XOLREMDI Helps Improve Immune Function
Study Results Showed XOLREMDI Raised Certain White Blood Cell Levels in the Bloodstream
In a clinical study, people taking XOLREMDI had higher levels of certain white blood cells (neutrophils and lymphocytes) in their bloodstream for significantly longer than people taking placebo.
AVERAGE TIME ABOVE THE TARGET LEVEL* IN A DAY†
Neutrophils
Lymphocytes
AVERAGE TIME ABOVE THE TARGET NEUTROPHIL LEVEL* IN A DAY†
AVERAGE TIME ABOVE THE TARGET LYMPHOCYTE LEVEL* IN A DAY†
When neutrophils and lymphocytes are above the target level*, the risk of infection goes down
XOLREMDI was evaluated in a 1-year clinical study of 31 people aged 12 years and older with WHIM syndrome. People in the study were randomly assigned into 2 groups: 14 people took XOLREMDI, 17 people took a placebo (sugar pill), and results were compared.
The study results for XOLREMDI are an average of all people studied and differed among individuals. Your experience may be different.
*The target neutrophil level was defined as an absolute neutrophil count (ANC) ≥500 cells/μL, measured with a blood test. Below this level is considered severe neutropenia. The target lymphocyte level was defined as an absolute lymphocyte count (ALC) ≥1,000 cells/μL, measured with a blood test. Below this level is considered lymphopenia.
†The average time above the target level over a 24-hour period was measured 4 times throughout the study.
The Effect of XOLREMDI on Infections and Warts
Additional study results:
Infection Frequency and Severity (called Infection Score)
People who took XOLREMDI had on average a 40% decrease in infection score compared with people who took placebo.
Changes to Warts (called Wart Change Score)
There was no difference in wart change score between people who took XOLREMDI compared with people who took placebo.
XOLREMDI Resulted in Fewer Infections
People taking XOLREMDI had on average 60% fewer infections throughout the year compared with people taking placebo.
ON AVERAGE, NUMBER OF INFECTIONS OVER 1 YEAR‡
Over 1 year,
people taking XOLREMDI HAD 1.7 INFECTIONS ON AVERAGE compared with 4.2 infections for people taking placebo.
‡Presented as annualized infection rate.
Side Effects of XOLREMDI
The most common side effects§ were:
- Low platelet count (thrombocytopenia)
- Rash (including a kind called pityriasis)
- Nasal irritation
- Nosebleeds
- Vomiting
- Dizziness
§Experienced by at least 10% of people taking XOLREMDI and more often than people taking placebo.
In patients with certain risk factors, XOLREMDI may cause a serious heart rhythm problem (QT prolongation).
These are not all the possible side effects of XOLREMDI. Talk to your healthcare provider if you have any questions about side effects.
Ask Your Healthcare Provider About XOLREMDI
This resource can help guide your discussion about XOLREMDI with your healthcare provider
Learn More About XOLREMDI
A comprehensive guide to XOLREMDI: how it works to help improve immune function, common side effects, dosing, and X4Connect patient support
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking XOLREMDI?
Before taking XOLREMDI, tell your healthcare provider if you are pregnant, nursing, or plan to become pregnant. XOLREMDI can harm your unborn baby. You must use a reliable method of birth control (contraception) during treatment and for three weeks after you stop taking XOLREMDI. Talk to your healthcare provider about options for effective birth control and the best way to feed your baby while taking XOLREMDI.
Tell your healthcare provider if you have kidney, liver, or heart problems.
Tell your healthcare provider about all the prescription and over-the-counter medicines you take, as well as vitamins and herbal supplements, such as goldenseal and St. John's Wort. XOLREMDI may affect the way other medicines work, and other medicines may affect how XOLREMDI works. It is especially important to tell your healthcare provider if you are taking a type of pain medicine called opioids or any medications for depression or other mental health disorders, abnormal heart rhythm, high blood pressure, or breast cancer. If you are taking these medications while you are taking XOLREMDI, your healthcare provider may stop XOLREMDI, decide to change your dose, or monitor you more closely.
You should not eat grapefruit or drink grapefruit juice while taking XOLREMDI.
What are the possible side effects of XOLREMDI?
In patients with certain risk factors, XOLREMDI may cause a serious heart rhythm problem (QT prolongation).
The most common side effects of XOLREMDI are low platelet count (thrombocytopenia), rash (including a kind of rash called pityriasis), nasal irritation, nosebleeds, vomiting, and dizziness.
These are not all the possible side effects of XOLREMDI. Tell your healthcare provider if you have any side effects that bother you or do not go away. For more information, ask your healthcare provider. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088. You may also call X4 Pharmaceuticals at 1-866-MED-X4MI (1-866-633-9464).
WHAT IS XOLREMDITM (mavorixafor)?
XOLREMDI is an oral prescription medicine used in people 12 years of age and older with WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome to increase the number of certain white blood cells (neutrophils and lymphocytes) circulating in the bloodstream.
Please see the full Prescribing Information for XOLREMDI.