ired to reconstitute and inject the drug as described below. CIMZIA should be brought to room temperature before reconstituting to facilitate dissolution.
Reconstitute each lyophilized vial of CIMZIA using appropriate aseptic technique, with 1 mL of sterile Water for Injection, USP, and a syringe with a 20 gauge needle. Gently swirl each vial of CIMZIA without shaking so that all of the lyophilized powder comes into contact with the sterile Water for Injection. Leave the vials undisturbed to fully reconstitute (this may take as long as 30 minutes). Reconstituted CIMZIA has a concentration of approximately 200 mg/mL. Once reconstituted, CIMZIA is a clear to opalescent, colorless to pale yellow liquid essentially free from particulates.
Prior to injecting, reconstituted CIMZIA should be at room temperature. Do not leave reconstituted CIMZIA at room temperature for more than 2 hours prior to administration. Using a new 20 gauge (reconstitution) needle for each vial, withdraw the reconstituted solution into a separate syringe for each vial, so that each syringe contains 1 mL of CIMZIA (200 mg of certolizumab pegol). Switch each 20 gauge needle to a 23 gauge (dosing) needle and inject the full contents of each syringe subcutaneously into the thigh or abdomen. Where a 400 mg dose is required, separate sites should be used for each 200 mg injection.
Once reconstituted, CIMZIA can be stored in the vials for up to 24 hours at 2 to 8°C (36 to 46 °F) prior to injection. Do not freeze.
2.4 Preparation and Administration 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.
Patients using the CIMZIA Prefilled Syringe should be instructed to inject the full amount in the syringe (1 mL), according to the directions provided in the Patient Instructions for Use.
2.5 Monitoring to Assess Safety
Before initiation of therapy with CIMZIA, all patients must be eva luated 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 preva lence 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.
2.6 Concomitant Medications
CIMZIA may be used as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs). In rheumatoid arthritis clinical studies, patients on CIMZIA therapy also took concomitant methotrexate (MTX) with the recommended CIMZIA dose of 200 mg every other week. CIMZIA should not be used in combination with biological DMARDs or other tumor necrosis factor (TNF) blocker therapy.
3 DOSAGE FORMS AND STRENGTHS
Lyophilized Powder for Reconstitution
Sterile, white, lyophilized powder for reconstitution and then subcutaneous administration. Each single-use vial provides approximately 200 mg of CIMZIA.
Prefilled Syringe
A single-use, 1 mL prefilled glass syringe with a fixed 25 gauge ½ inch thin wall needle, providing 200 mg per 1 mL of CIMZIA.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Serious Infections
(see also Boxed Warning)
Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ |
