XOLREMDI 100 mg/1
mavorixafor · CAPSULE, GELATIN COATED · X4 Pharmaceuticals, Inc.
Mavorixafor (Xolremdi) is an oral capsule medication that works by blocking a specific chemokine receptor involved in immune cell movement, used to treat certain rare immunodeficiency disorders. This prescription medication comes in 100 mg capsules and is taken by mouth as directed by your doctor.
Key Facts
- Brand Name
- XOLREMDI
- Generic Name
- mavorixafor
- NDC Code (Product)
83296-100- Manufacturer
- X4 Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA218709
- Drug Class
- CXC Chemokine Receptor 4 Antagonist [EPC]
- Marketing Start
- 05/21/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XOLREMDI is 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 lympocytes. 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: Weight more than 50 kg: 400 mg orally once daily. ( 2 ) Weight less than or equal to 50 kg: 300 mg orally once daily. ( 2 ) Administer XOLREMDI on an empty stomach after an overnight fast, and at least 30 minutes before food. ( 2 ) 2.1 Recommended Dosage The recommended dosage of XOLREMDI is: Weight more than 50 kg: 400 mg orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food. Weight less than or equal to 50 kg: 300 mg orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food. Swallow the capsules whole. Do not open, break, or chew capsules. If a dose of XOLREMDI is missed, the next dose should be taken as scheduled. Do not take more than 1 XOLREMDI dose each day. 2.2 Dosage Modifications for Strong CYP3A4 inhibitors Reduce daily dosage of XOLREMDI to 200 mg when used concomitantly with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ] .
Contraindications
4 CONTRAINDICATIONS Use of XOLREMDI is contraindicated with drugs that are highly dependent on CYP2D6 for clearance [see Drug Interactions (7.2) ] . Use with drugs highly dependent on CYP2D6 for clearance. ( 4 , 7.2 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Reduce XOLREMDI daily dosage. ( 2.2 , 7.1 ) P-gp inhibitors or moderate CYP3A4 inhibitors: Monitor more frequently for XOLREMDI adverse reactions and reduce XOLREMDI daily dosage if necessary. ( 7.1 ) Strong CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) CYP3A4 or P-gp substrates: Monitor more frequently for substrate adverse reactions unless otherwise recommended. ( 7.2 ) 7.1 Effect of Other Drugs on XOLREMDI Strong or Moderate CYP3A4 Inhibitors Reduce XOLREMDI daily dosage to 200 mg when used concomitantly with a strong CYP3A4 inhibitor [see Dosage and Administration (2.2) ] . Monitor more frequently for XOLREMDI adverse reactions that may be associated with an increase in mavorixafor exposure when used concomitantly with moderate CYP3A4 inhibitor and reduce the XOLREMDI daily dosage by steps of 100 mg, if necessary, but not to a dose less than 200 mg. Mavorixafor is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases mavorixafor maximal concentrations (C max ) and area under the concentration-time curve (AUC) [see Clinical Pharmacology (12.3) ] , which may increase the risk of XOLREMDI adverse reactions. Str…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QTc Interval Prolongation [see Warnings and Precautions (5.2) ] The most common adverse reactions (›10% and at a frequency higher than placebo) were: thrombocytopenia, pityriasis, rash, rhinitis, epistaxis, vomiting, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact X4 Pharmaceuticals, Inc. at 1-866-MED-X4MI (1-866-633-9464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XOLREMDI was evaluated in Study 1, a randomized placebo-controlled trial of 31 adult and pediatric patients 12 years and older with WHIM syndrome [see Clinical Studies (14) ] . Patients received XOLREMDI 400 mg or 200 mg, based on age and body weight (N=14) or placebo (N=17). One patient received the 200 mg dose, and 13 patients received the 400 mg dose. Note that the 200 mg …
Frequently Asked Questions
What is XOLREMDI used for?
Mavorixafor (Xolremdi) is an oral capsule medication that works by blocking a specific chemokine receptor involved in immune cell movement, used to treat certain rare immunodeficiency disorders. This prescription medication comes in 100 mg capsules and is taken by mouth as directed by your doctor.
Is XOLREMDI a controlled substance?
XOLREMDI is not classified as a controlled substance by the DEA.
What is the generic name for XOLREMDI?
The generic name for XOLREMDI is mavorixafor. There are no other listed brand versions of mavorixafor.
What is the NDC code for XOLREMDI 100 mg/1?
The NDC (National Drug Code) for XOLREMDI 100 mg/1 is 83296-100, listed by X4 Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)