Abatacept (a-BAT-a-sept)

Treats rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA). Prevents acute graft-versus-host disease (aGVHD) in patients who will undergo hematopoietic stem cell transplantation (HSCT).

Brand Name(s):

Orencia, Orencia ClickJect Autoinjector, Orencia Pre-Filled Syringe

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin or into a vein.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is available in 3 forms: a vial (glass container), a prefilled syringe, or a ClickJect™ autoinjector. The prefilled syringe and ClickJect™ autoinjector are the dosage forms you can use at home.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, scaly, or hard, or have scars or stretch marks.
• Use a new needle and syringe each time you inject your medicine.
• Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
• Do not remove the needle cover from the prefilled syringe or ClickJect™ autoinjector until you are ready to use it.
• Check the liquid in the prefilled syringe or ClickJect™ autoinjector. It should be clear and colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, if you see particles in it, or if the prefilled syringe or ClickJect™ autoinjector looks cracked or broken.
• If the amount of liquid in the prefilled syringe does not fall at or just above the fill line, do not use that syringe.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how abatacept works. Tell your doctor if you are using adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, or tocilizumab.
• While you are being treated with this medicine or within 3 months after using it, do not have any vaccines without your doctor's approval. Your child's vaccines need to be current before treatment with abatacept.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have cancer, diabetes, lung or breathing problems (including COPD), any infection (including the flu, cytomegalovirus, Epstein-Barr virus), hepatitis B, tuberculosis (TB), or are scheduled to have surgery.
• This medicine may cause the following problems:
  • Serious infections, including pneumonia, sepsis
  • Increased risk of cancer, including skin cancer
• You will need a skin test for TB before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a TB skin test.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination
• Dizziness or lightheadedness
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, sore throat, runny or stuffy nose, tiredness, and body aches
• Warm, red, or painful skin
• Trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Headache
• Nausea, stomach upset
• Pain, itching, burning, redness, swelling, or a lump under your skin where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088