Gynecologic cancers:
Indications for: ELAHERE
Folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, in adults who have received 1–3 prior systemic treatment regimens.
Adult Dosage:
Select patients based on the presence of FRα tumor expression. Premedicate with a corticosteroid (IV), antihistamine, antipyretic, and antiemetic, and with ophthalmic topical steroids, lubricating eye drops; see full labeling. Administer as an IV infusion 6mg/kg adjusted ideal body weight (AIBW) once every 3 weeks (21-day cycle), until disease progression or unacceptable toxicity. Infuse initially at a rate of 1mg/min; may increase to 3mg/min if well tolerated after 30mins, then to 5mg/min after next 30mins (max rate). Dose modifications and reductions: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Ocular toxicity.
ELAHERE Warnings/Precautions:
Monitor for ocular toxicity; withhold, reduce, or permanently discontinue based on severity of reactions. Conduct eye exam including visual acuity and slit lamp exam prior to initiation, every other cycle for the first 8 cycles, and as clinically indicated. Advise to avoid contact lenses during treatment. Monitor for pneumonitis; withhold and consider reducing dose if persistent or recurrent Grade 2 pneumonitis develop; permanently discontinue if Grade 3/4 penumonitis occurs. Monitor for neuropathy; if new or worsening peripheral neuropathy occurs, withhold, reduce dose, or permanently discontinue based on severity of reactions. Moderate to severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 7 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
ELAHERE Classification:
Folate receptor alpha-directed antibody-drug conjugate.
ELAHERE Interactions:
May be potentiated by strong CYP3A4 inhibitors; monitor.
Adverse Reactions:
Vision impairment, fatigue, nausea, keratopathy, abdominal pain, peripheral neuropathy, diarrhea, constipation, dry eye, lab abnormalities (increased AST/ALT/ALP, decreased lymphocytes, decreased albumin, decreased magnesium, decreased leukocytes, decreased neutrophils, decreased hemoglobin); intestinal obstruction, ascites, infection, pleural effusion, pneumonitis, infusion-related reactions, hypersensitivity, others.
Drug Elimination:
Renal. Half-life: 4.8 days.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (20mL)—1
