Axatilimab

Axatilimab is used to treat chronic graft-versus-host disease in adults and children weighing at least 88.2 pounds (40 kg) who have received at least two prior treatments for this condition.

Axatilimab is given after other treatments did not work or stopped working.

Axatilimab may also be used for purposes not listed in this medication guide.

Axatilimab is given as an infusion into a vein over 30 minutes. A healthcare provider will give you this infusion.

Axatilimab is usually given every 2 weeks. Your doctor will determine how long you should receive this medicine.

You will be watched for a short time to make sure you do not have an allergic reaction or serious side effects.

Your treatments may be delayed or stopped if you have certain side effects.

Doses are based on weight. Your dose may change if you gain or lose weight.

You will need frequent blood tests to check your liver function.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

Axatilimab is given only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• liver disease.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while receiving axatilimab and for at least 30 days after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while receiving axatilimab, and for at least 30 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the infusion. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Common side effects of axatilimab may include:

• viral or bacterial infections, fever;
• muscle, bone, or joint pain;
• lack of energy, headache;
• nausea;
• abnormal blood tests;
• shortness of breath;
• cough; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Graft Versus Host Disease:

Weight at least 40 kg: 0.3 mg/kg IV every 2 weeksMaximum dose: 35 mgDuration of therapy: Until disease progression or unacceptable toxicityComments:-Infuse over 30 minutes.-The manufacturer product information should be consulted for infusion rates.Use: For the treatment of chronic graft-versus-host disease after failure of at least 2 prior lines of systemic therapy

Usual Pediatric Dose for Graft Versus Host Disease:

Weight at least 40 kg: 0.3 mg/kg IV every 2 weeksMaximum dose: 35 mgDuration of therapy: Until disease progression or unacceptable toxicityComments:-Infuse over 30 minutes.-The manufacturer product information should be consulted for infusion rates.Use: For the treatment of chronic graft-versus-host disease after failure of at least 2 prior lines of systemic therapy

Call your doctor for instructions if you miss an appointment for your axatilimab infusion.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect axatilimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.