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Indications 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.

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age 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.

Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) is indicated for the treatment of adult patients with active PsA.

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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Indications and Usage

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age 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.

ORENCIA—proven to reduce signs and symptoms of moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA)1-6

Studied in two pivotal clinical trials: Offering the flexibility of two administration options

  • Intravenous (IV) infusion (6 years of age and older)
  • Once-weekly subcutaneous (SC) pre-filled syringe (2 years of age and older)
  • IV EFFICACY
  • SC EFFICACY
  • SAFETY RESULTS
  • IV/ SC DOSING

ORENCIA IV efficacy was demonstrated in the AWAKEN study1

AWAKEN Study: ORENCIA IV study to assess efficacy and safety in patients with JIA with an inadequate response to current treatment1

A Phase III, multicenter, double-blind, randomized, placebo-controlled withdrawal trial of DMARD-IR patients 6-17 years of age with moderately to severely active polyarticular JIA (disease duration of ~4 years).1

Key baseline patient characteristics

MEAN
AGE
12.4 YEARS
MEAN DISEASE
DURATION
4.4 YEARS
MEAN ACTIVE
JOINTS
16.2
MEAN JOINTS WITH
LIMITED RANGE OF MOTION
16.3
MEAN
CRP
0.32 mg/dL
RECEIVING
MTX
73%

At study entry, 74% of patients were receiving MTX and remained on a stable dose of MTX throughout the trial (those not receiving MTX did not initiate MTX treatment during the study).

In the double-blind period, baseline characteristics of ORENCIA IV and placebo IV arms were generally comparable

Primary endpoint results in double-blind Period B (P=0.0002, LOG-RANK TEST)1:

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

ORENCIA IV has been proven to significantly reduce the occurrence of flares in patients with moderate to severe JIA1

Secondary endpoint

During the double-blind randomized withdrawal phase (Period B), ORENCIA-treated patients experienced significantly fewer disease flares compared to placebo-treated patients (20% vs 53%, P=0.0003).1

80% of patients taking ORENCIA IV had no flares compared with 47% taking placebo

Pie ChartPie Chart

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.

Additional Endpoints

In the AWAKEN IV 4-month, open-label lead-in period

Improvement in signs and symptoms was demonstrated in patients with and without previous anti-tumor necrosis factor (anti-TNF) experience1

ACR Pediatric responses at month 41

Bar Graph: ACR Pediatric Responses, Month 4Bar Graph: ACR Pediatric Responses, Month 4

In the AWAKEN IV 6-month, double-blind period

ORENCIA significantly improved symptoms of JIA versus placebo1

Patients with ACR Pediatric responses at 6 months1

Bar Graph: Patients with ACR Pediatric Responses, Month 6Bar Graph: Patients with ACR Pediatric Responses, Month 6

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 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.

Over 5 years, ORENCIA IV demonstrated sustained symptom relief for patients with JIA4

ACR PEDIATRIC RESPONSES OVER TIME‡§4

Line Graph Plotting ACR Pediatric responses over time between ACR Pediatric 30, ACR Pediatric 70, and Inactive Disease statesLine Graph Plotting ACR Pediatric responses over time between ACR Pediatric 30, ACR Pediatric 70, and Inactive Disease states

*Flare was defined as worsening of 30% or more in at least three of the six ACR core-response variables for JIA, and at least 30% improvement in no more than one variable during the double-blind period.

Defined as having no joint with active disease, a physician's global assessment of disease severity score ≤10 mm, and an ESR ≤20 mm/hour.

ACR Pediatric 30/50/70/90 responses were defined as ≥30%/50%/70%/90% improvement in at least 3 of the 6 JIA core set variables and ≥30% worsening in ≤1 variable.

§Clinical efficacy analyses were based on data derived from patients for whom data were available at each time point (as-observed).

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

A phase III, multicenter, double-blind, randomized, placebo-controlled withdrawal trial of DMARD-IR patients 6-17 years of age with moderately to severely active polyarticular JIA (disease duration of ~4 years).

Period A was a 4-month, open-label, lead-in period where all patients received ORENCIA. ORENCIA was infused for 30 minutes at 10 mg/kg on Days 1, 15, 29, 57, and 85, and every 28 days thereafter. Patients achieving an ACR Pediatric 30 response at the end of Period A 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. Period C was a 5-year open-label long-term extension and included patients who received ORENCIA IV or placebo during Period B.

Patients studied had a history of ≥5 active joints and, at screening, at least 2 active joints and 2 joints with limited range of motion.

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 efficacy of ORENCIA SC injection was demonstrated in a Phase III open-label trial of DMARD-IR patients with JIA

ORENCIA SC in patients with moderate to severe polyarticular JIA and inadequate response to biologic or non-biologic DMARDs: pharmacokinetics, efficacy and safety

A 4-month, single-arm, open-label Phase III study (Period A) of DMARD-IR patients with active polyarticular JIA with a 20-month open-label extension (Period B).3

Key baseline patient characteristics (6-17 cohort)3,5

MEAN
AGE
12.3 YEARS
MEAN DISEASE
DURATION
2.8 YEARS
MEAN ACTIVE
JOINTS
12.4
MEAN JOINTS WITH
LOSS OF MOTION
10.7
MEAN
CRP
1.2 mg/dL

At study entry, 80% of patients were receiving MTX and remained on a stable dose of MTX.

Primary endpoint result1

  • Primary: evaluation of PK in order to support the extrapolation of efficacy based on exposure to ORENCIA supported by descriptive efficacy
  • Target therapeutic steady-state trough concentrations (Cminss) were achieved with ORENCIA SC at 4 months

The efficacy of ORENCIA SC injection was demonstrated in a Phase III open-label trial of DMARD-IR patients with JIA3

  • JIA ACR 30/50/70 responses assessed at 4 months in the 2- to 17-year-old patients were consistent with the results from the IV study, AWAKEN3
  • ORENCIA SC Improved JIA symptoms starting at Day 253,5,6
  • 30% of patients taking ORENCIA achieved JIA-ACR 90 within 4 months3,5,6

JIA-ACR responses through 4 months6*

JIA-ACR responses over 4 months (JIA-ACR 30, JIA-ACR 50, JIA-ACR 70, JIA-ACR 90, Inactive Disease)JIA-ACR responses over 4 months (JIA-ACR 30, JIA-ACR 50, JIA-ACR 70, JIA-ACR 90, Inactive Disease)

Response to treatment was improved or maintained beyond 4 months in the SC Study 20-month, long-term extension period.5

Based on the subsets of subjects, ages 6-17, that were observed at each time point, the proportions of JIA-ACR 30/50/70/90/100, and inactive disease responders increased during the cumulative period, continuing the trend observed in the double-blind period.5

The proportions of JIA-ACR30 and JIA-ACR50 responders increased from:

  • JIA-ACR30: 80.9% (140/173) on Day 113 to 90.3% (130/144) on Day 197
  • JIA-ACR50: 71.1% (123/173) on Day 113 to 88.2% (127/144) on Day 197

Patients remained stable for those subsets of subjects with longer ORENCIA exposure.

  • The proportion of JIA-ACR70 responders increased from 52.6% (91/173) at Day 113, to 80.9% (72/89) at Day 309, and remained stable

During the cumulative period, the proportions of JIA-ACR90, JIA-ACR100, and inactive disease responders increased nearly linearly. From Day 113 to Day 309, these proportions were, respectively:

  • JIA-ACR90: 28.9% (50/173) to 56.2% (50/89)
  • JIA-ACR100: 14.5% (25/173) to 34.8% (31/89)
  • Inactive disease: 29.5% (51/173) to 56.3% (49/87)

Responses for these criteria continued to increase linearly beyond Day 309 until the last measurement (Day 561) for subjects with longer ORENCIA exposures.

*JIA ACR 30/50/70/90 responses were defined as ≥30%/50%/70%/90% improvement in at least 3 of the 6 JIA core set variables and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease was defined as no active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL.

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.

STUDY DESIGN–2-17 YEAR OLDS3
  • A 4-month, single-arm, open-label phase III study (Period A) of DMARD-IR patients with active polyarticular JIA with a 20-month open-label extension (Period B)
  • Patients had a mean disease duration of 2.5 years with active joints (mean, 11.9), joints with loss of motion (mean, 10.4), and elevated C-reactive protein (CRP) levels (mean, 1.2 mg/dL)
  • Patients had ≥2 active joints and ≥2 joints with limited range of motion, active articular disease, and previous use of ≥1 biologic or non-biologic DMARD
  • At study entry, 80% of patients were receiving MTX and remained on a stable dose of MTX

Safety results for ORENCIA IV and SC in patients with JIA

AWAKEN: ORENCIA IV Safety Results1

ADVERSE EVENTS (AEs)* 4-MONTH OPEN-
LABEL PERIOD
6-MONTH DOUBLE-
BLIND PERIOD
  ORENCIA IV
(n=190)
ORENCIA IV
(n=60)
Placebo IV
(n=62)
Total SAEs 6 (3%) 0 2 (3%)
Total AEs* 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%) 2 (3%)
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.

Safety Events in LTE4

Safety events reported during the LTE phase, were comparable to the three treatment groups, one death occurred and was considered to be unrelated to study drug. Six patients discontinued participation in the study due to AEs during the LTE phase, including urticaria and bronchospasm, worsening vitiligo, skin lesions, temporal lobe epilepsy and multiple sclerosis, appendicitis, and bacterial arthritis. With the exception of worsening arthritis, no individual SAE was reported by >2 patients in any group during the LTE phase. During the LTE phase (n=153), 10 serious infections were reported at an incidence rate of 1.72 per 100 patient years of exposure. Serious infections that were considered possibly related to the study treatment included appendicitis, limb abscess, impetigo, herpes zoster infection, varicella, and bacterial arthritis, all of which resolved following treatment. The most frequently reported serious infections were pyelonephritis, bacterial arthritis, and appendicitis (2 patients each).

Most serious adverse events (SAEs)

During the 4-month, lead-in, open-label Period A, 6 serious 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 AEs

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 SC Safety Results3,4

In patients 2 to 17 years of age with juvenile idiopathic arthritis, the safety experience and immunogenicity for ORENCIA administered subcutaneously were consistent with the intravenous Study JIA-1 (AWAKEN).3,4

Summary of AEs during the combined initial 4-month and 20-month extension period.

AEs PATIENTS AGED 2-5
(n=32)5
PATIENTS AGED 6-17
(n=173)5
Deaths 0 0
All AEs 26 (81.3%) 127 (73.4%)
Related AEs 11 (34.4%) 45 (26.0%)
Infections and infestations 8 (25.0%) 24 (13.9%)
Upper respiratory tract
infection
3 (9.4%) 6 (3.5%)
Nasopharyngitis 2 (6.3%) 13 (7.5%)
Tonsillitis 2 (6.3%) 1 (0.6%)
Respiratory, thoracic and
mediastinal disorders
4 (12.5%) 5 (2.9%)
Cough 2 (6.3%) 2 (1.2%)
General disorders and
administration-site conditions
2 (6.3%) 17 (9.8%)
AEs leading to discontinuation 0 4 (2.3%)
SAEs 0 8 (4.6%)
Related SAEs 0 1 (0.6%)
SAEs leading to discontinuation 0 2 (1.2%)
AEs of special interest
Infections 22 (68.8%) 90 (52.0%)
Malignancies 0 1 (0.6%)
Autoimmune disorders 0 3 (1.7%)§
AEs within 24 hours of drug
administration
11 (34.4%) 59 (34.1%)
Local injection site reactions 0 10 (5.8%)

*Exanthema (n=1) and fatigue (n=1), both related to study drugs (as well as the two SAEs leading to discontinuation).
Sepsis (n=1), related to study drug; stage III ovarian germ cell teratoma (n=1), not related to study drug.
The most common infections were nasopharyngitis and upper respiratory tract infections.
§Episckerurus (n=1), Raynaud’s phenomenon (n=1) and psoriasis (n=1).

 

Serious Adverse Events

Seven SAEs were reported among 5 ORENCIA patients during the initial 4-month period (anemia, abdominal pain, chest pain, sepsis, hypomagnesemia, synovitis, and ovarian germ cell teratoma stage III); 1 patient with malignancy (ovarian germ cell teratoma stage III) – unrelated to study drug; 2 patients with autoimmune events: both mild and unrelated to study drug.

There were no reported cases of hypersensitivity reactions. Local injection-site reactions occurred at a frequency of 4.4%.

ORENCIA offers the flexibility of subcutaneous (SC) or intravenous (IV) administration for patients with JIA2

ORENCIA IV is administered as a 30-minute infusion3

  • <75 kg = 10 mg/kg based on body weight at each visit
  • ≥75 kg = follow adult weight-based dosing schedule (shown below), not to exceed maximum dose of 1000 mg

Dosing Schedule

Dosing Schedule: Day 1 - 1st Dose, Day 15 - 2nd Dose, Day 29 - 3rd DoseDosing Schedule: Day 1 - 1st Dose, Day 15 - 2nd Dose, Day 29 - 3rd Dose

Actual day of dosing may vary based on patient scheduling.

After the initial dose, ORENCIA IV should be administered at 2 and 4 weeks, then every 4 weeks thereafter.

Any unused portions in the vials must be immediately discarded.

Adult, weight-based dosing chart: < 60kg (<<> 132lbs), 2 vials; 60kg to 100kg (132lbs to 220lbs), 3 vials; > 100kg (> 220lbs), 4 vialsAdult, weight-based dosing chart: < 60kg (< 132lbs), 2 vials; 60kg to 100kg (132lbs to 220lbs), 3 vials; > 100kg (> 220lbs), 4 vials

Once-weekly ORENCIA SC is administered with a pre-filled syringe3

  • Ph Levels of 6.8 to 7.4

ORENCIA SC should be initiated without an IV loading dose.

Weight-based dosing for pre-filled syringes (ages 2 and older): 10kg to 25kg (22lbs to 55lbs, 50mg/0.4mL; 25kg to 50kg (55lbs to 110lbs), 87.5mg/0.7mL; ≥ 50kg (≥ 110lbs), 125mg/1mLWeight-based dosing for pre-filled syringes (ages 2 and older): 10kg to 25kg (22lbs to 55lbs, 50mg/0.4mL; 25kg to 50kg (55lbs to 110lbs), 87.5mg/0.7mL; ≥ 50kg (≥ 110lbs), 125mg/1mL

Selected Important Safety Information

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.

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 RA 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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and 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 adult RA 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 RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA 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 JIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJectTM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Please click here for 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 RA 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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and 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 adult RA 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 RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA 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 JIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJectTM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

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References:

Ruperto N, Lovell DJ, Quartier P, et al; Paediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008;372(9636):383-391.

Ruperto N, Lovell DJ, Quartier P, et al; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010;62(6):1792-1802.

ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.

Lovell DJ, Ruperto N, Mouy R, et al; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015;67(10):2759-2770.

Data on file ABAT 148. Princeton, NJ; Bristol-Myers Squibb.

Data on file ABAT 147. Princeton, NJ; Bristol-Myers Squibb.