DOSING

Prophylactic Medications Prophylactic Medications Calculating AIBW Instructions for Preparation Administration

Preparation & Administration Preparation & Administration Dose Modifications

Prophylactic medications CAN HELP MANAGE the infusion experience¹

Help reduce the incidence and severity of infusion-related reactions and emesis by following the ELAHERE premedication guidelines¹

Premedication	Route of administration	Examples (or equivalent)	Administration time prior to ELAHERE infusion
Corticosteroid	IV	Dexamethasone 10 mg
Antihistamine	Oral or IV	Diphenhydramine 25 mg to 50 mg	At least 30 minutes prior
Antipyretic	Oral or IV	Acetaminophen 325 mg to 650 mg
Antiemetic	Oral or IV	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 experience infusion-related reactions¹

IV=intravenous.

Dosage and Calculating AIBW¹*

The recommended dosage of ELAHERE is 6 mg/kg AIBW administered once every 3 weeks (21-day cycle)

ELAHERE is an IV infusion and is administered until disease progression or unacceptable toxicity

Dosing based on AIBW reduces exposure variability for patients who are either underweight or overweight

*This was the dose calculation process used in the clinical trials.

AIBW=adjusted ideal body weight.

The total dose of ELAHERE is calculated based on each patient’s AIBW using the following formula¹:

Ensure all weight measurements are recorded in kilogram (kg) units and height measurements are recorded in centimeters (cm) for ELAHERE dose calculations.

In the MIRASOL clinical study, the mean AIBW was 59.1 kg²
Based on an AIBW of 59.1 kg, the dose would be 355 mg per cycle (4 vials). One vial contains 100 mg/20 mL (5 mg/mL) of mirvetuximab soravtansine-gynx¹
Dose modifications may help manage treatment-related toxicities¹

The above calculator is provided for US healthcare professionals only, as a guide for determining AIBW. The information provided is not intended to supersede independent clinical judgment, and calculations should be confirmed.

Instructions for preparation¹

STEP 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. More than 1 vial will be needed for a full dose. ELAHERE is available in 100-mg/20-mL (5-mg/mL) single-dose vials

STEP 2

Remove the vials of ELAHERE from the refrigerator and allow to warm to room temperature

STEP 3

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

STEP 4

Gently swirl and inspect each vial prior to withdrawing the calculated dose volume of ELAHERE. Do not shake the vial

STEP 5

Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent dilution

STEP 6

ELAHERE contains no preservatives and is intended for single dose only. Discard any unused drug remaining in the vial

Administration¹

Administer ELAHERE as an IV infusion only, using a 0.2 or 0.22 μm PES in-line filter. Prior to administration, ELAHERE must be diluted with 5% Dextrose Injection, USP to a final concentration of 1 mg/mL to 2 mg/mL

Administer the first dose at the rate of 1 mg/min

If well tolerated after 30 minutes, the infusion rate can be increased to 3 mg/min
If well tolerated after 30 minutes, 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

ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures

DO NOT mix ELAHERE with other drugs or IV fluids

DO NOT mix ELAHERE with normal saline (0.9% Sodium Chloride Injection)

For the full Preparation and Administration Instructions, please refer to Section 2.5 of the ELAHERE Prescribing Information.

min=minute; PES=polyethersulfone.

Dosing information on demand

The Dosing and Administration Booklet provides
easy-to-access information about how ELAHERE is
dosed and administered. DOWNLOAD BOOKLET

Need ordering information?

The ELAHERE Ordering Information Sheet has a list
of participating specialty distributors and specialty
pharmacy partners. DOWNLOAD THE LIST