Tafasitamab-cxix Injection

WHY is this medicine prescribed?

Tafasitamab-cxix injection is used in adults along with lenalidomide (Revlimid) to treat certain types of non-Hodgkin's lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection) that have returned or that did not respond to other treatments in those who cannot receive a stem cell transplant. Tafasitamab-cxix injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

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?

Tafasitamab-cxix comes as a powder to be mixed with a liquid and given into a vein by a doctor or nurse in a healthcare setting. Tafasitamab-cxix is usually given on days 1, 4, 8, 15, and 22 of cycle 1, on days 1, 8, 15 and 22 on cycles 2 and 3, and on days 1 and 15 of cycles 4 to 12. Each treatment cycle is 28 days and tafasitamab-cxix is given for up to 12 cycles. The length of treatment depends on how well your body responds to the medication and any side effects you experience.

Tafasitamab-cxix may cause serious reactions while you receive the medication. You may be given other medications to treat or help prevent reactions to tafasitamab-cxix. A doctor or nurse will watch you closely while you are receiving the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: chills, flushing, headache, or shortness of breath.

Your doctor may temporarily or permanently stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with tafasitamab-cxix.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tafasitamab-cxix,

• tell your doctor and pharmacist if you are allergic to tafasitamab-cxix, any other medications, or any of the ingredients in tafasitamab-cxix injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back.

• tell your doctor if you are pregnant or plan to become pregnant. You should use birth control to prevent pregnancy during your treatment with tafasitamab-cxix and for at least 3 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while receiving tafasitamab-cxix injection, call your doctor.

• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment with tafasitamab-cxix and for 3 months after your final dose.

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 to receive a tafasitamab-cxix, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

• diarrhea
• constipation
• nausea
• vomiting
• loss of appetite
• back pain
• muscle spasms

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

• sore throat, fever, chills, cough, burning or painful urination, or other signs of infection
• fever or unusual bruising or bleeding
• pale skin, fatigue, or shortness of breath

Tafasitamab-cxix may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tafasitamab-cxix.

Ask your pharmacist any questions you have about tafasitamab-cxix.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.