Posted on January 12th, 2016 by
Generic Name: abatacept
Trade Name: Orencia®
For which conditions is this drug approved? Orencia is approved for use in adults with moderate to severe rheumatoid arthritis (RA). This includes patients who have tried other medicines for RA that have not worked well enough. Orencia can be used alone or with other RA treatments, except for RA treatments known as tumor necrosis factor (TNF) antagonists. Orencia can also be used for the treatment children and teenagers, six years of age and older, with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). In patients with JIA, Orencia can be used alone or with methotrexate.
What is the mechanism of action? In patients with RA, Orencia works by suppressing the immune system to prevent it from damaging tissues and joints. The immune system helps protect the body from harmful substances such as infectious agents and bacteria. In people with RA, however, the immune system attacks and destroys normal tissue—namely, the tissue around the joints. This leads to inflammation and damage to the cartilage and bone and causes pain. Specifically, Orencia blocks the action of immune cells called T-lymphocytes to stop these cells from attacking normal tissue.
How is Orencia typically given (administered)? Orencia is given as an intravenous (IV) infusion. Each infusion takes about 30 minutes. After you receive your first dose, you’ll receive a second dose two weeks later and then every four weeks after that. You can also receive Orencia as an injection under your skin. Your doctor may decide that it’s safe for you to give yourself the injection or have it administered by a caregiver. Your doctor will show you or your caregiver how to give the injections.
How are patients typically monitored? During treatment with Orencia, your doctor will check you regularly for the following:
What are some of the side effects (occur in 10% to 29% of patients) of treatment with Orencia?
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.
What can patients do to help alleviate or prevent discomfort and side effects?
Before you start taking Orencia, tell your doctor if you:
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
Tell your doctor right away if:
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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