Datopotamab Deruxtecan (Datroway) is a novel Trop-2-directed antibody-drug conjugate (ADC) linked to a topoisomerase inhibitor, which has shown favorable efficacy in the treatment of specific types of breast cancer.
Indications of Datopotamab Deruxtecan (Datroway)
Primary Therapeutic Indications
Datopotamab Deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Specifically, it applies to patient populations with immunohistochemistry (IHC) test results of IHC 0, IHC 1+, or IHC 2+/ISH-.
This drug should be used in such patients who have received endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Patient Population Characteristics
This drug is specifically intended for patients whose disease has progressed and who are deemed unsuitable for further endocrine therapy.
Usage Restrictions
Datopotamab Deruxtecan is not indicated for the suppressive treatment of benign thyroid nodules and non-toxic diffuse goiter in iodine-sufficient patients.
It is also not recommended for the treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Patients with a history of interstitial lung disease (ILD)/pneumonitis requiring steroid treatment or with persistent ILD/pneumonitis should be excluded from using this drug.
Dosage Form and Properties of Datopotamab Deruxtecan (Datroway)
Basic Dosage Form Characteristics
Datopotamab Deruxtecan is a white to yellowish-white lyophilized powder, supplied in single-dose vials for injection.
Each vial contains 100 mg of the active ingredient (datopotamab deruxtecan-dlnk), as well as excipients including L-histidine (3.88 mg), L-histidine hydrochloride monohydrate (5.25 mg), polysorbate 80 (1.50 mg), and sucrose (450 mg).
Properties After Reconstitution
When reconstituted with 5 mL of sterile water for injection, the solution has a concentration of 20 mg/mL and a pH of 6.0.
The reconstituted solution should be clear, colorless to pale yellow. If visible particles, turbidity, or discoloration are observed, the solution must not be used.
The solution contains no preservatives. After reconstitution, it can be stored in the original vial under refrigeration (2°C to 8°C) for a maximum of 24 hours.
Storage Methods for Datopotamab Deruxtecan (Datroway)
Storage of Unreconstituted Drug
The lyophilized powder of Datopotamab Deruxtecan should be stored under refrigeration (2°C to 8°C) in its original packaging, protected from light and freezing.
This drug is a hazardous medication and must be handled in accordance with special procedures. The carton should remain intact during storage, and the vial should only be removed immediately before use.
Storage Requirements After Reconstitution
The reconstituted solution should be diluted and used immediately.
If immediate use is not possible, it can be stored at room temperature (≤25°C) for a maximum of 4 hours or under refrigeration (2°C to 8°C) for 24 hours.
The total time from reconstitution to the completion of administration must not exceed 24 hours. The diluted infusion bag should be stored protected from light.
