Xolremdi – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Xolremdi, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- Inside the pack you will find a patient card which you should read carefully.
ℹ️ 1. What Xolremdi is and what it is used for
Xolremdi contains the active substance mavorixafor. Mavorixafor belongs to a group of medicines known as other immunostimulants.
Xolremdi is used to treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) in patients aged 12 years and older.
Hypogammaglobulinemia is a condition in which the level of antibodies is low. Myelokathexis is a condition in which the body fails to release mature blood cells from the bone marrow.
WHIM syndrome is an inherited disorder caused by mutations (changes) in a person’s genes that affect the immune system, making it harder for the body to fight infections. Xolremdi is used in patients with WHIM syndrome caused by a change in the CXCR4 gene.
The active substance in Xolremdi, mavorixafor, works by increasing the movement of immune cells from the bone marrow to the blood. The increased number of immune cells in the blood decreases the risk of infection in patients with WHIM syndrome.
⚠️ 2. What you need to know before you take Xolremdi
Do not take Xolremdi
- if you are allergic to mavorixafor or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.
31 – if you are taking any medicines which are broken down in the body by a liver enzyme (protein) known as CYP2D6, such as medicines to: o relieve cough (such as codeine, dextromethorphan); o treat pain (such as codeine, tramadol).
Warnings and precautions
Talk to your doctor or pharmacist before taking Xolremdi, if
- you are pregnant, think you may be pregnant or are planning to have a baby.
- you have risk factors for QTc prolongation (abnormal electrical activity of the heart that affects its rhythm) such as: o hypokalaemia (low blood potassium levels), o congestive heart failure (when the heart does not pump blood as well as it should) o long QT syndrome (a heart rhythm that causes fast, chaotic heartbeats), or take medicines that can cause QTc prolongation or that increase the levels of Xolremdi in the blood (see “Other medicines and Xolremdi”).
This can increase the risk of serious side effects affecting the electrical activity of the heart such as Torsades de Pointes (abnormal electrical activity in the heart with life-threatening rhythm disturbance), serious arrhythmias (abnormal or irregular heartbeat) and sudden death. In this case, your doctor will correct any modifiable risk factor for QTc prolongation and will check the electrical activity of your heart before and during treatment with Xolremdi and may decide to give you a lower dose or advise that you should not take Xolremdi.
Children and adolescents
Do not give this medicine to children below the age of 12 years. It has not been studied in these patients.
Do not give this medicine to children between the ages of 2 and 11 years, because it is not known if it is safe. Do not give this medicine to children under 2 years of age as it may cause developmental defects.
Other medicines and Xolremdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines and supplements should not be taken together with Xolremdi as they may reduce the effectiveness of Xolremdi by decreasing the amount of Xolremdi in the blood. Tell your doctor or pharmacist before you take Xolremdi if you are taking any of the following medicines to:
- treat anxiety and depression ( St. John’s wort );
- treat cancer (such as apalutamine, enzalutamide, mitotane );
- treat seizures and other conditions (such as carbamazepine, phenytoin, phenobarbital );
- treat infections ( rifampicin , only when used for ≥ 5 days).
The following medicines may increase the risk of side effects with Xolremdi by increasing the amount of Xolremdi in the blood:
- medicines used to treat fungal infections (such as fluconazole, itraconazole, ketoconazole );
- antibiotics used to treat bacterial infections (such as clarithromycin, erythromycin );
- medicines used to treat depression (such as nefazodone );
- medicines used to treat heart conditions (such as amiodarone, diltiazem, verapamil ).
Xolremdi may increase the side effects of the following medicines by increasing the amount of these medicines in the blood:
- medicines used to relieve allergies (such as fexofenadine );
- medicines used to treat blood conditions (such as dabigatran etexilate , edoxaban );
- medicines to treat viral infections (such as telaprevir );
- medicines used to treat HIV infection and AIDS (such as atazanavir );
- medicines to treat cancer (such as ribociclib, ceritinib, everolimus );
32 – antibiotics used to treat bacterial infections (such as telithromycin );
- medicines to treat anxiety or sleep disorders (such as midazolam, alprazolam );
- a medicine used to treat a heart condition ( digoxin ).
Xolremdi may reduce the effectiveness of the following medicine by decreasing the amount of this in the blood:
- metformin , a medicine used to treat diabetes.
The following medicines can increase the risk of serious side effects affecting the electrical activity of the heart when taken with Xolremdi:
- medicines used to treat irregular heartbeat (such as amiodarone, disopyramide, procainamide ).
- other medicines that affect the electrical activity of the heart (such as chloroquine, halofantrine, clarithromycin, ciprofloxacin, levofloxacin, azithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide and intravenous ondansetron ).
If you are taking any of the medicines listed above, inform your doctor or pharmacist before taking Xolremdi.
Xolremdi with food and drink You should avoid eating or drinking products with grapefruit, as grapefruit may increase the risk of side effects from Xolremdi.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are pregnant as it is expected to be harmful to an unborn baby. You should have a negative pregnancy test before starting treatment.
There is little or no data on its use during pregnancy. Based on how it works, this medicine could harm your unborn baby.
Female and male contraception Inside your pack of Xolremdi you will find a patient card which you should read carefully.
If you are a woman who can become pregnant, you must use highly effective birth control (e.g., double-barrier contraception (birth control) such as condom and diaphragm) during treatment with Xolremdi and for three weeks after the last dose. Your doctor can advise you on suitable methods of contraception . If you do become pregnant during treatment, tell your doctor right away.
If you are a man, you must use a condom when having sexual intercourse with a female partner who is able to become pregnant while you are taking Xolremdi and for three weeks after the last dose. You must tell your doctor if your female partner becomes pregnant.
Breast-feeding
Xolremdi has not been studied in breast-feeding women. It is not known whether Xolremdi passes into breast milk. A risk to the baby cannot be excluded.
If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine. Your doctor will discuss the potential risk(s) of treatment with Xolremdi whilst you are breast-feeding.
33 Fertility There is no human data on the effect of Xolremdi on male or female fertility. Based on animal studies, Xolremdi may reduce fertility in men. You should discuss with your doctor before starting treatment.
Driving and using machines
Xolremdi could have an effect on your ability to drive and use machines. If you experience dizziness or fainting, do not drive or use machines until you feel better.
Xolremdi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
💊 3. How to take Xolremdi
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Xolremdi is:
- For patients weighing more than 50 kg : 400 mg (four 100 mg capsules) taken by mouth, at least 30 minutes before breakfast on an empty stomach after an overnight fast.
- For patients weighing less than or equal to 50 kg : 300 mg (three 100 mg capsules) taken by mouth, at least 30 minutes before breakfast on an empty stomach after an overnight fast.
Your doctor may tell you to take a lower dose if you are taking other medicines which may cause serious side effects when taken together with Xolremdi.
Xolremdi capsules should be swallowed whole and not opened, broken or chewed.
Use in children and adolescents Xolremdi is intended for use in patients aged 12 years and older.
Do not give this medicine to children between the ages of 2 and 11 years, because it is not known if it is safe.
Do not give this medicine to children under 2 years of age as it may cause developmental defects.
If you take more Xolremdi than you should
If you have accidentally taken more Xolremdi than you should, stop taking this medicine and tell your doctor straight away.
If you forget to take Xolremdi
If you forget to take this medicine in the morning, skip the dose for the day and take your next dose the following morning as scheduled. Do not take a double dose to make up for a forgotten dose.
If you stop taking Xolremdi
Your doctor should determine how long you should take Xolremdi, and when treatment may be stopped. Do not stop taking your medicine until your doctor advises you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
34 Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea)
- Belly (abdominal) pain
- Indigestion (dyspepsia)
- Diarrhoea
- Vomiting
- Headache
- Rash, including a rash with small, flat, discolored patches (rash macular), itchy rash (rash pruritic) and a rash with small, raised bumps (rash papular)
Common (may affect up to 1 in 10 people)
- Dizziness
- Fainting (syncope)
- Nose bleeding (epistaxis)
- Dry skin
- Red, scaly patches on the skin, accompanied by itching and discomfort (psoriasiform dermatitis)
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Xolremdi
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
After the first opening of the bottle, the medicine should be used within 45 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Xolremdi contains
- The active substance is mavorixafor. Each hard capsule contains 100 mg of mavorixafor.
- The other ingredients are:
Capsule content: silica, colloidal anhydrous (E551), croscarmellose sodium (E468), calcium hydrogen phosphate dihydrate (E3431 (ii)), cellulose, microcrystalline (E460(i)), sodium lauril sulfate, and sodium stearyl fumarate. See section 2 “Xolremdi contains sodium”.
Capsule shell: indigotine (E132), gelatine (E441) and titanium dioxide (E171).
Printing ink: ammonia solution, concentrated (E527), black iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol (E1520) and shellac glaze in ethanol (E904).
What Xolremdi looks like and contents of the pack
Xolremdi 100 mg is supplied as an opaque white, hard capsule (capsule) with a light blue cap. The white capsule body is printed with “100 mg” in black ink, and the light blue capsule cap is printed with “MX4” in black ink.
35 Xolremdi is packaged in a high-density polyethylene round white bottle with child-resistant screw cap with integrated desiccant and label. The bottle contains 60, 90 or 120 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Norgine B.V.
Antonio Vivaldistraat 150 1083 HP Amsterdam The Netherlands
Manufacturer
Catalent Germany Schorndorf GmbH Steinbeisstrasse 1 – 2 73614 Schorndorf Germany
This leaflet was last revised in
This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Xolremdi (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2017).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.