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XOLREMDI

MAVORIXAFOR

Manufacturer: X4 Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

XOLREMDI (mavorixafor) is an orally bioavailable CXCR4 antagonist used to increase the number of circulating mature neutrophils and lymphocytes in patients 12 years and older with WHIM syndrome. The recommended dosage is 400 mg orally once daily for patients weighing more than 50 kg and 300 mg orally once daily for patients weighing less than or equal to 50 kg. XOLREMDI is contraindicated with drugs highly dependent on CYP2D6 for clearance, and its use may cause QTc interval prolongation. Common adverse reactions include thrombocytopenia, pityriasis, rash, rhinitis, epistaxis, vomiting, and dizziness.

Key Clinical Findings and Indications

  • XOLREMDI is indicated for patients 12 years and older with WHIM syndrome to increase the number of circulating mature neutrophils and lymphocytes
  • XOLREMDI is a CXCR4 antagonist that blocks the binding of the CXCR4 ligand, stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12)

Important Safety Information

Warning

XOLREMDI may cause QTc interval prolongation

Contraindications

  • Use with drugs highly dependent on CYP2D6 for clearance

Adverse Reactions

  • Thrombocytopenia
  • Pityriasis
  • Rash
  • Rhinitis
  • Epistaxis
  • Vomiting
  • Dizziness

Dosing Recommendations

General Guidance

Reduce daily dosage to 200 mg when used concomitantly with strong CYP3A4 inhibitors

WHIM syndrome

Adult Dose

400 mg orally once daily for patients weighing more than 50 kg

Pediatric Dose

300 mg orally once daily for patients weighing less than or equal to 50 kg

Special Population Considerations

Pregnancy

  • XOLREMDI is expected to cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to the fetus and to use effective contraception

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of XOLREMDI have been established in pediatric patients aged 12 years and older
  • The safety and effectiveness of XOLREMDI have not been established in pediatric patients younger than 12 years of age

Geriatric Use

  • Clinical studies did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients

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