Orencia

Orencia,

a trademark for abatacept.

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abatacept

Orencia

Pharmacologic class: Selective costimulation modulator

Therapeutic class: Antirheumatic

Pregnancy risk category C

Action

Inhibits T-cell activation by binding to CD80 and CD86, blocking interaction with CD28. (This interaction triggers costimulatory signal necessary for full activation of T cells, which are implicated in rheumatoid arthritis pathogenesis).

Availability

Powder for infusion (lyophilized): 250 mg/15 ml in single-use vial

⊘Indications and dosages

➣ To reduce signs and symptoms, slow progression of structural damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis who've responded inadequately to one or more disease-modifying antirheumatic drugs or tumor necrosis factor (TNF) antagonists (such as adalimumab, etanercept, or infliximab)

Adults weighing less than 60 kg (132 lb): 500 mg I.V. given over 30 minutes at weeks 0, 2, and 4; thereafter, give every 4 weeks

Adults weighing 60 to 100 kg (132 to 220 lb): 750 mg I.V. given over 30 minutes at weeks 0, 2, and 4; thereafter, give every 4 weeks

Adults weighing more than 100 kg: 1 g I.V. given over 30 minutes at weeks 0, 2, and 4; thereafter, give every 4 weeks

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• increased risk of infection or history of recurrent infections, immunocompromised state, chronic obstructive pulmonary disease (COPD)
• concurrent use of concomitant TNF antagonists
• patients older than age 65
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

☞ Reconstitute each vial with 10 ml sterile water for injection, using only silicone-free disposable syringe included with product.
☞ During reconstitution, rotate vial by swirling gently. Avoid prolonged or vigorous agitation. Don't shake.
• Further dilute reconstituted solution to volume of 100 ml with normal saline solution.
• Use silicone-free syringe to add drug to infusion bag or bottle, and mix gently. Resulting drug concentration should be 5 mg/ml for two vials, 7.5 mg/ml for three vials, or 10 mg/ml for four vials, respectively.
• Administer infusion over 30 minutes using infusion set and nonpyogenic, low-protein-binding filter.
• Complete infusion within 24 hours of vial reconstitution.
• Don't infuse other drugs concurrently through same I.V. line.
• Watch for infusion-related reactions (hypotension or hypertension, dyspnea, nausea, dizziness, headache, flushing, urticaria, pruritus, rash, cough, or wheezing), which usually occur within 1 hour of administration. Be prepared to intervene appropriately.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: headache, dizziness

CV: hypertension, hypotension

EENT: nasopharyngitis

GI: nausea, dyspepsia, diverticulitis

GU: urinary tract infection, acute pyelonephritis

Musculoskeletal: back pain, extremity pain

Respiratory: cough, upper respiratory tract infection (including herpes zoster infection), pneumonia, wheezing, bronchitis, dyspnea

Skin: rash, flushing, urticaria, pruritus

Other: malignancies, infusion-related reactions, hypersensitivity reaction

Interactions

Drug-drug. Immunizations: possible decrease in immunization efficacy

Patient monitoring

• Continue to monitor patient for infusion-related events.
• Assess patient's overall health at each visit to evaluate infection status.
• Closely monitor COPD patient because of increased likelihood of adverse events.

Patient teaching

• Instruct patient to report signs and symptoms of infection.
• Caution patient to avoid immunizations during or within 3 months of stopping drug.
• Tell female with childbearing potential that pregnancy and breastfeeding aren't recommended during therapy.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.