Abbreviated Prescribing Information
DATROWAY​

Presentation: Datroway powder for concentrate for solution for infusion 100mg.

Active ingredient: Datopotamab deruxtecan.

Indications: As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive and HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.

Dosage: 6mg/kg (up to a maximum of 540 mg for patients ≥90 kg), given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Precautions: Patients should be monitored signs and symptoms of ILD/pneumonitis; hypersensitivity; prophylaxis is recommended for keratitis; stomatitis; effective contraception should be advised to a pregnant woman and male patients with female partners of reproductive potential; administered with caution in patients with moderate or severe hepatic impairment.

Adverse Reactions: COVID-19, urinary tract infection, pneumonia, sepsis, anaemia, neutropenia, leukopenia, anaphylactic reaction, decreased appetite, dysgeusia, keratitis, dry eye, conjunctivitis, blurred vision, lacrimation increased, blepharitis, meibomian gland dysfunction, photophobia, visual impairment, ILD/pneumonitis, dyspnoea, stomatitis, vomiting, nausea, diarrhoea, constipation, dry mouth, alopecia, rash, pruritus, dry skin, skin hyperpigmentation, madarosis, fatigue, aspartate aminotransferase increased, alanine aminotransferase increased, infusion-related reaction.

Pharmaceutical forms: White to yellowish white lyophilised powder.

Storage condition: Store in 2-8oC, do not freeze, protected from light.

For further details, please refer to full prescribing information. Full local prescribing information is available upon request.

API.HK.DAT.0526

HK-13387 21/09/2026