effects with CIMZIA include:
Psoriasis. Some people using CIMZIA had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with CIMZIA.
Injection site reactions. Redness, rash, swelling, itching or bruising can happen in some people. These symptoms will usually go away within a few days. If you have pain, redness, or swelling around the injection site that doesn't go away within a few days or gets worse, call your doctor right away.
Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the side effects with CIMZIA. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about CIMZIA
Medicines are sometimes prescribed for purposes that are not mentioned in Medication Guides. Do not use CIMZIA for a condition for which it was not prescribed. Do not give CIMZIA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about CIMZIA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CIMZIA that is written for health professionals.
For more information go to www.CIMZIA.com or you can enroll in a patient support program by calling 1-866-4CIMZIA (424-6942).
How should I store CIMZIA?
Keep CIMZIA in the refrigerator at 36ºF - 46ºF (2ºC - 8ºC)
Let CIMZIA come to room temperature before injecting it.
Do not freeze CIMZIA.
Protect CIMZIA from light. Store CIMZIA in the carton.
Do not use CIMZIA if the medication is expired (today's date is past the date printed on the vial, prefilled syringe or carton), or if the liquid looks cloudy or discolored.
The vials and prefilled syringe are glass. Do not drop or crush them.
Always keep CIMZIA, injection supplies, puncture-proof container, and all other medicines out of the reach of children.
What are the ingredients in CIMZIA?
CIMZIA lyophilized powder:
Active ingredient: certolizumab pegol.
Inactive ingredients: sucrose, lactic acid, polysorbate.
The pack contains Water for Injection, for reconstitution of the lyophilized powder.
CIMZIA prefilled syringe:
Active ingredient: certolizumab pegol
Inactive ingredients: sodium acetate, sodium chloride, and Water for Injection.
CIMZIA has no preservatives.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Product developed and manufactured for:
UCB, Inc.
1950 Lake Park Drive
Smyrna, GA 30080
US License No. 1736
Revised 09/ 2011
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 50474-700-62
Rx only
cimzia®
(certolizumab pegol)
200 mg/vial
FOR SUBCUTANEOUS USE ONLY
No US standard of potency
MUST BE RECONSTITUTED
A Medication Guide is required to be given
with this product kit and is enclosed.
This package contains 2 vials of certolizumab
pegol, each containing 200 mg. To achieve a
dose of 400 mg requires 2 injections (200 mg
each) in different sites on the abdomen or
thigh. Each vial contains 200 mg/mL after
reconstitution.
After reconstitution with 1 mL of sterile
water, each mL contains 200 mg of
certolizumab pegol.
Storage
Refrige |
