Axatilimab Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 10, 2024.

Applies to axatilimab: intravenous solution.

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 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.

For healthcare professionals

Applies to axatilimab: intravenous solution.

General adverse events

The most frequently reported side effects (15% or greater) including laboratory abnormalities were increased AST, infection (pathogen unspecified), increased ALT, decreased phosphate, decreased hemoglobin, viral infection, increased GGT, musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (Alk Phos), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.^[Ref]

Cardiovascular

• Frequency not reported: Hypertension^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 10%)
• Frequency not reported: Pruritus^[Ref]

Rash included bullous dermatitis, exfoliative generalized dermatitis, rash, and maculopapular rash.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 23%), diarrhea (up to 18%), increased lipase (up to 34%), increased amylase (up to 32%)^[Ref]

Nausea included nausea and vomiting.

Diarrhea included colitis and diarrhea.^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (up to 48%), hemorrhage (up to 11%)^[Ref]

Hemorrhage included contusion, epistaxis, hematochezia, hematoma, and vaginal hemorrhage.^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 61%), increased ALT (up to 51%), increased GGT (up to 39%)^[Ref]

Hypersensitivity

• Very common (10% or more): Drug hypersensitivity (up to 13%), hypersensitivity reactions (up to 26%)^[Ref]

Drug hypersensitivity included bronchospasm, flushing, hot flush, hypersensitivity, infusion-related hypersensitivity reaction, infusion-related reaction, and urticaria.^[Ref]

Immunologic

• Frequency not reported: Antidrug antibodies, neutralizing antibodies

Metabolic

• Very common (10% or more): Decreased appetite (up to 11%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 35%), increased CPK (up to 25%)^[Ref]

Musculoskeletal pain included arthralgia, back pain, flank pain, musculoskeletal pain, myalgia, and pain in extremity.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 20%), dizziness (up to 11%)^[Ref]

Headache included headache and migraine.

Dizziness included dizziness and postural dizziness.^[Ref]

Ocular

• Frequency not reported: Periorbital edema^[Ref]

Other

• Very common (10% or more): Infection (pathogen unspecified; up to 57%), viral infection (up to 43%), fatigue (up to 32%), bacterial infection (up to 15%), pyrexia (up to 15%), decreased phosphate (up to 51%), increased calcium (up to 31%), increased Alk Phos (up to 28%), edema (up to 13%)^[Ref]

Infection (pathogen unspecified) included jaw abscess, atypical pneumonia, bacteremia, bronchitis, conjunctivitis, cystitis, device-related infection, infectious enterocolitis, gastroenteritis, gastrointestinal infection, groin abscess, hordeolum, liver abscess, nasopharyngitis, otitis media, acute otitis media, pneumonia, respiratory tract infection, rhinitis, sepsis, sinusitis, tooth infection, upper respiratory tract infection, urinary tract infection, and wound infection.

Viral infection included adenoviral upper respiratory infection, BK virus infection, COVID-19, coronavirus infection, enterovirus infection, astroviral gastroenteritis, viral gastroenteritis, herpes simplex, herpes zoster, influenza, metapneumovirus bronchiolitis, metapneumovirus infection, norovirus infection, oral viral infection, parainfluenza viral bronchitis, parainfluenza virus infection, respiratory syncytial virus infection, rhinovirus infection, viral infection, and viral upper respiratory tract infection.

Bacterial infection included bacterial diarrhea, bacterial vaginosis, Campylobacter gastroenteritis, Campylobacter infection, cellulitis, Clostridioides difficile colitis, C difficile infection, enterococcal infection, erysipelas, Haemophilus infection, bacterial lower respiratory tract infection, pseudomonal skin infection, staphylococcal bacteremia, staphylococcal infection, Stenotrophomonas infection, streptococcal infection, and enterococcal urinary tract infection.

Fatigue included asthenia, fatigue, and malaise.

Edema included localized edema and peripheral edema.^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 18%), dyspnea (up to 15%)
• Frequency not reported: Respiratory failure^[Ref]

Cough included cough and productive cough.

Dyspnea included dyspnea and exertional dyspnea.^[Ref]

See also:

Further information

Axatilimab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer