Skip to Content

ELAHERE SAFETY PROFILE1,2

Adverse events reported in ≥10% of patients receiving ELAHERE in SORAYA1,2

Adverse event
(N=106)

|

  All Grades (%) Grade 3 (%) Grade 4 (%)
Vision impairmenta 50 6.6 0
Keratopathyb 37 8.5 0.9
Dry eyec 27 1.9 0
Cataract 18 2.8 0
Photophobia 17 0 0
Eye paind 10 0 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Fatiguee 49 2.8 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Nausea 40 0 0
Abdominal painf 36 6.6 0
Diarrhea 31 2.8 0
Constipation 30 0.9 0
Vomiting 19 0 0
Abdominal distension 11 0 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Peripheral neuropathyg 33 1.9 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Decreased appetite 18 0.9 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Arthralgia 17 0 0
Myalgia 10 0 0

  All Grades (%) Grade 3 (%) Grade 4 (%)
Dyspneah 12 0 0

aVisual impairment includes vision blurred, vitreous floaters, visual acuity reduced, diplopia, presbyopia, accommodation disorder, visual impairment, and refraction disorder.
bKeratopathy includes corneal disorder, corneal epithelial microcysts, corneal epithelial defect, keratitis, keratopathy, corneal deposits, and punctate keratitis.
cDry eye includes dry eye and lacrimation increased.
dEye pain includes eye pain and ocular discomfort.
eFatigue includes fatigue and asthenia.
fAbdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort.
gPeripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, hypoesthesia, polyneuropathy, and neurotoxicity.
hDyspnea includes dyspnea and exertional dyspnea.

One patient reported Grade 1 alopecia after treatment with ELAHERE2*

Safety shield icon

Clinically relevant AEs occurring in <10% of patients who received ELAHERE in SORAYA include1:

  • Infusion-related reactions/hypersensitivity (9%)
  • Pneumonitis (8%)
  • Thrombocytopenia (5%)
  • Uveitis (1%)
Exclamation point icon

Serious AEs occurred in 31% of patients. The most common (≥2%) serious AEs were1:

  • Intestinal obstruction (8%)
  • Ascites (4%)
  • Infection (3%)
  • Pleural effusion (3%)

Fatal AEs occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%)1

Discontinuation icon

Permanent discontinuation due to AEs occurred in 11% of patients1

  • The most common (≥2%) AEs leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%)
  • One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation)
Timer icon

Dosage delays of ELAHERE due to an AE occurred in 39% of patients1

AEs which required dosage delays in ≥3% of patients included:

  • Visual impairment (15%)
  • Keratopathy (11%)
  • Neutropenia (6%)
  • Dry eye (5%)
  • Cataracts (3%)
  • Increased gamma-glutamyltransferase (3%)
dosage reductions due to an AE

Dose reductions of ELAHERE due to an AE occurred in 20% of patients1

  • AEs which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%)
Calendar icon

The median duration of treatment was 4.2 months (range: 0.7 to 13.3)1

Ocular events with ELAHERE1

Most common ocular AEs reported in ≥5% of patients (N=464)a

Adverse event All Grades (%)
Vision impairment 49
Keratopathy 36
Dry eye 26
Cataract 15
Photophobia 13
Eye pain 12

aThe pooled safety population reflects exposure to ELAHERE in 464 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer at 6 mg/kg AIBW administered intravenously once every 3 weeks until disease progression or unacceptable toxicity in Study 0417, Study 0403 (NCT02631876), and Study 0401 (NCT01609556). The median duration of treatment was 4.3 months (range: 0.7 to 30.4).1

  • Ocular AEs occurred in 61% of patients treated with ELAHERE
    • 9% of patients experienced Grade 3 ocular AEs, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; 1 patient (0.2%) experienced Grade 4 keratopathy
  • The median time to onset for first ocular AE was between cycles 2 and 3 (1.2 months [range: 0.03 to 12.9])
    • Ocular AEs led to permanent discontinuation of ELAHERE in 0.6% of patients

No patients had permanent ocular sequelae in the pooled safety analysis3

Laboratory abnormalities in SORAYA1

Select laboratory abnormalities ≥10% for all grades or ≥2% for Grades 3-4 in patients who received ELAHERE

Laboratory abnormality

ELAHEREa

|

  All Grades (%) Grades 3-4 (%)
Increased AST 50 2
Increased ALT 39 2
Increased alkaline phosphatase 30 1

  All Grades (%) Grades 3-4 (%)
Decreased lymphocytes 35 7
Decreased leukocytes 26 1
Decreased neutrophils 26 3
Decreased hemoglobin 25 3
Decreased platelets 18 2

  All Grades (%) Grades 3-4 (%)
Decreased albumin 31 1
Decreased magnesium 27 2
Increased creatinine 16 0
Decreased potassium 15 4

aThe denominator used to calculate the rate varied from 98 to 101 based on the number of patients with a baseline value and at least one post-treatment value.

Find out how ELAHERE is dosed and administered

Learn About Dosing

How to Test for FRα

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

How to Order ELAHERE

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

*One additional patient entered the study with Grade 1 alopecia. Alopecia was not a result of ELAHERE and grade did not change during treatment.2

AE=adverse event; AIBW=adjusted ideal body weight; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BCVA=best corrected visual acuity.

IMPORTANT SAFETY INFORMATION

BOXED 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 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%).

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% 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 0.6% 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 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases.

Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for 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)

PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).

Monitor patients for signs and symptoms of neuropathy. 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

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. 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 at least 1 month after the last dose.

Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

Hepatic Impairment

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

IMPORTANT SAFETY INFORMATION

BOXED 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 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%).

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% 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 0.6% 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 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases.

Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for 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)

PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).

Monitor patients for signs and symptoms of neuropathy. 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

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. 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 at least 1 month after the last dose.

Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

Hepatic Impairment

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

INDICATIONS AND USAGE

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.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full Prescribing Information including BOXED WARNING.

References

  1. ELAHERE. Package insert. ImmunoGen, Inc.; 2022.
  2. Data on file. ImmunoGen, Inc. Waltham, MA.
  3. Moore K, Lorusso D, Oaknin A, et al. Integrated safety summary of single-agent mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive recurrent ovarian cancer: phase 1 and 3 clinical trials. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3–7, 2022; Chicago, IL.