Axatilimab-csfr (Niktimvo™)

Monoclonal antibodies are created in a lab to attach to the targets found on specific types of cancer cells. The antibody “calls” the immune system to attack the cell it is attached to, resulting in the immune system killing the cell. These antibodies can work in different ways. They can help the immune system to kill the cell, blocking cell growth, or other functions needed for cell growth. Axatilimab-csfr is directed against colony-stimulating factor-1 receptors (CSF-1R), found on certain cells of the immune system. Axatilimab attaches itself to the CSF-1R to reduce pro-inflammatory immune cells which can lead to chronic graft versus host disease.

How to Take: Axatilimab-csfr (Niktimvo™)

Axatilimab-csfr is given by an intravenous (IV, into a vein) infusion. The amount given and schedule are based on your size. Make sure your care team is aware of all medications (including prescription and over-the-counter), supplements, and vitamins you are taking.

Possible Side Effects of Axatilimab-csfr

There are many things you can do to manage the side effects of axatilimab-csfr. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Increased Infection Risk

Taking this medication can make you more susceptible to infections. You should report any symptoms of infection to your healthcare provider right away, including a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning, or pain with urination.

The following infections have been reported in studies, so you should be aware of these symptoms:

• Herpes zoster: symptoms include a skin rash or blisters that may be painful or itchy, localized to one area.
• Bacterial and viral pneumonias: new or worsening cough, sore throat or cold, shortness of breath.
• Bacterial and viral diarrhea: increase in the number and frequency of loose bowel movements.

Muscle or Joint Pain/Aches and Headache

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (sodium, phosphate, calcium, potassium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Pancreas Problems

This medication can increase the enzymes amylase and lipase which may be signs of issues with your pancreas. You will have these levels checked while you take this medication. If you have sudden stomach pain or discomfort, nausea, or vomiting you should call your provider right away as these are signs of pancreatitis.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Important but Less Common Side Effects

• Infusion-Related Side Effects: Symptoms of an infusion reaction include: fever, chills, low blood pressure, shortness of breath, flushing, swelling of the throat or face, abdominal or back pain, rash, and itching. You may be given medications before the infusion such as antihistamine and antipyretic (Tylenol) to help prevent these reactions. Tell your infusion nurse immediately if you notice any of these symptoms, as they may need to slow or stop the infusion.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 30 days after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. This medication may affect your fertility, so you may want to consider sperm banking or egg harvesting if you wish to have a child in the future. Discuss these options with your oncology team. You should not breastfeed while receiving this medication and for at least 30 days after the last dose.