ABATACEPT(ORENCIA)

Pharmacologic class: Selective costimulation modulator
Therapeutic class: Antirheumatic
Pregnancy risk category C

MECHANISM OF 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

Injection: 125 mg/ml in prefilled syringes.

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

DOSAGE

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. Or, 500 mg I.V. as a loading dose followed by 125 mg subcutaneously within a day, followed by 125 mg subcutaneously once weekly.

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 Or 750 mg I.V. as a loading dose followed by 125 mg subcutaneously within a day, followed by 125 mg subcutaneously once weekly.

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. Or 1 g I.V. as a loading dose followed by 125 mg subcutaneously within a day, followed by 125 mg subcutaneously once weekly.

CONTRAINDICATIONS AND PRECAUTIONS

Hypersensitivity to drug.
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).

SIDE EFFECTS

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, pneumonia, wheezing, bronchitis, dyspnoea.

Skin: rash, flushing, urticaria, pruritus.

Other: herpes zoster, pain, injection site reactions, malignancies, infusion related reactions, hypersensitivity reaction.

PATIENT TEACHING

  • If patient will self-administer drug, tell him to follow exact directions for injection and proper disposal of needles and syringes.
  • 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.