Below are the general guidelines for dosing Cimzia (certolizumab). Note that these dosages may be adjusted on a case-by-case basis for individual patients. Always follow your prescribing physician’s instructions for taking Cimzia.
The following information comes from DailyMed, an FDA label information provider.
What if I miss a dose of Cimzia?
According to Mayo Clinic, you should call your doctor or pharmacist immediately if you have missed a dose of Cimzia.
What if I overdose on Cimzia?
The maximum tolerated dose of certolizumab pegol has not been established. Doses of up to 800 mg subcutaneous and 20 mg/kg intravenous have been administered without evidence of dose-limiting toxicities. In cases of overdosage, it is recommended that patients be monitored closely for any adverse reactions or effects, and appropriate symptomatic treatment instituted immediately. If you believe you or someone you know has overdosed on cimzia or any medications call 911 and call poison control.
Dosage and Administration
CIMZIA is administered by subcutaneous injection . 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 (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
The solution 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 in the syringe or vial should be discarded.
2.1 Crohn’s Disease
The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.
2.2 Rheumatoid Arthritis
The recommended dose of CIMZIA for adult patients with rheumatoid arthritis is 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg every 4 weeks can be considered [see CLINICAL STUDIES (14.2)] .
2.3 Psoriatic Arthritis
The recommended dose of CIMZIA for adult patients with psoriatic arthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg every 4 weeks can be considered [see CLINICAL STUDIES (14.3)] .
2.4 Ankylosing Spondylitis
The recommended dose of CIMZIA for adult patients with ankylosing spondylitis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.
2.5 Non-radiographic Axial Spondyloarthritis
The recommended dose of CIMZIA for adult patients with non-radiographic axial spondyloarthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.
2.6 Plaque Psoriasis
The recommended dose of CIMZIA for adults with moderate-to-severe plaque psoriasis is 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.
For some patients (with body weight ⤠90 kg), CIMZIA 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week can be considered [see CLINICAL STUDIES (14.6)] .
2.7 Preparation and Administration of CIMZIA Using the Lyophilized Powder for Injection
CIMZIA Lyophilized powder should be prepared and administered by a health care professional. CIMZIA is provided in a package that contains everything required to reconstitute and inject the drug [see HOW SUPPLIED/STORAGE AND HANDLING (16)] . Step-by-step preparation and administration instructions are provided below.
Preparation and Storage
- If refrigerated, remove CIMZIA from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting. Do not warm the vial in any other way. Use appropriate aseptic technique when preparing and administering CIMZIA.
- Reconstitute the vial(s) of CIMZIA with 1 mL of Sterile Water for Injection, USP using the 20-gauge needle provided. The sterile water for injection should be directed at the vial wall rather than directly on CIMZIA.
- Gently swirl each vial of CIMZIA for about one minute without shaking, assuring that all of the powder comes in contact with the Sterile Water for Injection. The swirling should be as gentle as possible in order to avoid creating a foaming effect.
- Continue swirling every 5 minutes as long as non-dissolved particles are observed. Full reconstitution may take as long as 30 minutes. The final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow liquid essentially free from particulates.
- Once reconstituted, CIMZIA can be stored in the vials for up to 24 hours between 2° to 8° C (36° to 46° F) prior to injection. Do not freeze.
Administration
- Prior to injecting, reconstituted CIMZIA should be at room temperature but do not leave reconstituted CIMZIA at room temperature for more than two hours prior to administration.
- Withdraw the reconstituted solution into a separate syringe for each vial using a new 20-gauge needle for each vial so that each syringe contains 1 mL of CIMZIA (200 mg of certolizumab pegol).
- Replace the 20-gauge needle(s) on the syringes with a 23-gauge(s) for administration.
- Inject the full contents of the syringe(s) subcutaneously, by pinching the skin of the thigh or abdomen. Where a 400 mg dose is required, two injections are required, therefore, separate sites should be used for each 200 mg injection.
2.8 Preparation and Administration of CIMZIA Using the Prefilled Syringe
After proper training in subcutaneous injection technique, a patient may self-inject with the CIMZIA Prefilled Syringe if a physician determines that it is appropriate.After proper training in subcutaneous injection technique, a patient may self-inject with the CIMZIA Prefilled Syringe if a physician determines that it is appropriate.
- If refrigerated, remove the prefilled syringe from the carton and let it warm to room temperature.
- Inspect the liquid in the prefilled syringe. It should be clear and colorless to yellow and free from particulates. Discard the syringe if cloudy, discolored or contains particulates.
- Suitable sites for injection include the thigh or abdomen at least 2 inches away from the navel. Inject at least 1 inch from the previous site.
- Do not inject into areas where the skin is tender, bruised, red or hard, or where there are scars or stretch marks.
The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause allergic reactions and should be handled with caution by latex-sensitive individuals [see WARNINGS AND PRECAUTIONS (5.4)] .
2.9 Monitoring to Assess Safety
Before initiation of therapy with CIMZIA, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. The possibility of undetected latent tuberculosis should be considered in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or had close contact with a person with active tuberculosis. Appropriate screening tests (e.g. tuberculin skin test and chest x-ray) should be performed in all patients.
2.10 Concomitant Medications
CIMZIA may be used as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
The use of CIMZIA in combination with biological DMARDs or other tumor necrosis factor (TNF) blocker therapy is not recommended.
How is Cimzia supplied?
Storage and Stability
Refrigerate carton between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not separate contents of carton prior to use. Do not use beyond expiration date, which is located on the drug label and carton. Protect solution from light.
Unopened CIMZIA vials may also be stored at room temperature up to a maximum of 25°C (77°F) for 6 months, but not exceeding the original expiration date. If stored at room temperature, do not place back in refrigerator and write the new expiration date on the carton in the space provided.
Lyophilized Powder for Reconstitution:
NDC 50474-700-62
CIMZIA (certolizumab pegol) for injection is supplied as a sterile white, lyophilized powder in a single-dose vial for subcutaneous use.
| Qty. | Item |
| 2 | Type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized CIMZIA for reconstitution. |
| 2 | 2 mL Type I glass vials containing 1 mL sterile Water for Injection |
| 2 | 3 mL plastic syringes |
| 4 | 20 gauge needles (1 inch) |
| 2 | 23 gauge needles (1 inch) |
| 8 | Alcohol swabs |
Prefilled Syringe
NDC 50474-710-79
CIMZIA (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use.
2 alcohol swabs and 2 single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200 mg (1 mL) of CIMZIA. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause allergic reactions and should be handled with caution by latex-sensitive individuals [see WARNINGS AND PRECAUTIONS (5.4)].
Prefilled Syringe Starter Kit
NDC 50474-710-81
6 alcohol swabs and 6 single dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle. The Starter Kit contains 3 sets of 2 prefilled syringes to provide sufficient drug supply for the initial 3 induction doses at the start of treatment. Each prefilled syringe contains 200 mg (1 mL) of CIMZIA.
When necessary, CIMZIA prefilled syringes may be stored at room temperature up to 77 °F (25 °C) in the original carton to protect from light for a single period of up to 7 days. Once a CIMZIA prefilled syringe has been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within the 7-day period.
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