Class: Immunologic agent
- Injection, lyophilized powder for solution 250 mg
Decreases T cell proliferation and inhibits the production of the cytokines tumor necrosis factor (TNF) alpha, interferon-γ, and interleukin-2.
C max is 295 mcg/mL.
Vd is 0.07 L/kg.
Systemic Cl is 0.22 mL/h/kg; terminal t ½ is 13.1 days.
Special PopulationsRenal Function Impairment
No formal studies were conducted.Hepatic Function Impairment
No formal studies were conducted.
Indications and Usage
Reducing signs and symptoms, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis; reducing signs and symptoms in children 6 yr of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept may be used as monotherapy or concomitantly with methotrexate.
Dosage and AdministrationAdult Rheumatoid Arthritis
IV Dose based on weight: Less than 60 kg, 500 mg; 60 to 100 kg, 750 mg; more than 100 kg, 1 g. Subsequent doses at 2 wk, 4 wk, and every 4 wk thereafter.Juvenile Idiopathic Arthritis
Children 6 yr of age and older
IV Dose based on weight: Less than 75 kg, administer 10 mg/kg; 75 kg or more should be administered based on adult regimen (max, 1,000 mg/dose). Following the initial administration, give subsequent doses 2 and 4 wk after the first infusion and every 4 wk thereafter.
- For IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
- Administer each dose as a 30-min infusion.
- Reconstitute powder for injection with 10 mL of sterile water for injection using only the silicone-free disposable syringe provided. Do not use the vial if the vacuum is not present. Rotate vial with gentle swirling until contents completely dissolve. Avoid prolonged or vigorous agitation. Do not shake. Vent the vial with a needle to dissipate any foam that may be present.
- Reconstituted solution must be further diluted to 100 mL. Discard any unused portions in vials.
- Do not infuse concurrently in the same IV line with other agents.
Store unopened vials in refrigerator (36° to 46°F). Protect from light. Infusion of fully diluted abatacept solution must be completed within 24 h of reconstitution of the abatacept vials. If not used immediately, fully diluted abatacept solution may be stored at room temperature or in refrigerator before use.
Concurrent use is not recommended.Immunizations
Do not administer live vaccines during treatment or for 3 mo following discontinuation of abatacept treatment.TNF antagonists
Increased risk of infections. Concurrent therapy is not recommended.
Laboratory Test Interactions
Maltose present in this product may interfere with readings of blood glucose using glucose dehydrogenase pyrroloquinoline quinone, resulting in falsely elevating blood glucose readings on the day of infusion. Consider use of tests not reacting with maltose (eg, glucose oxidase method).
Headache (18%); dizziness (9%); pyrexia (at least 5%).
Nasopharyngitis (12%); rhinitis (less than 5%).
Nausea (at least 10%); dyspepsia (6%); abdominal pain, diarrhea (at least 5%).
UTI (5% to 13%).
Back pain (7%).
Respiratory disorders, including COPD exacerbation, cough, dyspnea, and rhonchi (43%); upper respiratory tract infection (at least 10%); bronchitis, sinusitis (5% to 13%); cough (8%); pneumonia (less than 5%).
Influenza (5% to 13%); herpes simplex (less than 5%); pain in extremity (3%); acute infusion-related events (including dizziness, headache, and hypertension (1% to 2%); malignancies (including melanoma and myelodysplastic syndrome; bile duct, bladder, breast, cervical, endometrial, lung, ovarian, prostate, renal, skin, thyroid, and uterine cancer) (1%).
When transitioning from TNF antagonist therapy to abatacept, monitor patients for signs of infection. Closely monitor patients who develop a new infection during therapy. Monitor COPD patients closely for worsening of their respiratory status.
Category C .
Safety and efficacy not established in children younger than 6 yr of age.
Use with caution because of higher incidence of infections and malignancies in elderly patients.
Anaphylaxis, anaphylactoid reactions, hypotension, urticaria, and dyspnea have occurred.
Greater risk of respiratory adverse reactions (eg, COPD exacerbations, cough, dyspnea, rhonchi) during abatacept therapy.
May reduce T cell–mediated host defenses against infections and malignancies.
Use with caution in patients with history of recurrent infections, underlying conditions that predispose to infections, or chronic, latent, or localized infections. Discontinue therapy if serious infection develops.
Screen all patients for latent tuberculosis with a tuberculin skin test before starting abatacept therapy. Treat patients testing positive by standard medical practice prior to therapy with abatacept.
Doses up to 50 mg/kg IV have been administered without apparent toxicity.
- Advise patient that medication will be prepared and administered by health care provider in a medical setting.
- Advise patient to review the patient information leaflet carefully before starting therapy and to read and check for new information prior to each treatment session.
- Instruct patient to immediately notify health care provider if any of the following occur: signs or symptoms of infection (eg, chills, diarrhea, fever, rash, sore throat, or redness, swelling, or pain around a cut or open sore), rash, hives, difficulty breathing or unexplained shortness of breath, wheezing, and/or swelling of throat or around mouth or eyes.
- Inform patients that live vaccines should not be given with abatacept or within 3 mo of its discontinuation.
- Advise diabetic patients that abatacept can give falsely elevated blood glucose readings.
Copyright © 2009 Wolters Kluwer Health.