Risk of Serious Infections
Patients treated with certolizumab pegol are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis.
The risks and benefits of treatment with certolizumab pegol should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab pegol, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy .
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 be 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 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Suppressant
Pharmacologic Class: Monoclonal Antibody
Certolizumab pegol is used to decrease signs and symptoms of moderately to severely active Crohn's disease in adult patients who have not been helped by other medicines. It is also used to treat the symptoms of moderately to severely active rheumatoid arthritis.
certolizumab pegol 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 certolizumab pegol, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to certolizumab pegol 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 pegol 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 pegol in the elderly. However, certolizumab pegol may cause more serious infections in the elderly, which may require caution in patients receiving certolizumab pegol.
|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.
Using certolizumab pegol 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.
The presence of other medical problems may affect the use of certolizumab pegol. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you certolizumab pegol. certolizumab pegol is given as a shot under your skin, usually on the abdomen or thigh.
Certolizumab pegol may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using certolizumab pegol 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.
certolizumab pegol comes with a Medication Guide and patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you use certolizumab pegol at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
To use the prefilled syringe:
Do not inject certolizumab pegol if blood enters the syringe. If you notice blood inside the syringe, pull the needle out and throw away the syringe and needle in a hard-closed container.
The dose medicines in this class 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 these medicines. 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.
If you miss a dose of certolizumab pegol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store in the refrigerator. Do not freeze.
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.
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 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 certolizumab pegol is working properly. Blood tests may be needed to check for unwanted effects.
Certolizumab pegol 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 certolizumab pegol. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.
Do not have any live vaccines (immunizations) while you are being treated with certolizumab pegol. Check with your doctor before having any vaccines.
Check with your doctor right away if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right sided abdominal pain, fever, or severe tiredness.
certolizumab pegol may cause other unwanted effects that may not occur until months or years after certolizumab pegol is used. A small number of people (including children and teenagers) who have used certolizumab pegol have developed certain types of 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 with breathing; weight gain; or wheezing. These may be signs of a heart condition called congestive heart failure (CHF).
Certolizumab pegol may cause serious allergic reactions. Check with your doctor right away if you have a rash; itching; swelling of the face, throat, legs, or feet; or troubled breathing after you receive the injection.
Some people who have used certolizumab pegol developed lupus-like symptoms during treatment and got better after certolizumab pegol was stopped. Make sure your doctor knows if you start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.
Do not change or stop using certolizumab pegol without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Do not take other medicines unless they have been discussed with your doctor. Your doctor will discuss with you any changes in your medicine.
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 or nurse immediately if any of the following side effects occur:More common
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:More common
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.
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