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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Crohn’s Disease

Used to reduce signs and symptoms of Crohn’s disease and to induce and maintain clinical remission in adults with moderate to severe active disease who have had an inadequate response to conventional therapies (e.g., corticosteroids, mesalamine or sulfasalazine, azathioprine or mercaptopurine).

Used to reduce the number of draining enterocutaneous and rectovaginal fistulas and to maintain fistula closure in adults with fistulizing Crohn’s disease (designated an orphan drug by FDA for this use). Consider use when fistulas have not responded to appropriate anti-infective regimens (e.g., ciprofloxacin and/or metronidazole) and/or immunosuppressive therapy (e.g., azathioprine or mercaptopurine).

Has been used for the management of signs and symptoms of active Crohn’s disease in a limited number of children ≥6 years of age†. Under investigation for this use.

Rheumatoid Arthritis in Adults

Used in conjunction with methotrexate to manage the signs and symptoms of rheumatoid arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.

Ankylosing Spondylitis

Management of the signs and symptoms of active ankylosing spondylitis.

Psoriatic Arthritis

Used to manage the signs and symptoms of active arthritis in adults with psoriatic arthritis.

Ulcerative Colitis

Used to manage the signs and symptoms, to achieve clinical remission and mucosal healing, and to eliminate corticosteroid use in adults with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapies.

Juvenile Arthritis

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Has been used with some success in a limited number of adults and pediatric patients with juvenile arthritis†.

Behcet’s Syndrome

Has been used in a limited number of patients with Behcet’s syndrome†.

Dosage and Administration

General

Premedication and Patient Monitoring

• Consider administration of premedication prior to each dose to minimize risk of infusion-related reactions.
• Patients receiving initial infusion and patients without a history of acute infusion reactions: Oral diphenhydramine hydrochloride (25–50 mg) and acetaminophen (650 mg) can be given before the infusion.
• Patients with a history of acute infusion reactions: Oral or IV prednisone (40 mg) or hydrocortisone (100 mg), oral or IV diphenhydramine hydrochloride (25–50 mg), and acetaminophen (650 mg) can be given before the infusion.
• Monitor patients closely during and after each IV infusion. Measure vital signs (pulse and BP) immediately prior to infusion, during the infusion (every 30 minutes in patients without a history of acute infusion reactions and every 15 minutes in those with a history of reactions), and for 30 minutes after completion of the infusion.
• If DBP drops 15–20 mm Hg or symptoms of hypersensitivity (e.g., urticaria, shortness of breath) occur, stop the infusion immediately, evaluate manifestations, and initiate appropriate therapy.
• If the reaction is not severe and is mitigated with a regimen of oral diphenhydramine hydrochloride (25–50 mg), oral acetaminophen (650 mg), and oral or IV prednisone (40 mg), the infusion may be resumed with caution following the rate titration schedule using an initial rate of 10 mL/hour. (See Rate Titration Schedule Table under Dosage and Administration.)
• The infusion should be discontinued and not completed if the reaction does not resolve with the regimen described above or is more severe and/or requires treatment with epinephrine.

Crohn’s Disease

• Corticosteroids, mesalamine, sulfasalazine, azathioprine, mercaptopurine, methotrexate, and anti-infective agents may be continued.

Rheumatoid Arthritis

• Intended for use concomitantly with methotrexate; only limited data available regarding the efficacy of infliximab without concomitant methotrexate.
• Corticosteroids and NSAIAs may be continued.

Psoriatic Arthritis

• Corticosteroids, NSAIAs, and methotrexate may be continued.

Ulcerative Colitis

• Corticosteroids, azathioprine, mercaptopurine, and 5-aminosalicylates may be continued.

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 of ≤1.2 mcm.

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

Reconstitution

Reconstitute vial containing 100 mg of infliximab powder with 10 mL of sterile water for injection to provide a solution containing 10 mg/mL. Reconstitute the number of vials needed to provide the indicated dosage of infliximab.

Direct diluent toward the side of the vial with a sterile syringe and a ≤21-gauge needle; swirl vial gently to ensure dissolution; do not shake or agitate vigorously (to avoid foaming).

Allow reconstituted solution to stand for 5 minutes before dilution.

Dilution

Remove the volume of diluent equal to the total required volume of reconstituted infliximab solution from a 250-mL bag or bottle of 0.9% sodium chloride injection. Slowly add reconstituted infliximab to the bag to a total volume of 250 mL; mix gently. Concentration of the solution for infusion should be 0.4–4 mg/mL.

Rate of Administration

Infuse over a period of at least 2 hours.

IV infusions may be given at a rate of 2 mL/minute or, alternatively, a rate titration schedule may be used in an attempt to prevent or ameliorate acute infusion reactions.

A rate titration schedule can be used in patients receiving an initial infliximab dose, those without a history of acute infusion reactions, and those with a history of such reactions.

Dosage

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Crohn’s Disease

IV

Children ≥ 6 years of age: 5 mg/kg. Pediatric patients have received 1–3 doses over a 12-week period.†

Adults

Crohn’s Disease

Management of Moderate or Severe Active Crohn’s Disease or Fistulizing Crohn’s Disease

IV

5 mg/kg at 0, 2, and 6 weeks (induction regimen), then every 8 weeks (maintenance regimen).

Consider dose of 10 mg/kg for patients who respond initially but subsequently lose response.

Patients who do not respond by week 14 are unlikely to respond with continued administration; consider discontinuing the drug.

Rheumatoid Arthritis

Moderate to Severe Active Rheumatoid Arthritis

IV

3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

Increase dosage up to 10 mg/kg and/or administer as often as once every 4 weeks for patients who have an incomplete response to 3 mg/kg; consider that risk of serious infection is increased with higher dosages.

Ankylosing Spondylitis

IV

5 mg/kg at 0, 2, and 6 weeks, then every 6 weeks.

Psoriatic Arthritis

IV

5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

Ulcerative Colitis

Moderate to Severe Active Ulcerative Colitis

IV

5 mg/kg at 0, 2, and 6 weeks (induction regimen), then every 8 weeks (maintenance regimen).