Pronunciation: Online audio
- Reduction of signs/symptoms and disease progression in moderate to severely active rheumatoid arthritis in adults (to be used as monotherapy or in with other disease modifying antirheumatic drugs (DMARDS), other than tumor-necrosis factor (TNF) inhibitors.
- Reduction of signs/symptoms in children (≥6 yr) with moderate to severely active polyarticular juvenile idiopathic arthritis (to be used as monotherapy or with methotrexate).
Inhibits T cell activation (and the inflammatory process) by binding to specific receptors.
Decreased progression of rheumatoid arthritis.
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Unknown.
Half-life: 13 days.
TIME/ACTION PROFILE (improvement in symptoms)
|IV||within 15 days–3 mo||6–12 mo||3 yr (maintenance of response)|
- Concurrent use of tumor necrosis factor (TNF) antagonists or anakinra
- Lactation: Discontinue drug or provide formula.
Use Cautiously in:
- Patients with chronic obstructive pulmonary disease (↑ risk of exacerbations and other adverse events)
- Geri: ↑ risk of adverse reactions
- Pedi: Children <6 yr (safety not established)
- OB: Use only if clearly needed.
Adverse Reactions/Side Effects
CNS: headache, dizziness
Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFECTIONS, infusion-related events
* CAPITALS indicate life-threatening.
Italics indicate most frequent.
- Concurrent use with tumor necrosis factor (TNF) antagonists may ↑ risk and severity of infections.
IV: (Adults) <60 kg–500 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter; 60–100 kg–750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter; >100 kg–1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter.
SC: (Adults) Patient should receive single IV dose (according to weight-based dosing guidelines above), then give 125 mg subcut within 1 day, then give 125 mg subcut once weekly; if patient cannot receive IV dose, initiate once weekly subcut injections; if transitioning from IV therapy, administer next scheduled dose as subcut injection.
Juvenile Idiopathic Arthritis
IV: (Children 6–17 yr and ≥75 kg): 75–100 kg–750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter; >100 kg–1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter.
IV: (Children 6–17 yr and <75 kg): 10 mg/kg initially; repeat dose at 2 wk and 4 wk after initial dose, then q 4 wk thereafter.
Lyophilized powder for IV administration: 250 mg/vial
Solution for subcut administration (prefilled syringes): 125 mg/syringe
- Assess range of motion, degree of swelling, and pain in affected joints before and periodically during therapy.
- Assess for infusion-related reaction (dizziness, headache, hypertension) and signs of allergic reaction (hypotension, urticaria, dyspnea). Infusion-related reactions usually occur within 1 hr of start of infusion. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
- Assess for latent tuberculosis with a tuberculin skin test. If positive, tuberculosis should be treated prior to abatacept therapy.
- Assess health status at each session. Monitor patients who develop a new infection while taking abatacept closely. Discontinue therapy in patients who develop a serious infection or sepsis. Do not initiate therapy in patients with active infections.
Lab Test Considerations:
Pre-screen patient for viral hepatitis prior to therapy; may reactivate hepatitis. If test is positive, do not start abatacept.
- Patients receiving IV abatacept may record false positive blood glucose due to maltose in injection; discuss with health care professional.
- Do not confuse Orencia with Oracea.
- SC: Remove prefilled syringe from refrigerator and allow to reach room temperature for 30–60 min; do not use other methods to warm solution. Leave needle cover on during warming. Inspect solution; do not administer solutions that are discolored, contain particulate matter; are expired, or do not have the correct amount of fluid in syringe. Front of thigh is the preferred site; abdomen except for 2 inches from navel or upper arm if administered by caregiver, may also be used. Pinch skin and inject at a 45° angle. Do not rub injection site. Rotate each injection at least 1 inch from last injection, avoid areas where skin is tender, bruised, red, or hard, or contains scars or stretch marks.
- Intermittent Infusion: Reconstitute each vial with 10 mL of Sterile Water for Injection, using ONLY the SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL and an 18–21 gauge needle for a concentration of 25 mg/mL. Discard solutions prepared using siliconized syringes. Additional silicone-free syringes are available from manufacturer. Direct stream of sterile water to side of vial. Rotate vial by gently swirling to minimize foaming. Do no shake. Upon dissolution, vent vial to dissipate foam. Solution should be clear and colorless to pale yellow. Do not use solutions that are discolored or contain particulate matter. Diluent: Further dilute solution to 100 mL of 0.9% NaCl by withdrawing volume of abatacept solution from 100 mL infusion bag or bottle. Slowly add reconstituted solution using the same SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL. Mix gently. Concentration Concentration will be 5, 7.5, or 10 mg/mL depending on whether 2, 3, or 4 vials were used. Discard unused portion of vial. Infusion must be completed within 24 hr of reconstitution. Diluted solution may be stored at room temperature or refrigerated before use.
- Rate: Administer over 30 min with a sterile non-pyrogenic, low-protein-binding filter with a 0.2–1.2 micron pore size.
- Y-Site IncompatibilityDo not infuse in same infusion line as other agents.
- Instruct patient on purpose of abatacept. Advise patient to read the Orencia Patient Information leaflet prior to each session. Provide an opportunity for patient to ask questions. If a dose is missed, ask health care professional when to schedule next dose.
- Advise patient not to receive live vaccines during or 3 mo following therapy. Parents should be advised that children should complete immunizations to date before initiation of abatacept.
- Advise patient that methotrexate, analgesics, NSAIDs, corticosteroids, and salicylates may be continued during therapy.
- Instruct patient that abatacept should not be taken with TNF antagonists may increase risk for infections.
- Instruct patient to notify health care professional if upper respiratory or other infections occur. Therapy may need to be discontinued if serious infection occurs.
- Advise patient to notify health care professional if pregnancy is planned or suspected. Caution patient to avoid breastfeeding during therapy.
Reduction in symptoms of rheumatoid arthritis.