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Indication and Usage

Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

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Indication and Usage

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in pediatric patients aged 6 years and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Moderate to severe
Juvenile Idiopathic Arthritis (JIA)

  • ACR PEDI
    ALL PATIENTS
  • ACR PEDI BY PRIOR
    ANTI-TNF USE
  • RISK OF
    DISEASE FLARE
  • SAFETY
    RESULTS
  • ORENCIA IV
    DOSING

AWAKEN study results for ORENCIA® (abatacept) in JIA

Clinical results for ORENCIA in moderately to severely active polyarticular JIA patients ages 6 years and older1

PRIMARY ENDPOINT: AWAKEN1

TIME TO OCCURRENCE OF DISEASE FLARE IN DOUBLE-BLIND PERIOD B
(P=0.0002, LOG-RANK TEST)

  • Median time to flare: ~6 months for placebo patients
  • Insufficient events occurred in the ORENCIA-treated patients for assessment of median time to flare*

OTHER RESULTS1

ACR PEDI 30/50/70/90 AT 4 MONTHS (OPEN-LABEL, LEAD-IN PERIOD A)

Adapted from The Lancet, Vol. 372, pages 383-391, Copyright 2008, with permission from Elsevier.

Selected Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63 %) and serious infections (4.4 %) compared to patients treated with only TNF antagonists (43 % and 0.8 %, respectively), without an important enhancement of efficacy.

 

*Flare defined as: ≥30 % worsening in ≥3 of 6 core variables of ACR Pedi, with ≥30 % improvement in ≤1 variable; ≥2 cm of worsening of the Physician or Parent Global Assessment was necessary if used as 1 of the 3 JIA core set variables used to define flare, and worsening in ≥2 joints was necessary if the number of active joints or joints with limitation of motion was used as 1 of the 3 JIA core set variables used to define flare.2

ACR Pedi 30 defined as ≥30 % improvement in ≥3 of the 6 JIA core variables and ≥30 % worsening in ≤1 variable.2

STUDY DESIGN1,2

AWAKEN Study: The efficacy and safety of ORENCIA IV were evaluated in a placebo-controlled trial in 190 patients with JIA. It was a Phase III, multicenter, double-blind trial that randomized patients 6-17 years of age with JIA ~4 years with moderate to severe active disease at study entry (extended oligoarticular [16%], polyarticular [64%] [20% rheumatoid factor positive], or systemic with polyarticular course 20%). A 4-month, open-label, lead-in period (Period A) was followed by a 6-month, double-blind, withdrawal period (Period B). The first part of the trial was a 4-month, open-label, lead-in period (Period A) where all patients received ORENCIA. ORENCIA, a lyophilized powder, was infused for 30 minutes at 10 mg/kg, not to exceed 1000 mg (according to body weight each visit) on days 1, 15, 29, 57, and 85, and every 28 days thereafter. Patients achieving an ACR Pedi 30 response at the end of this open-label, lead-in period were randomized into the double-blind period (Period B) to receive either ORENCIA or placebo every 28 days for 6 months or until disease flare. At study entry, 74% of patients were receiving MTX and remained on a stable dose of MTX (those not receiving MTX did not initiate MTX treatment during the study). The primary endpoint was time to flare of JIA.

AWAKEN study results for ORENCIA® (abatacept) in JIA

Clinical results for ORENCIA in moderately to severely active polyarticular JIA patients ages 6 years and older1

PRIMARY ENDPOINT1

TIME TO OCCURRENCE OF DISEASE FLARE IN DOUBLE-BLIND PERIOD B
(P=0.0002, LOG-RANK TEST)

  • Median time to flare: ~6 months for placebo patients
  • Insufficient events occurred in the ORENCIA-treated patients for assessment of median time to flare*

OTHER RESULTS1

ACR PEDI 30/50/70/90 AT 4 MONTHS (OPEN-LABEL, LEAD-IN PERIOD A) IN PATIENTS WITH NO PREVIOUS ANTI-TNF USE

Based on a post-hoc analysis.

Adapted from The Lancet, Vol. 372, pages 383-391, Copyright 2008, with permission from Elsevier.

OTHER RESULTS: AWAKEN1

ACR PEDI 30/50/70/90 AT 4 MONTHS (OPEN-LABEL, LEAD-IN PERIOD A) IN PATIENTS WITH PREVIOUS ANTI-TNF USE

Based on a post-hoc analysis.

Adapted from The Lancet, Vol. 372, pages 383-391, Copyright 2008, with permission from Elsevier.

Selected Important Safety Information

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occured in <0.9% of patients. In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

 

*Flare defined as: ≥30 % worsening in ≥3 of 6 core variables of ACR Pedi, with ≥30 % improvement in ≤1 variable; ≥2 cm of worsening of the Physician or Parent Global Assessment was necessary if used as 1 of the 3 JIA core set variables used to define flare, and worsening in ≥2 joints was necessary if the number of active joints or joints with limitation of motion was used as 1 of the 3 JIA core set variables used to define flare.2

ACR Pedi 30 defined as ≥30 % improvement in ≥3 of the 6 JIA core variables and ≥30 % worsening in ≤1 variable.2

STUDY DESIGN1,2

AWAKEN study: The efficacy and safety of ORENCIA IV were evaluated in a placebo-controlled trial in 190 patients with JIA. It was a Phase III, multicenter, double-blind trial that randomized patients 6-17 years of age with JIA ~4 years with moderate to severe active disease at study entry (extended oligoarticular [16%], polyarticular [64%] [20% rheumatoid factor positive], or systemic with polyarticular course 20%). A 4-month, open-label, lead-in period (Period A) was followed by a 6-month, double-blind, withdrawal period (Period B). The first part of the trial was a 4-month, open-label, lead-in period (Period A) where all patients received ORENCIA. ORENCIA, a lyophilized powder, was infused for 30 minutes at 10 mg/kg, not to exceed 1000 mg (according to body weight each visit) on days 1, 15, 29, 57, and 85, and every 28 days thereafter. Patients achieving an ACR Pedi 30 response at the end of this open-label, lead-in period were randomized into the double-blind period (Period B) to receive either ORENCIA or placebo every 28 days for 6 months or until disease flare. At study entry, 74% of patients were receiving MTX and remained on a stable dose of MTX (those not receiving MTX did not initiate MTX treatment during the study). The primary endpoint was time to flare of JIA.

AWAKEN study results for ORENCIA® (abatacept) in JIA

Clinical results for ORENCIA in moderately to severely active polyarticular JIA patients ages 6 years and older1

PRIMARY ENDPOINT1

TIME TO OCCURRENCE OF DISEASE FLARE IN DOUBLE-BLIND PERIOD B
(P=0.0002, LOG-RANK TEST)

  • Median time to flare: ~6 months for placebo patients
  • Insufficient events occurred in the ORENCIA-treated patients for assessment of median time to flare*

OTHER RESULTS1

PROPORTION OF PATIENTS WITHOUT DISEASE FLARE (DOUBLE-BLIND PERIOD B)

Reprinted from The Lancet, Vol. 372, pages 383-391, Copyright 2008, with permission from Elsevier.

Kaplan-Meier analysis of the time to disease flare during the double-blind withdrawal period. P value represents the comparison of the time to disease flare between the abatacept and placebo groups.

 
  • ORENCIA-treated patients experienced significantly fewer disease flares compared to placebo-treated patients (20 % vs 53 %); 95 % CI of the difference (15 %, 52 %)1
  • The risk of disease flare among patients continuing on ORENCIA was less than one-third than that for patients during the double-blind period (hazard ratio=0.31, 95 % CI [0.16, 0.59]1

Selected Important Safety Information

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

STUDY DESIGN1,2

AWAKEN Study: The efficacy and safety of ORENCIA IV were evaluated in a placebo-controlled trial in 190 patients with JIA. It was a Phase III, multicenter, double-blind trial that randomized patients 6-17 years of age with JIA ~4 years with moderate to severe active disease at study entry (extended oligoarticular [16%], polyarticular [64%] [20% rheumatoid factor positive], or systemic with polyarticular course 20%). A 4-month, open-label, lead-in period (Period A) was followed by a 6-month, double-blind, withdrawal period (Period B). The first part of the trial was a 4-month, open-label, lead-in period (Period A) where all patients received ORENCIA. ORENCIA, a lyophilized powder, was infused for 30 minutes at 10 mg/kg, not to exceed 1000 mg (according to body weight each visit) on days 1, 15, 29, 57, and 85, and every 28 days thereafter. Patients achieving an ACR Pedi 30 response at the end of this open-label, lead-in period were randomized into the double-blind period (Period B) to receive either ORENCIA or placebo every 28 days for 6 months or until disease flare. At study entry, 74% of patients were receiving MTX and remained on a stable dose of MTX (those not receiving MTX did not initiate MTX treatment during the study). The primary endpoint was time to flare of JIA.

*Flare defined as: ≥30 % worsening in ≥3 of 6 core variables of ACR Pedi, with ≥30 % improvement in ≤1 variable; ≥2 cm of worsening of the Physician or Parent Global Assessment was necessary if used as 1 of the 3 JIA core set variables used to define flare, and worsening in ≥2 joints was necessary if the number of active joints or joints with limitation of motion was used as 1 of the 3 JIA core set variables used to define flare.2

Safety results

Adverse events (AEs) in the AWAKEN trial were similar in frequency and type to those seen in adult patients that received ORENCIA® (abatacept) IV.1,2

Adverse Events* 4-MONTH OPEN-
LABEL PERIOD
6-MONTH DOUBLE-
BLIND PERIOD
  ORENCIA IV
(n=190)
ORENCIA IV
(n=60)
Placebo IV
(n=62)
Total serious adverse events 6 (3%) 0 2 (3%)
Total adverse events* 133 (70%) 37 (62%) 34 (55%)
Infections and infestations 68 (36%) 27 (45%) 27 (44%)
Influenza 7 (4%) 5 (8%) 4 (7%)
Bacteriuria 3 (2%) 4 (7%) 0
Nasopharyngitis 11 (6%) 4 (7%) 3 (5%)
Upper respiratory tract infection 14 (7%) 4 (7%) 5 (8%)
Gastroenteritis 1 (0.5%) 3 (5%) 1 (2%)
Sinusitus 6 (3%) 3 (5%) 1 (2%)
Rhinitis 8 (4%) 1 (2%) 4 (7%)
Gastrointestinal disorders 66 (35%) 10 (17%) 9 (15%)
Abdominal pain 9 (5%) 3 (5%) 1 (2%)
Nausea 19 (10%) 2 (3%) 4 (7%)
Diarrhea 17 (9%) 1 (2%) 1 (2%)
Upper abdominal pain 10 (5%) 1 (2%) 0
General disorders and administration site conditions 26 (14%) 4 (7%) 9 (15%)
Pyrexia 12 (6%) 4 (7%) 5 (8%)
Nervous system disorders 30 (16%) 3 (5%) 2 (3%)
Headache 25 (13%) 3 (5%) 1 (2%)
Respiratory, thoratic and mediastinal disorders 32 (17%) 6 (10%) 3 (5%)
Cough 17 (9%) 0 2 (3%)

*AEs that occurred in at least 5 % of patients in the open-label and double-blind phases.

Most serious adverse reactions2

During the 4-month, lead-in, open-label Period A, 6 serious adverse events (AEs) (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare [2] and joint wear) were reported during treatment with ORENCIA. During the double-blind Period B, no serious AEs occurred in the ORENCIA group and 2 occurred in the placebo group.

Other adverse events2

One case of hypersensitivity reaction (0.5 %) was reported. During Periods A, B, and C, acute infusion-related events occurred at a frequency of 4 %, 2 %, and 3 %, respectively, and were consistent with types of adult events. In open-label extension Period C, AEs were similar except for one patient diagnosed with multiple sclerosis.

ORENCIA® (abatacept) IV dosing for JIA

Dosing in patients 6 to 17 years who weigh <75 kg and who have moderate to severe active polyarticular JIA is 10 mg/kg based on body weight at each visit.

Pediatric patients weighing ≥75 kg should follow the adult intravenous (IV) dosing schedule, not to exceed the maximum dose of 1000 mg.

ADULT INTRAVENOUS (IV) DOSING SCHEDULE

Body weight of patient* Dose (mg) Number of vials Billable units (abatacept per 10 mg)
<60 kg (<132 lbs) 500 mg 2 50
60 kg to 100 kg
(132 lbs to 220 lbs)
750 mg 3 75
>100 kg (> 220 lbs) 1000 mg 4 100

*1 kg-2.2 lbs.
Each vial provides 250 mg of ORENCIA for administration.

JIA INFUSION SCHEDULE

ORENCIA should be administered as a 30-minute intravenous infusion.

Following an initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. Any unused portions in the vials must be immediately discarded.

Month 1 Continue

Day 1 1st Dose

Day 15 2nd Dose

Day 29 3rd Dose

Every 4 Weeks thereafter Actual day of dosing may vary based on patient scheduling.

Click Here to learn more about the preparation, administration, and storage of ORENCIA IV.

Selected Important Safety Information

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations.It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA have not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

 More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations.It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA have not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

References: 1. Ruperto N, Lovell DJ, Quartier P, et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008;372:383-391. 2. ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.