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 is a prescription medicine used for the long-term treatment of Gaucher disease type 1 (GD1) in adults who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. Your doctor will perform a test to make sure that CERDELGA is right for you.
Limitations of Use:
Certain patients should not use CERDELGA based on their CYP2D6 metabolizer status due to an increased risk of side effects, including heart problems. Do not use CERDELGA if you are:
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 may cause an increased risk of side effects, including changes in electrical activity of your heart (ECG changes) and irregular heart beat (arrhythmias). Especially tell your doctor if you take St. John’s Wort, or medicines for fungal infections, tuberculosis, seizures, heart conditions, 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 all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements before you start taking them.
Before taking CERDELGA, tell your doctor about all of your medical conditions, including heart problems (including a condition called long QT syndrome), a history of heart attack, kidney or liver problems. If you are pregnant or plan to become pregnant or breastfeed, talk to your doctor. It is not known if CERDELGA will harm your unborn baby. Talk to your doctor if you are breastfeeding or planning to breastfeed. It is not known if CERDELGA passes into your breast milk. You and your doctor will decide if you should take CERDELGA or breastfeed. You should not do both.
CERDELGA, used with certain other medicines, may cause changes in the electrical activity of your heart (ECG changes) and irregular heart beat (arrhythmias). Tell your doctor if you have new symptoms such as palpitations, fainting, or dizziness.
The most common side effects (≥10%) of CERDELGA include: tiredness, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. Call your doctor for medical advice about adverse effects.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CERDELGA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
It is not known if CERDELGA is safe and effective in children.
Please see the full Prescribing Information, including the Patient Medication Guide, for CERDELGA.