ms of infection, including tuberculosis and reactivation of hepatitis B virus infections.
Counsel patients about the possible risk of lymphoma and other malignancies while receiving CIMZIA.
Allergic Reactions
Advise patients to seek immediate medical attention if they experience any symptoms of severe allergic reactions. The prefilled syringe components do not contain any latex or dry natural rubber.
Other Medical Conditions
Advise patients to report any signs of new or worsening medical conditions such as heart disease, neurological disease, or autoimmune disorders. Advise patients to report promptly any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever.
17.2 Instruction on Prefilled Syringe Self-Injection Technique
After proper training by a qualified healthcare professional in subcutaneous injection technique, a patient may self inject with CIMZIA using the Prefilled Syringe if a healthcare provider determines that it is appropriate. A patient's ability to administer CIMZIA subcutaneous injections should be checked to ensure correct administration. Suitable sites for injection include the thigh or abdomen. CIMZIA should be injected when the liquid is at room temperature. Full injection instructions are provided in the Patient Instructions for Use for the Prefilled Syringe, packaged in each CIMZIA Prefilled Syringe kit
To avoid needle-stick injury, patients and healthcare providers should not attempt to place the needle cover back on the syringe or otherwise recap the needle. Be sure to properly dispose of needles and syringes in a puncture-proof container, and instruct patients and caregivers in proper syringe and needle disposal technique. Actively discourage any reuse of the injection materials.
Manufactured by:
UCB, Inc.
1950 Lake Park Drive
Smyrna, GA 30080
US License No. 1736
MEDICATION GUIDE
CIMZIA® (CIM-zee-uh)
(certolizumab pegol)
Read the Medication Guide that comes with CIMZIA before you start using it, and before each injection of CIMZIA. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about CIMZIA?
CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.
Your doctor should test you for TB before starting CIMZIA.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.
Before starting CIMZIA, tell your doctor if you:
think you have an infection. You should not start taking CIMZIA if you have any kind of infection.
are being treated for an infection
have signs of an infection, such as a fever, cough, flu-like symptoms
have any open cuts or sores on your body
get a lot of infections or have infections that keep coming back
have diabetes
have HIV
have tuberculosis (TB), or have been in close contact with someone with TB
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an i |
