ELAHERE

Generic Name/API: mirvetuximab soravtansine-gynx

Manufacturer: ImmunoGen, Inc.

Dosage Forms & Strength:
Injection: 100 mg/20 mL (5 mg/mL) in a single-dose vial.

Storage:
Store ELAHERE vials upright in a refrigerator at 2°C to 8°C (36°F to 46°F) until the time of preparation in the
original carton to protect from light.
Do not freeze or shake.
ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:

have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.

ELAHERE was FDA-approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of ELAHERE.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, or new or worsening vision changes.

Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.
What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:

Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with ELAHERE. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness or tingling in your hands or feet or muscle weakness.
The most common side effects of ELAHERE include:

feeling tired
increased liver enzymes in the blood
nausea
stomach-area (abdominal) pain
decreased red or white blood cell counts
diarrhea
decreased albumin level in the blood
constipation
decreased magnesium level in the blood
Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems.
have liver problems.
are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.

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