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Abatacept

Pronunciation: a-BAT-a-sept
Class: Immunologic agent

Trade Names

Orencia
- Injection, lyophilized powder for solution 250 mg

Pharmacology

Decreases T cell proliferation and inhibits the production of the cytokines tumor necrosis factor (TNF) alpha, interferon-γ, and interleukin-2.

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Pharmacokinetics

Absorption

C max is 295 mcg/mL.

Distribution

Vd is 0.07 L/kg.

Elimination

Systemic Cl is 0.22 mL/h/kg; terminal t ½ is 13.1 days.

Special Populations

Renal 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.

Contraindications

Standard considerations.

Dosage and Administration

Adult Rheumatoid Arthritis
Adults

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.

General Advice

  • 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.

Storage/Stability

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.

Drug Interactions

Anakinra

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).

Adverse Reactions

Cardiovascular

Hypertension (7%).

CNS

Headache (18%); dizziness (9%); pyrexia (at least 5%).

Dermatologic

Rash (4%).

EENT

Nasopharyngitis (12%); rhinitis (less than 5%).

GI

Nausea (at least 10%); dyspepsia (6%); abdominal pain, diarrhea (at least 5%).

Genitourinary

UTI (5% to 13%).

Musculoskeletal

Back pain (7%).

Respiratory

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%).

Miscellaneous

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%).

Precautions

Monitor

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.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 yr of age.

Elderly

Use with caution because of higher incidence of infections and malignancies in elderly patients.

Hypersensitivity

Anaphylaxis, anaphylactoid reactions, hypotension, urticaria, and dyspnea have occurred.

COPD

Greater risk of respiratory adverse reactions (eg, COPD exacerbations, cough, dyspnea, rhonchi) during abatacept therapy.

Immunosuppression

May reduce T cell–mediated host defenses against infections and malignancies.

Infections

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.

Tuberculosis

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.

Overdosage

Symptoms

Doses up to 50 mg/kg IV have been administered without apparent toxicity.

Patient Information

  • 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.

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