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Explore ORENCIA for moderate to severe polyarticular juvenille idiopathic arthritis (pJIA)
Is it time to consider another treatment option in moderate to severe pJIA?
ORENCIA was studied in 2 registrational clinical trials in moderate
to severe pJIA
ORENCIA offers the flexibility of subcutaneous (SC) or intravenous (IV) administration for patients with moderate to severe pJIA
ORENCIA IV−only for patients 6 years of age and older (ORENCIA SC is only for patients
2 years of age and older)
ORENCIA IV is administered as a 30-minute infusion
- <75 kg = 10 mg/kg based on body weight at each visit
- ≥75 kg = administer per the adult weight-based dosing schedule (shown below), not to exceed maximum dose of 1000 mg
Dosing schedule
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.
Immediately discard any unused portion in the vials.
Adult weight-based dosing
Each vial provides 250 mg of abatacept for administration.
Selected Important
Safety Information
Increased Risk of Infection with 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−only for patients 2 years of age and older
Once-weekly ORENCIA SC is administered with a prefilled syringe.
- pH levels of 6.8 to 7.4
ORENCIA SC should be initiated without an
IV
loading dose.
Weight-based prefilled syringes for patients
2
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.
Selected Important
Safety Information
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.
severe pJIA
information, and the administration options.
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severe pJIA
information, and the administration options.
If you need Adobe Reader, click the link below to
download
the free reader.
Link to Adobe Reader Download page.
Registry Brochure
If you need Adobe Reader, click the link below to
download
the free reader.
Link to Adobe Reader Download page.