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Learn more about ORENCIA for adults with active psoriatic arthritis (PsA)

Is it time to consider another treatment option for your patients with active psoriatic arthritis?

ORENCIA Is Indicated for Adults With Active Psoriatic Arthritis (PsA)

ORENCIA was studied in 2 clinical trials in patients with active psoriatic arthritis.

Want to learn more about ORENCIA
for active PsA?
For more details about clinical efficacy and safety results, dosing, and administration options, explore the guide to ORENCIA in active PsA.
Want to learn more about ORENCIA
for active PsA?
For more details about clinical efficacy and safety results, dosing, and administration options, explore the guide to ORENCIA in active PsA.

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

ORENCIA IV is a 30-minute infusion

ORENCIA® (abatacept) single-dose vial for IV infusion ORENCIA® (abatacept) single-dose vial for IV infusion

4-week dosing schedule

Following the starter doses, ORENCIA IV is maintained with a regular 4-week schedule.*

IV infusion dosing schedule

*Actual day of dosing may vary based on patient scheduling.

Adult weight-based dosing

patient weight and number of vials patient weight and number of vials

For injection: 250 mg white lyophilized powder in a single-dose vial (one may use less than the full contents of the vials or use more than one vial).

Immediately discard any unused portion
in the vials.

If there are any product defects, call 1-800-ORENCIA (1-800-673-6242)
to receive a new vial.

Selected Important
Safety Information

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: 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% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

ORENCIA SC allows patients once-weekly
self-injection at home

Recommendations for subcutaneous administration with ORENCIA prefilled syringe

  • ORENCIA prefilled syringes are intended for:
    • Subcutaneous use only and are not intended for intravenous infusion
    • Use under the guidance of a physician or healthcare practitioner
  • After proper training in subcutaneous injection technique, a patient or the patient’s caregiver may administer a subcutaneous injection of ORENCIA (prefilled syringe) if a healthcare practitioner determines that it is appropriate
  • Instruct patients and/or caregivers to follow the directions provided in the Instructions for Use for additional details on administration. Specifically instruct them to inject the full amount (which provides the proper dose of ORENCIA), rotate injection sites, and to avoid injections into areas where the skin is tender, bruised, red, or hard
  • Visually inspect for particulate matter and discoloration prior to administration. Do not use ORENCIA prefilled syringes exhibiting particulate matter or discoloration. ORENCIA should be clear to slightly opalescent and colorless to pale yellow

ORENCIA prefilled syringes may be initiated without the need for an IV loading dose

125-mg SC injection is supplied in a prefilled syringe with BD UltraSafe Passive™ needle guard for once-weekly use.

For patients switching from ORENCIA intravenous infusions to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Device highlights*

*125-mg syringe shown.
(29-gauge needle)

ORENCIA ClickJect™ Autoinjector—automatically delivers the full dose
with one push of a button

125-mg SC injection is supplied in the ClickJect™ Autoinjector for once-weekly use.

Recommendations for subcutaneous administration

  • ORENCIA ClickJect autoinjectors are intended for:
    • Subcutaneous use only and are not intended for intravenous infusion
    • Use under the guidance of a physician or healthcare practitioner
  • After proper training in subcutaneous injection technique, a patient or the patient’s caregiver may administer a subcutaneous injection of ORENCIA (ClickJect™ autoinjector) if a physician/healthcare practitioner determines that it is appropriate
  • Instruct patients and/or caregivers to follow the directions provided in the Instructions for Use for additional details on administration. Specifically instruct patients to inject the full amount (which provides the proper dose of ORENCIA), rotate injection sites, and to avoid injections into areas where the skin is tender, bruised, red, or hard
  • Visually inspect for particulate matter and discoloration prior to administration. Do not use ORENCIA ClickJect autoinjectors exhibiting particulate matter or discoloration. ORENCIA should be clear to slightly opalescent and colorless to pale yellow

ORENCIA ClickJect™ autoinjectors may be initiated without the need for an IV loading dose

125-mg SC injection is supplied in a prefilled syringe with BD UltraSafe Passive™ Needle Guard for once-weekly use.

For patients switching from ORENCIA intravenous infusions to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Device highlights

Accurate dose self-injection comes with push-button operation and confirmation that the full dose has been injected.

Important Safety Information
for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: 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% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis 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 pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). 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 intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. 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: Prior to initiating ORENCIA
in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA
or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of
some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. 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 COPD should
be undertaken with caution, and such
patients monitored for worsening of their
respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in
patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

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 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 pJIA patients were diarrhea, cough, pyrexia, and abdominal
pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information  

Reference: ORENCIA [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.