ELAHERE Dosage & Rx Info | Uses, Side Effects

Elahere Generic Name & Formulations

Legal Class

General Description

Mirvetuximab soravtansine-gynx 5mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Folate receptor alpha-directed antibody-drug conjugate.

How Supplied

Single-dose vial (20mL)—1

Manufacturer

ImmunoGen, Inc.

Generic Availability

Mechanism of Action

Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine-gynx is internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death.

Elahere Indications

Indications

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.

Elahere Dosage and Administration

Adult

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

Not established.

Elahere Contraindications

Not Applicable

Elahere Boxed Warnings

Boxed Warning

Ocular toxicity.

Elahere Warnings/Precautions

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. Severe renal impairment or ESRD. 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 Pharmacokinetics

Distribution

Volume of distribution: 2.6 L. Human plasma protein binding of DM4 and S-methyl DM4 was >99%, in vitro.

Metabolism

Hepatic. >99% serum protein bound.

Elimination

Renal. Half-life: 4.8 days. Total plasma clearance: 19 mL/hour.

Elahere Interactions

Interactions

May be potentiated by strong CYP3A4 inhibitors; monitor.

Elahere Adverse Reactions

Adverse Reactions

Fatigue, blurred vision, nausea, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, dry eye, constipation, vomiting, decreased appetite, lab abnormalities (increased AST/ALT/ALP, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, decreased leukocytes, decreased albumin, decreased neutrophils); intestinal obstruction, ascites, infection, pleural effusion, pneumonitis, infusion-related reactions, hypersensitivity, others.

Elahere Clinical Trials

See Literature

Elahere Note