Frequently Asked Questions

abatacept

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Orencia

Antirheumatics Selective immunosuppressants


What is abatacept?

Abatacept is a man-made protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. It is also used to treat arthritis in children who are at least 6 years old.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept may also be used for purposes not listed in this medication guide.

What is the most important information I should know about abatacept?

You should not use abatacept if you are allergic to it, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), natalizumab (Tysabri), rituximab (Rituxan), or tocilizumab (Actemra).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Slideshow: Drug Treatment for Rheumatoid Arthritis - What Are Your Options?

Also tell your doctor if you have a weak immune system, any type of infection (including skin infection or open sores), COPD, diabetes, a history of hepatitis, or if you have scheduled to receive any vaccinations.

Children using this medication should be current on all childhood immunizations before starting treatment with abatacept.

Serious infections may occur during treatment with abatacept. Contact your doctor right away if you have signs of infection such as: fever, chills, dry cough, sore throat, night sweats, tired feeling, weight loss, or painful warmth or redness of your skin.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

What should I discuss with my healthcare provider before using abatacept?

You should not use abatacept if you are allergic to it, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), natalizumab (Tysabri), rituximab (Rituxan), or tocilizumab (Actemra).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure you can safely use abatacept, tell your doctor if you have any of these other conditions:

  • a weak immune system;

  • any type of infection including a skin infection or open sores;

  • COPD (chronic obstructive pulmonary disease);

  • diabetes;

  • if you have ever had hepatitis; or

  • if you are scheduled to receive any vaccines.

FDA pregnancy category C. It is not known whether abatacept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of abatacept on the baby.

It is not known whether abatacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using abatacept.

Children using this medication should be current on all childhood immunizations before starting treatment with abatacept.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

How should I use abatacept?

Before you start treatment with abatacept, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Abatacept is injected under the skin, or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

Abatacept must be given slowly when infected into a vein, and the IV infusion can take at least 30 minutes to complete.

This medication is usually given every 1 to 4 weeks. Follow your doctor's instructions.

You may need to mix abatacept with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Each single-use vial (bottle) or prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you need surgery, tell the surgeon ahead of time that you are using abatacept.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abatacept. Visit your doctor regularly.

This medication can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to check your blood sugar while you are using abatacept.

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store this medication in the refrigerator. Do not freeze and protect from light. Keep the medicine in original carton to protect it from light. Do not use abatacept if the expiration date on the medicine label has passed.

Abatacept that has been mixed with a diluent may be stored in a refrigerator or at room temperature and used within 24 hours.

What happens if I miss a dose?

Call your doctor for instructions if you miss your abatacept dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using abatacept?

Do not receive a "live" vaccine while using abatacept, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Abatacept side effects

Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with abatacept. Stop using abatacept and call your doctor right away if you have signs of infection such as:

  • fever, chills, night sweats, flu symptoms, weight loss;

  • feeling very tired;

  • dry cough, sore throat; or

  • warmth, pain, or redness of your skin.

Call your doctor at once if you have any of these other serious side effects:

  • trouble breathing;

  • stabbing chest pain, wheezing, cough with yellow or green mucus;

  • pain or burning when you urinate; or

  • signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Less serious side effects may include:

  • nausea, diarrhea, stomach pain, indigestion; or

  • headache, dizziness;

  • cold symptoms such as stuffy nose, sneezing, sore throat, cough;

  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Abatacept dosing information

Usual Adult Dose for Rheumatoid Arthritis:

IV administration:
If less than 60 kg, give 500 mg
If 60 to 100 kg, give 750 mg
If greater than 100 kg, give 1000 mg
Administer once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Subcutaneous administration:
After a single IV infusion as a loading dose (as per body weight categories above), 125 mg administered by subcutaneous injection should be given within a day, followed by 125 mg subcutaneously once a week.
Patients who are unable to receive an infusion may initiate weekly injections subcutaneously without an intravenous loading dose.
Patients transitioning from IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

Reduction of signs and symptoms in patients with moderately to severely active polyarticular juvenile idiopathic arthritis:
6 to 17 years:
If less than 75 kg, give 10 mg/kg IV
75 kg to 100 kg, give 750 mg IV
If greater than 100 kg, give 1000 mg IV

The maximum dose per intravenous administration should not exceed 1000 mg.

Administer once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or concomitantly with methotrexate.

What other drugs will affect abatacept?

There may be other drugs that can interact with abatacept. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about abatacept.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2011-09-19, 11:14:38 AM.

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.

For the Consumer

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
  • 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
  • flu
  • 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
  • shortness of breath or troubled breathing
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness
Less common
  • 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
Rare
  • Abdominal or stomach pain or tenderness
  • 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
  • sweating
  • swelling of the face, throat, or tongue

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
  • Acid or sour stomach
  • 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
Less common
  • Diarrhea
  • pain in the arms or legs

For Healthcare Professionals

Applies to abatacept: intravenous powder for injection, subcutaneous solution

Respiratory

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

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

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

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

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

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

Genitourinary side effects have included urinary tract infection.[Ref]

Dermatologic

Dermatologic side effects have included rash.[Ref]

Nervous system

Nervous system side effects including headache (11.79%) have been reported.[Ref]

Local

Local side effects including infusion reactions have been reported.[Ref]

Other

Other side effects have included limb abscess (0.4%).[Ref]

References

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.

More about abatacept

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Interactions
  • Support Group
  • En Espanol
  • 9 Reviews - Add your own review/rating

Consumer resources

  • Abatacept
  • Abatacept Intravenous (Advanced Reading)
  • Other brands: Orencia

Professional resources

  • Abatacept (AHFS Monograph)
  • Abatacept (Wolters Kluwer)

Related treatment guides

  • Juvenile Idiopathic Arthritis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.