VEDOLIZUMAB
Background and Date of Approval
Vedolizumab received its initial approval from the U.S. Food and Drug Administration (FDA) on May 20, 2014. It is indicated for the treatment of moderate to severe ulcerative colitis, Crohn’s disease, and chronic pouchitis in adults.
Uses
It is used as a second line of treatment option for adults dealing with moderate to severe cases of ulcerative colitis (inflammation of the large bowel), crohn's disease (inflammation affecting the digestive system), and chronic pouchitis (inflammation of the lining of a pouch created during surgery to treat ulcerative colitis) to help alleviate the signs and symptoms of these conditions.
How is it administered?
Vedolizumab is available as a 300mg injection. It is given only in a hospital setup by a healthcare provider. It is infused directly into your veins by your physician. Your physician will decide the dosage and frequency of this injection based on the severity of your disease and other factors.
Side Effects
Vedolizumab can cause some side effects like any other drug. The most common side effects are headaches, joint pain, and cold. Some of the serious side effects are allergic reactions (wheezing or difficulty breathing, hives, itching of the skin, swelling, feeling sick, pain at the infusion site, redness of the skin), serious infections (chills, shivering, high fever, or rash), progressive multifocal leukoencephalopathy - PML (a rare fatal opportunistic infection of the central nervous system) and severe liver injury.
Warnings
Do not take this medication if you are under 18 or have allergies to vedolizumab or its components. Additionally, it is essential to avoid this medication if you have an active severe infection, such as tuberculosis (TB), blood poisoning, severe diarrhea and vomiting (gastroenteritis), or a nervous system infection. Another critical point is that you should not take this medication with other biological medicines that suppress your immune system such as natalizumab or rituximab. Seek medical attention immediately if you ever experience symptoms suggestive of progressive multifocal leukoencephalopathy (PML), such as blurred vision, loss of vision, double vision, speech difficulties, weakness in an arm or leg, changes in your gait or balance, persistent numbness, decreased sensation, or memory issues, during the treatment with vedolizumab.
Precautions
It is essential to inform your doctor if you are pregnant, breastfeeding, or intending to get vaccinated. If you are a woman of reproductive age, use reliable contraception during the treatment and for four and half months following the last infusion.
Word of Advice
Vedolizumab injection is for in-hospital use only and must be administered by a healthcare provider. Safety and effectiveness in elderly patients do not differ significantly from younger adults, though close monitoring remains important in this population. If you experience symptoms suggestive of progressive multifocal leukoencephalopathy (PML)—including blurred vision, loss of vision, double vision, speech difficulties, weakness in an arm or leg, changes in gait or balance, persistent numbness, decreased sensation, or memory issues—inform your healthcare provider immediately. In patients with very active Crohn's disease, vedolizumab may require up to 14 weeks to demonstrate full effect. Inform your doctor if you do not notice improvement in your condition. Adhere to your scheduled doses throughout treatment. A diet including whole grains, vegetables, fruits, healthy fats, lean meats, fish, beans, and eggs supports immunity. Avoid smoking and alcohol consumption to maintain a healthier lifestyle.
References
Takeda Pharma A/S, Electronic medicines compendium (EMC), [Revised on April 2022] [Accessed on 22nd Sep 2023], https://www.medicines.org.uk/emc/product/5442/pil Takeda Pharmaceuticals America, Inc, US Food and Drug Administration (FDA), [Issued on May 2014] [Accessed on 22nd Sep 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf Goodman and Gilmanâs The Pharmacological Basis of Therapeutics, Pharmacology of Inflammatory Bowel Disease, 13th Edition, 2018, 950-951
Frequently Asked Questions
Is vedolizumab injection indicated for children?
No, vedolizumab injection should not be administered to children and adolescents under 18.
How long should I take the vedolizumab injection?
If the vedolizumab injection works well for you, you can expect to follow a planned treatment regimen for approximately one year. Following this initial period, your doctor will evaluate your progress to determine if the treatment is still providing benefits. If it is, you have to continue with the treatment. To ensure that this medicine remains the right choice for you, schedule a review for every 12 months.
What precautions should I take during the treatment with vedolizumab injection?
Vedolizumab injection can make you immunocompromised and prone to infections. Hence, to protect yourself, avoid contact with sick people and wash your hands frequently. Inform your doctor immediately if you get a fever, cold, cough, flu-like symptoms, unusual tiredness, or weakness.
What are the most common side effects of vedolizumab injection?
The most common side effects of vedolizumab injection are common cold, headache, and joint pain.
Can I receive vedolizumab injections while taking other medications?
Inform your doctor about any prescribed medications, over-the-counter medicines, nutritional or vitamin supplements, and herbal products you take or have taken before the treatment. Tell your healthcare provider if you take or have recently taken any other immunosuppressive medications such as natalizumab, rituximab, corticosteroids, or chemotherapy medications.