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Drug Information For:

ORENCIA 250MG INJ, 1 VIAL

Ingredient Name:

ABATACEPT (a-ba-ta-sept)

Drug Manufacturer:

B-M SQUIBB U.S. (PRIMARY CARE)

Common Uses:

This medicine is an antirheumatic agent used to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat certain types of moderate to severe juvenile arthritis in children. It may be used alone or in combination with other medicines. It may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine:

Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking anakinra, tocilizumab, or a tumor necrosis factor (TNF) blocker (eg, adalimumab, etanercept). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking rituximab or medicines used to suppress the immune system (eg, tacrolimus). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Tell your doctor if you have recently received a vaccine, you are scheduled for a vaccine, or if you need to be brought up to date with your vaccines. Tell your doctor if you have a history of tuberculosis (TB) or a positive skin test for TB, or if you have had close contact with someone who has TB. Inform your doctor of any other medical conditions, including a current infection, a history of chronic or recurring infections, if you are at risk for developing an infection, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of chronic obstructive pulmonary disease (COPD), diabetes, or hepatitis. Tell your doctor if you are scheduled for surgery. Use of this medicine in children under age 6 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine:

Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. This medicine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine should be clear and colorless to pale yellow. Do NOT use this medicine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. This medicine is usually handled and stored by a health care provider. If you are using this medicine at home, STORE THIS MEDICINE as directed by your pharmacist or health care provider. KEEP THIS MEDICINE, as well as syringes and needles, out of the reach of children and away from pets. Use this medicine regularly to receive the most benefit from it. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately. Your doctor will establish a new dosing schedule.

Cautions:

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. SEVERE AND POSSIBLY FATAL ALLERGIC REACTIONS have been rarely reported after the first dose of this medicine. Symptoms may include rash, hives, itching, trouble breathing, swelling of the face, eyelids, lips or tongue; or severe or persistent dizziness. Contact your doctor at once if you have any of these symptoms during or for the first day after you receive this medicine. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, along with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Serious and sometimes fatal infections have been reported in patients using this medicine. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Tell your doctor right away if you notice signs of infection (eg, fever, chills, or persistent cough or sore throat; warm, red, or painful skin; frequent, difficult, or painful urination; severe or persistent diarrhea or stomach pain; unusual tiredness). YOUR DOCTOR MAY TEST YOU FOR TUBERCULOSIS (TB) OR VIRAL HEPATITIS before you begin using this medicine. Check with your doctor if you have any questions. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) while you use this medicine or within 3 months after you stop using it. CHECK WITH YOUR DOCTOR BEFORE HAVING IMMUNIZATIONS (VACCINATIONS) while you are using this medicine. RARELY, PATIENTS USING THIS MEDICINE HAVE DEVELOPED CANCER. It is unknown if this medicine may increase your risk of developing cancer. Discuss any questions or concerns with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially the risk of infection or cancer. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. DIABETES PATIENTS: This medicine may cause false test results with some blood glucose tests. Check with your doctor before adjusting the dose of your diabetes medicine or changing your diet.

Possible Side Effects:

SIDE EFFECTS that may occur while using this medicine include diarrhea; dizziness; headache; mild pain, swelling, bruising, or redness at the injection site; nausea; nose or throat irritation; stomach pain or upset; or stuffy nose. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience fainting; flu-like symptoms; light-headedness; night sweats; severe or persistent headache or dizziness; unusual lumps or growths; unexplained weight loss; shortness of breath; or wheezing. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose:

IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.

Additional Information:

If your symptoms do not improve or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Copyright 2014 Wolters Kluwer Health, Inc.

Disclaimer

- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.