Brand Name(s): Niktimvo^®

WHY is this medicine prescribed?

Axatilimab-csfr injection is used to treat graft versus host disease (GVHD; a condition in which the immune system begins attacking newly transplanted organs, stem cells or bone marrow) in adults and some children who have not responded to two other therapies. Axatilimab-csfr is in a class of medications called monoclonal antibodies. It works by stopping the immune system from attacking the newly transplanted tissue, cells, or bone marrow.

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?

Axatilimab-csfr comes as a solution (liquid) to be given intravenously (into the vein) by a doctor or nurse at a hospital or clinic. It is usually given over 30 minutes every 2 weeks.Your doctor will decide how long you should receive axatilimab-csfr.

Your doctor will draw labs to check for side effects axatilimab-csfr. Your doctor may adjust your dose or interrupt your therapy based on these results. Your doctor may give you other medications before receiving axatilimab-csfr to prevent infusion-related side effects (fever, chills, rash, flushing, difficulty breathing). It is important that you tell your doctor or nurse how you feel during treatment.

What SPECIAL PRECAUTIONS should I follow?

Before receiving axatilimab-csfr injection,

• tell your doctor and pharmacist if you are allergic to axatilimab-csfr, any other medications, or any of the ingredients in axatilimab-csfr injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• 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 liver problems.

• tell your doctor if you are pregnant or plan to become pregnant. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your axatilimab-csfr treatment and for 30 days after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking axatilimab-csfr, call your doctor.Axatilimab-csfr may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with axatilimab-csfr and for at least 30 days after your final dose.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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

• muscle, bone or joint pain
• low energy
• nausea
• headache
• diarrhea

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

• fever, cough, shortness of breath
• lower abdominal pain, yellowing of skin or whites of eyes, dark urine
• severe upper abdominal pain, tenderness in the upper abdomen, fever
• fever, difficulty or painful urination or frequent urination, lower back pain
• low energy, pale skin, chest pain, shortness of breath

Axatilimab-csfr 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 will order certain lab tests to check your body's response to axatilimab-csfr.

If you miss an appointment to receive your dose, call your doctor right away.

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 20, 2024.