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.

Crohn's Disease

The recommended starting adult dose of certolizumab is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. If certolizumab is effective, the recommended maintenance regimen is 400 mg every four weeks.

Rheumatoid Arthritis

The recommended dose of certolizumab for adult patients with rheumatoid arthritis is 400 mg (given as two subcutaneous injections of 200 mg) to start and at Weeks 2 and 4, followed by 200 mg every other week. For maintenance dosing, certolizumab 400 mg every 4 weeks can be considered.

Psoriatic Arthritis

The recommended dose of certolizumab for adult patients with psoriatic arthritis is 400 mg to start and at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, certolizumab 400 mg every 4 weeks can be considered.

Ankylosing Spondylitis 

The recommended dose of certolizumab for adult patients with ankylosing spondylitis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks.

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.

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.

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.

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.

Keep certolizumab in the refrigerator at 36ºF - 46ºF (2ºC - 8ºC) and let certolizumab come to room temperature before injecting it.

Certolizumab is a medicine that affects your immune system. Certolizumab can lower the ability of the immune system to fight 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.