INDICATIONS AND USAGE（适应症）

Crohn's Disease

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis

CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Psoriatic Arthritis

CIMZIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Ankylosing Spondylitis

CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis (AS).

Non-radiographic Axial Spondyloarthritis

CIMZIA is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Plaque Psoriasis

CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. 

DOSAGE（服用剂量）

CIMZIA is administered by subcutaneous injection . Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. When a 400 mg dose is needed (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.

The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded.

Crohn's Disease

The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

Rheumatoid Arthritis

The recommended dose of CIMZIA for adult patients with rheumatoid arthritis is 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg every 4 weeks can be considered.

Psoriatic Arthritis

The recommended dose of CIMZIA for adult patients with psoriatic arthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg every 4 weeks can be considered.

Ankylosing Spondylitis

The recommended dose of CIMZIA for adult patients with ankylosing spondylitis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.

Non-radiographic Axial Spondyloarthritis

The recommended dose of CIMZIA for adult patients with non-radiographic axial spondyloarthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.

Plaque Psoriasis

The recommended dose of CIMZIA for adults with moderate-to-severe plaque psoriasis is 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.

For some patients (with body weight ≤ 90 kg), CIMZIA 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week can be considered.

ADVERSE REACTIONS（不良反应）

Serious Infections

Malignancies

Heart Failure

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b4c2c9dc-a0bb-4d64-a667-a67ebe88392d/spl-doc?hl=Certolizumab#S16

Cimziainformation