Tecoland supplies Eliglustat bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Eliglustat is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.
What is Eliglustat?
Eliglustat (INN, USAN;trade name Cerdelga) is a treatment for Gaucher’s disease discovered at the University of Michigan and developed by Genzyme Corp that was approved by the FDA August 2014.Commonly used as the tartrate salt, the compound is believed to work by inhibition of glucosylceramide synthase.According to an article in Journal of the American Medical Association the oral substrate reduction therapy resulted in “significant improvements in spleen volume, hemoglobin level, liver volume, and platelet count” in untreated adults with Gaucher disease Type 1.
How does Eliglustat work?
Eliglustat works by decreasing the amount of a certain natural fatty substance (glucosylceramide) that builds up due to this condition. This can improve symptoms of Gaucher’s disease, such as bruising, tiredness, pain in the joints/bones, and a swollen liver/spleen.
What is Eliglustat used for?
Eliglustat is used to treat mild to moderate type 1 Gaucher disease in adults. Eliglustat is used only if a specific liver enzyme (2D6) in your body breaks down or metabolizes drugs at a certain rate.
Eliglustat Side effects:
Cerdelga (eliglustat) is a small molecule inhibitor of glucosylceramide synthase used for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. Common side effects of Cerdelga include:
• joint pain
• headache or migraine
• gas
• nausea
• mouth and throat pain
• fatigue
• diarrhea
• back pain
• pain in the extremities, and
• abdominal pain
The recommended dosage of CerdelgA is 84 mg twice daily in CYP2D6 EMs and IMs. The recommended dosage in CYP2D6 PMs is 84 mg once daily. Cerdelga may interact with drugs that inhibit CYP2D6 and CYP3A. Tell your doctor all medications and supplements you use. During pregnancy, Cerdelga should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Cerdelga (eliglustat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Eliglustat Precautions:
Before taking eliglustat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver problems.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Eliglustat may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using eliglustat, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Eliglustat Drug Interaction:
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Other medications can affect the removal of eliglustat from your body, which may affect how eliglustat works. Examples include azole antifungals (such as fluconazole, ketoconazole), HIV protease inhibitors (such as ritonavir, saquinavir), macrolide antibiotics (such as erythromycin, clarithromycin), rifamycins (such as rifabutin, rifampin), paroxetine, St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), among others.
Disclaimer:
Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.
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