Miscellaneous antineoplastics
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Elahere Injection Dosage

Drug Detail:Elahere (Mirvetuximab soravtansine [ mir-ve-tux-i-mab-soe-rav-tan-seen ])

Generic Name: MIRVETUXIMAB SORAVTANSINE 100mg in 20mL

Dosage Form: injection, solution

Drug Class: Miscellaneous antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with ELAHERE based on the presence of FRα tumor expression [see Indications & Usage (1) and Clinical Studies (14)] using an FDA-approved test.

Information on FDA-approved tests for the measurement of FRα tumor expression is available at http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dose 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 [see Dosage and Administration (2.5)].

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

Premedication and Required Eye Care

Premedication

Administer the premedications in Table 1 prior to each infusion of ELAHERE to reduce the incidence and severity of infusion related reactions (IRRs), nausea, and vomiting.

Table 1: Premedication Prior to Each ELAHERE Infusion
Premedication Route of Administration Examples (or equivalent) Administration Time Prior to ELAHERE Infusion
Corticosteroid intravenous dexamethasone 10 mg At least 30 minutes prior
Antihistamine oral or intravenous diphenhydramine 25 mg to 50 mg
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

Consider additional premedications including corticosteroids the day prior to ELAHERE administration for patients who experienced IRRs.

Ophthalmic Exams and Premedication

Ophthalmic exam: 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.

Ophthalmic Topical Steroids: The use of ophthalmic topical steroids is recommended. The initial prescription and renewals of any corticosteroid medication should be made only after examination with a slit lamp. Administer one drop of ophthalmic topical steroids in each eye 6 times daily starting the day prior to each infusion until day 4; then administer one drop in each eye 4 times daily for days 5-8 of each cycle of ELAHERE [see Warnings and Precautions (5.1)].

Lubricating Eye Drops: The use of lubricating eye drops at least four times daily and as needed is recommended during treatment with ELAHERE. Instruct patients to use lubricating eye drops and advise to wait at least 10 minutes after ophthalmic topical steroid administration before instilling lubricating eye drops [see Warnings and Precautions (5.1)].

Dosage Modifications

Table 2 provides dose reductions and modifications for adverse reactions. Adjust the schedule of administration to maintain a 3-week interval between doses.

Table 2: Dosage Reduction Schedule
ELAHERE Dose Levels
*
Permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.
Starting Dose 6 mg/kg AIBW
First Dose Reduction 5 mg/kg AIBW
Second Dose Reduction 4 mg/kg AIBW*
Table 3: Dosage Modifications for Adverse Reactions
Adverse Reaction Severity of Adverse Reaction* Dosage Modification
*
Unless otherwise specified, National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Keratitis/Keratopathy
[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]		 Nonconfluent superficial keratitis Monitor.
Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity Withhold dose 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 dose until improved or resolved, then reduce by one dose level.
Corneal perforation Permanently discontinue.
Uveitis
[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]		 Grade 1/ Rare cell in anterior chamber Monitor.
Grade 2/ 1-2+ Cell or Flare in anterior chamber Withhold dose until Grade 1 or less, then maintain dose at same dose level.
Grade 3/ 3+ Cell or Flare in anterior chamber Withhold dose until Grade 1 or less, then reduce dose by one dose level.
Grade 4/ Hypopyon Permanently discontinue.
Pneumonitis
[see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]		 Grade 1 Monitor.
Grade 2 Withhold dose until Grade 1 or less, then resume at same dose level or one lower dose level at the discretion of the healthcare provider.
Grade 3 or 4 Permanently discontinue.
Peripheral Neuropathy
[see Warnings and Precautions (5.3) and Adverse Reactions (6.1)]		 Grade 2 Withhold dose until Grade 1 or less, then reduce by one dose level.
Grade 3 or 4 Permanently discontinue.
Infusion-Related Reactions/Hypersensitivity
[see Adverse Reactions (6.1)]		 Grade 1 Maintain infusion rate.
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.
Other Adverse Reactions
[see Adverse Reactions (6.1)]		 Grade 3 Withhold dose until Grade 1 or less, then resume at one lower dose level.
Grade 4 Permanently discontinue.

Instructions for Preparation and Administration

Preparation

  • ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures1.
  • 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 (2.2) and Dose Modifications (2.4)]. 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 for subsequent further dilution. Do not shake the vial.
  • Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent further 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 12 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 (2.3)].
  • 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.
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