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Antirheumatics Selective immunosuppressants
In the U.S.
Available Dosage Forms:
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 in children 6 years of age and older for juvenile idiopathic arthritis (JIA).
abatacept is available only with your doctor's prescription.
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 abatacept, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to abatacept 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.
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.
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.
|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.|
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.
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 abatacept, 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 abatacept 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.
Using abatacept 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.
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.
The presence of other medical problems may affect the use of abatacept. Make sure you tell your doctor if you have any other medical problems, especially:
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 a Patient Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor 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 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.
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.
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.
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. Stop using abatacept and check with your doctor right away if you or your child have 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. 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 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, 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 talk to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®), or rituximab (Rituxan®). 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:More common
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
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.
See also: Side effects (in more detail)
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Not all side effects for abatacept may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to abatacept: powder for solution, solution
In addition to its needed effects, some unwanted effects may be caused by abatacept. In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking abatacept, check with your doctor or nurse immediately:More common
Some of the side effects that can occur with abatacept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to abatacept: intravenous powder for injection, subcutaneous solution
Respiratory side effects have included upper respiratory tract infection (5.8% to 12.7%), nasopharyngitis (7.8% to 11.5%), sinusitis (6.2%), bronchitis (5.8%), and pneumonia. Patients with COPD treated with abatacept developed adverse effects more frequently than those treated with placebo (97% vs. 88%, respectively). These have included COPD exacerbations, cough, rhonchi, dyspnea, and pneumonia. Bacterial pneumonia and influenzal pneumonia have been reported in 0.4% of patients.[Ref]
Hypersensitivity side effects have included anaphylaxis or anaphylactoid reactions. Other adverse events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea generally occurred within 24 hours of abatacept infusion.[Ref]
Oncologic side effects have included lymphomas and lung cancer. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers.[Ref]
General side effects have included acute infusion-related adverse reactions occurring within one hour of the start of the infusion. The acute infusion-related events have included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea. The most frequently reported events were dizziness, headache, and hypertension. Other symptoms reported as mild to moderate included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Back pain and pain in extremity have also been reported.[Ref]
Immunologic side effects have included the development of binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. No correlation of antibody development to clinical response or adverse effects has been observed. Streptococcal sepsis (0.4%) has been reported.[Ref]
Gastrointestinal side effects including nausea (6.6% to 11.5%), diarrhea (5.8% to 6.91%), diverticulitis (0.4%), peridiverticular abscess (0.4%), and dyspepsia have been reported.[Ref]
Genitourinary side effects have included urinary tract infection.[Ref]
Dermatologic side effects have included rash.[Ref]
Nervous system side effects including headache (11.79%) have been reported.[Ref]
Local side effects including infusion reactions have been reported.[Ref]
Other side effects have included limb abscess (0.4%).[Ref]
1. Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN "The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis." J Rheumatol 33 (2006): 2398-408
2. Genovese MC, Becker JC, Schiff M, et al. "Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition." N Engl J Med 353 (2005): 1114-23
3. Nogid A, Pham DQ "Role of abatacept in the management of rheumatoid arthritis." Clin Ther 28 (2006): 1764-78
4. "Product Information. Orencia (abatacept)." Bristol-Myers Squibb, Princeton, NJ.
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