Niktimvo - Axatilimab Injection

What is this medication?

AXATILIMAB (AX a TIL i mab) treats graft versus host disease, a condition that can occur after a stem cell transplant. It is often prescribed when other treatment options have not worked well enough or cannot be tolerated. It works by decreasing inflammation. It also prevents the buildup of scar tissue. It is a monoclonal antibody.

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

COMMON BRAND NAME(S): NIKTIMVO

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

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

• Liver disease
• An unusual or allergic reaction to axatilimab, 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.

Talk to your care team about the use of this medication in children. While it may be given to children for selected conditions, precautions do apply.

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 unable to keep an appointment.

What may interact with this medication?

Interactions are not expected.

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?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

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.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 30 days after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 30 days after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 30 days after the last dose.

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
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded

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

• Bone, joint, or muscle pain
• Cough
• Diarrhea
• Fatigue
• Headache
• Nausea

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.