Xolremdi®

Drug - Xolremdi® (mavorixafor) [X4 Pharmaceuticals, Inc.]

June 2025

Therapeutic Area - WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)

Initial approval criteria

Age ≥ 12 years; AND
Diagnosis of warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome; AND
Genotype-confirmed variant of CXC chemokine receptor 4 (CXCR4) consistent with WHIM syndrome; AND
Confirmed absolute neutrophil count (ANC) ≤ 400 cells/μL (or total white blood cell [WBC] count ≤ 400 cells/μL if ANC is below lower limit of detection); AND
Prescriber attestation to assess QTc at baseline and to monitor QTc periodically during treatment for patients with risk factors for QTc prolongation; AND
Patient is NOT taking the following:
- Another CXCR4 antagonist (e.g., plerixafor [Mozobil®]); OR
- Any medication that is highly dependent on cytochrome P450 (CYP) 2D6 for clearance (e.g., amitriptyline, fluoxetine); OR
- A strong CYP3A4 inducer (e.g., rifampin, phenytoin); AND
Patients of reproductive potential must have a confirmed negative pregnancy test prior to initiation AND must attest to use effective contraception during treatment and for 3 weeks after the last dose.
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist) or prescriber has consulted with a specialist in the area of patient’s diagnosis.
Initial approval is for 3 months

Patient must continue to meet the above criteria; AND
Patient must have disease improvement (e.g., improvement in ANC and/or absolute lymphocyte counts [ALC], reduction in infections); AND
Patient has not experienced any treatment-restricting adverse effects (e.g., significant QTc prolongation).
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist) or prescriber has consulted with a specialist in the area of patient’s diagnosis
Renewal approval is for 12 months

120 capsules per 30 days. Maximum dose is 400 mg daily

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