Updated December 29, 2014.
Orencia (abatacept) is a biologic drug approved for the treatment of moderate to severe rheumatoid arthritis in adults and the treatment of moderate to severe polyarticular (many joints involved) juvenile idiopathic arthritis in children 6 years old and older. Orencia is not a TNF blocker, as is Enbrel, Remicade, and Humira. Orencia is a T-cell co-stimulation modulator -- it modulates a co-stimulatory signal which is required for full T-cell activation.
T-cells play a prominent role in inflammation. Orencia is a 30 minute intravenous infusion (IV) given every 4 weeks after the initial setup (first dose, then at 2 weeks and 4 weeks, followed by every 4 weeks). It is also available, as of 2011, in a subcutaneous formulation, too.
There are 10 things you should know about Orencia -- essentially they are safety warnings. To enhance the safe use of Orencia, prescribing information must be followed. Patients with certain conditions should be cautious about using Orencia or possibly not use the drug.
1 -- Orencia should not be given together with TNF blockers.
In clinical trials, adult rheumatoid arthritis patients receiving Orencia and a TNF blocker had more infections (63%) and serious infections (4.4%) compared to patients treated only with a TNF blocker -- who experienced fewer infections (43%) and serious infections (0.8%). The use of Orencia and a TNF blocker together is not recommended.
2 -- Hypersensitivity, anaphylaxis, and anaphylactoid reactions can occur with Orencia.
There were two cases of anaphylaxis or anaphylactoid (anaphylactic-like) reactions that occurred in clinical trials which included 2688 patients.
Other adverse events associated with drug hypersensitivity (e.g. low blood pressure, hives) occurred in less than 1% of patients. Though there were few cases, immediate medical treatment for hypersensitivity should be available.
3 -- Patients with a history of infection, recurring infections, or those who have conditions that predispose them to infection may develop more infections while being treated with Orencia.
Patients who develop a new infection on Orencia should be carefully monitored. If a serious infection develops, Orencia should be discontinued.
4 -- Patients should be screened for latent tuberculosis (TB) with a tuberculin skin test before starting treatment with Orencia.
Orencia has not been studied in patients who are positive for the tuberculosis screening test. The safety of Orencia in patients with latent TB is unknown. Patients testing positive for the tuberculosis screening must be treated before starting Orencia.
5 -- Live vaccines should not be given while you are being treated with Orencia. Also, live vaccines should not be given for 3 months after discontinuation of Orencia.
The effectiveness of vaccination in patients treated with Orencia is unknown. Orencia could possibly interfere with the effectiveness of some vaccinations. Prior to starting Orencia treatment, children 6 years old or old should have their immunizations current per immunization guidelines.
6 -- Patients with chronic obstructive pulmonary disease (COPD) should be carefully monitored while treated with Orencia.
In clinical trials, patients with COPD treated with Orencia developed more frequent adverse events -- including worsening COPD, cough, and difficulty breathing. Orencia should be used with caution in COPD patients.
7 -- Orencia may interfere with the accuracy of certain glucose monitors used by diabetics.
Orencia contains maltose which can falsely elevate glucose monitor readings on the day of infusion. There are glucose monitoring methods that do not react with maltose and those would be optimal for patients being treated with Orencia.
8 -- There are no well-controlled studies of Orencia in pregnant woman.
Orencia should only be used in pregnant woman if the benefit to the mother outweighs the potential risk to the fetus. Orencia has been shown to cross the placenta in animal studies.
9 -- It is not recommended that female patients taking Orencia breastfeed.
Mothers should choose between discontinuing Orencia or discontinuing nursing -- after considering the importance of Orencia for the mother. There is potential for serious adverse events to a nursing baby if the mother is being treated with Orencia.
10 -- Elderly patients being treated with Orencia should be monitored carefully -- especially for infection and malignancy.
The frequency of serious infection and malignancy among patients over 65 years old who were being treated with Orencia was higher than for those younger than 65 years old, in clinical trials. To minimize the potential for problems, elderly patients should be carefully observed when treated with Orencia.
Sources:
Orencia. Prescribing Information. Bristol-Myers Squibb. April 2008.
http://packageinserts.bms.com/pi/pi_orencia.pdf (PDF)
Orencia. Patient Information. Bristol-Myers Squibb. April 2008.
http://packageinserts.bms.com/ppi/ppi_orencia.pdf (PDF)