Description
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
- 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.
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