Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Orencia

Descriptions


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 in children 6 years of age and older for juvenile idiopathic arthritis (JIA).

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Solution
  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of abatacept injection in children with JIA. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abatacept injection in the elderly. However, elderly patients are more likely to have cancer and serious infections, which may require caution in patients receiving abatacept injection.

Pregnancy

Information about this abatacept-intravenous-route-subcutaneous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adalimumab
  • Anakinra
  • Etanercept
  • Golimumab
  • Infliximab

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cancer or
  • Chronic obstructive pulmonary disease (COPD)—Use with caution. May make these conditions worse.
  • Infections (e.g., hepatitis B, bacteria, virus, fungus), active or history of or
  • Tuberculosis, active or history of—Patients with these conditions may have an increased chance of side effects.

Proper Use

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

If this medicine 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 this medicine 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 this medicine 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.

This medicine comes with a Patient Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use this medicine 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.

This medicine is available in two forms: a vial (glass container) or a prefilled syringe. The prefilled syringe is the only form you can use at home.

If the medicine in the prefilled syringe has changed color, or if you see particles in it, do not use it.

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

Missed Dose

This medicine 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.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine 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. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have 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 this medicine. 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, 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.

This medicine 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 talk to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®), or rituximab (Rituxan®). Using any of these together with this medicine may increase your chance of having serious side effects.

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:

More common

  1. Back pain
  2. bladder pain
  3. bloody or cloudy urine
  4. body aches or pain
  5. chills
  6. cough
  7. cough producing mucus
  8. difficult or labored breathing
  9. difficult, burning, or painful urination
  10. dizziness
  11. ear congestion
  12. fever
  13. flu
  14. frequent urge to urinate
  15. headache
  16. loss of voice
  17. lower back or side pain
  18. nausea or vomiting
  19. noisy breathing
  20. pain or tenderness around the eyes and cheekbones
  21. shortness of breath or troubled breathing
  22. sneezing
  23. sore throat
  24. stuffy or runny nose
  25. tightness of the chest or wheezing
  26. unusual tiredness or weakness

Less common

  1. Blurred vision
  2. burning or stinging of the skin
  3. chest pain
  4. nervousness
  5. painful cold sores or blisters on the lips, nose, eyes, or genitals
  6. pounding in the ears
  7. skin rash
  8. slow or fast heartbeat

Rare

  1. Abdominal or stomach pain or tenderness
  2. confusion
  3. difficulty with swallowing
  4. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  5. flushing
  6. hives or welts
  7. itching, pain, redness, swelling, tenderness, or warmth on the skin
  8. sweating
  9. swelling of the face, throat, or tongue

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:

More common

  1. Acid or sour stomach
  2. belching
  3. 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
  4. heartburn
  5. indigestion
  6. stomach discomfort or upset

Less common

  1. Diarrhea
  2. 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.