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 mild (Grade 1) alopecia after treatment with ELAHERE2*

Clinically relevant AEs occurring in <10% of patients who received ELAHERE in SORAYA included infusion-related reactions/hypersensitivity (9%), pneumonitis (8%), thrombocytopenia (5%), and uveitis (1%)

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

Permanent discontinuation due to AEs occurred in 11% of patients
- 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)

Dosage delays of ELAHERE due to an AE occurred in 39% of patients
- AEs 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 AE occurred in 20% of patients
- AEs which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%)

The median duration of treatment was 4.2 months (range: 0.7 to 13.3)
Ocular events from a pooled safety analysis of ELAHERE (N=464)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 DosingHow to Test for FRα
To test for FRα expression, labs have been validated to perform the FDA-approved test.
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; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BCVA=best corrected visual acuity.