Xolremdi Application Scope

Xolremdi (mavorixafor) is a first-in-class oral CXCR4 antagonist approved by the FDA for treating WHIM syndrome in patients aged 12 and older to increase circulating neutrophils and lymphocytes.

xolremdi

Characteristics

Ingredients: Each capsule contains 100 mg of mavorixafor, an orally bioavailable CXC chemokine receptor 4 (CXCR4) antagonist.

Properties:
- Mavorixafor is an oral CXCR4 antagonist that blocks the binding of CXCL12 (also known as SDF-1α) to the CXCR4 receptor.
- This action disrupts the CXCR4/CXCL12 signaling pathway, which is responsible for retaining leukocytes in the bone marrow.
- By inhibiting this interaction, mavorixafor promotes the release of neutrophils and lymphocytes into the peripheral bloodstream, thereby
Packaging Specification:
- Supplied as opaque white, hard gelatin capsules with a light blue cap, containing 100 mg of mavorixafor.
- The capsule body is imprinted with “100 mg” and the cap with “MX4” in black ink.
- Available in child-resistant bottles of 60, 90, or 120 capsules.

Storage:
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Keep the bottle tightly closed and store it in the original container to protect it from moisture.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) in April 2024.
Approval Number: National Drug Code (NDC): 83296-100-60 (for 60-count bottle).
Date of Revision: April 23, 2024
Manufacturer: X4 Pharmaceuticals, Inc.

Guidelines for the Use of Xolremdi

Dosage and Administration:
- For patients weighing more than 50 kg: 400 mg orally once daily (4 capsules).
- For patients weighing 50 kg or less: 300 mg orally once daily (3 capsules).
- Take on an empty stomach after an overnight fast, at least 30 minutes before food.
- Swallow capsules whole; do not open, break, or chew.
- If a dose is missed, take the next dose as scheduled. Do not take more than one dose per day.

Adverse Reactions: Common adverse reactions (occurring in >10% of patients and more frequently than placebo) include thrombocytopenia, pityriasis, rash, rhinitis, epistaxis, vomiting, and dizziness.
Contraindications: Co-administration with drugs highly dependent on CYP2D6 for clearance.
Precautions:
- Embryo-Fetal Toxicity:
  - XOLREMDI is expected to cause fetal harm.
  - Verify pregnancy status before starting treatment.
  - Advise females of reproductive potential to use effective contraception during treatment and for three weeks after the final dose.
- QTc Interval Prolongation:
  - XOLREMDI causes concentration-dependent QTc prolongation.
  - Correct any modifiable risk factors, assess QTc at baseline, and monitor during treatment as clinically indicated.
  - Dose reduction or discontinuation may be required.

Interactions

Drug Interactions:
- Avoid co-administration with strong CYP3A4 inducers.
- Reduce XOLREMDI daily dosage to 200 mg when administered with strong CYP3A4 inhibitors.
- Monitor for adverse reactions when used concomitantly with moderate CYP3A4 inhibitors or P-gp inhibitors; dosage reduction may be necessary.

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.