Mirvetuximab Soravtansine-Gynx Injection Application Scope

Mirvetuximab soravtansine-gynx is primarily used for the treatment of platinum-resistant ovarian cancer. It is an ADC that targets folate receptor alpha (FRα), which is overexpressed in many epithelial ovarian cancer cells. The treatment is mainly for patients with FRα-positive tumors who have failed prior chemotherapy.

Mirvetuximab Package Insert

Ingredients:

Active ingredient: Mirvetuximab soravtansine-gynx (a monoclonal antibody-drug conjugate composed of an anti-FRα monoclonal antibody and a cytotoxic agent).

Properties:

Mirvetuximab soravtansine-gynx is a targeted therapy that combines the specificity of a monoclonal antibody with the potency of a cytotoxic agent, aiming to selectively deliver the chemotherapy to tumor cells expressing folate receptor alpha.

Specification:

The exact concentration and dose will depend on the specific treatment regimen but typically involves an intravenous (IV) infusion.

Packaging Specification:

Packaging varies depending on the manufacturer, but it is usually provided as a vial containing the drug solution for intravenous administration.

Storage:

Mirvetuximab soravtansine-gynx should be stored at 2–8°C (36–46°F) and protected from light. It should not be frozen.

Expiry Date:

This will be specified on the packaging, and it generally follows standard practices for biologics, often 24–36 months from manufacturing date.

Executive Standard:

The executive standard for this drug would be based on the regulatory standards set by the relevant health authorities, such as FDA or EMA.

Approval Number:

The approval number will depend on the country and regulatory agency (e.g., FDA approval number in the U.S.).

Date of Revision:

The date of revision would be on the product labeling or datasheet, typically after any updates or new approvals.

Manufacturer:

ImmunoGen

Guidelines For The Use Of Mirvetuximab Soravtansine-Gynx Injection

Dosage and Administration:

Mirvetuximab soravtansine-gynx is typically administered via intravenous (IV) infusion. The exact dosage and frequency would be determined based on the patient’s condition, response to treatment, and other factors like kidney or liver function.
Recommended dosage: The recommended dose is typically based on the patient’s weight, often in a dosing range of 6 mg/kg every 3 weeks for adult patients with platinum-resistant ovarian cancer.

Mirvetuximab Side Effects：

The most common adverse reactions include ocular toxicities (such as blurred vision, dry eye, or photophobia), myelosuppression (low blood counts), nausea, fatigue, and diarrhea. Rare but serious adverse events could involve hepatic toxicities and peripheral neuropathy.
Monitoring for eye issues and other side effects like liver function is recommended during treatment.

Mirvetuximab Soravtansine-Gynx Injection Medication Limitations

Contraindications:

Hypersensitivity to mirvetuximab soravtansine-gynx or any component of the formulation.
Patients with known severe ocular toxicities or pre-existing conditions that may exacerbate eye issues are typically contraindicated.

Precautions:

Patients should be monitored for ocular toxicities, such as vision changes, and be advised to undergo routine eye exams.
Special caution is necessary in patients with liver impairment, as the drug could exacerbate liver toxicity.
It may not be recommended for pregnant or breastfeeding women unless the potential benefit outweighs the risks.

Mirvetuximab Soravtansine-Gynx Injection Interactions

Drug Interactions:

The interactions with other drugs are not fully established in clinical trials. However, as it is an ADC with a cytotoxic agent, caution is recommended when using with other myelosuppressive agents or drugs that could exacerbate ocular toxicity.
Combination therapy with other chemotherapy agents or targeted therapies should be closely monitored for any cumulative toxicities, especially in the liver and eyes.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.