Monday, September 19, 2016

abatacept


Generic Name: abatacept (a BAY ta sept)

Brand Names: Orencia


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.


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.


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.



More abatacept resources


  • Abatacept Side Effects (in more detail)
  • Abatacept Use in Pregnancy & Breastfeeding
  • Abatacept Drug Interactions
  • Abatacept Support Group
  • 5 Reviews for Abatacept - Add your own review/rating


  • abatacept Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Abatacept Professional Patient Advice (Wolters Kluwer)

  • Abatacept MedFacts Consumer Leaflet (Wolters Kluwer)

  • Abatacept Monograph (AHFS DI)

  • Orencia Prescribing Information (FDA)

  • Orencia Consumer Overview



Compare abatacept with other medications


  • Juvenile Idiopathic Arthritis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis


Where can I get more information?


  • Your doctor or pharmacist can provide more information about abatacept.

See also: abatacept side effects (in more detail)


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