Class: Biological Therapy
Generic Name: certolizumab pegol
Trade Name: Cimzia®
How is this drug used? Cimzia is approved for the treatment of adults with active psoriatic arthritis (PsA) or anklosing spondylitis (AS); for adults with moderate to severe rheumatoid arthritis (RA); or for reducing signs and symptoms of adult patients with active Crohn’s disease who have not responded well to conventional therapies.
What is the mechanism of action? Cimzia is an antibody that works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNFα) in RA and other conditions associated with inflammation. The body produces TNFα when there is inflammation.
How is Cimzia given (administered)? Cimzia is given by an injection into the skin. The specific schedule and dose depend on which condition is being treated. Cimzia is not suitable for children.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Cimzia. Patients will especially be monitored for tuberculosis as serious infections have happened in patients taking Cimzia. Your healthcare provider should test you for TB before starting treatment.
What are the most common side effects of treatment with Cimzia?
- Upper respiratory tract infections (flu, cold)
- Urinary tract infection
What are some of the less common but potentially serious side effects of Cimzia?
- Heart failure
- Hepatitis B virus reactivation in patients who carry the virus in their blood
- New or worsening nervous system problems
- Blood problems
- Immune reactions including a lupus-like syndrome
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
Are there any special warnings or precautions patients should be aware of before starting treatment? Before starting Cimzia, tell your healthcare provider about all of your medical conditions, including if you:
- Have an infection.
- Have or have had any type of cancer.
- Have congestive heart failure.
- Have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis.
- Are scheduled to receive a vaccine. Do not receive a live vaccine while taking Cimzia.
- Are allergic to any of the ingredients in Cimzia.
- Are pregnant or planning to become pregnant. It is not known if Cimzia will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving Cimzia.
- Are breastfeeding or plan to breastfeed. It is not known if Cimzia passes into your breast milk. You and your healthcare provider should decide if you will receive Cimzia or breastfeed.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Additional warnings regarding cancer while taking TNF blocker medicines:
- The chances of getting lymphoma may increase.
- People with RA, especially severe RA, may have a higher chance of lymphoma.
- A rare type of cancer called hepatosplenic T-cell lymphoma may occur.
- The chance of developing certain kinds of skin cancer may increase.
What should patients be aware of after treatment with Cimzia? After starting Cimzia, any sign of infection including a fever, cough, flu-like symptoms, or open cuts or sores on your body, call your healthcare provider right away. Cimzia can make you more likely to get infections or make any infection that you may have worse.
Cimzia is a medicine that affects your immune system and can lower your ability to fight infections. Serious infections have occurred in patients taking Cimzia, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.
When should patients notify their physician? The following could be symptoms of heart failure, allergic reactions, Hepatits B reactivation, nervous system problems, blood problems, and immune reactions. Your healthcare provider should be called immediately if you experience:
- Shortness of breath
- Swelling of your feet or ankles
- Sudden weight gain
- Skin rash
- Swelling or itching of face, tongue, lips, or throat
- Trouble breathing
- Feeling unwell
- Skin or eyes look yellow
- Poor appetite or vomiting
- Pain in the right side of your abdomen
- Numbness or tingling
- Problems with your vision
- Weakness in your arms or legs
- Fever that does not go away
- Bruising or bleeding very easily
- Pale skin
- Joint pain
- Rash on the cheeks or arms that won’t go away and worsens with sun exposure
Tell your healthcare provider if you notice any changes in the appearance of your skin, including growths on your skin, during or after treatment with Cimzia.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated on 12/16.
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