Mavorixafor

Mavorixafor is a prescription medication indicated for WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis) in patients 12 years of age and older to increase the number of circulating mature neutrophils and lymphocytes

• Mavorixafor is available under the following different brand names: Xolremdi

Common side effects of Mavorixafor include:

• thrombocytopenia 
• pityriasis
• rash
• rhinitis
• epistaxis
• vomiting
• dizziness

Serious side effects of Mavorixafor include:

• QT interval prolongation

Rare side effects of Mavorixafor include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 100mg

WHIM Syndrome

Adult dosage

• More than 50 kg: 400 mg orally once a day
• Less than or equal to 50 kg: 300 mg orally once a day

Pediatric dosage

• Below 12 years: Safety and efficacy not established
• Above 12 years
  • More than 50 kg: 400 mg orally once a day
  • Less than or equal to 50 kg: 300 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mavorixafor has severe interactions with no other drugs
• Mavorixafor has serious interactions with no other drugs
• Mavorixafor has moderate interactions with no other drugs
• Mavorixafor has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Drugs that are highly dependent on CYP2D6 for clearance

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mavorixafor?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mavorixafor?”

Cautions

• Based on its mechanism of action, Mavorixafor is expected to cause fatal harm when administered to pregnant females
• Drug interaction overview
  • Inhibitor of CYP2D6, CYP3A4, and P-gp
  • Substrate of CYP3A4 and P-gp
  • Strong or moderate CYP3A4 inhibitors
  • Modify dose/monitor
    • Coadministered with strong CYP3A4 inhibitors: Reduce mavorixafor dose
    • Coadministered with moderate CYP3A4 inhibitors: Monitor for adverse effects that may be associated with increased mavorixafor exposure; reduce daily dosage by steps of 100 mg, if necessary, but not below 200 mg
  • Strong CYP3A4 inducers
  • Avoid
    • Coadministration is predicted to decrease mavorixafor peak plasma concentration and AUC, which may reduce efficacy
  • P-gp inhibitors
    • Monitor/modify dose
    • Monitor for adverse effects that may be associated with increased mavorixafor exposure; reduce daily dosage by steps of 100 mg, if necessary, but not below 200 mg
  • CYP2D6 substrates
    • Contraindicated
    • Mavorixafor increases the exposure of CYP2D6 major substrates, which may increase risk of adverse reactions related to these substrates
  • Sensitive CYP3A4 substrates
  • Monitor
    • Monitor more frequently when coadministered with CYP3A4 substrates where minimal substrate concentration changes may lead to serious adverse reactions
  • P-gp substrates
  • Monitor
    • Monitor more frequently when coadministered with P-gp substrates where minimal substrate concentration changes may lead to serious adverse reactions
  • QTc interval prolongation H5
  • Monitor/modify dose
    • QT interval prolongation may occur when coadministered with medications that increase Mavorixafor exposure and/or drug products with a known potential to prolong QT
    • Correct any modifiable risk factors for QTc prolongation (eg, hypokalemia), assess QTc at baseline, and monitor QTc during treatment as clinically indicated in patients with risk factors for QTc prolongation
  • Mavorixafor dose reduction or discontinuation may be required

Pregnancy and Lactation

• Based on its mechanism of action, expected to cause fetal harm when administered to pregnant women
• Data are not available regarding use in pregnant women to determine the risk of embryo-fetal developmental toxicities
• Verify the pregnancy status in females of reproductive potential before initiating
• Contraception
  • Advise females of reproductive potential to use an effective form of contraception during treatment and for 3 weeks after the final dose
• Lactation
  • Data are not available regarding the presence of Mavorixafor in human or animal milk, effects on breastfed children, or effects on milk production
  • Because of the potential for serious adverse reactions in breastfed children, advise females that breastfeeding is not recommended during treatment and for 3 weeks after the final dose