Abatacept Intravenous

In the U.S.

• Orencia

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Antirheumatic

Abatacept injection is used alone or together with other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis. Abatacept helps keep joint damage from getting worse after other medicines have been used and did not work well.

Abatacept injection is also used alone or together with methotrexate in children 2 years of age and older for moderate to severe juvenile idiopathic arthritis (JIA).

Abatacept injection is also used alone or together with other medicines to treat psoriatic arthritis (PsA), which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body.

abatacept is available only with your doctor's prescription.

A nurse or other trained health professional will give you or your child abatacept. abatacept is given as a shot under your skin or into a vein.

If abatacept is given through a vein in your arm, it must be injected by your doctor slowly and your IV tube will need to stay in place for 30 minutes. You will receive abatacept again at 2 weeks and 4 weeks after your first dose and then every 4 weeks after.

Abatacept may be also given as a shot under your skin. It may sometimes be given at home to patients who do not need to be in the hospital. If you or your child are using abatacept at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

abatacept comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you use abatacept 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 or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

abatacept 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.

Check the liquid in the prefilled syringe or ClickJect™ autoinjector. It should be clear and colorless or slightly yellow. Do not use it if it is cloudy, discolored, or if you see particles in it. Do not use the prefilled syringe or ClickJect™ autoinjector if it looks cracked or broken.

Allow 30 minutes for the syringe to warm up to room temperature. Do not warm abatacept in any other way.

Do not remove the needle cover on the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove only if ready to use.

Check that the amount of liquid in the prefilled syringe falls at or just above the fill line. If the syringe does not have the right amount of liquid, do not use it.

Do not inject into skin areas that are red, bruised, tender, scaly, or hard, or have scars or stretch marks.

Dosing

The dose of abatacept will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of abatacept. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For juvenile idiopathic arthritis:
    • Children 2 years of age or older and weighs 50 kilograms (kg) or more—125 milligrams (mg) injected under your skin once a week.
    • Children 2 years of age or older and weighs 25 kg to less than 50 kg—87.5 mg injected under your skin once a week.
    • Children 2 years of age or older and weighs 10 kg to less than 25 kg—50 mg injected under your skin once a week.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For moderate to severe rheumatoid arthritis:
    • Adults—125 milligrams (mg) injected under your skin once a week. Some patients may need to have an intravenous loading dose, followed by the first 125 mg injected under your skin within a day of intravenous injection.
    • Children—Use and dose must be determined by your doctor.
  • For psoriatic arthritis:
    • Adults—125 milligrams (mg) injected under your skin once a week.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

abatacept needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that abatacept is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with abatacept. Check with your doctor right away if you or your child has any of the following symptoms while using abatacept: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

abatacept may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child has a rash, itching, swelling of the face, tongue, and throat, trouble with breathing, lightheadedness or fainting, or chest pain after you receive the medicine.

You or your child will need to have a skin test for tuberculosis before you start using abatacept. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

While you are being treated with abatacept injection or within 3 months after using it, do not have any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be current before he or she begins receiving abatacept injection. Be sure to ask your child's doctor if you have any questions about this.

abatacept contains maltose (a type of sugar) which may affect blood sugar levels. If you or your child have diabetes and you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor. Your doctor may need you to use a different test for your blood sugar levels.

Do not take other medicines for arthritis unless you talked to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), infliximab (Remicade®), rituximab (Rituxan®), or tocilizumab (Actemra®). Using any of these together with abatacept may increase your chance of having serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Back pain
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• cough producing mucus
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• headache
• loss of voice
• lower back or side pain
• nausea or vomiting
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest
• troubled breathing
• unusual tiredness or weakness

• Blurred vision
• burning or stinging of the skin
• chest pain
• nervousness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pounding in the ears
• skin rash
• slow or fast heartbeat

• Confusion
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• flushing
• hives or welts
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• stomach pain or tenderness
• sweating
• swelling of the face, throat, or tongue

• Redness, soreness, or itching of the skin
• sores, welts, blisters

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• heartburn
• indigestion
• stomach discomfort or upset

• Diarrhea
• pain in the arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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