Cimzia

Generic Name

certolizumab pegol (ser toe LIZ oo mab)(pe GOL)

 

Trade Name

Cimzia®.

 

What is certolizumab pegol?

Cimzia injection contains the active ingredient certolizumab, which is a type of medicine called a human monoclonal antibody.It works by suppressing part of the immune system and modifying the process of inflammation.  Certolizumab works in a similar way to the natural antibodies produced by our immune system.  Our natural antibodies recognize foreign invaders and bind to them, helping our immune systems to attack them and protect us from infections.  Monoclonal antibodies like certolizumab are made in laboratories and are designed to recognize particular proteins in a similar way.

Certolizumab specifically recognizes and binds to a protein produced by the body called tumor necrosis factor alpha (TNF alpha).  TNF alpha is involved in producing inflammation and can be found in the inflamed lining of the intestine of people with Crohn’s disease.

By binding to TNF alpha, certolizumab prevents the inflammatory responses it causes.  By reducing inflammation, it reduces related symptoms.

Cimzia is similar to Humira except that is contains a special chemical called polyethylene glycol (PEG), which delays its excretions from the body.  For this reason, Cimzia can be given less frequently than Humira.

 

What is it used for?

It is used to treat moderate to severe forms of rheumatoid arthritis and cases of severe active Crohn’s disease.

 

How do I take it?

Cimzia is administered as an injection subcutaneously (under the skin) every four weeks after an initial series of three injections given every two weeks.  It is usually given as an injection at your doctor’s office, hospital or clinic.  If you will be using Cimzia at home, a healthcare provider will teach you how to use it.  Be sure you understand how to use Cimzia.  Follow the procedures you are taught when you use a dose.  Contact your healthcare provider if you have any questions.  Do not use Cimzia if it contains particle, is cloudy or discolored, or if the vial is cracked or damaged.  Do not shake Cimzia.  Rotate injection sites.  New injections should be given at least 1 inch from an old site.  Do not inject into areas of the skin that are sore, bruised, red or hard.  Keep this product, as well as syringes and needles, out of the reach of children and pets.  Do not reuse needles, syringes or other materials.  Ask your healthcare provider how to dispose of these materials after use.  Follow all local rules for disposal.

 

What do I do for a missed dose?

It is important that you do not miss any scheduled doses.  If you miss a dose of Cimzia, however, call your doctor or pharmacist to establish a new dosing schedule.

 

Are there interactions with food or beverages?

The drug may be taken with food or milk.  There are no known interactions with food.

 

Are there interactions with other drugs?

An interaction generally means that one drug may increase or decrease the effect of another drug. Interactions with this drug may occur with abatacept (Orencia), abciximab (ReoPro), echinacea, natalizumab (Tysabri), rilonacept (Arcalyst), trastuzumab (Herceptin) and vaccines.  The most significant drug interaction can occur with anakinra (Kineret); this combination may increase the risk of serious infections.

 

Is there a problem if I have another disorder or disease?

At times, a drug may have a different or enhanced effect when other diseases are present. At other times, the drug may worsen or affect another disease. This drug should be used with caution for patients with decreased kidney function, decreased liver function, history of heptitis B, dormant (currently inactive) tuberculosis infection, history of recurrent infections, history of past/current cancer, mild heart failure, multiple sclerosis, heavy smokers and latex allergies.  People receiving long-term oral corticosteroids, chemotherapy, radiotherapy or medicine to prevent transplant rejection are at high risk when taking this medicine.  Please consult a physician beforehand.

 

What about allergies?

People who have known allergies or asthma may be at an increased risk for a reaction from any new medication. The physician should always know a patient’s allergy history. Signs of an allergic reaction are rash, hives or fever. Of course, a person should not take certolizumab if there has been a previous reaction to this medicine.  Also, patients with latex allergies should not use Cimzia, as the needle cover of the syringe contains latex.

 

What if I’m pregnant, considering pregnancy or breast-feeding?

There is no information about the safety of this medicine during pregnancy  It is not recommended for us during pregnancy as it could potentially be harmful to the developing baby.  Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least five months after their last injection.  If you think you could be pregnant at any point during treatment, you should tell your doctor right away.  It is not known if this medicine passes into breast milk; however, it is likely that it does.  Women should not breast-feed during treatment with this medicine, or for five months after their last dose.  Seek further medical advice from your doctor.

 

What are the effects on sexual function?

There are no known effects of certolizumab on sexual function.

 

Are there other precautions?

  • This medicine can compromise the body’s ability to fight infections.  Cases of tuberculosis (TB) and other serious infections have been seen in people treated with this medicine.  You should be tested for TB before treatment is started.  Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.
  • It is important to try and avoid exposure to infections during your treatment.  Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay.  This also applies for five months after you stop using this medicine, as this is how long it may take for the medicine to be fully removed from the body.  If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.

 

 

How long is it safe to take certolizumab pegol?

A period of a few weeks if usually necessary to determine the drug’s effectiveness.  Long-term use of months to years is generally necessary and safe, but does not require a physician’s supervision and periodic evaluation.

 

How about side effects?

Adverse reactions can occur with any drug, even over-the-counter medications. Some of these are mild such as a stomach upset, which may be avoided by taking the medication with food. Minor reactions may go away on their own but, if they persist, contact the physician. For major reactions, the patient should contact the physician immediately.

For certolizumab pegol, the following are the observed side effects:

Minor:

  • headache
  • rash
  • nausea
  • upset stomach
  • swelling, redness, pain and itching at the site of the injection

Major:

  • minor infections of the urinary tract, respiratory tract and sinuses
  • tuberculosis
  • sepsis (bacteria in the blood)
  • fungal infections

 

A physician’s comment…

The effects of Cimzia appear to be comparable to other anti-TNF agents like Humira and Remicade, though no comparative studies have yet been completed.  The most notable advantage to Cimzia is its less frequent administration.  Doctors prescribe Cimzia to patients with moderate to severe Crohn’s disease who had an inadequate response to conventional therapies.