DATROWAY (datopotamab deruxtecan-dlnk)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Interstitial lung disease

There are 6 severe adverse reactions.

More Frequent	Less Frequent
COVId-19 Skin rash	None.

Rare/Very Rare
Interstitial lung disease Pneumonia Pulmonary thromboembolism Urinary tract infection

There are 30 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Alopecia Anemia Anorexia Constipation Dry eye Fatigue Hypocalcemia Increased alkaline phosphatase Keratitis Leukopenia Lymphopenia Nausea Neutropenic disorder Stomatitis Vomiting	Blepharitis Blurred vision Conjunctivitis Dry skin Dyschromia Eye tearing Headache disorder Injection site sequelae Madarosis of eyelid Meibomianitis Photophobia Pruritus of skin Vision impairment Xerostomia

Rare/Very Rare
None.

Based on its mechanism of action, datopotamab deruxtecan can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of datopotamab deruxtecan (DXd) is genotoxic and affects actively dividing cells. There are no available data on the use of datopotamab deruxtecan-dlnk in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with datopotamab deruxtecan and for 1 month after the last dose.

Of the 365 patients in the TROPION-Breast01 study treated with datopotamab deruxtecan-dlnk 6 mg/kg, 25% were >=65 years of age and 5% were >=75 years of age. Grade >=3 and serious adverse reactions were more common in patients >=65 years of age (42% and 25%, respectively) compared to patients <65 years of age (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients >=65 years of age versus younger patients.