What To Ask Your Doctor
Cimzia may improve your rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, or other condition. But it may cause mild side effects in some people. In rare cases, it could also cause an infection or other serious side effects.
If you have questions about Cimzias side effects, talk with your doctor or pharmacist. For example, you may wonder:
- Which serious fungal infections can occur with Cimzia, and am I at risk?
- Which symptoms of heart failure should I watch for?
- What is my risk for infection if Im older than age 65 years and have lung disease?
- If Ive had low white blood cell levels in the past, can I still use Cimzia?
- What can I do to help prevent infection while using Cimzia?
Will Cimzia Cure My Condition
No. Cimzia cant cure your condition, but it can help relieve your symptoms. If you have Crohns disease or psoriasis, taking Cimzia may clear up your symptoms completely . But you must continue to take your medication to keep these results. So long-term treatment with Cimzia controls your condition, rather than cures it.
Study Design And Patients
CRIB was a prospective, postmarketing, multicentre, pharmacokinetic study designed to evaluate placental transfer of CZP from mothers to infants . This study was conducted between January 2014 and November 2016 across 11 sites in France, Netherlands, Switzerland and the USA and was approved by local Institutional Review Boards. All women provided informed consent to participate and, together with the designated holder of parental rights, to enrol their infant in the study.
CRIB study design.
aLast certolizumab pegol dose given within 35 days prior to delivery.
Eligible women were 30 weeks pregnant at the time of informed consent. Since CRIB was a postmarketing study, all women enrolled were being treated with commercial CZP for a locally approved indication , as prescribed by their treating physicians. Patients were required to receive a CZP dose within 35 days prior to delivery. The decision to continue CZP treatment during pregnancy was made by the treating physicians prior to and independently from study participation. CZP was not provided by the study sponsor.
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What If I Have Fertility Problems
Your arthritis is unlikely to affect your fertility, this is your ability to get pregnant. But fertility does decrease with age, so some women will need fertility treatments, such as egg boosting, intrauterine insemination or in vitro fertilisation .
Most women with arthritis are fine to have fertility treatments if their condition is under control.
If your condition is not currently under control, or you feel that now is not the right time to have a baby, you have the option of freezing your embryos or eggs to use at a later date.
Discuss any plans for fertility treatment with your rheumatologist. They can offer specific advice, liaise with your fertility consultant regarding any recommended adjustments to your treatment and consider referral to an obstetric rheumatology clinic for pre-pregnancy counselling.
To improve the outcome of your fertility treatment, its recommended that you continue taking your anti-rheumatic medication thats pregnancy safe.
Can You Take Cimzia While Pregnant
Its not fully known whether taking Cimzia while pregnant increases the risk of adverse effects for either the parent or the fetus. Some people may decide with their doctors that this medication is the best available option for them, even if they are pregnant or planning to become pregnant.
If someone decides to use Cimzia while pregnant, they are invited to join the Cimzia pregnancy registry so that researchers can learn more about if and how the medication influences pregnancy.
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Help Us Better Understand The Effects Of Cimzia In Pregnancy
Many people need to take medication during pregnancy to appropriately manage their chronic health condition. In some cases, avoiding or stopping medication use during pregnancy may be more harmful than taking medication. Yet fewer than 10% of medications have enough information to determine their safety for use in pregnancy this is where you come in!
MotherToBaby is currently enrolling people who are pregnant in a study examining the use of Cimzia® to treat rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or Crohns disease during pregnancy.
There is a huge need to generate more data for all of the drugs that people who are pregnant need to take.
Christina Chambers, PhD, MPH, Lead Investigator, MotherToBaby Pregnancy Studies
Are you currently pregnant? Did you take Cimzia® at any point in your current pregnancy? If you answered yes to both of these questions, then you have the opportunity to help us learn more about Cimzia® use in pregnancy.
Will you take the step and become our partner? Make an impact on the health of future families today by joining our Cimzia® & Pregnancy Study!
Biologic Therapies And Pregnancy: Inflammation Control
The main things that we then turn our attention to, which are priorities for women who come to see me in my preconception clinic, are how will IBD affect pregnancy and how will pregnancy affect IBD?
It all goes back to the theme of inflammation control being king. We break it down into each trimester. In the first trimester, the bigger emphasis is on answering their question of, Does inflammation affect my ability to stay pregnant? Is the miscarriage rate higher in the face of active inflammation? In the high-risk world, they talk a lot about the role of inflammation and its impact on the rates of miscarriages. So we do explain to our female patients that control of inflammation is very important in the first trimester, because we want to minimize the risk of losing a baby.
We clear up that story and tell them they cant use methotrexate, thalidomide, or other therapies that have been linked to malformations. The bigger complex discussion happens when we talk about the newer therapies like tofacitinib, because we dont have much data. We have scant reports of women in the trial getting pregnant. Once they get pregnant they have to leave the trial. The good news is that so far the data on that exposure during the first trimester have not resulted in an increased rate of malformation as they saw in the animal study. So thats really a focus during the first trimester.
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How Is Cimzia Given
Before you start treatment with Cimzia, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Cimzia is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Cimzia is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor’s dosing instructions very carefully.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use Cimzia if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Cimzia can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.
Store Cimzia in its original carton in the refrigerator. Protect from light and do not freeze.
Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.
Unopened prefilled syringes may also be stored at room temperature for up to 7 days, away from heat and light. Throw away any prefilled syringe not used within 7 days. Do not put it back in the refrigerator.
Each prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside.
Cimzia For Crohns Disease
Cimzia is FDA-approved for Crohns disease in adults. Its used to reduce symptoms in people who have moderate to severe Crohns disease thats active .
Crohns disease is a form of inflammatory bowel disease that causes symptoms such as diarrhea, blood in your stools, and abdominal cramps. Cimzia is used when other treatments havent helped enough.
Effectiveness for Crohns disease
In clinical studies, Cimzia was more effective than a placebo at reducing symptoms of Crohns disease. In one study, after 26 weeks of treatment:
- 37% of people who took Cimzia had reduced symptoms
- 29% of people who took Cimzia were in remission
- 27% of people who took a placebo had reduced symptoms
- 18% of people who took a placebo were in remission
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How Cimzia Is Given
You should take Cimzia according to your doctors or healthcare professionals instructions.
When you first start using Cimzia, your doctor will give you the injection at their office. They can also teach you how to give yourself injections at home if youd like to start doing it yourself.
Cimzia is given by subcutaneous injection . The injection sites used are the thigh or tummy. You may need one or two injections for each dose. If you need two injections, they should be given in different places at these injection sites.
The manufacturer of Cimzia has produced a video series of instructions on how to give yourself Cimzia injections. They also provide written step-by-step instructions as a .
When Should I Start Trying
The best time to have a baby is when it feels right for you.
Its better to try for a baby when your condition isnt very active, as this will improve the chances of having a successful pregnancy for both you and your baby.
If youre struggling to get pregnant after a year of trying, you should seek advice from a fertility expert. If youre over 36 years old, or already know you may have fertility problems, you should seek advice sooner.
It may take slightly longer for women with arthritis to become pregnant, so you might want to bear this in mind.
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What Are The Serious Side Effects Of Cimzia
Cimzia may cause serious side effects. In general, these side effects are rare. But some people may have a higher risk for certain serious side effects. Before starting treatment, talk with your doctor about your risk for serious side effects from this drug.
Serious side effects of Cimzia can include:
- immune system reactions, such as lupus-like syndrome
- blood disorders, such as leukopenia or thrombocytopenia
- nervous system disorders, such as seizure disorder and optic neuritis
More Common Side Effects Of Cimzia
Cimzia can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Cimzia in clinical trials:
- mild allergic reaction*
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration approves a drug, it tracks side effects of the medication. If you develop a side effect while using Cimzia and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see Side effect specifics below.
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Test For Antiphospholipid Antibodies
You may need a blood test to check for antiphospholipid antibodies, as they can interfere with the bodys ability to regulate blood clotting. These antibodies are present in women with antiphospholipid syndrome and in about half of patients with lupus.
Antiphospholipid antibodies dont always cause problems, but they can increase the risk of pregnancy complications. So, if you test positive, youll usually see a consultant with expertise in high-risk pregnancies. Its likely youll be given a low-dose aspirin tablet to take every day to make your blood less sticky. You may also need daily injections of the blood thinner heparin.
Side Effects And Risks
Cimzia and Humira are both TNF blockers. Therefore, these medications can cause very similar side effects. Below are examples of these side effects.
More common side effects
This list contains examples of more common side effects that can occur with both Cimzia and Humira :
- review of several studies. This review found that Humira may be more effective than Cimzia for treating Crohns disease.
- Psoriatic arthritis: These drugs havent been directly compared for psoriatic arthritis, but studies have found both Cimzia and Humira to be effective for this condition.
What If I Miss A Dose
Its important to keep your appointments with your doctor for Cimzia injections. If you miss an appointment, call your doctors office right away to reschedule.
If youre using Cimzia at home and forget to take a dose, take it as soon as you remember and then talk with your doctor. They can help you set up a new schedule for your Cimzia treatment.
To help make sure you dont miss a dose, write your Cimzia schedule on your calendar. You can also try setting a reminder on your phone.
Alcohol Use And Cimzia
Cimzia should be safe to use if you drink alcohol.
But alcohol can damage your liver. And other drugs that are used with Cimzia, such as methotrexate , can also harm your liver. Drinking alcohol with methotrexate may raise your risk for liver problems. Because of this, you shouldnt drink alcohol if you use methotrexate. In addition, alcohol could also make your autoimmune or inflammatory condition worse.
If youve had a hepatitis B infection in the past and are using Cimzia, it may not be safe for you to drink alcohol.
If you drink alcohol, ask your doctor how much may be safe for you to drink with your condition and treatment plan.
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How Long Does It Take To Work
Cimzia starts to work as soon as you have your first injection. However, it may take a few weeks before you notice an improvement in your symptoms.
In clinical studies, about two-thirds of people taking Cimzia for Crohns disease had improved symptoms after 6 weeks of treatment. Almost half of those with ankylosing spondylitis and about 20% of those with arthritis had improved symptoms in the first 2 weeks of treatment. However, for most people it may take about 12 weeks before symptoms improve.
Here are answers to some frequently asked questions about Cimzia.
Cimzia For Ankylosing Spondylitis
Effectiveness for ankylosing spondylitis
In one clinical study, Cimzia was more effective than a placebo at reducing symptoms of ankylosing spondylitis. Cimzia was also more effective than a placebo at improving physical function . After 12 weeks:
- symptoms improved by at least 20% in:
- 57% of people who took 200 mg of Cimzia every 2 weeks
- 64% of people who took 400 mg of Cimzia every 4 weeks
- 37% of people who took a placebo
- 50% of people who took 400 mg of Cimzia every 4 weeks
- 19% of people who took a placebo
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Cimzia And Other Medications
Below is a list of medications that can interact with Cimzia. This list does not contain all drugs that may interact with Cimzia.
Before taking Cimzia, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Cimzia and immunosuppressant drugs
Immunosuppressants are drugs that weaken your immune system. Cimzia can also weaken your immune system. Taking Cimzia with an immunosuppressant can raise your risk for getting infections.
Examples of immunosuppressant drugs that can raise the risk of infections with Cimzia include:
- corticosteroids such as prednisone
Cimzia and certain other biologics
Examples of other biologics that are not recommended for use with Cimzia include:
Its safe to get inactive vaccines, such as the flu shot, while youre using Cimzia.
Does Cimzia Cause Weight Gain Or Weight Loss
No, Cimzia isnt known to cause weight changes. Weight loss or weight gain werent seen in clinical studies of Cimzia. But these may be symptoms of other serious side effects of Cimzia.
Weight gain due to fluid retention could be a sign of heart failure. In rare cases, Cimzia has caused heart failure or made existing heart failure worse.
Lastly, weight changes can be caused by the autoimmune or inflammatory condition youre using Cimzia to treat. For example, many people with rheumatoid arthritis or Crohns disease experience unintentional weight loss.
If you have unexplained weight changes during your Cimzia treatment, talk with your doctor right away.
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