Certolizumab: Arthritis Uses, Side Effects & Dosage (original) (raw)
Generic Name: certolizumab
Brand Name: Cimzia
Drug Class: DMARDs, TNF Inhibitors; Immunosuppressants
What is certolizumab, and what is it used for?
Certolizumab is an injectable synthetic (man-made) protein antibody that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis and Crohn's disease.
Adalimumab (Humira) and etanercept (Enbrel) are two other injectable drugs that block TNFα. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints.
In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation. Certolizumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented. The FDA approved Certolizumab in April 2008.
Warnings
- Like other drugs that block TNFα, use of certolizumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with certolizumab. Certolizumab may worsen or cause new diseases of the nervous system. Certolizumab also may cause or worsen congestive heart failure.
- In studies, some patients who used certolizumab or other TNFα blocking drugs developed cancer. Since patients with Crohn's disease have a higher risk of cancers than the general population, the connection between cancer and use of certolizumab is unclear.
- Other side effects of certolizumab include hypersensitivity (allergic) reactions (including anaphylaxis) and reduced levels in the blood of platelets and red blood cells (aplastic anemia). Certolizumab may increase the risk of reactivating hepatitis B virus in chronic carriers of the virus.
- Certolizumab is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
- The needle shield inside the removable cap of the certolizumab prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.
What is the dosage for certolizumab?
Certolizumab is injected under the skin (thigh or abdomen). Injection sites should be rotated.
- The recommended dose for treating Crohn's disease is 400 mg initially (2 injections of 200 mg), followed by 400 mg at weeks 2 and 4. For those who respond, the recommended maintenance dose is 400 mg every 4 weeks.
- The recommended dose for treating rheumatoid arthritis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.
- The recommended dose for treating psoriatic arthritis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 400 mg every other week.
- The recommended dose for treating ankylosing spondylitis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.
SLIDESHOW What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
Which drugs interact with certolizumab?
Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) or natalizumab (Tysabri) with certolizumab may result in reduced white blood cells in the blood (neutropenia), serious infections and no additional benefit.
Certolizumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with certolizumab. Certolizumab may interfere with tests of coagulation in patients receiving blood thinners.
Pregnancy and breastfeeding
There are no adequate studies of certolizumab in pregnant women.
It is not known whether certolizumab is excreted in breast milk.
What else should I know about certolizumab?
What preparations of certolizumab are available?
Injection (powder): 200 mg. Injection (prefilled syringe): 200 mg
How should I keep certolizumab stored?
Certolizumab should be stored refrigerated at 2 to 8 C (36 to 46 F). Reconstituted certolizumab should be used within two hours if kept at room temperature or within 24 hours if refrigerated.
Health News
Summary
Certolizumab is an injectable protein antibody (man-made) that binds to the tumor necrosis factor alpha. Cimzia is prescribed for the treatment of rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The most common side effects were respiratory tract infections, urinary tract infections, arthralgia (pain in the joints), abdominal pain, diarrhea, intestinal obstruction, redness, pain and itching at the site of injection.
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Related Disease Conditions
- Rheumatoid Arthritis (RA) Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body.
- Arthritis (Joint Inflammation) Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and gout.
- Crohn's Disease Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestines, but it can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms and signs.
- Psoriatic Arthritis Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms of psoriatic arthritis include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves anti-inflammatory medications and exercise.
- Non-Radiographic Axial Spondyloarthritis Non-radiographic spondyloarthritis (nr-axSpA) is inflammatory arthritis that mainly affects the joints of the spine. Morning stiffness and back pain are the usual symptoms of non-radiographic spondyloarthritis (nr-axSpA).
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Medically Reviewed on 10/13/2023
References
FDA prescribing information for Cimzia