Datopotamab deruxtecan

Generic name: datopotamab deruxtecan
Brand name: Datroway
Dosage form: intravenous powder for injection (dlnk 100 mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com on Feb 18, 2025. Written by Cerner Multum.

What is datopotamab deruxtecan?

Datopotamab deruxtecan is used in adults to treat breast cancer that has spread to other parts of the body (metastatic), cannot be removed with surgery, or after other treatments did not work or stopped working.

Your doctor will make sure you have the correct tumor type to be treated with datopotamab deruxtecan.

Datopotamab deruxtecan may also be used for purposes not listed in this medication guide.

Datopotamab deruxtecan side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Datopotamab deruxtecan may cause serious side effects. Call your doctor at once if you have:

• fever, chills, cough with mucus, chest pain, feeling short of breath, wheezing, trouble breathing;

• dry eyes or watery eyes, blurred vision;

• signs of eye infection--swelling, redness, severe discomfort, crusting or drainage;

• feeling like something is in your eye; or

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

Common side effects of datopotamab deruxtecan may include:

• nausea, vomiting, constipation;

• tiredness;

• low blood calcium --muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes);

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• hair loss;

• dry eyes; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not take datopotamab deruxtecan if you are allergic to it.

Tell your doctor if you have ever had:

• lung disease or breathing problems;

• eye problem; or

• use contact lenses.

Datopotamab deruxtecan can harm an unborn baby if the mother or the father is using datopotamab deruxtecan.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Datopotamab deruxtecan may affect fertility in men or women.

How is datopotamab deruxtecan given?

Your doctor will perform tests to make sure datopotamab deruxtecan is the right treatment for you.

Datopotamab deruxtecan is given as an infusion into a vein by a healthcare provider.

Datopotamab deruxtecan is given in a 21-day treatment cycle. You will receive an injection only on certain days of this cycle.

Your healthcare provider will decide how long you should be treated with datopotamab deruxtecan based on response.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Use preservative free eye drops at least 4 times daily or as prescribed by your doctor.

You may need frequent vision exams.

Use a steroid mouthwash to help prevent and treat mouth sores. Hold ice chips or ice water in the mouth during infusion.

Datopotamab deruxtecan dosing information

Usual Adult Dose for Breast Cancer:

6 mg/kg IV every 3 weeks (21-day cycle)
Maximum dose: 540 mg/dose
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-First infusion: Administer over 90 minutes; observe patients during the infusion and for at least 1 hour after the initial dose for signs/symptoms of infusion-related reactions.
-Second infusion: If first infusion was tolerated, administer over 30 minutes; observe patients during the infusion and for at least 1 hour after infusion.
-Subsequent infusions: Administer over 30 minutes if prior infusions were tolerated; observe patients during the infusion and for at least 30 minutes after infusion.

Use: For the treatment of patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization [ISH]-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your datopotamab deruxtecan injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving datopotamab deruxtecan?

Avoid wearing contact lenses during treatment with datopotamab deruxtecan.

What other drugs will affect datopotamab deruxtecan?

Other drugs may affect datopotamab deruxtecan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Datopotamab deruxtecan Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for datopotamab deruxtecan.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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