Brand Name

    US Brand Name

    Xolremdi


    Description

    Mavorixafor is used to increase the number of white blood cells (eg, neutrophils, lymphocytes) in patients with an immune system problem called WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis).

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of mavorixafor in children younger than 12 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mavorixafor in the elderly.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Amitriptyline
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Atomoxetine
    • Bepridil
    • Carvedilol
    • Cisapride
    • Clomipramine
    • Codeine
    • Desipramine
    • Deutetrabenazine
    • Dextromethorphan
    • Doxepin
    • Doxorubicin
    • Doxorubicin Hydrochloride Liposome
    • Dronedarone
    • Duloxetine
    • Eliglustat
    • Encainide
    • Fenfluramine
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Haloperidol
    • Iloperidone
    • Imipramine
    • Ketoconazole
    • Lofexidine
    • Mesoridazine
    • Metoprolol
    • Mexiletine
    • Nebivolol
    • Nortriptyline
    • Ondansetron
    • Oxycodone
    • Paroxetine
    • Perphenazine
    • Pimozide
    • Piperaquine
    • Pitolisant

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abemaciclib
    • Abrocitinib
    • Acalabrutinib
    • Adagrasib
    • Alfentanil
    • Alfuzosin
    • Alogliptin
    • Amiodarone
    • Amisulpride
    • Amprenavir
    • Anagrelide
    • Apalutamide
    • Apomorphine
    • Aprepitant
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Asunaprevir
    • Atazanavir
    • Atorvastatin
    • Axitinib
    • Azithromycin
    • Bedaquiline
    • Berotralstat
    • Boceprevir
    • Bosutinib
    • Brigatinib
    • Buprenorphine
    • Buserelin
    • Canagliflozin
    • Capmatinib
    • Captopril
    • Carbamazepine
    • Ceritinib
    • Chloroquine
    • Chlorpromazine
    • Cimetidine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Grapefruit Juice

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Heart rhythm problems—Use with caution. May make these conditions worse.
    • Kidney disease, severe or end-stage or
    • Liver disease, moderate to severe—Use is not recommend in patients with these conditions.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Swallow the capsule whole. Do not open, break, or chew it.

    It is best to take this medicine on an empty stomach after an overnight fast, and at least 30 minutes before a meal.

    Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (capsules):
      • To increase the number of white blood cells:
        • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor.
          • Weighing more than 50 kilograms (kg)—400 milligrams (mg) once a day.
          • Weighing 50 kg or less—300 mg once a day.
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store in the refrigerator. Do not freeze.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 3 weeks after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

    Do not use this medicine together with dextromethorphan (Robitussin®).

    This medicine can cause a change in heart rhythm called QT prolongation. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Call your doctor right away if you have any of these symptoms, or any questions.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, goldenseal, St. John's wort) or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Black, tarry stools
    • bleeding gums
    • blood in the urine or stools
    • pinpoint red spots on the skin
    • unusual bleeding or bruising

    Less common

    • Chills
    • cough
    • fever
    • lower back or side pain
    • painful or difficult urination
    • pale skin
    • sore throat
    • trouble breathing
    • ulcers, sore, or white spots in the mouth
    • unusual tiredness or weakness

    Incidence not known

    • Fainting
    • irregular heartbeat

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Bloody nose
    • dizziness
    • sneezing
    • stuffy or runny nose
    • vomiting

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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