About CYP2D6 Metabolizer Status
Before your doctor can determine if you are a candidate to take Cerdelga, he or she must determine your CYP2D6 metabolizer status. A genetic test (a simple blood test) can determine your CYP2D6 metabolizer status.
Understanding whether treatment with Cerdelga is right for you starts by understanding your CYP2D6 metabolizer status. CYP2D6 metabolizer status describes your body’s ability to break down (metabolize) certain drugs, including Cerdelga.
Your doctor can order a simple blood test to determine your CYP2D6 metabolizer status. This test is called “CYP2D6 genotyping.”
It takes about two weeks to determine your CYP2D6 metabolizer status from your blood sample. The results will be sent to your doctor who will discuss your results with you.
You or your doctor may already know the genotype of your Gaucher disease gene, but this genotyping is different. Gaucher disease results from changes in the GBA gene. GBA and CYP2D6 are two different genes that do different things.
Talk with your doctor for more information on CYP2D6 genotyping and to find out if Cerdelga is right for you.
CERDELGA (eliglustat) capsules is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Limitations of Use:
CERDELGA is contraindicated in EMs or IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in IMs or PMs taking a strong CYP3A inhibitor due to the risk of significantly increased eliglustat blood concentration, which may result in prolongation of cardiac intervals that could result in cardiac arrhythmias.
Your doctor will perform a test to help determine if CERDELGA is right for you.
CERDELGA can affect the way other medicines work and other medicines can affect how CERDELGA works. Using CERDELGA with other medicines or herbal supplements (including St. John’s Wort) may cause an increased risk of side effects, including ECG changes and irregular heart beat. Especially tell your doctor if you take medicines for fungal infections, tuberculosis, seizures, heart rhythm and rate problems, high blood pressure, or depression or other mental health problems. Your doctor may need to prescribe a different medicine, change your dose of other medicines, or change your dose of CERDELGA. Tell your doctor about any new medicines before you start taking them.
Before taking CERDELGA, tell your doctor about all of your medical conditions, including kidney or liver problems, history of heart attacks, or heart rhythm problems (including long QT syndrome). If you are pregnant or plan to become pregnant or breastfeed, talk to your physician. It is not known if CERDELGA will harm your unborn baby.
It is not known if CERDELGA is safe and effective in children.
Swallow the capsule whole, preferably with water. If you miss a dose of CERDELGA, take the next dose at the usual time. Do not take two doses of CERDELGA at the same time. Avoid eating or drinking grapefruit products while taking CERDELGA. Grapefruit products can increase the amount of CERDELGA in your body.
The most common adverse reactions (≥10%) for CERDELGA are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. Call your doctor for medical advice about adverse effects.
You may report adverse effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If you would like more information, talk with your doctor. You may also go to www.cerdelga.com for the Full Prescribing Information, including the Patient Medication Guide, or call Sanofi Genzyme at 1-800-745-4447.