Axatilimab Dosage

Medically reviewed by Drugs.com. Last updated on Mar 3, 2025.

Applies to the following strengths: csfr 22 mg/0.44 mL; csfr 9 mg/0.18 mL

Usual Adult Dose for Graft Versus Host Disease

Weight at least 40 kg: 0.3 mg/kg IV every 2 weeks
Maximum dose: 35 mg
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

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 weeks
Maximum dose: 35 mg
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Liver dysfunction: Data not available

If AST or ALT elevation develops during therapy:

On the day of dosing:
Grade 3 with total bilirubin up to grade 1: Withhold this drug until recovery to grade 2, then resume this drug at 0.2 mg/kg (up to 23 mg) IV every 2 weeks.
Regardless of the time of the reaction:
ALT or AST at least 3 times the upper limit of normal (3 x ULN) with total bilirubin at least 2 x ULN and alkaline phosphatase less than 2 x ULN: Withhold this drug and investigate for drug-induced liver injury; if confirmed, permanently discontinue this drug.
Grade 4: Permanently discontinue this drug.

Dose Adjustments

Recommended Dosage Modifications for Adverse Reactions:
Infusion-related reactions:

Grade 1 or 2:
Temporarily interrupt the infusion until resolution or decrease infusion rate by 50%.
Initiate symptomatic treatment (e.g., antihistamines and antipyretics).
For subsequent infusions, premedicate and resume the infusion at 50% of the prior infusion rate.
Grade 3 or 4: Discontinue this drug permanently.

Elevation of creatine phosphokinase, amylase, or lipase:

Grade 3 or greater:
If diagnostic evaluation results show no evidence of end-organ damage, continue this drug without dose reduction.
If diagnostic evaluation results show evidence of end-organ damage, discontinue this drug permanently.
Symptomatic grade 3 or greater: Discontinue this drug permanently.

Other nonhematologic adverse reactions:

Grade 3: Dosing should be suspended until recovery to grade 2.
If delayed by 4 weeks or less from the planned infusion, resume this drug at 0.2 mg/kg (maximum 23 mg) IV every 2 weeks.
If delayed by more than 4 weeks from the planned infusion, discontinue this drug permanently.
Grade 4: Discontinue this drug permanently.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in pediatric patients weighing less than 40 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Administer through a dedicated infusion line that includes a sterile, low-protein binding 0.2-micron in-line or add-on polyethersulfone filter.
Do not coadminister other drugs through the same infusion line.
If refrigerated, allow the diluted solution to come to room temperature prior to administration.
The diluted solution must be administered within 4 hours (including infusion time) once it is removed from the refrigerator.
After administration, flush the infusion line with 0.9% Sodium Chloride Injection.

Storage requirements:

Vials: Store in a refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light. Do not freeze or shake.
Diluted solution: If not used immediately, can store at room temperature or in refrigerator:
At room temperature (up to 25C [77F]) for no more than 4 hours from the time of preparation to the end of the infusion.
In refrigerator at 2C to 8C (36F to 46F) for no more than 24 hours.
Do not freeze or shake the diluted solution.

Reconstitution/preparation techniques:

Visually inspect the vial for particulate matter and discoloration prior to dilution. This drug is slightly opalescent, pale brownish yellow solution. Discard the vial if the solution is cloudy, discolored, or contains extraneous particulate matter.
Discard vial with any unused portion.
Mix diluted solution by gentle inversion. Do not shake.
The manufacturer product information should be consulted.

IV compatibility:

Compatible diluent: 0.9% Sodium Chloride Injection
Compatible materials for IV infusion bag: Polyvinyl chloride, polyolefin, polyolefin with polyamide, ethylene vinyl acetate

Monitoring:

Gastrointestinal: Amylase and lipase (before initiating therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved)
General: Alkaline phosphatase (before initiating therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved); for signs or symptoms of infusion-related reactions
Hepatic: AST and ALT (before initiating therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved)
Musculoskeletal: Bone growth and development in pediatric patients; creatine phosphokinase (before initiating therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved)

Patient advice:

Read the US FDA-approved patient labeling (Patient Information).
Infusion-related reactions may occur; seek medical care if signs and symptoms occur.
Females of reproductive potential: Use effective contraception during treatment and for 30 days after the last dose; notify your health care provider of a known/suspected pregnancy.
Breastfeeding is not recommended during use of this drug and for 30 days after the last dose.