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Uses

Rheumatoid Arthritis

Used alone or in combination with DMARDs other than tumor necrosis factor (TNF)-blocking agents or anakinra to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to slow progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more DMARDs (e.g., methotrexate, TNF-blocking agents).

Do not use concomitantly with TNF blocking agents (e.g., adalimumab, etanercept, infliximab) or anakinra. (See Infectious Complications under Cautions and see Specific Drugs under Interactions.)

Dosage and Administration

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Administer with an in-line, sterile, nonpyrogenic, low-protein-binding filter with a pore diameter ≤1.2 mcm.

Consult manufacturer’s labeling for additional information on reconstitution, dilution, and administration.

Reconstitution

Determine the number of vials needed to achieve the proper dosage. Reconstitute each vial containing 250 mg of abatacept lyophilized powder with 10 mL of sterile water for injection to provide a solution containing 25 mg/mL.

Use only the silicone-free disposable syringe provided by the manufacturer and an 18- to 21-gauge needle. If a siliconized syringe is inadvertently used, translucent particles may develop and solution should be discarded.

Direct sterile water for injection toward the side of the vial during reconstitution; swirl gently to minimize foaming. Do not shake. Upon dissolution, insert a vented needle into the vial to dissipate foam. Must be diluted further before IV administration.

Dilution

Remove the volume of diluent equal to the total required volume of reconstituted abatacept solution from a 100-mL bag of 0.9% sodium chloride injection.

Using same silicone-free disposable syringe used for reconstitution, slowly add reconstituted abatacept to the bag to a total volume of 100 mL; mix gently. Concentration of the solution for infusion should be 5, 7.5, or 10 mg/mL depending on the number of vials of abatacept used (2, 3, or 4, respectively).

Rate of Administration

Infuse over 30 minutes.

Dosage

Adults

Rheumatoid Arthritis

IV

Adults weighing <60 kg: 500 mg at 0, 2, and 4 weeks, then every 4 weeks.

Adults weighing 60–100 kg: 750 mg at 0, 2, and 4 weeks, then every 4 weeks.

Adults weighing >100 kg: 1 g at 0, 2, and 4 weeks, then every 4 weeks.

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to abatacept or any ingredient in the formulation.

Warnings/Precautions

Warnings

Infectious Complications

Serious infections (including pneumonia, cellulitis, urinary tract infections, bronchitis, diverticulitis, and acute pyelonephritis) reported, particularly in patients receiving concomitant TNF-blocking agents (e.g., adalimumab, etanercept, infliximab).

Concomitant use of abatacept and TNF-blocking agents is not recommended. Monitor patients being switched from TNF-blocking agents to abatacept for infection. (See Specific Drugs under Interactions.)

Discontinue abatacept if serious infection develops. Closely monitor patients who develop new infections.

Use caution in patients with a history of recurring infections, underlying conditions that may predispose them to infections, or chronic, latent, or localized infections.

Evaluate all patients for active or latent tuberculosis prior to initiation of abatacept therapy. When indicated, initiate appropriate antimycobacterial regimen for the treatment of latent tuberculosis infection prior to abatacept.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis or anaphylactoid reactions reported. Other allergic reactions (e.g., hypotension, urticaria, dyspnea) reported rarely.

If serious hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).

Acute Infusion Reactions

Acute infusion reactions (e.g., dizziness, headache, hypertension, hypotension, dyspnea, nausea, flushing, urticaria, cough, pruritus, rash, wheezing) reported within 1 hour after IV infusion.

General Precautions

Vaccination

Vaccine efficacy may be reduced; avoid live virus vaccines during abatacept therapy or within 3 months after discontinuance of the drug. (See Vaccines under Interactions.)

COPD

Possible exacerbations of COPD, cough, rhonchi, and dyspnea.

Use with caution; careful monitoring recommended for worsening of respiratory function.

Immunosuppression

Possibility exists for agents that inhibit T-cell activation, including abatacept, to affect host defenses against infection and malignancies. (See Infectious Complications and also see Malignancies and Lymphoproliferative Disorders under Cautions.)

Malignancies and Lymphoproliferative Disorders

Lymphoma and lung cancer reported more frequently in patients receiving abatacept versus control. Rheumatoid arthritis patients, especially those with highly active disease, may be at increased risk of lymphoma.

Other malignancies (e.g., myelodysplastic syndrome, melanoma, breast, bile duct, bladder, cervical, endometrial, ovarian, prostate, renal, thyroid, uterine, and nonmelanoma skin cancer) also reported.

Role of abatacept in the development and course of malignancies not fully determined.

Immunogenicity

Antibodies to abatacept may develop; not associated with decreased clinical response or increased adverse events.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.

Possible increased incidence of infections and malignancies in geriatric patients; use with caution.(See Infectious Complications and also Malignancies and Lymphoproliferative Disorders under Cautions.)

Common Adverse Effects

Upper respiratory infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, bronchitis, acute infusion reactions, headache, nausea, back pain, cough, dizziness, hypertension, dyspepsia.