Elahere

About Elahere 

• Elahere received approval from the US FDA administration on November 14, 2022
• Elahere is an antineoplastic,which belongs to the class of miscellaneous antineoplastics. 
• Elahere is a treatment designed for adult patients with folate receptor alpha (FRα)-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. 
• This antibody and microtubule inhibitor conjugate is indicated for individuals who have undergone one to three prior systemic treatment regimens.
• Your physician will conduct tests to ensure that Elahere is the appropriate treatment for you. The safety and effectiveness of Elahere in children are not known.

Strength

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

Recommended Dosage

Before administering parenteral drug products, visually inspect for particulate matter and discoloration whenever the solution and container permit. Elahere is a clear to slightly opalescent, colorless solution. Ensure not to freeze the prepared infusion solution.

• For Elahere injection, the suggested dose is 6 mg per kilogram of your adjusted ideal body weight. 
• This is given through an intravenous infusion every 3 weeks, following a 21-day cycle. 
• This continues until either your disease progresses or there are side effects that are too severe to tolerate.
• Before the procedure, use a corticosteroid, antihistamine, and antipyretic as premedication. Additionally, premedicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops.

Important

Before commencing the new medication, it is crucial to notify your doctor if you are presently taking any medications. Patients are strongly encouraged to share comprehensive information about all concurrent medications, including prescription drugs, over-the-counter medications, vitamins, and herbal products, with their healthcare providers. This open communication ensures a thorough understanding of the patient’s medication profile and aids in safe and effective treatment planning.

Warnings & Precautions

• Elahere may lead to severe ocular toxicities, causing visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. 
• Before initiating Elahere and every other cycle for the first 8 cycles, as well as when clinically indicated, conduct an ophthalmic exam, including visual acuity and slit-lamp examination. 
• Prophylactic artificial tears and ophthalmic topical steroids should be administered. In case of ocular toxicities, withhold Elahere until improvement and resume at the same or reduced dose. 
• Discontinue Elahere for Grade 4 ocular toxicities. For pneumonitis, withhold Elahere for persistent or recurrent Grade 2 cases and consider dose reduction. Permanently discontinue Elahere for Grade 3 or 4 pneumonitis. 
• Monitor patients for new or worsening peripheral neuropathy, and, based on severity, withhold dosage, reduce dose, or permanently discontinue Elahere. It is crucial to promptly inform your physician if you experience any symptoms related to these conditions.

Common Elahere Side Effects:

• Vision impairment
• Fatigue
• Increased aspartate aminotransferase
• Nausea
• Increased alanine aminotransferase
• Keratopathy
• Abdominal pain
• Decreased lymphocytes
• Peripheral neuropathy
• Diarrhea
• Decreased albumin
• Constipation
• Increased alkaline phosphatase
• Dry eye
• Decreased magnesium
• Decreased leukocytes
• Decreased neutrophils
• Decreased hemoglobin

Use in Specific Population

• Elahere poses a risk of embryo-fetal harm due to the presence of the genotoxic compound DM4, affecting actively dividing cells. Hence,  it is essential to inform your doctor if you are pregnant, planning pregnancy, or suspect pregnancy before starting treatment. 
• Breastfeeding is not advised during Elahere treatment and for one month after the last dose due to potential serious adverse reactions in the child. 
• Females of reproductive age should employ effective contraception during Elahere treatment and for seven months post-treatment. 
• The safety and efficacy of Elahere are not established in pediatric patients. 
• In patients aged 65 and older, no clinically significant differences in efficacy or safety were noted compared to younger patients. 
• No dosage adjustment is recommended for mild to moderate renal impairment (CLcr 30 to 90 mL/min), but Elahere use is discouraged in patients with moderate or severe hepatic impairment.
• For more information on fertility geriatric, and pediatric use, consult your healthcare provider.

Storage and Handling

• Store within the temperature range of 2°C to 8°C (36°F to 46°F).
• Protect Elahere from light and moisture.
• Do not freeze.
• Do not store Elahere where it may be exposed to heat or humidity.
• Keep Elahere out of the reach of children and pets.