CIMZIA® (certolizumab pegol) (2023)

Important Safety Information you should know about CIMZIA® (certolizumab pegol)

(Video) How to Inject Cimzia (certolizumab pegol)

What is the most important information I should know about CIMZIA?

CIMZIA may cause serious side effects, including:

  • CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that can lower the ability of your immune system to fight infections. Some people who received CIMZIA have developed serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death.
    • Your healthcare provider should test you for TB before starting CIMZIA.
    • Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.

    Before starting CIMZIA, tell your healthcare provider if you:

    • think you have an infection or have symptoms of an infection such as:
      • fever, sweat, or chills
      • muscle aches
      • cough
      • shortness of breath
      • blood in phlegm
      • weight loss
      • warm, red, or painful skin or sores on your body
      • diarrhea or stomach pain
      • burning when you urinate or urinate more often than normal
      • feeling very tired
    • are being treated for an infection
    • get a lot of infections or have infections that keep coming back
    • have diabetes, HIV-1 or a weak immune system. People with these conditions have a higher chance for infections.
    • have tuberculosis (TB), or have been in close contact with someone with TB
    • were born in, live, have lived, or traveled to certain countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
    • live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis). These infections may develop or become more severe if you receive CIMZIA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
    • have or have had hepatitis B
    • use the medicine Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab)

    Stop using CIMZIA, and tell your healthcare provider right away if you have any of the symptoms of an infection listed above.

    (Video) How Cimzia (certolizumab pegol) Works in Crohn's Disease

  • Cancer.
    • For people who receive TNF blockers, including CIMZIA, the chances of getting certain types of cancers may increase.
    • Some children, teenagers, and young adults who received TNF blockers, including CIMZIA, have developed lymphoma and other certain types of rare cancers, some of which have caused death. These cancers are not usually seen in this age group. CIMZIA is not for use in children.
    • People with inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.
    • Some people who receive TNF blockers, including CIMZIA, have developed a rare type of cancer which may cause death, called hepatosplenic T-cell lymphoma. Most of these people were male teenagers and young adult males with Crohn's disease or ulcerative colitis. Also, most of these people had been treated with both a TNF blocker and another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6-MP).
    • Some people who receive CIMZIA have developed certain types of skin cancer. Tell your healthcare provider if you develop any changes in the appearance of your skin, including growths on your skin, during or after treatment with CIMZIA. You should see your healthcare provider periodically during treatment for skin examinations, especially if you have a history of skin cancer.

What is CIMZIA?

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used in adults to:

  • Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in adults who have not been helped enough by usual treatments
  • Treat moderately to severely active rheumatoid arthritis (RA)
  • Treat active psoriatic arthritis (PsA)
  • Treat active ankylosing spondylitis (AS)
  • Treat active non-radiographic axial spondyloarthritis (nr-axSpA) with measures of inflammation
  • Treat moderate to severe plaque psoriasis (PsO) in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)

It is not known if CIMZIA is safe and effective in children.

Before receiving CIMZIA, tell your healthcare provider about all of your medical conditions, including if you:

(Video) Certolizumab (Cimzia)

  • have an infection
  • have or have had lymphoma or any other type of cancer
  • have or had congestive heart failure
  • have or have had seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or Guillain-Barre syndrome.
  • are scheduled to receive a vaccine. Do not receive a live vaccine while receiving CIMZIA.
  • are allergic to certolizumab pegol or any of the ingredients in CIMZIA. See the Medication Guide for a complete list of the ingredients in CIMZIA.
  • are pregnant or plan to become pregnant. You and your doctor should decide if you should continue to take CIMZIA while you are pregnant. It is not known if CIMZIA will harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA. You can enroll in this registry by calling 1-877-311-8972. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.
  • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with CIMZIA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I receive CIMZIA?

CIMZIA comes as a lyophilized powder or a solution in a prefilled syringe for injection. If your healthcare provider prescribes the CIMZIA powder, CIMZIA should be injected by a healthcare provider. If your healthcare provider prescribes the prefilled syringe, you will be trained on how to inject CIMZIA. See the booklet called “Instructions for Use” packaged in your CIMZIA prefilled syringe kit on how to inject CIMZIA the right way. Do not give yourself an injection of CIMZIA unless you have been shown by your healthcare provider, or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your healthcare provider will tell you how much and how often to inject CIMZIA. Do not use more CIMZIA or inject more often than prescribed.

(Video) The Impact of Certolizumab Pegol in Treating Nr-AxSpA

What are the possible side effects of CIMZIA?

CIMZIA can cause serious side effects, including:

  • See “What is the most important information I should know about CIMZIA?”
  • Heart failure including new heart failure or worsening of heart failure you already have. Symptoms include shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Allergic reactions. Signs of an allergic reaction include a skin rash; swelling or itching of the face, tongue, lips, or throat; or trouble breathing.The plastic needle shield inside the removable cap of the prefilled syringe contains natural rubber and may cause an allergic reaction if you are sensitive to latex.
  • Hepatitis B virus reactivation in people who carry the virus in their blood. In some cases, people who received CIMZIA have died because of the hepatitis B virus being reactivated. Your healthcare provider should monitor you carefully before and during treatment with CIMZIA to see if you carry the hepatitis B virus in your blood. Tell your healthcare provider if you have any of the following symptoms:
    • feel unwell
    • skin or eyes look yellow
    • tiredness (fatigue)
    • poor appetite or vomiting
    • pain on the right side of your stomach (abdomen)
  • New or worsening nervous system problems, such as multiple sclerosis (MS), Guillain-Barre syndrome, seizures, or inflammation of the nerves of the eyes. Symptoms may include:
    • dizziness
    • numbness or tingling
    • problems with your vision
    • weakness in your arms or legs
  • Blood problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Tell your healthcare provider right away if you have any bruising, bleeding or a fever that does not go away.
  • Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on your cheeks or arms that worsens with sun exposure.

Call your healthcare provider right away if you have any serious side effects listed above.

The most common side effects of CIMZIA include upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).

(Video) Pregnancy Outcomes with Certolizumab: Dr. Kathryn Dao

These are not all of the possible side effects of CIMZIA. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the Medication Guide for CIMZIA and discuss it with your healthcare provider.

FAQs

What is certolizumab pegol used for? ›

Certolizumab pegol is a drug that reduces the signs and symptoms of moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, and Crohn's disease. It works to improve such symptoms as joint swelling, pain, fatigue, and morning stiffness.

How long does it take for CIMZIA to get out of your system? ›

Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period (see section 4.3).

Is CIMZIA a high risk medication? ›

Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Do you gain weight on CIMZIA? ›

Does Cimzia cause weight gain or weight loss? No, Cimzia isn't known to cause weight changes. Weight loss or weight gain weren't seen in clinical studies of Cimzia. But these may be symptoms of other serious side effects of Cimzia.

What does CIMZIA do to your body? ›

Cimzia is called a tumor necrosis factor (TNF) inhibitor. The drug blocks TNF, which is a protein that plays an important role in your immune system. But when TNF is overactive, it can cause disease. By blocking TNF, Cimzia helps to control inflammation that occurs in diseases caused by your immune system.

Do CIMZIA injections make you tired? ›

Tiredness. You may feel tired while using Cimzia. In clinical studies, fatigue (lack of energy) was reported in some people who took Cimzia. In people with rheumatoid arthritis, fatigue was reported in 3% of people who took Cimzia with methotrexate.

Can you drink alcohol on Cimzia? ›

You may drink alcohol while taking certolizumab. If you are also taking methotrexate you should be cautious about how much alcohol you drink.

What happens when you stop biologics? ›

Stopping biologics could make your arthritis flare. A relapse not only affects your quality of life, but could also lead to more joint-damaging inflammation, Ghosh says. If your symptoms haven't improved on your biologic, or if you're having side effects, you do have other options, Haberman says.

Do biologics stop working after a while? ›

Biologics Can Stop Working and Trigger Relapse

“That can happen within months or even many years after a patient has been on a drug,” says John Hardin, MD, professor of medicine in the division of rheumatology at the Albert Einstein College of Medicine, in the Bronx, New York.

Does CIMZIA make you feel sick? ›

The following symptoms that could be compatible with hypersensitivity reactions have been reported rarely following CIMZIA administration to patients: angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, injection site reactions, malaise, pyrexia, rash, serum sickness, and (vasovagal) ...

Why does CIMZIA cause weight gain? ›

If you are on Cimzia and have sudden weight gain, along with swollen ankles or feet with shortness of breath, it could be due to fluid retention from heart failure. This can be a serious side effect of Cimzia so it is important to contact your doctor immediately.

What is the safest biologic for rheumatoid arthritis? ›

What is the safest biologic for rheumatoid arthritis? All biologics carry a risk of side effects such as infection. However, research has found that Abatacept carries a lower risk of serious infection than other biologics for RA.

Can Cimzia cause depression? ›

No, depression wasn't reported as a side effect in Cimzia's clinical studies. It's not uncommon for depression to affect people with the conditions Cimzia is used to treat, including Crohn's disease. So, it's possible you may have depression due to your condition rather than this medication.

What are the most common side effects of Cimzia? ›

While results may vary, and every person taking CIMZIA is different, the most common side effects of CIMZIA include: Upper respiratory infections (flu, cold) Rash. Urinary tract infections (bladder infections)

What drugs interact with Cimzia? ›

Most frequently checked interactions
  • amitriptyline.
  • cyclobenzaprine.
  • Cymbalta (duloxetine)
  • folic acid.
  • gabapentin.
  • Humira (adalimumab)
  • lisinopril.
  • Lyrica (pregabalin)

Does cimzia help with joint pain? ›

Proven Results Even With Prior Biologic Use

Nearly 5 out of 10 § people taking CIMZIA saw improvement in signs and symptoms of rheumatoid arthritis at week 12, even if they had previously been on another anti-TNF therapy. 51% of CIMZIA patients at 12 weeks vs. 26% of placebo patients (Overall total number of patients).

Can cimzia help with back pain? ›

7% of placebo patients; 21% of CIMZIA patients at 2 weeks vs. 1% of placebo patients. Based on a tool that measures disease activity such as back pain, stiffness, and joint swelling. People taking CIMZIA had 33% less back pain than placebo-treated patients at week 12.

When should I take Cimzia? ›

The CIMZIA starter dose is provided at the start of therapy at week 0 (day 0), week 2 (day 14), and week 4 (day 28). Each starter dose is 400 mg, given under the skin as two separate injections of 200 mg each.

Can Cimzia work immediately? ›

Official answer. Cimzia injection can work as fast as 1 or 2 weeks in some people for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Its full effectiveness can range from 4 months to 1 year based on your specific medical condition.

How much does a Cimzia shot cost? ›

The cost for Cimzia subcutaneous kit 200 mg is around $5,379 for a supply of 1 kits, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

Can I take antibiotics while on Cimzia? ›

Cimzia can be taken together with methotrexate, antibiotics, corticosteroids, such as prednisone or pain medications including non-steroidal anti-inflammatory drugs.

Can you have surgery while on Cimzia? ›

What if I need surgery? concerning medications & herbal supplements you are taking • You may need to miss one dose of Cimzia prior to surgery. Cimzia is not restarted until at least 2 weeks after the surgery. The incision must be healed, with no open wounds and no signs of infection.

Is red wine good for rheumatoid arthritis? ›

Red wine contains a compound called resveratrol, which has potent anti-inflammatory effects. Studies show that red wine consumption is associated with a reduced risk of knee-related osteoarthritis. It can also cut risk factors contributing to rheumatoid arthritis.

Does cimzia cause sun sensitivity? ›

Photosensitivity is a common side-effect of methotrexate, Plaquenil, and NSAIDs such as Celebrex or Advil. Photosensitivity may also be a serious side-effect of anti-TNF drugs such as Cimzia, Enbrel, Humira, Remicade, and Simponi, as well as sulfasalazine.

Can you start and stop biologics? ›

It's usually best not to stop taking a biologic, since most of these medications don't work as well when restarted. Reasons you might stop taking a biologic include failure to respond well to the medication, serious side effects, pregnancy, elective surgery, and necessary vaccinations.

How do you stay healthy during biologics? ›

Eat healthy while you're taking a biologic.
...
Try Foods That Fight Inflammation
  1. Fatty fish like tuna, salmon, and sardines.
  2. Nuts such as walnuts, almonds, and pistachios.
  3. Berries and citrus fruits like oranges and grapefruit.
  4. Green vegetables like broccoli, spinach, and kale.
  5. Beans, including red and kidney beans.
13 Dec 2021

Can you take a break from biologics? ›

If you pause your biologic, you may no longer experience the drug's side effects. But over time, stopping and starting a biologic can cause the medication to not work as well. You may also have a lower risk of infection, so in the case of some life events, like pregnancy or surgery, it may be a reasonable option.

How do I know if biologic is working? ›

Your doctor will want to see you more often at the beginning of your treatment to see how you're doing on your biologic, whether it's working, and if you have side effects. To see how it's working, your doctor will probably give you a physical exam and ask you about symptoms like pain, swelling, and red, hot joints.

What are the long term effects of biologics? ›

All biologics suppress the immune system and increase the risk of infections. Common infections. People who take biologics are morel likely to get infections such as upper respiratory infections, pneumonia, urinary tract infections, and skin infections. Opportunistic infections.

Can you become immune to biologics? ›

Almost all biologic medications can lead to the development of anti-drug antibodies, though the risk is different for each individual drug. This is true for biologics whether they are derived from human, animal, or microorganism sources. The anti-drug antibodies could make the drug less effective.

Is headache a side effect of Cimzia? ›

Mild side effects that have been reported with Cimzia include: headache. skin rash. respiratory infection, such as the common cold.

How many people take Cimzia? ›

MORE THAN 200,000 PEOPLE TREATED WITH CIMZIA SINCE 2008

Today, thousands of doctors choose CIMZIA for their adult patients with chronic inflammatory conditions. Its molecular structure makes CIMZIA the only biologic treatment of its kind.

What is the most successful drug for rheumatoid arthritis? ›

Three years later, methotrexate won FDA approval for treating RA, and it soon became the treatment of choice for people with this condition and other forms of inflammatory arthritis as well. About 90% of RA patients use methotrexate at some point.

What is the strongest medication for rheumatoid arthritis? ›

Methotrexate is usually the first medicine given for rheumatoid arthritis, often with another DMARD and a short course of steroids (corticosteroids) to relieve any pain. These may be combined with biological treatments.
...
The DMARDs that may be used include:
  • methotrexate.
  • leflunomide.
  • hydroxychloroquine.
  • sulfasalazine.

What is the new pill for rheumatoid arthritis? ›

New Treatments for Rheumatoid Arthritis - Latest FDA Approvals
DrugDrug Class
rituximab (Rituxan)CD20-directed cytolytic antibody
abatacept (Orencia)selective T cell costimulation modulator
adalimumab (Humira)tumor necrosis factor (TNF) blocker
anakinra (Kineret)interleukin-1 receptor antagonist
12 more rows

Do biologics make you emotional? ›

Mood disorders linked to biologic initiation, switching in rheumatic diseases. medwireNews: Depression and anxiety are significantly associated with the introduction and switching of biologic DMARDs in patients with inflammatory rheumatic diseases (IRDs), population-based study data show.

Can CIMZIA cause joint pain? ›

Very rarely, certolizumab pegol may cause a condition called drug-induced lupus. Symptoms include a rash, fever and increased joint pain. If you have any these symptoms you should tell your rheumatology team.

Does CIMZIA cause shortness of breath? ›

Cimzia (certolizumab) can raise your risk of getting a severe or life-threatening infection. If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while taking Cimzia (certolizumab), go to the hospital right away so you can be tested for an infection.

When should I take CIMZIA? ›

The CIMZIA starter dose is provided at the start of therapy at week 0 (day 0), week 2 (day 14), and week 4 (day 28). Each starter dose is 400 mg, given under the skin as two separate injections of 200 mg each.

What type of drug is certolizumab? ›

Certolizumab injection is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes inflammation.

What are the symptoms of CIMZIA? ›

What are the side effects of Cimzia (certolizumab)?
  • Serious allergic reactions: hives, itching, swelling of face or tongue, difficulty breathing.
  • Severe or deadly infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills, burning when you urinate, urinating more frequently.
28 Sept 2021

Can CIMZIA work immediately? ›

Official answer. Cimzia injection can work as fast as 1 or 2 weeks in some people for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Its full effectiveness can range from 4 months to 1 year based on your specific medical condition.

Does CIMZIA make you cold? ›

Common Side Effects of CIMZIA

Upper respiratory infections (flu, cold) Rash. Urinary tract infections (bladder infections)

When should you stop taking biologics? ›

It's usually best not to stop taking a biologic, since most of these medications don't work as well when restarted. Reasons you might stop taking a biologic include failure to respond well to the medication, serious side effects, pregnancy, elective surgery, and necessary vaccinations.

Does Cimzia cause depression? ›

No, depression wasn't reported as a side effect in Cimzia's clinical studies. It's not uncommon for depression to affect people with the conditions Cimzia is used to treat, including Crohn's disease. So, it's possible you may have depression due to your condition rather than this medication.

Can cimzia raise blood pressure? ›

Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal antiinflammatory drugs.

What is an adverse effect of certolizumab? ›

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 use the medicine. Some people using this medicine developed lupus-like symptoms.

Can cimzia cause eye problems? ›

Eye-related side effects

Cimzia may cause optic neuritis (swelling of the area around your optic nerve). This may cause symptoms such as vision loss or eye pain. Also, Cimzia may increase the risk of nerve problems such as multiple sclerosis. This condition may cause changes in your vision.

How effective is Cimzia for rheumatoid arthritis? ›

Proven Results Even With Prior Biologic Use

Nearly 5 out of 10 § people taking CIMZIA saw improvement in signs and symptoms of rheumatoid arthritis at week 12, even if they had previously been on another anti-TNF therapy. 51% of CIMZIA patients at 12 weeks vs. 26% of placebo patients (Overall total number of patients).

How many people are on Cimzia? ›

MORE THAN 200,000 PEOPLE TREATED WITH CIMZIA SINCE 2008

Today, thousands of doctors choose CIMZIA for their adult patients with chronic inflammatory conditions.

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