Datopotamab deruxtecan-dlnk Injection

WHY is this medicine prescribed?

Datopotamab deruxtecan-dlnk injection is used to treat certain types of breast cancer. Datopotamab deruxtecan-dlnk injection is in a class of medications called antibody drug conjugates. It works by stopping cancer cell growth.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Datopotamab deruxtecan-dlnk injection comes as a powder to be mixed with a liquid to be given by invtravenous infusion (infusion into the vein) by a healthcare provider at a hospital or clinic. It is given every 3 weeks. Your doctor will decide how many infusions you should receive.

Your first infusion will be given over 90 minutes. If you have no problems with your first infusion, your next infusions may be given over 30 minutes. Your doctor or nurse will monitor you for 1 hour after your first 2 infusions. If you tolerate those infusions, then they will monitor you for 30 minutes after each infusion.

Your doctor will give you medicines prior to your infusion of datopotamab deruxtecan-dlnk and after to decrease the risk of side effects. It is important to tell your doctor how you feel during and after your infusion with datopotamab deruxtecan-dlnk. Your doctor may need to slow or pause your infusion if you have certain side effects.

You should use a preserative-free lubricant eye drop several times a day while receiving datopotamab deruxtecan-dlnk to help prevent side effects that can affect the eyes.

What SPECIAL PRECAUTIONS should I follow?

Before receiving datopotamab deruxtecan-dlnk,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had a respiratory or breathing condition such as asthma, chronic obstructive pulmonary disease (COPD), or emphysema; corneal disease or other eye diseases; kidney or liver disease.

• tell your doctor if you wear contact lenses. You will likely be told to avoid using contact lenses while receiving datopotamab deruxtecan-dlnk.

• you or your partner should not become pregnant while receiving datopotamab deruxtecan-dlnk. datopotamab deruxtecan-dlnk can harm the fetus. You may be asked to take a pregnancy test before starting datopotamab deruxtecan-dlnk. If you are capable of becoming pregnant, you should use effective contraception during and for 7 months after therapy with datopotamab deruxtecan-dlnk. If your partner is capable of becoming pregnant, you and/or your partner should use effective contraception during and for 4 months after datopotamab deruxtecan-dlnk therapy. Talk to your doctor about what contraception is right for you. If you or your partner become pregnant while receiving datopotamab deruxtecan-dlnk, call your doctor immediately.

• do not breastfeed while receiving or for 1 month after the final dose of datopotamab deruxtecan-dlnk.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment for a schedule infusion of datopotamab deruxtecan-dlnk, call your doctor right away to reschedule.

What SIDE EFFECTS can this medicine cause?

Datopotamab deruxtecan-dlnk may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea and/or vomiting
• constipation
• diarrhea
• stomach pain
• fatigue
• hair loss
• rash
• decreased appetite
• cough

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• shortness of breath, painful breathing, cough, fever
• dry eye, eye redness, eye pain, excessive tearing or discharge from the eye, eyelid pair or irritation or swelling, blurred vision, reduced vision, sensitivity to light, feeling like something is in your eye or scratchy eye
• sores or ulcers in mouth such as on the gums, tongue, lips or cheeks; pain when chewing or swallowing

Datopotamab deruxtecan-dlnk may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to datopotamab deruxtecan-dlnk.

Your doctor will send you to get an eye exam before, during and after treatment with datopotamab deruxtecan-dlnk. It is important to keep these appointments to monitor the effect of datopotamab deruxtecan-dlnk on the eyes closely.

Ask your pharmacist any questions you have about datopotamab deruxtecan-dlnk.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.