Telisotuzumab Vedotin Injection

What is this medication?

TELISOTUZUMAB VEDOTIN (tel EYE soe TOOZ ue mab ve DOE tin) treats lung cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Emrelis

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Eye or vision problems
• Liver disease
• Lung or breathing disease
• Nerve pain, tingling or numbness in the hands or feet
• An unusual or allergic reaction to telisotuzumab vedotin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are not able to keep your appointment.

What may interact with this medication?

• Grapefruit juice
• Some antivirals for HIV or hepatitis
• Some medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

This medication can cause serious infusion reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team if you or your partner may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 2 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 1 month after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Dry cough, shortness of breath or trouble breathing
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Pain, tingling, or numbness in the hands or feet

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Blurry vision
• Dry eyes
• Fatigue
• Loss of appetite
• Sensitivity to light
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.