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|Orencia

Orencia

Orencia is used for:

Treating moderate to severe rheumatoid arthritis in patients who have not been helped by other medicines. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Orencia is selective costimulation modulator. It works by stopping the immune system from attacking healthy tissues in the body.

Do NOT use Orencia if:

• you are allergic to any ingredient in Orencia
• you are using anakinra or tumor necrosis factor (TNF) blockers (eg, etanercept)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Orencia :

Some medical conditions may interact with Orencia . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an infection (including an infection that will not go away), tuberculosis (TB), or a positive skin test for TB, or you have recently been in close contact with someone who has had TB
• if you are at risk for developing an infection or have a history of infections that keep coming back
• if you have chronic obstructive pulmonary disease (COPD)
• you are scheduled for surgery, or you recently received a vaccination or are scheduled for a vaccination

Some MEDICINES MAY INTERACT with Orencia . Tell your health care provider if you are taking any other medicines, especially any of the following:

• TNF blockers (eg, etanercept) because the risk of serious infection may be increased
• Anakinra because the risk of side effects may be increased
• Live vaccinations because their effectiveness may be decreased by Orencia

This may not be a complete list of all interactions that may occur. Ask your health care provider if Orencia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Orencia :

Use Orencia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Orencia comes with an additional patient leaflet. Read it carefully and reread it each time you get Orencia refilled.
• This medicine is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Orencia at home, carefully follow the injection procedures taught to you by your health care provider.
• If you miss a dose of Orencia , contact your doctor immediately. Your doctor will establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Orencia .

Important safety information:

• Orencia may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Orencia . Using Orencia alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Orencia may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Orencia .
• Do not receive a live vaccine during or within 3 months after stopping therapy with Orencia . Talk to your doctor before receiving any vaccinations while you are using Orencia .
• You may need to have a TB skin test before you begin using Orencia . Contact your doctor with any questions you may have about whether you should receive a TB skin test before using Orencia .
• Rarely, patients using Orencia have developed cancer. It is unknown if Orencia may have contributed to the development of cancer. Contact your doctor with any questions or concerns.
• Use Orencia with caution in the ELDERLY because they may be more sensitive to its effects, especially risk of infection or cancer.
• Use Orencia with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Orencia , discuss with your doctor the benefits and risks of using Orencia during pregnancy. It is unknown if Orencia is excreted in breast milk. Do not breast-feed while using Orencia .

Possible side effects of Orencia :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; mild pain, swelling, or redness at the injection site; nausea; sore throat; stomach upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills, fever, or persistent sore throat; flu-like symptoms; increased cough; increased, decreased, or painful urination; night sweats; severe or persistent dizziness; shortness of breath; unexplained weight loss; unusual lumps or growths; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Orencia is usually handled and stored by a health care provider. If you are using Orencia at home, store Orencia as directed by your pharmacist or health care provider. Keep Orencia out of the reach of children and away from pets.

General information:

• If you have any questions about Orencia , please talk with your doctor, pharmacist, or other health care provider.
• Orencia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Orencia . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.