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This site is intended for US-based Health Care Professionals only.
Learn more about ORENCIA for patients >/= 2 years of age with active psoriatic arthritis (PsA)
Is it time to consider another treatment option for your patients with active psoriatic arthritis?
ORENCIA was studied in 2 clinical trials in adults with active psoriatic arthritis.
The safety and effectiveness of subcutaneous ORENCIA have been established for treatment of psoriatic arthritis in pediatric patients 2 to 17 years old. Use of ORENCIA in this age group is supported by evidence from adequate and well-controlled studies of ORENCIA in adults with PsA, pharmacokinetic data from adult patients with RA, adult patients with PsA, and pediatric patients with pJIA, and safety data from clinical studies in pediatric patients 2 to 17 years old with pJIA using the subcutaneous formulation.
IV, intravenous; SC, subcutaneous.
ORENCIA IV is a 30-minute infusion for adults with active PsA
4-week dosing schedule
Following the starter doses, ORENCIA IV is maintained with a regular
*Actual day of dosing may vary based on patient scheduling.
IV administration is not approved for pediatric patients with psoriatic athritis1
Adult weight-based dosing
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
ORENCIA SC allows patients once-weekly
self-injection at home
125-mg SC injection is supplied in a prefilled syringe with BD UltraSafe Passive™ needle guard for once-weekly use.
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 provider
- 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 provider 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
- 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
Pediatric patients with psoriatic arthritis may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determine it is appropriate.
ORENCIA SC may be initiated with or without an IV loading dose
- For patients initiating therapy with an IV loading dose, administer ORENCIA as a single IV infusion (as per body weight categories below), followed by the first ORENCIA SC injection administered within 1 day of the IV infusion
- Patients switching from ORENCIA IV to ORENCIA SC administration should take their first SC dose instead of their next scheduled IV dose
Weight-based dosing for patients 2 years of age and older
Pediatric patients with pJIA or PSA may self-inject with ORENCIA or the patient's
caregiver may administer ORENCIA if both the healthcare provider and the
parent/legal guardian determine it is appropriate. The ability of pediatric patients
to self-inject with the autoinjector has not been tested. ORENCIA SC should be
initiated without an IV loading dose in patients with pJIA.
Device highlights*
*125-mg syringe shown (29-gauge needle).
*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.
The ability of pediatric patients to self-inject with the autoinjector has not been tested.
Recommendations for subcutaneous administration
- ORENCIA ClickJectTM autoinjectors are intended for:
- Subcutaneous use only and are not intended for intravenous infusion
- Use under the guidance of a physician or healthcare practitioner
- Do not twist cap
- 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
Pediatric patients with psoriatic arthritis may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determine it is appropriate.
ORENCIA SC may be initiated with or without an IV loading dose
- For patients initiating therapy with an IV loading dose, administer ORENCIA as a single IV infusion (as per body weight categories above), followed by the first ORENCIA SC injection administered within 1 day of the IV infusion
- Patients switching from ORENCIA IV to ORENCIA SC administration should take their first SC dose instead of their next scheduled IV dose
ORENCIA for active PsA?
and administration options for adult patients, explore the guide
to ORENCIA in active PsA.
ORENCIA for active PsA?