Axatilimab-Csfr | Chronic Graft-Versus-Host Disease | HongKong DengYue Medicine

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 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.