adverse Reaction | Severity of Adverse Reaction* | Dosage Modification |
| Nonconfluent superficial keratitis | Monitor. | |
| Keratitis/Keratopathy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] | Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity | Withhold until improved or resolved, then maintain at same dose level or consider dose reduction. |
| Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse | Withhold until improved or resolved, then reduce by one dose level. | |
| Corneal perforation | Permanently discontinue. | |
| Grade 1/ Rare cell in anterior chamber | Monitor. | |
| Uveitis [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] | Grade 2/ 1-2+ Cell or Flare in anterior chamber | Withhold until Grade 1 or less, then maintain dose at same dose level. |
| Grade 3/ 3+ Cell or Flare in anterior chamber | Withhold until Grade 1 or less, then reduce dose by one dose level. | |
| Grade 4/ Hypopyon | Permanently discontinue. | |
| Grade 1 | Monitor. | |
| Pneumonitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] | Grade 2 | Withhold until Grade 1 or less, then maintain at same dose level or consider dose reduction. |
| Grade 3 or 4 | Permanently discontinue. | |
| Peripheral Neuropathy [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)] | Grade 2 | Withhold until Grade 1 or less, then reduce by one dose level. |
| Grade 3 or 4 | Permanently discontinue. | |
| Grade 1 | Maintain infusion rate. | |
| Infusion-Related Reactions/Hypersensitivity [see Adverse Reactions (6.1)] | Grade 2 | Interrupt infusion and administer supportive treatment. After recovery from symptoms, resume the infusion at 50% of the previous rate, and if no further symptoms appear, increase rate as appropriate until infusion is completed [see Dosage and Administration (2.5)]. Administer additional premedication for future cycles [see Dosage and Administration (2.3)]. |
| Grade 3 or 4 | Immediately stop infusion and administer supportive treatment. Advise patient to seek emergency treatment and immediately notify their healthcare provider if the infusion-related symptoms recur. Permanently discontinue. | |
| Hematological [see Adverse Reactions (6.1)] | Grade 3 or 4 | Withhold until Grade 1 or less, then resume at one lower dose level. |
| Other Adverse Reactions | Grade 3 | Withhold until Grade 1 or less, then resume at one lower dose level. |
| [see Adverse Reactions (6.1)] | Grade 4 | Permanently discontinue. |
Drug interactions
Check mirvetuximab soravtansine against a medication listLabel text (2 paragraphs)
Strong CYP3A4 Inhibitors: Closely monitor for ELAHERE adverse reactions. ( 7.1 )
7.1 Effects of Other Drugs on ELAHERE Strong CYP3A4 Inhibitors DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of ELAHERE adverse reactions [see Adverse Reactions ( 6 )] . Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors [ see Warnings and Precautions ( 5 ) ] .
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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 [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, ELAHERE has the potential to be transmitted from the mother to the developing fetus. There are no available human data on ELAHERE use in pregnant women to inform a drug-associated risk. No reproductive or developmental animal toxicity studies were conducted with mirvetuximab soravtansine-gynx.
Advise patients of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data: No reproductive or developmental animal toxicity studies have been conducted with mirvetuximab soravtansine-gynx. The cytotoxic component of ELAHERE, DM4, disrupts microtubule function, is genotoxic, and can be toxic to actively dividing cells, suggesting it has the potential to cause embryotoxicity and teratogenicity.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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