Datopotamab Deruxtecan-dlnk Application Scope

Datroway is approved for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Datopotamab Deruxtecan-dlnk Characteristics

Ingredients: Datroway is a TROP2-directed antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody linked to a topoisomerase I inhibitor (DXd) via a cleavable linker
Properties: It is supplied as a white to yellowish-white lyophilized powder in a single-dose vial for reconstitution and further dilution.
Packaging Specification: 100 mg per vial.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
Expiry Date: Refer to the expiration date printed on the vial label and carton.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA).
Approval Number: Biologics License Application (BLA) 761394.
Date of Revision: January 17, 2025.
Manufacturer: Daiichi Sankyo, Inc., in collaboration with AstraZeneca.

Guidelines for the Use of Datopotamab Deruxtecan-dlnk

Dosage and Administration:
- Recommended Dose: 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle). For patients weighing ≥90 kg, the dose should not exceed 540 mg per infusion.
- Administration: Reconstitute and dilute before intravenous infusion. Administer in a setting equipped for cardiopulmonary resuscitation.
Adverse Reactions:
- Common adverse reactions (≥20%) include stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.
- Serious adverse reactions include interstitial lung disease (ILD)/pneumonitis, which occurred in 4.2% of patients, including fatal cases.
Contraindications: None listed
Precautions:
- Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening respiratory symptoms. Permanently discontinue Datroway in patients with Grade ≥2 ILD/pneumonitis.
- Ocular Toxicity: Monitor for eye problems. Advise patients to use preservative-free lubricating eye drops and avoid contact lenses unless directed by an eye care professional.
- Stomatitis: Advise patients to use a steroid-containing mouthwash four times daily and as needed.
- Embryo-Fetal Toxicity: Datroway can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Datopotamab Deruxtecan-dlnk Interactions

Drug Interactions: No specific drug interaction studies have been conducted with Datroway.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from 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.