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CIMZIA® (certolizumab pegol) Indications for Use

CIMZIA® (certolizumab pegol) is indicated for the treatment of moderate to severe rheumatoid arthritis in adult patients when methotrexate (MTX) alone has not been effective. CIMZIA can be used in combination with MTX or as monotherapy in patients intolerant to MTX. It also slows the progression of joint damage and improves physical function.

• Active ingredient: Certolizumab pegol (200 mg).
• Mechanism of action: CIMZIA is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha (TNF-α), a key molecule in the inflammatory process. By inhibiting TNF-α, CIMZIA helps reduce inflammation and autoimmune activity in rheumatoid arthritis.

CIMZIA® (certolizumab pegol) Dosage Information

The recommended starting dose of CIMZIA for rheumatoid arthritis is 400 mg, administered as two subcutaneous injections of 200 mg each at weeks 0, 2, and 4. After the initial doses, the maintenance dose is 200 mg every two weeks.

• Administration:
  • Delivered via subcutaneous injection.
  • Preferred injection sites: abdomen or thighs.
  • Patients can self-administer the injections after proper training.
• Missed dose: Patients should take the next dose as soon as they remember, then continue with their regular dosing schedule (every two weeks).

CIMZIA® (certolizumab pegol) Side Effects and Precautions

CIMZIA is generally well-tolerated, but some patients may experience side effects ranging from mild to severe.

• Very common side effects (affecting more than 1 in 10 patients):
  • Infections: Upper respiratory tract infections (e.g., colds, sinusitis).
• Common side effects (affecting 1 in 10 to 1 in 100 patients):
  • Headache, nausea, fever, and rash.
  • Injection site reactions (pain, swelling, redness).
• Uncommon side effects (affecting 1 in 100 to 1 in 1,000 patients):
  • Severe infections, including tuberculosis (TB), fungal infections, and other opportunistic infections.
  • Allergic reactions like hives, difficulty breathing, or swelling of the face and lips.

Precautions:

• Infections: Patients should be screened for latent tuberculosis before starting CIMZIA. If active infections are detected, treatment should be delayed until infections are controlled.
• Heart failure: CIMZIA is contraindicated in patients with moderate to severe heart failure (NYHA class III/IV).
• Cancer risk: TNF inhibitors like CIMZIA have been associated with an increased risk of certain cancers, such as lymphoma.

CIMZIA® (certolizumab pegol) Clinical Studies and Real-World Outcomes

CIMZIA’s efficacy was evaluated in several clinical trials, including two pivotal studies (RA-I and RA-II) involving patients with rheumatoid arthritis. These studies demonstrated CIMZIA’s ability to significantly reduce the signs and symptoms of rheumatoid arthritis, as well as its role in inhibiting the progression of joint damage.

• ACR 20 response:
  • RA-I (24-week results): 59% of patients treated with CIMZIA achieved an ACR 20 response (a 20% improvement in rheumatoid arthritis symptoms), compared to 14% in the placebo group.
  • RA-II (24-week results): 57% of patients receiving CIMZIA achieved ACR 20, compared to 9% in the placebo group.
• Joint damage progression: Radiographic studies showed that patients treated with CIMZIA had significantly less progression of joint damage, as measured by mTSS (modified Total Sharp Score).
• Long-term outcomes: Patients receiving CIMZIA for up to two years maintained improvements in joint damage and physical function, with ACR 20 responses observed in up to 91% of patients at 148 weeks.

CIMZIA® (certolizumab pegol) Drug Interactions

CIMZIA may interact with other medications, especially those that affect the immune system.

• Drug interactions:
  • Methotrexate (MTX): CIMZIA is often used with MTX, which enhances its efficacy. However, CIMZIA has no significant effect on the pharmacokinetics of MTX.
  • Live vaccines: Live vaccines should not be administered to patients receiving CIMZIA due to the risk of infection.
  • Other biologics: Concurrent use with other TNF blockers or biologic agents (e.g., anakinra, abatacept) is not recommended due to increased risks of infections.