Cimzia injection for inflammatory diseases including Crohn's and arthritis

Cimzia is an injectable medication used to treat several inflammatory conditions by blocking a protein called tumor necrosis factor (TNF). It is prescribed for adults and children aged 2 years and older to reduce symptoms and maintain response in Crohn's disease, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and moderate-to-severe plaque psoriasis.

• Crohn's disease: For adults with moderately to severely active disease unresponsive to conventional therapy to reduce symptoms and maintain response.
• Rheumatoid arthritis: For adults with moderately to severely active disease.
• Polyarticular juvenile idiopathic arthritis (pJIA): For active disease in patients 2 years and older.
• Psoriatic arthritis: For adults with active disease.
• Ankylosing spondylitis: For adults with active disease.
• Non-radiographic axial spondyloarthritis: For adults with active disease and objective signs of inflammation.
• Plaque psoriasis: For adults with moderate-to-severe disease who are candidates for systemic therapy or phototherapy.

certolizumab pegol

Cimzia works by blocking tumor necrosis factor (TNF), a protein in the immune system that causes inflammation in certain diseases. By inhibiting TNF, Cimzia helps reduce inflammation, leading to decreased symptoms in inflammatory conditions such as Crohn's disease and various forms of arthritis and psoriasis.

General Administration

Cimzia is given as a subcutaneous injection. Injection sites should be rotated, avoiding areas with tender, bruised, red, or hardened skin.

Crohn's Disease (Adults)

400 mg (two 200 mg injections) initially, then at weeks 2 and 4. For patients who respond, 400 mg every 4 weeks maintenance.

Rheumatoid Arthritis (Adults)

400 mg (two 200 mg injections) initially and at weeks 2 and 4, followed by 200 mg every other week. Maintenance of 400 mg every 4 weeks can be considered.

Polyarticular Juvenile Idiopathic Arthritis (Patients ≥2 years)

Doses below 200 mg require healthcare professional administration using vial kits; self-injection available only for doses 200 mg or higher.

Psoriatic Arthritis (Adults)

400 mg (two 200 mg injections) initially, at weeks 2 and 4, then 200 mg every other week. Maintenance with 400 mg every 4 weeks can be considered.

Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis (Adults)

400 mg (two 200 mg injections) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.

Plaque Psoriasis (Adults)

400 mg (two 200 mg injections) every other week. For some patients weighing ≤90 kg, loading dose of 400 mg initially and at weeks 2 and 4 followed by 200 mg every other week can be considered.

Preparation and Injection

• Lyophilized powder must be reconstituted with sterile water and administered by healthcare professionals.
• Prefilled syringes may be used for self-injection after proper training.
• Warm refrigerated syringes to room temperature before use; inspect before injection.

History of severe hypersensitivity reactions to certolizumab pegol or any excipients, including angioedema, anaphylaxis, serum sickness, and urticaria.

Infections

Cimzia increases the risk of serious infections, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and opportunistic infections. Screen patients for latent TB before treatment and monitor during and after therapy. Discontinue Cimzia if serious infection or sepsis develops.

Malignancies

Lymphoma and other cancers, some fatal, have been reported in children and adolescents treated with TNF blockers.

Hypersensitivity

Severe reactions including anaphylaxis and serum sickness have occurred. Discontinue if these occur.

Hepatitis B Virus Reactivation

Test for HBV before starting Cimzia; monitor carriers during and months after therapy. Discontinue if reactivation occurs and begin antiviral therapy.

Neurologic Effects

May worsen or cause new demyelinating diseases; use caution in patients with such history.

Hematologic Reactions

Use caution in patients with blood disorders; advise immediate medical attention if symptoms appear.

Drug Combinations

Not recommended to combine with other biologic DMARDs or TNF blockers due to increased infection risk.

Vaccines

Avoid live vaccines during treatment.

Common Side Effects

• Injection site reactions such as redness, itching, pain, or swelling
• Upper respiratory tract infections
• Headache
• Rash

Serious Side Effects

• Serious infections potentially leading to hospitalization or death
• Reactivation of latent tuberculosis
• Hypersensitivity reactions including anaphylaxis
• Lymphoma and malignancies in children and adolescents
• Hepatitis B reactivation

• Use with anakinra, abatacept, rituximab, or natalizumab increases risk of serious infections; concomitant use is not recommended.
• Avoid live vaccines during therapy.

• Store lyophilized powder refrigerated; allow vials 30 minutes at room temperature before reconstitution.
• Do not freeze reconstituted solution; store up to 24 hours at 2° to 8° C (36° to 46° F) before injection.
• Prefilled syringes should be refrigerated and warmed to room temperature before use.