Drug Safety Information for ORENCIA (Abatacept)

Safety-related Labeling Changes for ORENCIA (ABATACEPT) Biological Drug: FDA Link

Required post-approval safety study:

Observational study in pediatric patients 2 to 5 years of age with juvenile idiopathic arthritis (JIA) treated with abatacept to evaluate the long term safety of abatacept, with respect to the risk of malignancies, autoimmune diseases, and serious infections. Due Date: 2029-06-30

Required post-approval safety study:

A JIA patient safety registry comprised of at least 500 patients. The protocol for this study should include a plan for more intensive scrutiny for the first 3 years, with annual follow ups (which could be telephonic) assessing for occurrence of malignancies, other autoimmune diseases, and serious infections, for a total of 10 years. Patients turning 18 years of age or older should continue to be followed until they have completed the 10 year follow-up period. Information on these patients may be obtained via annual questionnaire/telephonic follow-up with attention to key adverse events rather than full clinic visit with examination. Occurrence of these serious events should be formally compared to the expected rate of these events in historical controls. Due Date: 2029-06-30

Original FDA Drug Approval Date for ORENCIA: 2005-12-23

Adverse Drug Reactions for ORENCIA* (Abatacept)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ORENCIA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	1656
2	Headache	547
3	Fatigue	476
4	Nausea	460
5	Pain	452
6	Arthralgia	381
7	Rheumatoid arthritis	381
8	Malaise	339
9	Pneumonia	315
10	Dyspnoea	307
11	Rash	296
12	Pain in extremity	263
13	Arthropathy	244
14	Pyrexia	242
15	Death	237
16	Diarrhoea	223
17	Cough	222
18	Vomiting	215
19	Dizziness	211
20	Hypersensitivity	208

* This side effect also appears in "Top 10 Side Effects of ORENCIA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ORENCIA
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Rheumatoid arthritis	14319
2	Product used for unknown indication	2227
3	Renal transplant	927
4	Juvenile arthritis	187
5	Immunosuppression	166
6	Psoriatic arthropathy	163
7	Polyarthritis	147
8	Arthritis	112
9	Prophylaxis against transplant rejection	106
10	Liver transplant	95

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for ORENCIA

Total Reports Filed with FDA: 29270

Number of FDA Adverse Event Reports by Patient Age for ORENCIA

Total Reports Filed with FDA: 29270*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Abatacept (Bms224818, Orencia, Belatacept, Bms-224818)

Charts are based on 29270 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.