Mavorixafor

Mavorixafor is used to treat WHIM syndrome (warts, hypogammaglobulinemia, immunodeficiency, myelokathexis syndrome; an immune system problem that decreases your ability to fight infections from bacteria and viruses, especially human papillomavirus [HPV] infection) in adults and children 12 years of age and older. Mavorixafor is in a class of medications called CXC Chemokine Receptor 4 (CXCR4) antagonists. It works by increasing the number of neutrophils (a type of blood cell needed to fight infection) and lymphocytes (a type of white blood cell) in the body.

Mavorixafor comes as a capsule to take by mouth. It is usually taken once a day on an empty stomach, at least 30 minutes before breakfast. Take mavorixafor at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mavorixafor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking mavorixafor,

• tell your doctor and pharmacist if you are allergic to mavorixafor, any other medications, or any of the ingredients in mavorixafor capsules. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with mavorixafor. Other medications may cause dosing changes or extra monitoring when taken with mavorixafor. Make sure you have discussed any medications you are currently taking or plan to take before starting mavorixafor with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking mavorixafor, please get the advice of your doctor or pharmacist.
• The following nonprescription or herbal products may interact with mavorixafor: St. John's wort and goldenseal. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using mavorixafor. Do not start these medications while using mavorixafor without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), low levels of potassium in your blood, or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. Do not take mavorixafor if you are pregnant. You will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 3 weeks after your final dose. If you become pregnant while taking mavorixafor, call your doctor immediately. Mavorixafor may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking mavorixafor and for 3 weeks after your final dose.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose on the same day to make up for a missed one.

Mavorixafor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• rash
• itching
• runny or stuffy nose
• dizziness
• vomiting

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual bruising or bleeding
• nose bleed

Mavorixafor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to mavorixafor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Xolremdi^®