Vedolizumab is used to treat moderate to severe ulcerative colitis and Crohn’s disease in adults who have been intolerant to corticosteroids and TNF antagonists. It is also useful in patients in which TNF antagonists do not show desired efficacy.
In some patients, it also might be suggested as a first-line treatment. Although various researches have proved vedolizumab to be beneficial in pediatric ulcerative colitis and Crohn’s disease, it hasn’t been approved yet.
What is Entyvio (vedolizumab) and how it works?
Entyvio (vedolizumab) is a monoclonal antibody that binds to α4β7 integrin, which is expressed by gastrointestinal lymphocytes in inflammation. Vedolizumab binds to α4β7 integrin and inhibits its binding to the surface of mucosal endothelial cells. This phenomena aids in reducing inflammation.
Vedolizumab is a biological drug (can be created in living cells) it is a gut-selective integrin blocker. Unlike TNF antagonists, vedolizumab only acts on the gut rather than the whole body. Vedolizumab action varies among people. It may start its effects in six weeks in some people while in some people it might take as long as 14 weeks to act.
How is Entyvio (Vedolizumab) administered?
Vedolizumab is given as an IV infusion. It cannot be taken orally (in tablet form) as it is readily destroyed by the digestive system.
How effective is Entyvio (vedolizumab)?
Vedolizumab has been proved to be more beneficial than TNF antagonists in the treatment of inflammatory bowel disease. Although the response rates among people vary greatly, vedolizumab use is associated with less use of corticosteroids and a faster rate of clinical remission.
Who should not receive Entyvio (vedolizumab)?
Entyvio must not be administered in patients who have the following medical conditions:
- People who have any sort of infection or have a history of recurring infections must not receive Entyvio.
- People with liver problems must not receive Entyvio.
- Tuberculosis (TB) patients or those who have been in contact with someone who has TB.
- Patients who have recently been vaccinated.
- Pregnant females must not receive Entyvio as it can cause harm to the developing fetus
- Lactating females or those planning t breastfeed must not take Entyvio as it can pass into the breast milk.
Most Common Side Effects of Entyvio (vedolizumab):
Vedolizumab is generally safe with a very low rate of complications. But it can have side effects like other drugs. Some of the common side effects include:
- Difficulty breathing
- A rapid heart rate
- Itchy skin
- Pain at the injection site
- High fever and chills
Other less common side effects of Entyvio (vedolizumab):
Other common side effects include
- Flu-like symptoms
- Sore throat
- High blood pressure
- Bowel difficulties (bloating, diarrhea, Hemorrhoids)
- Urinary tract infections
- Hair loss is not mentioned in the side effects profile of vedolizumab. However, individual reviews by patients have associated hair fall with its use. Furthermore, hair loss can occur as a result of the disease.
Seek immediate medical attention if you develop any of these symptoms:
- Difficulty speaking
- Blurred or double vision
- Unable to maintain balance while walking
- Weakness in arms or legs
- Memory loss or confusion
- Persistent numbness
Serious Side Effects of Entyvio (vedolizumab):
Serious side effects are rare very rare. Some of them include:
Progressive Multifocal Leukoencephalopathy (PML):
- Although it is extremely rare but it may be possible for a person to have Progressive Multifocal Leukoencephalopathy (PML). It is a rare but serious brain disorder caused by a virus. People with a weakened immune system are at greater risk of having PML. Symptoms include loss of balance, thinking problems, confusion, blurred vision or loss of vision, decreased strength, which may cause disability and even death. There is no treatment or cure available for PML.
- Some serious infections include pneumonia, anal abscess, gastroenteritis, and appendicitis. Microbial infections like Clostridium difficile infections, Shigella infections, Campylobacter infections, and Yersinia infections
- Neoplasms including benign Skin Papilloma and Melanocytic Naevus and malignant neoplasms such as Basal Cell Carcinoma and Squamous Cell Carcinoma have an occurrence rate of <1% (0.3-0.4%)
- Entyvio usage is associated with increased levels of transaminase and bilirubin. In patients with Ulcerative colitis and Crohn’s disease trials reported serious events of hepatitis within the first five weeks of administration of Entyvio although all the patients recovered by use of corticosteroids
Entyvio (Vedolizumab) Drug Interactions:
Following drugs must be avoided while on vedolizumab therapy
- The combined use of vedolizumab with natalizumab increases the risk of PML that’s why these drugs must not be used together.
- TNF antagonists’ use with vedolizumab must be avoided to avoid serious infections due to drug interaction.
- Live vaccination must not be done while on vedolizumab therapy.
Entyvio (vedolizumab) effect on pregnancy and fertility:
Vedolizumab is generally ranked in pregnancy B category drugs. There is no data available on the harmful effects of vedolizumab on fertility or during pregnancy. It is not recommended to use vedolizumab during pregnancy. Women of childbearing age must use a contraceptive with vedolizumab and should continue taking it even after five months of vedolizumab therapy. It is secreted in breastmilk that’s why it must be avoided in lactating women.
Overall Safety Profile of Entyvio (Vedolizumab):
Vedolizumab is the safest treatment for Inflammatory Bowel Disease (IBD). The key advantage of this drug over others is that the other immunosuppressive agents affect the entire body while vedolizumab targets only the gut. That’s why its safety profile does not include the side effects associated with TNF inhibitors or corticosteroids.
The side effect profile of vedolizumab is superior to other immunosuppressive. No class of drugs is superior to vedolizumab in efficacy therefore it must be used as a first-line treatment.[Ref]
Entyvio has a very low risk of side effects and a long-term safety profile which makes it the safest treatment for Inflammatory bowel disease. Although it might cause side effects in some people, it has the lowest rate of side effects among other agents.