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CIMZIA
Arthritis/rheumatic disorders
Colorectal disorders
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Drug Name:

CIMZIA Rx

Generic Name and Formulations:
Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free.

Company:
UCB Inc.

Therapeutic Use:

Indications for CIMZIA:

Treatment of adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), or active ankylosing spondylitis (AS).

Adult:

Rotate inj site. Give by SC inj in abdomen or thigh. RA or PsA: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every other week. Maintenance: may consider 400mg every 4 weeks. AS: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every 2 weeks or 400mg every 4 weeks.

Children:

Not established.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB or history of, those having risk factors for TB, and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Lymphoma and other malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). CHF (monitor). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Pregnancy. Nursing mothers.

Interactions:

Concomitant anakinra, abatacept, rituximab, etanercept, natalizumab, live or attenuated vaccines, other biological DMARDs or TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT).

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

Adverse Reactions:

Upper respiratory infections, rash, UTI; TB, HBV reactivation, other infections, malignancies (eg, lymphoma; esp. children), heart failure; rare: hypersensitivity reactions, neurological disorders, lupus-like syndrome with antibody formation.

Generic Availability:

NO

How Supplied:

Pack—1 (2 single-dose vials w. syringes, needles, supplies); Single-use prefilled syringes—2 (w. supplies); Prefilled Syringe Starter Kit—6 (w. supplies)

Indications for CIMZIA:

In moderately-to-severely active Crohn's disease: to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy.

Adult:

Rotate inj site. Give by SC inj in abdomen or thigh. 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4; maintenance 400mg every 4 weeks.

Children:

Not established.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB or history of, those having risk factors for TB, and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Lymphoma and other malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). CHF (monitor). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Pregnancy. Nursing mothers.

Interactions:

Concomitant anakinra, abatacept, rituximab, etanercept, natalizumab, live or attenuated vaccines, other biological DMARDs or TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT).

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

Adverse Reactions:

Upper respiratory infections, rash, UTI; TB, HBV reactivation, other infections, malignancies (eg, lymphoma; esp. children), heart failure; rare: hypersensitivity reactions, neurological disorders, lupus-like syndrome with antibody formation.

Generic Availability:

NO

How Supplied:

Pack—1 (2 single-dose vials w. syringes, needles, supplies); Single-use prefilled syringes—2 (w. supplies); Prefilled Syringe Starter Kit—6 (w. supplies)

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