Axatilimab

Axatilimab is a prescription medication indicated for chronic graft-versus-host disease (cGVHD) after failure of two or more prior lines of systemic therapy in adults and pediatric patients weighing at least 40 kg.

• Axatilimab is available under the following different brand names: Niktimvo, axatilimab-csfr.

Common side effects of Axatilimab include:

• infections 
• increased blood level of pancreatic enzymes 
• nausea
• increased blood level of liver enzymes
• headache
• low energy  
• diarrhea
• decreased blood level of phosphate 
• increased blood level of calcium 
• cough
• increased blood level of a muscle enzyme
• fever
• low red blood cell count (anemia) 
• shortness of breath
• increased blood level of a bone enzyme
• muscle, bone, or joint pain 

Serious side effects of Axatilimab include:

• infusion-related reactions 

Rare side effects of Axatilimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• 50 mg/mL single-dose vial

Chronic graft-versus-host disease

Adult dosage

• 0.3 mg/kg (maximum, 35 mg) IV every 2 weeks until disease progression or unacceptable toxicity

Pediatric dosage

• Children weighing 40 kg and more: 0.3 mg/kg (maximum, 35 mg) IV every 2 weeks until disease progression or unacceptable toxicity
• Children weighing less than 40 kg: Safety and efficacy not established

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Axatilimab has no noted severe interactions with any other drugs
• Axatilimab has no noted serious interactions with any other drugs
• Axatilimab has no noted moderate interactions with any other drugs
• Axatilimab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Axatilimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Axatilimab?”

Cautions

• Infusion-related reactions
  • Infusion-related reactions (e.g., hypersensitivity reactions) reported
  • Premedicate with antihistamine and antipyretic with subsequent infusions if a reaction occurs
  • Monitor for signs and symptoms (e.g., fever, chills, rash, flushing, dyspnea, hypertension)
  • Interrupt or slow the rate of infusion or permanently discontinue based on severity
• Embryo-fetal toxicity
  • Fetal harm may occur if used during pregnancy
  • Advise pregnant women of potential risk to the fetus
  • Effective contraception is recommended during and after therapy in females of reproductive potential

Pregnancy and Lactation

• May cause fetal harm if administered to pregnant women, based on the mechanism of action
• Data are not available in pregnant women to evaluate for drug-associated risk
• No animal reproductive and developmental toxicity studies have been conducted
• Targeted mutation of CSF-1R or CSF-1 in rodent models resulted in prenatal and perinatal death, deficits in growth, and pleiotropic impact on multiple organ systems (e.g., skeletal, reproductive)
• Regulation by CSF-1R on non-mononuclear phagocytic cells and macrophages plays a role in the innate immune protection of the fetus, pregnancy maintenance, and embryo-fetal development
• Human immunoglobulin G (IgG) is known to cross the placenta
• Advise pregnant women of potential risk to a fetus
• Perform pregnancy testing before initiation in females of reproductive potential
• Contraception
  • Females of reproductive potential: Use effective contraception during therapy and for 30 days after the last dose
• Lactation
  • Data are unavailable on the presence of the drug in human milk, its effects on breastfed children or milk production
  • Maternal IgG is present in human milk
  • Avoid breastfeeding during therapy and for 30 days after the last dose due to the risk of serious adverse effects in nursing children