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CIMZIA is a brand name for Certolizumab Pegol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS ...............................................................................................4 WARNINGS AND PRECAUTIONS ..............................................................................5…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations CIMZIA (certolizumab pegol) is intended for use under the guidance and supervision of a healthcare professional. A patient may self-inject CIMZIA if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
CIMZIA may be used alone or in combination with methotrexate (MTX). In the psoriatic arthritis and ankylosing spondylitis clinical study, oral corticosteroids, DMARDs (methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) and non-steroidal anti-inflammatory drugs (NSAIDs) were permitted as concomitant therapy (see CLINICAL TRIALS, Psoriatic Arthritis, Study Demographics and Trial Design and CLINICAL TRIALS, Ankylosing Spondylitis, Study Demographics and Trial Design).
CIMZIA should not be used in combination with other biologic disease modifying anti- rheumatic drugs (DMARDs) or other TNF blocking agents. Recommended Dose and Dosage Adjustment Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis Loading Dose The recommended loading dose of CIMZIA for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially (Week 0) and at Weeks 2 and 4.
Maintenance Dose Rheumatoid Arthritis After the loading dose, the recommended maintenance dose of CIMZIA for adult patients with rheumatoid arthritis is 200 mg every 2 weeks. Alternatively, CIMZIA 400 mg every 4 weeks may be considered.
Psoriatic Arthritis After the loading dose, the recommended maintenance dose of CIMZIA for adult patients with psoriatic arthritis is 200 mg every 2 weeks. Alternatively, CIMZIA 400 mg every 4 weeks may be considered (see CLINICAL TRIALS, Psoriatic Arthritis, Study Results).
Ankylosing Spondylitis After the loading dose, the recommended maintenance dose of CIMZIA for adult patients with ankylosing spondylitis is 200 mg every 2 weeks or 400 mg every 4 weeks. CIMZIA® (certolizumab pegol) - Product Monograph Page 33 of 78 Non-radiographic Axial Spondyloarthritis After the loading dose, the recommended maintenance dose of CIMZIA for adult patients with non-radiographic axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
Plaque Psoriasis The recommended dose of CIMZIA for adult patients with plaque psoriasis is 400 mg every 2 weeks. A dose of 400 mg initially (Week 0) and at Weeks 2 and 4 followed by 200 mg every 2 weeks may be considered (see CLINICAL TRIALS, Plaque Psoriasis, Study Results).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Missed Dose Patients who miss a dose of CIMZIA should be advised as follows: if the next scheduled dose is within 1 week, patients should wait until the next scheduled dose. If the next scheduled dose is 1 week or longer away, patients should inject the missed dose as soon as they become aware of it, then follow with their next scheduled dose.
Administration CIMZIA is administered by subcutaneous injection. The solution in the pre-filled syringe or autoinjector 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 after use should be discarded. Patients using CIMZIA should be instructed to inject the full amount, which provides 200 mg of CIMZIA, according to the directions provided in the Consumer Information Leaflet.
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, each 200 mg injection should occur at separate sites in the thigh or abdomen.
OVERDOSAGE Doses of up to 800 mg SC and 20 mg/kg intravenous (IV) have been administered to patients in clinical studies without evidence of dose-limiting toxicities. In cases of overdosage, it is recommended that patients are monitored closely for any signs and symptoms of adverse reactions or effects, and appropriate symptomatic treatment instituted immediately.
For management of a suspected drug overdose, contact your regional Poison Control Centre. CIMZIA® (certolizumab pegol) - Product Monograph Page 34 of 78 ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Certolizumab pegol has a high affinity for human TNFα and binds with a KD of 90pM.
TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol selectively neutralizes TNFα (90% inhibitory concentration [IC90] of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin α (TNF).
Certolizumab pegol was shown to neutralize membrane associated and soluble human TNFα in a dose-dependent manner. Incubation of monocytes with certolizumab pegol resulted in a dose- dependent inhibition of lipopolysaccharide-induced TNFα and interleukin-1β production in human monocytes.
Certolizumab pegol does not contain a fragment crystallizable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody- dependent cell-mediated cytotoxicity. It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulation.
Pharmacodynamics Biological activities ascribed to TNFα include the up regulation of cellular adhesion molecules and chemokines, upregulation of major histocompatibility complex (MHC) class I and class II molecules, and direct leukocyte activation.
TNFα stimulates the production of downstream inflammatory mediators, including interleukin-1, prostaglandins, platelet activating factor, and nitric oxide. Elevated levels of TNF have been implicated in the pathology of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and plaque […]