Orencia Side Effects & Safety

The safety of intravenous (IV) Orencia has been studied in randomized, controlled trials in which 1,955 patients received Orencia and 989 received placebo. In these studies, 391 patients received either Orencia or placebo for a double-blind treatment phase lasting 6 months, and 2,853 patients received Orenica or placebo for a double-blind treatment phase lasting 1 year. Most of these patients also received conventional disease-modifying anti-rheumatic drug (DMARD) treatment during treatment with Orencia and a smaller group received a concomitant (administered at the same time) biologic treatment (204 patients who received Orencia and 134 who received placebo).1

The most serious side effects or adverse reactions with Orencia were infections and cancers, with infections accounting for the majority of instances where treatment with Orencia was stopped or interrupted. The most common infections resulting in discontinuation were pneumonia (affected 0.2% of patients), localized infection (0.2%), and bronchitis (0.1%). Overall rates of cancers in the placebo-controlled portions of trials were similar for patients who received Orencia and placebo at 1.3% and 1.1%, respectively. Rates of lung cancer were higher in patients who received Orencia (0.2% versus 0%) and lymphomas (cancers that originate in the lymph nodes) occurred with Orencia at 3.5 times the rate seen in the general population.1

The most common side effects occurring in at least 10% of patients who received Orencia were headache, upper respiratory tract infection, nasopharyngitis, and nausea.1


Most common side effects occurring in Orencia RA clinical trials

Side effect Orencia (N=1,955**) Placebo (N=989***)
Headache 18% 13%
Nasopharyngitis 12% 9%
Dizziness 9% 7%
Cough 8% 7%
Back pain 7% 6%
Hypertension 7% 4%
Dyspepsia 6% 4%
Urinary tract infection 6% 5%
Rash 4% 3%
Pain in extremity 3% 2%
*Occurring in at least 3% or more of Orencia patients and at least 1% more frequently than in placebo patients.
**Included 204 patients who received concomitant biologics (adalimumab, anakinra, etanercept, or infliximab).
***Included 134 patients who received concomitant biologics (adalimumab, anakinra, etanercept, or infliximab).


Warnings and precautions

There are several warnings and precautions related to Orencia you should be aware of before you start treatment.

Infections. Your risk for infections increases if you use Orencia with an anti-TNF drug (examples include Cimzia [certolizumab pegol], Humira [adalimumab], Remicade [infliximab], and Enbrel [etanercept]).1

Patients with a history of recurrent infections may experience more infections with Orencia. If you develop a serious infection while taking Orencia, you should contact your doctor and discontinue the drug.1

Patients with chronic pulmonary obstructive disease (COPD) may experience increased respiratory side effects with Orenica.1

Before starting treatment with Orencia, you should be tested for latent tuberculosis (TB), and, if positive, you should receive treatment for TB before starting Orencia. All patients should be monitored for active TB during treatment with Orencia.1

Patients should not receive live vaccines while taking Orencia or within three months of discontinuing Orencia.1

Hypersensitivity reactions. Orencia can cause hypersensitivity (allergic) reactions including anaphylaxis.1


Pregnancy and nursing

Orencia is a pregnancy category C drug. In animal studies, while Orencia did not result in birth defects in the developing fetus, changes in fetal immune function were detected. There have been no well-controlled studies of Orencia taken during pregnancy in humans. Orencia should only be used in pregnant women if the potential benefits justify the risk to the fetus.1

It is unknown whether Orencia is excreted into human milk. Because of the potential for adverse effects to the nursing infant, a nursing woman should either stop taking the drug or discontinue nursing while taking Orencia.1


Drug interactions

Use of anti-TNF treatments (examples include Cimzia [certolizumab pegol], Humira [adalimumab], Remicade [infliximab], and Enbrel [etanercept]) with Orencia is not recommended. Use of anti-TNF drugs with Orencia can increase the risk for serious infections and does not provide any increase in efficacy.1

Concurrent use of other biologic DMARDs (examples include Kineret [anakinra] and Rituxan [rituxamab]) with Orenica is not recommended. There is currently insufficient efficacy and safety data to support use of these treatments with Orencia.1

Written by: Jonathan Simmons | Last reviewed: September 2013.
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