|
CIMZIA(certolizumab pegol)kit
|
HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA.
CIMZIA (certolizumab pegol)
Lyophilized powder or solution for subcutaneous use
Initial U.S. Approval: 2008
|
WARNING: RISK OF SERIOUS INFECTIONS
See full prescribing information for complete boxed warning.
-
Increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (5.1).
-
CIMZIA should be discontinued if a patient develops a serious infection or sepsis (5.1).
-
Perform test for latent TB; if positive, start treatment for TB prior to starting CIMZIA (5.1).
-
Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1)
-
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member (5.2). CIMZIA is not indicated for use in pediatric patients.
|
|
RECENT MAJOR CHANGES
|
|
Boxed Warning |
09/2011 |
|
Warnings and Precautions, Risk of Serious Infections (5.1) |
09/2011 |
|
|
INDICATIONS AND USAGE
|
|
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:
-
Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy (1.1)
-
Treatment of adults with moderately to severely active rheumatoid arthritis (1.2)
|
|
DOSAGE AND ADMINISTRATION
|
|
CIMZIA is administered by subcutaneous injection. The initial dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg).
Crohn's Disease (2.1)
-
400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks
Rheumatoid Arthritis (2.2)
-
400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered
|
|
DOSAGE FORMS AND STRENGTHS
|
-
200 mg lyophilized powder for reconstitution, in a single-use glass vial, with 1 mL of sterile Water for Injection, USP (3)
-
200 mg/mL solution in a single-use prefilled glass syringe (3)
|
|
CONTRAINDICATIONS
|
|
|
|
WARNINGS AND PRECAUTIONS
|
-
Serious infections – do not start CIMZIA during an active infection. If an infection develops, monitor carefully, and stop CIMZIA if infection becomes serious (5.1)
-
Invasive fungal infections – for patients who develop a systemic illness on CIMZIA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1)
-
Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers (5.2)
-
Heart failure, worsening or new onset may occur (5.3)
-
Anaphylaxis or serious allergic reactions may occur (5.4)
-
Hepatitis B virus reactivation – monitor HBV carriers during and several months after therapy. If reactivation occurs, stop CIMZIA and begin anti-viral therapy (5.5)
-
Demyelinating disease, exacerbation or new onset, may occur (5.6)
-
Cytopenias, pancytopenia – advise patients to seek immediate medical attention if symptoms develop, and consider stopping CIMZIA (5.7)
-
Lupus-like syndrome – stop CIMZIA if syndrome develops (5.9)
|
|
ADVERSE REACTIONS
|
|
The most common adverse reactions (incidence ≥7% and higher than placebo): upper respiratory tract infection, rash, and urinary tract infection (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
|
|
DRUG INTERACTIONS
|
-
Use with Biological DMARDs – increased risk of serious infections (5.8, 7.1)
-
Live vaccines – do not give with CIMZIA (5.10, 7.2)
-
Laboratory tests – may interfere with aPTT tests (7.3)
|
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide |
Revised: 09/2011 |
Back to Highlights and Tabs
|
FULL PRESCRIBING INFORMATION: CONTENTS* |
|
|
|
WARNINGS
1 INDICATIONS AND USAGE
1.1 Crohn's Disease
1.2 Rheumatoid Arthritis
2 DOSAGE AND ADMINISTRATION
2.1 Crohn's Disease
2.2 Rheumatoid Arthritis
2.3 Preparation and Administration Using the Lyophilized Powder for Solution
2.4 Preparation and Administration Using the Prefilled Syringe
2.5 Monitoring to Assess Safety
2.6 Concomitant Medications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Serious Infections
5.2 Malignancies
5.3 Heart Failure
5.4 Hypersensitivity Reactions
5.5 Hepatitis B Virus Reactivation
5.6 Neurologic Reactions
5.7 Hematological Reactions
5.8 Use with Biological Disease-Modifying Antirheumatic Drugs (Biological DMARDs)
5.9 Autoimmunity
5.10 Immunizations
5.11 Immunosuppression
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Use with Anakinra, Abatacept, Rituximab, and Natalizumab
7.2 Live Vaccines
7.3 Laboratory Tests
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
14 CLINICAL STUDIES
14.1 Crohn's Disease
14.2 Rheumatoid Arthritis
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Patient Counseling
17.2 Instruction on Prefilled Syringe Self-Injection Technique
|
FULL PRESCRIBING INFORMATION
WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
-
Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use.
-
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
-
Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member [see Warnings and Precautions (5.2)]. CIMZIA is not indicated for use in pediatric patients.
1 INDICATIONS AND USAGE
1.1 Crohn's Disease
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
1.2 Rheumatoid Arthritis
CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
2 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 Preparation and Administration Using the Lyophilized Powder for Solution
The 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 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 |
|
