Datopotamab Deruxtecan (Datroway) is a novel Trop-2-directed antibody-drug conjugate (ADC) linked to a topoisomerase inhibitor. It has demonstrated favorable efficacy in the treatment of specific types of breast cancer.

Indications for 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-.

Such patients must have received endocrine-based therapy and chemotherapy for unresectable or metastatic disease prior to using this drug.

Patient Population Characteristics

This drug is specifically targeted at 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 or 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 persistent ILD/pneumonitis should be excluded from using this drug.

Specifications 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 100mg of the active ingredient datopotamab deruxtecan-dlnk, along with excipients including L-histidine (3.88mg), L-histidine hydrochloride monohydrate (5.25mg), polysorbate 80 (1.50mg), and sucrose (450mg).

Characteristics After Reconstitution

After reconstitution with 5mL of sterile water for injection, the solution has a concentration of 20mg/mL and a pH of 6.0.

The reconstituted solution should be clear, colorless to pale yellow. It must not be used if visible particles, turbidity, or discoloration are observed.

The solution contains no preservatives. After reconstitution, it can be stored in the original vial under refrigeration at 2°C to 8°C for a maximum of 24 hours.

Storage Methods for Datopotamab Deruxtecan (Datroway)

Storage of Unreconstituted Drug

Datopotamab Deruxtecan lyophilized powder should be stored in its original packaging under refrigeration at 2°C to 8°C, 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 at 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.