Pronunciation:

ax-a-TIL-i-mab - csfr

Brand Names:

• Niktimvo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Axatilimab

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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

Back pain

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

bloody or cloudy urine

body aches or pain

bruise

burning, dry, or itching eyes

burning or stinging of the skin

chest pain or tightness

collection of blood under the skin

confusion

cough or hoarseness

cough producing mucus

deep, dark purple bruise

diarrhea

difficult, burning, or painful urination

difficulty in swallowing

discharge, excessive tearing

dizziness

ear congestion

fainting

fast heartbeat

fever or chills

flushing

frequent urge to urinate

headache

heavy nonmenstrual vaginal bleeding

increased menstrual flow or vaginal bleeding

itching, pain, redness, swelling, tenderness, warmth on the skin

lightheadedness

loss of appetite

loss of taste or smell

loss of voice

lower back or side pain

muscle, bone, or joint pain

nausea

nervousness

nosebleeds

pain or tenderness around the eyes and cheekbones

painful blisters on trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or sex organs

paralysis

pounding in the ears

prolonged bleeding from cuts

rapid weight gain

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

red or black, tarry stools

red or dark brown urine

sneezing

sore throat

stomach pain, cramps, or tenderness

stuffy or runny nose

swelling of the face, throat, or tongue

tingling of hands or feet

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

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

Arm or leg pain

blistering, crusting, irritation, itching, or reddening of the skin

changes in vision

cracked, dry, scaly skin

difficulty in moving

ear pain

general feeling of discomfort or illness

hot flush

lack or loss of strength

muscle stiffness

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.