Axatilimab-Csfr Application Scope

Axatilimab-csfr is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

axatilimab-csfr

Axatilimab-Csfr Characteristics

Ingredients:
Active Ingredient: Axatilimab-csfr, a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody.

Properties:

Mechanism of Action: Axatilimab-csfr targets CSF-1R, reducing the drivers of inflammation and fibrosis associated with cGVHD.

Packaging Specification:
Available in 9 mg and 22 mg single-dose vials.

Storage:
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.

Expiry Date:
Refer to the expiration date printed on the vial and packaging.

Executive Standard:
Manufactured in accordance with FDA-approved standards and guidelines.

Approval Number:
FDA approval date: August 14, 2024.

Date of Revision:
October 10, 2024.

Manufacturer:
Co-developed and co-commercialized by Incyte Corporation and Syndax Pharmaceuticals.

Guidelines for the Use of Axatilimab-Csfr

Dosage and Administration:

Recommended Dose: 0.3 mg/kg (up to a maximum of 35 mg) administered as an intravenous infusion over 30 minutes every two weeks.
Administration: Dilute the injection solution prior to administration. Administer through a dedicated infusion line with a sterile, low-protein binding 0.2-micron in-line or add-on polyethersulfone (PES) filter.

Adverse Reactions:
Common adverse reactions (≥15%) include:

Increased aspartate aminotransferase (AST)
Infection (pathogen unspecified)
Increased alanine aminotransferase (ALT)
Decreased phosphate
Decreased hemoglobin
Viral infection
Increased gamma-glutamyl transferase (GGT)
Musculoskeletal pain
Increased lipase
Fatigue
Increased amylase
Increased calcium
Increased creatine phosphokinase (CPK)
Increased alkaline phosphatase (ALP)
Nausea
Headache
Diarrhea
Cough
Bacterial infection
Pyrexia (fever)
Dyspnea (shortness of breath)

Contraindications:
None identified.

Precautions:

Infusion-Related Reactions: Occurred in 18% of patients; premedicate with an antihistamine and antipyretic for patients with prior reactions. Monitor for signs such as fever, chills, rash, flushing, dyspnea, and hypertension.
Embryo-Fetal Toxicity: May cause fetal harm; advise females of reproductive potential to use effective contraception during treatment and for 30 days after the last dose.
Lactation: Advise women not to breastfeed during treatment and for 30 days after the last dose due to potential for serious adverse reactions in the breastfed child.

Axatilimab-Csfr Interactions

Drug Interactions:
No specific drug interaction studies have been conducted with axatilimab-csfr.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.