Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Niktimvo

Descriptions

Axatilimab-csfr injection is used to treat chronic graft-versus-host disease (cGVHD) in patients who have received at least 2 previous treatments that did not work.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of axatilimab-csrf injection in children weighing less than 40 kilograms (kg). Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of axatilimab-csrf injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. May make this condition worse.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV may need to stay in place for at least 30 minutes every 2 weeks.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may also give you other medicines (eg, allergy medicine, fever medicine) to help prevent infusion-related reactions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 30 days after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause infusion-related reactions. Check with your doctor right away if you have fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

1. Back pain
2. bladder pain
3. bleeding gums
4. bloating or swelling of the face, arms, hands, lower legs, or feet
5. blurred vision
6. bloody or cloudy urine
7. body aches or pain
8. bruise
9. burning, dry, or itching eyes
10. burning or stinging of the skin
11. chest pain or tightness
12. collection of blood under the skin
13. confusion
14. cough or hoarseness
15. cough producing mucus
16. deep, dark purple bruise
17. diarrhea
18. difficult, burning, or painful urination
19. difficulty in swallowing
20. discharge, excessive tearing
21. dizziness
22. ear congestion
23. fainting
24. fast heartbeat
25. fever or chills
26. flushing
27. frequent urge to urinate
28. headache
29. heavy nonmenstrual vaginal bleeding
30. increased menstrual flow or vaginal bleeding
31. itching, pain, redness, swelling, tenderness, warmth on the skin
32. lightheadedness
33. loss of appetite
34. loss of taste or smell
35. loss of voice
36. lower back or side pain
37. muscle, bone, or joint pain
38. nausea
39. nervousness
40. nosebleeds
41. pain or tenderness around the eyes and cheekbones
42. painful blisters on trunk of the body
43. painful cold sores or blisters on the lips, nose, eyes, or sex organs
44. paralysis
45. pounding in the ears
46. prolonged bleeding from cuts
47. rapid weight gain
48. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
49. red or black, tarry stools
50. red or dark brown urine
51. sneezing
52. sore throat
53. stomach pain, cramps, or tenderness
54. stuffy or runny nose
55. swelling of the face, throat, or tongue
56. tingling of hands or feet
57. trouble breathing
58. unusual tiredness or weakness
59. unusual weight gain or loss
60. vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Arm or leg pain
2. blistering, crusting, irritation, itching, or reddening of the skin
3. changes in vision
4. cracked, dry, scaly skin
5. difficulty in moving
6. ear pain
7. general feeling of discomfort or illness
8. hot flush
9. lack or loss of strength
10. muscle stiffness
11. redness or swelling in the ear

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: Sept. 01, 2024

Original article: https://www.mayoclinic.org/zh-hans/drugs-supplements/axatilimab-csfr-intravenous-route/description/drg-20572460