Tuberculosis, invasive fungal infections, bacterial, viral, and other opportunistic infections, some fatal, have been observed in patients receiving certolizumab pegol. Patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection prior to initiating certolizumab pegol and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with certolizumab pegol. Monitor patients receiving certolizumab pegol for signs and symptoms of infection including tuberculosis in patients who tested negative for latent tuberculosis infection. Lymphoma and other malignancies, some fatal, have been reported in pediatric patients (not indicated in this population) treated with tumor necrosis factor (TNF) blockers .
Monoclonal Antibody Fragment
Certolizumab injection is used for Crohn disease in adult patients who have not been helped by other medicines. It is also used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Certolizumab works on the immune system to decrease inflammation.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of certolizumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of certolizumab injection in the elderly. However, this medicine may cause more serious infections in the elderly, which may require caution in patients receiving certolizumab.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the abdomen (stomach) or upper thighs.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Certolizumab may also be given at home. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
To use the prefilled syringe:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.
Throw away used syringes in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Certolizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
While you are being treated with certolizumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Certolizumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Check with your doctor right away if you have symptoms of liver problems such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.
This medicine may cause other unwanted effects that may not occur until months or years after this medicine is used. A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, leukemia, skin cancer). Some patients developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, weight gain, or wheezing. These may be symptoms of a heart condition called congestive heart failure.
Certolizumab may cause serious allergic reactions. Check with your doctor right away if you have a rash, itching, dizziness, fainting, or lightheadedness, swelling of the face, throat, legs, or feet, or troubled breathing after you receive the medicine.
Some people using this medicine developed lupus-like symptoms. Make sure your doctor knows if you start having chest pain, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.