What is certolizumab? What is certolizumab 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.
What brand names are available for certolizumab?
Cimzia
Is certolizumab available as a generic drug?
No
Do I need a prescription for certolizumab?
Yes
What are the side effects of certolizumab?
The most common adverse effects in clinical studies were:
- respiratory tract infections,
- urinary tract infections, and
- arthralgia (pain in the joints),
- abdominal pain,
- diarrhea,
- intestinal obstruction,
- redness,
- pain and
- itching at the site of injection.
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.
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.
QUESTION
The term arthritis refers to stiffness in the joints.
See Answer
Which drugs or supplements 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.
Is certolizumab safe to take if I’m pregnant or 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.