Disitamab Vedotin(注射用维迪西妥单抗)

Introduction of Disitamab Vedotin

Disitamab Vedotin for Injection is China’s first HER2-targeted antibody-drug conjugate (ADC). It was launched in 2021 and included in the National Reimbursement Drug List, providing a brand-new treatment option for patients with advanced tumors.

Indications

This product is indicated for patients with HER2-overexpressing locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction) who have received at least two lines of systemic chemotherapy. HER2 overexpression is defined as a HER2 immunohistochemistry (IHC) test result of 2+ or 3+.

This product is indicated for patients with HER2-overexpressing locally advanced or metastatic urothelial carcinoma who have previously received platinum-containing chemotherapy. HER2 overexpression is defined as a HER2 immunohistochemistry (IHC) test result of 2+ or 3+.

The above indications are approved conditionally based on the objective response rate results from single-arm clinical trials. The full approval of the above indications will depend on whether the ongoing confirmatory clinical trials can verify the clinical benefits of this product in the aforementioned patient populations.

Overview

Dosage and Administration

This product shall be prescribed by physicians experienced in antineoplastic therapy.

Patient Selection

Patients receiving this product must be confirmed as HER2 expression with an immunohistochemistry (IHC) score of 2+ or 3+. The test must be performed in a specialized laboratory to ensure the reliability of results. For complete instructions on test performance and interpretation, please refer to the package insert of the relevant HER2 assay.

Recommended Dosage

For Gastric Cancer Patients: 2.5mg/kg administered as an intravenous infusion once every two weeks, until disease progression or unacceptable toxicity occurs.

For Urothelial Carcinoma Patients: 2.0mg/kg administered as an intravenous infusion once every two weeks, until disease progression or unacceptable toxicity occurs.

Contraindications

This product is contraindicated in patients hypersensitive to the active ingredients or excipients of disitamab vedotin.

Adverse Reactions

The most common adverse reactions are increased transaminase, decreased white blood cell count, alopecia, decreased neutrophil count, fatigue, hypoesthesia, anemia, nausea, decreased appetite, and weight loss.

Most of the reported adverse reactions are grade 1–2 in severity. 14.5% of patients reported serious adverse reactions after monotherapy with Disitamab Vedotin for Injection. The most common serious adverse reactions are abnormal liver function, decreased neutrophil count, intestinal obstruction, fatigue, hypoesthesia, and decreased white blood cell count.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

It is recommended that females of childbearing potential or the spouses of male patients undergo a pregnancy test (optional) prior to the initiation of treatment with this product.

Females of childbearing potential or the spouses of male patients should adopt effective contraceptive measures during the treatment period with this product and for at least 180 days after the last dose.

Male patients of childbearing potential should also use effective contraceptive measures during the treatment period and for at least 180 days after the last dose.

Pregnant Women

There are no clinical data on the use of this product in pregnant women.

If this drug is used during pregnancy, or if a patient becomes pregnant during treatment, the physician shall inform the patient of the potential risks to the fetus.

Based on the pharmacodynamic mechanism of action, the small-molecule component of this product is MMAE, a microtubule inhibitor, which may have teratogenicity and potential embryotoxicity.

Fertility

There are no clinical data regarding the effects of this product on human fertility.

No non-clinical fertility studies have been conducted with this product.

Given that its small-molecule component is MMAE, a microtubule inhibitor, this product may have teratogenicity and potential embryotoxicity.

Lactating Women

It is not yet clear whether this product and its metabolites are excreted in human milk.

Potential risks to breastfed infants cannot be ruled out.

It is recommended that breastfeeding be discontinued during the course of treatment with this product.

Alternatively, a decision should be made to either discontinue breastfeeding or discontinue the drug, after a full assessment of the importance of the drug to the lactating woman.

Pediatric Use

The safety and efficacy of this product in children and adolescents under 18 years of age have not been established.

Geriatric Use

Among 414 patients treated with this product, 102 (24.6%) were aged 65 years or older.

No significant differences in efficacy and safety were observed between these patients and the overall patient population.

For more detailed drug information, please consult the official package leaflet.

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