A DETAILED SAFETY PROFILE TO HELP YOU
SUPPORT YOUR PATIENTS THROUGH TREATMENT

Most Common ARs Most Common ARs Laboratory Abnormalities

Adverse REACTIONS reported in ≥ 10% of patients receiving ELAHERE in SORAYA

Adverse reaction (N=106)

EYE DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Blurred vision*	50	7
Keratopathy^†	37	9
Dry eye^‡	27	2
Cataract	18	3
Photophobia	17	0
Eye pain^§	10	0

*Blurred vision includes vision blurred, vitreous floaters, visual acuity reduced, diplopia, presbyopia, accommodation disorder, visual impairment, and refraction disorder.¹

^†Keratopathy includes corneal disorder, corneal epithelial microcysts, corneal epithelial defects, keratitis, keratopathy, corneal deposits, and punctate keratitis.¹

^¶Dry eye includes dry eye and lacrimation increased.¹

^§Eye pain includes eye pain and ocular discomfort.¹

GENERAL DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Fatigue^¶	49	3

^¶Fatigue includes fatigue and asthenia.¹

GASTROINTESTINAL DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Nausea	40	0
Abdominal pain^#	36	7
Diarrhea	31	3
Constipation	30	1
Vomiting	19	0
Abdominal distension	11	0

^#Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain, lower abdominal pain lower, abdominal discomfort.¹

NERVOUS SYSTEM DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Peripheral neuropathy^\|\|	33	2

^||Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, hypoesthesia, polyneuropathy, and neurotoxicity.¹

METABOLISM AND NUTRITION DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Decreased appetite	18	1

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS¹

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

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS¹

	All Grades (%)	Grades 3-4 (%)
Dyspnea**	12	0

**Dyspnea includes dyspnea and exertional dyspnea.¹

Dosage delays of ELAHERE due to an AR occurred in 39% of patients. ARs that required dosage delays in ≥3% of patients included¹:

Blurred vision (15%)
Dry eye (5%)
Keratopathy (11%)
Cataracts (3%)
Neutropenia (6%)
Increased gamma-glutamyl transferase (3%)

Clinically relevant ARs occurring in <10% of patients who received ELAHERE in SORAYA included¹:

Infusion-related reactions/hypersensitivity (9%)
Pneumonitis (8%)
Uveitis (1%)

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

ARs that required dose reductions in ≥3% of patients included blurred vision (9%) and keratopathy (7%)

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

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

Permanent discontinuation due to ARs occurred in 11% of patients¹

The most common (≥2%) ARs 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)

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

AR=adverse reaction; BCVA=best corrected visual acuity.

Laboratory abnormalities in SORAYA

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

Laboratory abnormalities for ELAHERE

LIVER FUNCTION TESTS¹

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

ALT=alanine aminotransferase; AST=aspartate aminotransferase.

HEMATOLOGY¹*

	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

*The denominator used to calculate the rate varied from 98 to 101 based on the number of patients with a baseline value and at least 1 posttreatment value.¹

CHEMISTRY¹

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

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A DETAILED SAFETY PROFILE TO HELP YOUSUPPORT YOUR PATIENTS THROUGH TREATMENT

Adverse REACTIONS reported in ≥ 10% of patients receiving ELAHERE in SORAYA

EYE DISORDERS1

Blurred vision*

Keratopathy†

Dry eye‡

Cataract

Photophobia

Eye pain§

GENERAL DISORDERS1

Fatigue¶

GASTROINTESTINAL DISORDERS1

Nausea

Abdominal pain#

Diarrhea

Constipation

Vomiting

Abdominal distension

NERVOUS SYSTEM DISORDERS1

Peripheral neuropathy||

METABOLISM AND NUTRITION DISORDERS1

Decreased appetite

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS1

Arthralgia

Myalgia

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS1

Dyspnea**

Dosage delays of ELAHERE due to an AR occurred in 39% of patients. ARs that required dosage delays in ≥3% of patients included1:

Clinically relevant ARs occurring in <10% of patients who received ELAHERE in SORAYA included1:

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

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

Permanent discontinuation due to ARs occurred in 11% of patients1

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

Laboratory abnormalities in SORAYA

LIVER FUNCTION TESTS1

Increased AST

Increased ALT

Increased alkaline phosphatase

HEMATOLOGY1*

Decreased lymphocytes

Decreased leukocytes

Decreased neutrophils

Decreased hemoglobin

Decreased platelets

CHEMISTRY1

Decreased albumin

Decreased magnesium

Increased creatinine

Decreased potassium