Posted on April 1st, 2011 by
Class: Supportive Care
Generic Name: Eltrombopag
Trade Name: Promacta®
How is this drug used? Promacta is used to treat thrombocytopenia (low platelet counts) in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. It is also used to treat thrombocytopenia in patients with chronic hepatitis C to allow for interferon-based therapy whose degree of thrombocytopenia prevents initiation of therapy, and also for patients with severe aplastic anemia who have had insufficient response to to immunosuppressive therapy.
Promacta should only be used for chronic ITP patients whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Promacta should not be used to normalize platelet levels.
What is the mechanism of action? Promacta increases the number of platelets.
How is Promacta given (administered)? Promacta is given orally (by mouth). Doses differ depending on indication and other factors.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Promacta. Patients may undergo blood tests, physical examinations, or other measures to assess side effects and response to therapy. Promacta can cause liver problems in some patients, and liver function will be assessed before and during treatment with Promacta.
What are potentially serious side effects of Promacta?
What are the most common side effects of Promacta?
In patients with ITP:
In patients with hepatitis C:
In patients with severe aplastic anemia:
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
Because of the risk of liver problems and other side effects, access to Promacta is limited to physicians, pharmacists, and patients who are registered in a program designed to monitor safety and encourage appropriate use.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician? Tell your doctor if you experience any unusual symptoms. Some side effects require immediate medical treatment. Tell your doctor if you experience any bruising or bleeding that happens while you take Promacta or after you stop Promacta. Tell your doctor if you take more than the recommended amount of Promacta. Tell your doctor if you experience symptoms of liver problems (such as jaundice, unusual darkening of the urine, unusual tiredness, or pain the right upper stomach area), cataracts (such as changes in vision), or blood clots (symptoms of a blood clot in the leg include pain, swelling, or tenderness in the leg).
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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