Usual Adult Dose for Crohn's Disease - Acute

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter; treatment with 10 mg/kg IV may be considered for patients who respond and then lose their response

Comments:

• The infusion should be administered over a period of not less than 2 hours.
• For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg IV.
• Patients who do not respond by week 14 are unlikely to respond with continued dosing. Therapy should be discontinued in these patients.
• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Uses: To reduce symptoms and induce and maintain remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Crohn's Disease - Maintenance

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter; treatment with 10 mg/kg IV may be considered for patients who respond and then lose their response

Comments:

• The infusion should be administered over a period of not less than 2 hours.
• For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg IV.
• Patients who do not respond by week 14 are unlikely to respond with continued dosing. Therapy should be discontinued in these patients.
• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Uses: To reduce symptoms and induce and maintain remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Ulcerative Colitis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter

Comments:

• The infusion should be administered over a period of not less than 2 hours.
• Patients who do not respond by week 14 are unlikely to respond with continued dosing. Therapy should be discontinued in these patients.
• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: To reduce symptoms, induce and maintain remission and mucosal healing, and eliminate corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Usual Adult Dose for Rheumatoid Arthritis

3 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 3 mg/kg IV every 8 weeks thereafter; adjusting the dose up to 10 mg/kg IV every 8 weeks or treating as often as every 4 weeks may be considered for patients who have an incomplete response

Comments:

• This drug should be given in combination with methotrexate.
• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: In combination with methotrexate for reducing symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Ankylosing Spondylitis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 6 weeks thereafter

Use: To reduce symptoms in patients with active ankylosing spondylitis

Usual Adult Dose for Psoriatic Arthritis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter

Comments:

• This drug may be administered alone or in combination with methotrexate.
• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: To reduce symptoms of active arthritis, inhibit the progression of structural damage, and improve physical function in patients with psoriatic arthritis

Usual Adult Dose for Psoriasis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter

Comment:

• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: For the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate; this drug should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Usual Pediatric Dose for Crohn's Disease - Acute

6 years or older:
5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Comment:

• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: To reduce symptoms and induce and maintain remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy

Usual Pediatric Dose for Crohn's Disease - Maintenance

6 years or older:
5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Comment:

• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: To reduce symptoms and induce and maintain remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy

Usual Pediatric Dose for Ulcerative Colitis

6 years or older:
5 mg/kg as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Comment:

• Patients should be evaluated for active tuberculosis and tested for latent infection before initiating treatment and periodically during therapy.

Use: To reduce symptoms and induce and maintain remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Doses greater than 5 mg/kg should not be used in patients with moderate to severe heart failure (NYHA Class III/IV. Caution should be exercised in patients with mild heart failure (NYHA Class I/II). All patients should be closely monitored and therapy should be stopped if the patient develops new or worsening symptoms of heart failure.

Precautions

US BOXED WARNINGS:
SERIOUS INFECTIONS:

• Patients treated with this drug are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Therapy should be discontinued if a patient develops a serious infection or sepsis.
• Healthcare providers should perform a test for latent TB; if positive, treatment for TB should be started prior to starting therapy with this drug. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.

MALIGNANCY:

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including this drug.
• Cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Most cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males.

CONTRAINDICATIONS:

• The use of this drug at doses greater than 5 mg/kg is contraindicated in patients with moderate or severe heart failure
• This drug is contraindicated in patients with a previous severe hypersensitivity reaction to the active ingredient or any of the inactive ingredients or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness)

Safety and efficacy have not been established in patients younger than 6 years for Crohn's disease or ulcerative colitis. Safety and efficacy have not been established in patients younger than 18 years for all other indications.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The infusion solution should be administered over a period of not less than 2 hours through an infusion set with an inline, sterile, nonpyogenic, low-protein-binding filter (pore size of 1.2 microns or less).
• Adult patients who have tolerated 3 initial 2 hour infusions of infliximab may be considered for administration of subsequent infusions over a period of not less than 1 hour.

Storage requirements: Refer to the manufacturer's product information

Reconstitution/preparation techniques: Refer to the manufacturer's product information

IV compatibility: Refer to the manufacturer's product information

Monitoring:

• Patients should be monitored for 1 to 2 hours post infusion for acute infusion related reactions.
• Emergency equipment e.g., adrenaline, antihistamines, corticosteroids, and an artificial airway should be available.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?
• What are the new drugs for the treatment of plaque psoriasis?
• How many biosimilars have been approved in the United States?
• What is the mechanism of action of infliximab?
• What is the difference between Inflectra and Remicade?
• What is the difference between Renflexis and Remicade?
• What is the difference between Ixifi and Remicade?