• Moderately-to-severely active Crohn's disease when response to conventional therapy has been inadequate.
• Moderately-to-severely active rheumatoid arthritis.
• Active psoriatic arthritis
• Active ankylosing spondylitis

Contraindicated in:

• Active infection (including localized)
• Concurrent use of anakinra.

Use Cautiously in:

• History of chronic or recurrent infection or underlying illness/treatment predisposing to infection
• History of exposure to tuberculosis
• History of opportunistic infection
• Patients residing, or who have resided, where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic
• History of demyelinating disorders (may exacerbate)
• History of heart failure
• Geri: May ↑ risk of infections
• OB: Use in pregnancy only if clearly needed; avoid breast feeding
• Pedi: Safety not established; ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL] in patients with Crohn's disease), leukemia, and other malignancies.

Derm: psoriasis, skin reactions (rarely severe).

Hemat: hematologic reactions.

MS: arthralgia.

Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS AND ANGIOEDEMA, infections (including reactivation tuberculosis, hepatitis B reactivation, and other opportunistic infections due to bacterial, invasive fungal, viral, mycobacterial, and parasitic pathogens), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER), lupus-like syndrome.

Drug-Drug:

• Concurrent use with anakinra↑ risk of serious infections (contraindicated).
• Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
• May ↓ antibody response to or ↑ risk of adverse reactions to live vaccines (contraindicated).

• Lyophilized powder for subcutaneous injection (requires reconstitution): 200 mg/vial;
• Prefilled syringe: 200 mg/mL;

Crohn's Disease

• SC (Adults): 400 mg initially, repeat 2 and 4 wk later; may be followed by maintenance dose of 400 mg every 4 wk.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

• SC (Adults): 400 mg initially, repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk (400 mg every 4 wk may be used alternatively).

Cimzia

• Neutralizes tumor necrosis factor (TNF), a prime mediator of inflammation; pegylation provides a long duration of action.

• Decreased signs/symptoms of Crohn's disease.
• Decreased pain and swelling, decreased rate of joint destruction and improved physical function in rheumatoid arthritis.
• Decreased joint swelling and pain in psoriatic arthritis
• Decreased spinal pain and inflammation in ankylosing spondylitis

Therapeutic Classification: gastrointestinal anti-inflammatories, antirheumatics

Pharmacologic Classification: tumor necrosis factor blockers, dmards, monoclonal antibodies

Category B

Absorption: 80% absorbed following SC administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 14 days.

(blood levels)

• Advise patient of potential benefits and risks of certolizumab. Advise patient to read the Medication Guide prior to starting therapy.
• Inform patient of risk of infection. Advise patient to notify health care professional if symptoms of infection (fever, cough, flu-like symptoms, or open cuts or sores), including TB or reactivation of HBV infection, occur.
• Counsel patient about possible risk of lymphoma and other malignancies while receiving certolizumab.
• Advise patient to notify health care professional if signs of hypersensitivity reactions (rash, swollen face, difficulty breathing), or new or worsening medical conditions such as heart or neurological disease or autoimmune disorders occur and to report signs of bone marrow depression (bruising, bleeding, or persistent failure).
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional prior to taking any Rx, OTC, vitamins, or herbal products.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

ser-toe-LIZ-u-mab pey-GOL

NDC Code^*

• 50474- UCB, Inc.
  • 50474-700- Cimzia
    • 50474-700-61- 2 KIT in 1 CARTON (50474-700-61) > 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

• 50474- UCB, Inc.
  • 50474-700- Cimzia
    • 50474-700-62- 2 KIT in 1 CARTON (50474-700-62) > 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

• 50474- UCB, Inc.
  • 50474-710- Cimzia
    • 50474-710-79- 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) > 1 mL in 1 SYRINGE, GLASS

• 50474- UCB, Inc.
  • 50474-710- Cimzia
    • 50474-710-80- 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) > 1 mL in 1 SYRINGE, GLASS

• 50474- UCB, Inc.
  • 50474-710- Cimzia
    • 50474-710-81- 3 CARTON in 1 BOX (50474-710-81) > 2 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS