Certolizumab

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

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

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

Certolizumab 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.

Certolizumab may be found in some form under the following brand names:

• Cimzia

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

Common side effects in people taking certolizumab are:

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

Other side effects with certolizumab include:

• New or Worsening Psoriasis. Some people using certolizumab 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 certolizumab.
• 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 certolizumab. 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 certolizumab with these medications.
• A TNF blocker such as Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept), or Simponi (golimumab).

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

Certolizumab 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 certolizumab, 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 certolizumab 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.

Certolizumab is a medicine that affects your immune system. Certolizumab 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 certolizumab use. Some patients have died from these infections.

Before starting certolizumab, your doctor should:

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

After starting certolizumab, 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. Certolizumab 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 certolizumab there are no specific foods that you must exclude from your diet when receiving certolizumab.

Before starting certolizumab, 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 certolizumab.
• are allergic to any of the ingredients in certolizumab

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Certolizumab 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 certolizumab 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 certolizumab is excreted in human breast milk or if it will harm your nursing baby.

Lyophilized Powder for Reconstitution:

• If your doctor prescribes the certolizumab powder for reconstitution, certolizumab should be injected by a healthcare provider. Each dose of certolizumab 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 certolizumab prefilled syringe, see the booklet called "Patient Instructions for Use" packed in your certolizumab prefilled syringe kit for complete instructions for use.
• Do not give yourself an injection of certolizumab 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.
• Certolizumab is given by an injection under the skin. Your doctor will tell you how much certolizumab to inject and how often to inject certolizumab, based on your condition to be treated. Do not use more certolizumab or inject more often than prescribed.
• Depending on the amount of certolizumab prescribed by your doctor, you may need more than one injection at a time.
• If you are prescribed to take 400 mg of certolizumab, you will need two injections. You will need to use two certolizumab prefilled syringes.
• Certolizumab 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 certolizumab prefilled syringe if the medicine looks cloudy or if there are large or colored particles.
• Do not miss any doses of certolizumab. If you forget to take certolizumab, 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 certolizumab call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If certolizumab 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 certolizumab in the refrigerator at 36ºF - 46ºF (2ºC - 8ºC)
• Let certolizumab come to room temperature before injecting it.
• Do not freeze certolizumab.
• Protect certolizumab from light. Store certolizumab in the carton.
• Do not use certolizumab 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 certolizumab, 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.

Certolizumab 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 certolizumab use and during therapy. Treatment for latent infection should be initiated prior to certolizumab 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 certolizumab 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, 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 certolizumab is a member. Certolizumab is not indicated for use in pediatric patients.