DOSING AND ADMINISTRATION1
Prophylactic medications1
Help reduce the incidence and severity of infusion-related reactions and emesis by following the ELAHERE premedication guidelines.
Premedication prior to each ELAHERE infusion
Calculating starting dose1

The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an IV infusion until disease progression or unacceptable toxicity
The total dose of ELAHERE is calculated based on each patient's AIBW using the following formula:



Female IBW = (0.9 x height in cm) - 92
AIBW is equivalent to adjusted body weight (AdjBW).
- In the SORAYA clinical study, the mean AIBW was 59.2 kg2
- Based on an AIBW of 59.2 kg, the dose would be 355 mg per cycle (4 vials)
Dose modifications may help manage treatment-related toxicities
Instructions for preparation1

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

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

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

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

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

ELAHERE contains no preservative and is intended for single dose only. Discard any unused drug remaining in the vial
Administration1

Administer ELAHERE as an intravenous infusion only. 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 intravenous fluids

DO NOT mix ELAHERE with normal saline (0.9% Sodium Chloride Injection)
Dose modifications1
Dose modifications may help manage treatment-related toxicities. Adjust the schedule of administration to maintain a 3-week interval between doses.
aPermanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.
Severity of adverse
eventa
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 dose 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 dose 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 dose until Grade 1 or less, then maintain dose at same dose level |
Grade 3: 3+ cell or flare in anterior chamber | Withhold dose until Grade 1 or less, then reduce dose by one dose level |
Grade 4: Hypopyon | Permanently discontinue |
Grade 1 | Monitor |
---|---|
Grade 2 | Withhold dose until Grade 1 or less, then resume at same dose level or one lower dose level at the discretion of the healthcare provider |
Grade 3 or 4 | Permanently discontinue |
Grade 2 | Withhold dose until Grade 1 or less, then reduce by one dose level |
---|---|
Grade 3 or 4 | Permanently discontinue |
Grade 1 | Maintain infusion rate |
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Grade 2 |
|
Grade 3 or 4 |
|
Grade 3 | Withhold dose until Grade 1 or less, then resume at one lower dose level |
---|---|
Grade 4 | Permanently discontinue |
aUnless otherwise specified, National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
The eye care provider (ophthalmologist or optometrist) who is conducting the regular eye exams should monitor for ocular AEs, and should notify you and your care team if any AEs are occurring that might require dose modification
Learn more about eye care and working with an eye care provider to manage ocular events.
Learn about Eye CareHow 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.
AE=adverse event; IBW=ideal body weight.