Cimzia

Cimzia is a prescription medicine used to treat adults with Crohn's disease, rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis. Cimzia belongs to a group of drugs called tumor necrosis factor (TNF) blockers. TNF is a natural substance in the body that can cause inflammation. Cimzia binds to TNF to decrease inflammation and to relieve the signs and symptoms of Crohn's disease, RA, PsA, and ankylosing spondylitis.

Cimzia comes is available as an injection and is injected under the skin (subcutaneously) every 2 or every 4 weeks. 

Common side effects of Cimzia include cold-like symptoms, rash, and bladder infections.

Cimzia is a prescription medication used in adult patients 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
• treat active ankylosing spondylitis 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• UCB, Inc.

Cimzia can cause serious side effects. See "Drug Precautions".

Common side effects in people taking Cimzia are:

• upper respiratory infections (flu, cold)
• rash
• urinary tract infections (bladder infections)

Other side effects with Cimzia include:

• New or Worsening Psoriasis. Some people using Cimzia had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Cimzia.
• Injection site reactions. Redness, rash, swelling, itching or bruising can happen in some people. These symptoms will usually go away within a few days. If you have pain, redness, or swelling around the injection site that doesn't go away within a few days or gets worse, call your doctor right away.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Cimzia. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take:

• Kineret (anakinra), Orencia (abatacept), Rituxan (rituximab), Tysabri (natalizumab). You have a higher chance for serious infections when taking Cimzia with these medications.
• A TNF blocker such as Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept), or Simponi (golimumab).

This is not a complete list of Cimzia  drug interactions. Ask your doctor or pharmacist for more information.

Cimzia can cause serious side effects including:

• 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.
• Nervous System Problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Symptoms include dizziness, numbness or tingling, problems with your vision, and weakness in your arms or legs.
• Allergic Reactions. Signs of an allergic reaction include a skin rash, swelling of the face, tongue, lips, or throat, or trouble breathing.
• Certain types of Cancer. There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. For people taking TNF-blocker medicines, including Cimzia, the chances of getting lymphoma or other cancers may increase. People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

• Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with Cimzia  if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms:
  • feel unwell
  • poor appetite
  • tiredness (fatigue)
  • fever, skin rash, or joint pain
• 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 doesn't go away, bruising or bleeding very easily, or looking very pale.
• Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.

Call your doctor right away if you develop any of the above side effects or symptoms.

Cimzia is a medicine that affects your immune system. Cimzia can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking this medication. Tuberculosis (TB) and reactivation of hepatitis B virus (HBV) are two of the more serious complications that are associated with Cimzia use. Some patients have died from these infections.

Before starting Cimzia, your doctor should:

• test you for TB and HBV before starting Cimzia.
• monitor you closely for signs and symptoms of TB or HBV during treatment with Cimzia.

After starting Cimzia, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Cimzia can make you more likely to get infections or make any infection that you may have worse.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cimzia there are no specific foods that you must exclude from your diet when receiving Cimzia.

Before starting Cimzia, tell your doctor about all of your medical conditions, including if you:

• have an infection
• have or have had any type of cancer
• have congestive heart failure
• have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis
• are scheduled to receive a vaccine. Do not receive a live vaccine while taking Cimzia
• are allergic to any of the ingredients in Cimzia 

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Cimzia has not been studied in pregnant or nursing women.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with this medication. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy. To enroll, healthcare providers or patients can call 1-877-311-8972.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Cimzia is excreted in human breast milk or if it will harm your nursing baby.

Lyophilized Powder for Reconstitution:

• If your doctor prescribes the Cimzia powder for reconstitution, Cimzia should be injected by a healthcare provider. Each dose of Cimzia will be given as one or two separate injections under the skin in your stomach area (abdomen) or upper leg (thigh).
• Make sure to keep all of your injection and follow-up appointments with your doctor.

Prefilled Syringe:

• If your doctor prescribes the Cimzia prefilled syringe, see the booklet called "Patient Instructions for Use" packed in your Cimzia  prefilled syringe kit for complete instructions for use.
• Do not give yourself an injection of Cimzia unless you have been shown by your doctor or nurse. Call your doctor if you have questions. Someone you know can also help you with your injection after they have been trained by your doctor or nurse.
• Cimzia is given by an injection under the skin. Your doctor will tell you how much Cimzia to inject and how often to inject Cimzia, based on your condition to be treated. Do not use more Cimzia or inject more often than prescribed.
• Depending on the amount of Cimzia prescribed by your doctor, you may need more than one injection at a time.
• If you are prescribed to take 400 mg of Cimzia, you will need two injections. You will need to use two Cimzia prefilled syringes.
• Cimzia may be injected into your abdomen or thigh area. If you are prescribed to have more than one injection, each injection should be given at a different site in your abdomen or thigh.
• Make sure the solution in the prefilled syringe is clear and colorless to light yellow. The solution should be essentially free from particles. Do not use the Cimzia prefilled syringe if the medicine looks cloudy or if there are large or colored particles.
• Do not miss any doses of Cimzia. If you forget to take Cimzia, inject a dose as soon as you remember. Then, take your next dose at your regularly scheduled time.
• Make sure to keep all follow-up appointments with your doctor.

Crohn's Disease

If you inject too much Cimzia call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Cimzia is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep Cimzia in the refrigerator at 36ºF - 46ºF (2ºC - 8ºC)
• Let Cimzia come to room temperature before injecting it.
• Do not freeze Cimzia.
• Protect Cimzia from light. Store Cimzia in the carton.
• Do not use Cimzia if the medication is expired (today's date is past the date printed on the vial, prefilled syringe or carton), or if the liquid looks cloudy or discolored.
• The vials and prefilled syringe are glass. Do not drop or crush them.
• Always keep Cimzia, injection supplies, puncture-proof container, and all other medicines out of the reach of children.

WARNINGS

SERIOUS INFECTIONS

Patients treated with this medication 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.

Cimzia should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Cimzia use and during therapy. Treatment for latent infection should be initiated prior to Cimzia  use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Cimzia  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 Cimzia, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. 

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients.