Generic Name: Certolizumab Vials (cer to LIZ u mab PEG ol)
Brand Name: Cimzia
- Very bad and sometimes deadly infections have happened in patients who take this medicine (certolizumab vials). Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
- TB (tuberculosis) has been seen in patients started on this medicine. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this medicine (certolizumab vials).
- Lymphoma and other cancers have happened in people who take this medicine or drugs like it. This has been deadly in some cases. Talk with the doctor.
- This medicine is not approved for use in children. Talk with the doctor.
Uses of Certolizumab Vials:
- It is used to treat Crohn's disease.
- It is used to treat rheumatoid arthritis.
- It is used to treat psoriatic arthritis.
- It is used to treat ankylosing spondylitis.
What do I need to tell my doctor BEFORE I take Certolizumab Vials?
- If you have an allergy to certolizumab pegol or any other part of this medicine (certolizumab vials).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have an infection.
- If you are taking any of these drugs: Abatacept, adalimumab, anakinra, etanercept, golimumab, infliximab, natalizumab, rituximab, or tocilizumab.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (certolizumab vials) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Certolizumab Vials?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- Talk with your doctor before getting any vaccines. Use with this medicine (certolizumab vials) may either raise the chance of an infection or make the vaccine not work as well.
- Do not get a weakened bacteria like BCG for bladder cancer while you use this medicine. Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (certolizumab vials).
- Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
- Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
- A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this medicine. These cases have been deadly. Most of the time, these cases happened in teenagers or young adults. Most of these patients were using this medicine (certolizumab vials) to treat certain types of bowel problems like Crohn disease and ulcerative colitis. This medicine is not approved for use to treat bowel problems like these. Tell the doctor if you have ever had any type of cancer. Talk with the doctor.
- If you are 65 or older, use this medicine with care. You could have more side effects.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (certolizumab vials) while you are pregnant.
- If you used this medicine when you were pregnant, tell your baby's doctor.
How is this medicine (Certolizumab Vials) best taken?
Use this medicine (certolizumab vials) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Wash your hands before and after use.
- Follow how to use as you have been told by the doctor or read the package insert.
- Move the site where you give the shot with each shot.
- Do not give into skin that is irritated, bruised, red, infected, or scarred.
- Do not use if the solution is cloudy, leaking, or has particles.
- This medicine is colorless to a faint yellow. Do not use if the solution changes color.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
- Before using this medicine, take it out of the refrigerator and leave it at room temperature for 30 minutes.
- Do not heat or microwave.
- This medicine must be mixed with sterile water before using. The sterile water that comes with this medicine (certolizumab vials) is meant for one use only. Throw away any part of the sterile water that is not used after one use.
- When making, do not shake vial.
- When ready to inject the mixed drug, it should be at room temperature. Do not leave any mixed drug at room temperature for more than 2 hours before using.
- Throw away any part of the opened vial not used after the shot is given.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Chest pain or pressure.
- Very bad dizziness or passing out.
- Very bad headache.
- Any unexplained bruising or bleeding.
- A big weight loss.
- Night sweats.
- Very bad irritation where the shot was given.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Lump in the armpit, groin, or neck.
- Feeling very tired or weak.
- Pale skin.
- Not able to pass urine or change in how much urine is passed.
- A skin lump or growth.
- Heart failure has happened with this medicine, as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of Certolizumab Vials?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Certolizumab Vials?
- Store in a refrigerator. Do not freeze.
- Protect from light.
- Use right away after mixing or you may store in a refrigerator for up to 24 hours.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (certolizumab vials) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine (certolizumab vials) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (certolizumab vials). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: December 6, 2017
More about certolizumab
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
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- Drug class: TNF alfa inhibitors
Other brands: Cimzia