abatacept

REMS

Moderate to severely active rheumatoid arthritis in adults (as monotherapy or in combination with other disease modifying antirheumatic drugs, other than tumor-necrosis factor (TNF) inhibitors.
Moderate to severely active polyarticular juvenile idiopathic arthritis (as monotherapy or in combination with methotrexate).
Active psoriatic arthritis.
Prophylaxis of acute graft versus host disease in patients undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated-donor (in combination with a calcineurin inhibitor and methotrexate).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Concurrent use of TNF inhibitors or anakinra.

Use Cautiously in:

Chronic obstructive pulmonary disease (↑ risk of exacerbations and other adverse events);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children <18 yr (rheumatoid arthritis) or 2 yr (all other indications);
Geri: ↑risk of adverse reactions in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Neuro: headache, dizziness

Misc: infection (including cytomegalovirus and Epstein-Barr virus reactivation), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , infusion-related events, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with TNF antagonists may ↑ risk and severity of infections.
May ↑ risk of adverse reactions and ↓ effectiveness of live-virus vaccines.

Availability ⬆ ⬇

Lyophilized powder for IV administration: 250 mg/vial
Solution for SUBQ administration (prefilled syringes): 50 mg/0.4 mL; 87.5 mg/0.7 mL; 125 mg/mL
Solution for SUBQ administration (prefilled ClickJect autoinjector): 125 mg/mL

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis

IV (Adults >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Adults 60–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Adults <60 kg): 500 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
SC (Adults ): Treatment may be initiated with or without a single IV dose (according to weight-based dosing guidelines above); then give 125 mg SUBQ within 1 day; then give 125 mg SUBQ once weekly; if patient does not receive IV dose, initiate once weekly SUBQ injections; if transitioning from IV therapy, administer next scheduled dose as SUBQ injection.

Juvenile Idiopathic Arthritis

IV (Children ≥6 yr and >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Children ≥6 yr and 75–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Children ≥6 yr and <75 kg): 10 mg/kg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
SC (Children ≥2 yr and ≥50 kg): 125 mg once weekly.
SC (Children ≥2 yr and 25–<50 kg): 87.5 mg once weekly.
SC (Children ≥2 yr and 10–<25 kg): 50 mg once weekly.

Psoriatic Arthritis

IV (Adults >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Adults 60–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
IV (Adults <60 kg): 500 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
SC (Adults ): 125 mg once weekly.
SC (Children ≥2 yr and ≥50 kg): 125 mg once weekly.
SC (Children ≥2 yr and 25–<50 kg): 87.5 mg once weekly.
SC (Children ≥2 yr and 10–<25 kg): 50 mg once weekly.

Prophylaxis of Acute Graft Versus Host Disease

IV (Adults and Children ≥6 yr): 10 mg/kg (max dose = 1000 mg) on the day before transplantation; repeat dose on Days 5, 14, and 28 after transplantation.
IV (Children 2–<6 yr): 15 mg/kg on the day before transplantation, then 12 mg/kg on Days 5, 14, and 28 after transplantation.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits T-cell activation (and the inflammatory process) by binding to specific receptors.

Therapeutic effects:

Decreased progression of rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.
Improved survival and graft versus host disease-free survival in patients undergoing hematopoietic stem cell transplantation.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics (DMARDs)

Pharmacologic Classification: fusion proteins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 13 days.

Time/Action Profile ⬆ ⬇

(improvement in symptoms)

ROUTE	ONSET	PEAK	DURATION
IV	within 15 days–3 mo	6–12 mo	3 yr (maintenance of response)

Patient/Family Teaching ⬆ ⬇

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. Advise patients and parents that adults and 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 signs and symptoms of upper respiratory or other infections or hypersensitivity reactions occur. Therapy may need to be discontinued if serious infection occurs.
Inform patient of increased risk of malignancies, including skin cancer. Advise patient to examine skin regularly for new or changes in lesions. Notify health care professional if changes in skin are seen.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Caution patient to avoid breastfeeding during therapy.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2187- ORENCIA
  - 0003-2187-10- 1 VIAL, SINGLE-USE in 1 CELLO PACK (0003-2187-10) > 15 mL in 1 VIAL, SINGLE-USE

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2187- ORENCIA
  - 0003-2187-13- 1 VIAL, SINGLE-USE in 1 CARTON (0003-2187-13) > 15 mL in 1 VIAL, SINGLE-USE

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-11- 4 SYRINGE, GLASS in 1 CARTON (0003-2188-11) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-21- 1 SYRINGE, GLASS in 1 CARTON (0003-2188-21) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-50- 1 SYRINGE, GLASS in 1 CARTON (0003-2188-50) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-51- 4 SYRINGE, GLASS in 1 CARTON (0003-2188-51) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-90- 1 SYRINGE, GLASS in 1 CARTON (0003-2188-90) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2188- ORENCIA
  - 0003-2188-91- 1 SYRINGE, GLASS in 1 CARTON (0003-2188-91) > 1 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2814- ORENCIA
  - 0003-2814-11- 4 SYRINGE, GLASS in 1 CARTON (0003-2814-11) > .4 mL in 1 SYRINGE, GLASS

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2818- ORENCIA
  - 0003-2818-11- 4 SYRINGE, GLASS in 1 CARTON (0003-2818-11) > .7 mL in 1 SYRINGE, GLASS

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Indications ⬇