Elahere is an antibody-drug conjugate that works by targeting folate receptor-alpha (FRa), a cell-surface protein highly expressed in ovarian cancer.

Elahere is a prescription medicine used to treat adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are no longer responding to platinum-based chemotherapy and have received 1 to 3 types of chemotherapy.

Your doctor will perform a tests to make sure Elahere is the right treatment for you.

It is not known if Elahere is safe and effective in children.

Call your doctor at once if you have any eye problems, including blurred vision, eye pain, or new or worsening vision problems.

Elahere is given as an infusion into a vein. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor may change, delay, or permanently discontinue your treatment with Elahere if you have certain side effects.

Elahere is usually given every 3 weeks as an infusion into your vein. Your doctor will decide how many cycles you need.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

You may need frequent vision exams.

Your doctor may prescribe eye drops before and during your treatment with Elahere. You should use these eye drops as directed by your doctor.

Usual Adult Dose for Ovarian Cancer:

Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity.

Usual Adult Dose for Fallopian Tube Cancer:

Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity.

Usual Adult Dose for Peritoneal Cancer:

Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-These indications have been granted accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
-Confirm the presence of folate receptor alpha tumor expression prior to initiation of treatment.
-Information regarding FDA-approved tests for folate receptor alpha tumor is available at http://www.fda.gov/CompanionDiagnostics.
-Refer to manufacturer product information for AIBW calculation.
-Administer premedications (corticosteroid, antihistamine, antipyretic, antiemetic) before each infusion of this drug to reduce the incidence of severity of infusion related reactions (IRRs), nausea, and vomiting.
-Refer to manufacturer product labeling for more information on dosing of premedications.

Use: Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with folate receptor alpha positive tumor expression who have previously received one to three lines of systemic treatments.

To make sure Elahere is safe for you, tell your doctor if you have ever had:

• vision or eye problems; or

• liver problems.

Elahere may harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using Elahere and for at least 7 months after your last dose. Tell your doctor if you become pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your Elahere injection.

In a medical setting an overdose would be treated quickly.

Avoid wearing contact lenses while using Elahere unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction to Elahere: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Elahere may cause serious side effects. Call your doctor at once if you have:

• dry eyes, sensitivity to light, blurred vision, eye pain, or new or worsening vision changes;

• cough, chest pain, trouble breathing, shortness of breath; or

• numbness, tingling, or burning pain in your hands or feet.

Common Elahere side effects may include:

• abnormal lab results;

• nausea, stomach pain, diarrhea, constipation;

• fever, mouth sores, skin sores, sore throat, cough; or

• pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can interact with mirvetuximab soravtansine, especially:

• nefazodone;

• cancer medicine - ceritinib, idelalisib, ribociclib, tucatinib;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; or

• antiviral medicine for HIV or hepatitis C - boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

This list is not complete and many other drugs may interact with mirvetuximab soravtansine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.