XOLREMDI

Generic Name/API: mavorixafor

Manufacturer: X4 Pharmaceuticals

Dosage Forms & Strength & Pack Size:
Capsules: 100 mg mavorixafor

Storage:
Store XOLREMDI refrigerated at 2°C to 8°C (36°F to 46°F). Keep bottle tightly closed. Store in and
dispense from original container to protect from moisture.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

XOLREMDI is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts,
hypogammaglobulinemia, infections and myelokathexis) to increase
the number of circulating mature neutrophils and lymphocytes.

 

 

 

 

WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Based on its mechanism of action, XOLREMDI is expected to cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.2)]. Animal models link reductions in CXCR4/SDF 1 signaling to adverse outcomes in mammalian embryo-fetal development and to abnormal placental development.
Verify the pregnancy status of female patients of reproductive potential prior to starting XOLREMDI.
Advise females of reproductive potential to use an effective method of contraception during treatment with XOLREMDI and for three weeks after the final dose [see Use in Specific Populations.
QTc Interval Prolongation
XOLREMDI causes concentration-dependent QTc interval prolongation. QT interval prolongation may occur when XOLREMDI is taken with concomitant medications that increase XOLREMDI exposure and/or drug products with a known potential to prolong QT. Correct any modifiable risk factors for
QTc prolongation (e.g., hypokalemia), assess QTc at baseline and monitor QTc during treatment as clinically indicated in patients with risk factors for QTc prolongation such as those receiving concomitant medications that increase XOLREMDI exposure and drug products with a known potential to prolong the QTc interval. A dose reduction in XOLREMDI or discontinuation of XOLREMDI may be required [see Drug Interactions (7.1, 7.3) and Clinical Pharmacology (12.2)].

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