Treatment with Cerdelga
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.
Sanofi Genzyme Case Managers are available to assess your unique situation and help you understand your insurance options for Cerdelga. Working closely with you and your family, your health care providers and insurance company, your Sanofi Genzyme Case Manager will help coordinate access to treatment with Cerdelga and make sure you get the support and care you need.
The Sanofi Genzyme Co-Pay Assistance Program helps eligible individuals in the United States pay for their eligible out-of-pocket costs for Cerdelga, including co-pays, co-insurance and deductibles, regardless of financial status.
Once enrolled in the Sanofi Genzyme's Co-Pay Assistance Program, Sanofi Genzyme will cover 100% of your eligible out-of-pocket costs for Cerdelga up to the program maximum.
Sanofi Genzyme is committed to helping meet the needs of people who are living with Gaucher disease. As part of this commitment, we provide resources, services, and information for those who have Gaucher disease type 1, their families, and caregivers.
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.