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Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

ORDER ELAHERE

Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

ORDER ELAHERE

DOSING AND ADMINISTRATION

Prophylactic medications prior to infusion1

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

Premedication prior to each ELAHERE infusion

Premedication table Premedication table

Calculating AIBW1*

3 Weeks Icon
  • 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 under- or overweight

Patient AIBW is calculated as follows:

STEP 1:

Calculate Ideal Body Weight (IBW) in kg, if unknown, with the below formula. Ensure that height is measured in cm.

IBW (kg)
(
0.9
multiply
)
subtract
92 =

If IBW is known, please enter value directly below.

STEP 2:

Calculate AIBW using IBW (kg) and the patient’s actual weight in kg, with the below formula.

AIBW =
Please enter IBW
plus
0.4
multiply
(
Please enter actual weight
subtract
IBW
(kg)
)

Female ideal body weight (IBW, kg) = (0.9 × height in cm) − 92

AIBW is equivalent to adjusted body weight (AdjBW).

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 of mirvetuximab soravtansine-gynx in 20 mL (5 mg/mL)1

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

Dose modifications may help manage treatment-related toxicities1

Instructions for preparation1

3 Vials Icon

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

Temperature Icon

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

Clear Liquid Icon

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

Swirl Icon

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

Withdraw Icon

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

Discard Icon

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

Administration1

Infusion Bag Icon

Administer ELAHERE as an intravenous infusion only, using a 0.2 or 0.22 μm polyethersulfone (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

Timer Icon

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

Hazard icon

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

No Pills Icon

DO NOT mix ELAHERE with other drugs or intravenous fluids

No Saline Icon

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.

Dose modifications1

Dose modifications may help manage treatment-related toxicities. Adjust the dose while maintaining a 3-week interval between doses

Recommended dose reduction schedule for AEs
  ELAHERE dose level
Starting dose   6 mg/kg AIBW q3w (21-day cycle)
First dose reduction   5 mg/kg AIBW q3w (21-day cycle)
Second dose reduction   4 mg/kg AIBW q3w (21-day cycle)a

aPermanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.

Recommended dose modification guidelines for AEs

Severity of adverse
eventb

Dosage modification

|

Nonconfluent superficial keratitis Monitor
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
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
Grade 2 Withhold until Grade 1 or less, then maintain at same dose level or consider dose reduction
Grade 3 or 4 Permanently discontinue

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
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
  • Administer additional premedication for future cycles
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

Grade 3 or 4 Withhold until Grade 1 or less, then resume at one lower dose level

Grade 3 Withhold until Grade 1 or less, then resume at one lower dose level
Grade 4 Permanently discontinue

bUnless otherwise specified, National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

An eye care provider will monitor for ocular AEs and notify you if any occur

Learn more about eye care and working with an eye care provider to manage ocular events

Learn about Eye Care

How to Test for FRα

Testing for FRα is carried out at labs that have been validated to perform the VENTANA FOLR1 IHC assay.

See Validated Labs

How to Order ELAHERE

Please contact your participating specialty distributor or specialty pharmacy partners listed in the ELAHERE Ordering Information Sheet.

Download the List

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

AE=adverse event; AIBW=adjusted ideal body weight; FOLR1=folate receptor 1; FRα=folate receptor alpha; IHC=immunohistochemistry; q3w=once every 3 weeks.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

  • ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
  • 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.
  • Administer prophylactic artificial tears and ophthalmic topical steroids.
  • Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
  • Discontinue ELAHERE for Grade 4 ocular toxicities.

WARNINGS and PRECAUTIONS

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%).

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. 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.

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. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

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%). 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 PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

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

The most common (≥20%) adverse reactions, including lab abnormalities, were 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.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

INDICATION

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.

Please see Full Prescribing Information, including Boxed WARNING.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

  • ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
  • 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.
  • Administer prophylactic artificial tears and ophthalmic topical steroids.
  • Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
  • Discontinue ELAHERE for Grade 4 ocular toxicities.

WARNINGS and PRECAUTIONS

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%).

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. 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.

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. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

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%). 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 PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

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

The most common (≥20%) adverse reactions, including lab abnormalities, were 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.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

INDICATION

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.

Please see Full Prescribing Information, including Boxed WARNING.

References

  1. ELAHERE. Package insert. ImmunoGen, Inc.; 2024.
  2. Data on file. ImmunoGen, Inc. Waltham, MA.

Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

ORDER ELAHERE