ENTYVIO is a prescription medicine used in adults with moderate to severe ulcerative colitis or Crohn’s disease.
- Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
- ENTYVIO may cause serious side effects, including:
- Infusion and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
- ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
- It may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
- Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
- The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
- Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Uses of ENTYVIO® (vedolizumab)
ENTYVIO is a prescription medicine used in adults:
- with moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider.
- with moderate to severe Crohn’s disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.
Please see the Full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.
If you have moderate to severe Crohn’s disease and the first medicines you try don’t help enough, your doctor may consider “biologics,” which are a different type of medicine.
Biologics attack enzymes or proteins that inflame your intestine. They don’t slow your whole immune system, as steroids tend to do. While they’re less likely to cause major problems, dangerous side effects are possible.
Several biologic drugs are approved to treat Crohn’s disease. Five of them are “TNF-blockers”:
- Adalimumab ( Humira) . You’ll get this as a shot every 2 weeks.
- Adalimumab-atto (Amjevita), a biosimilar to Humira. This medicine is given as a shot that you’ll take every 2 weeks.
- Certolizumab (Cimzia). You get this drug as a shot. After the first one, you get injections at 2 weeks and 4 weeks. After that you get a shot every 4 weeks.
- Infliximab ( Remicade ). You take this drug through an IV. After your first IV dose, you’ll get another IV dose at 2 weeks and 6 weeks. After that you’ll get an IV dose every 8 weeks.
- Infliximab-dyyb (Inflectra), which works like Remicade. Your doctor may call it a “biosimilar” medicine. You get it through an IV at your doctor’s office. This process will last at least 2 hours. After the first treatment, you will get more doses at 2 weeks and 6 weeks later. Then you’ll get a dose every 8 weeks.
Two other approved drugs work on a protein called integrin and block movement of inflammatory white blood cells:
- Natalizumab (Tysabri). You’ll get this through an IV every 4 weeks.
- Vedolizumab (Entyvio) is also given through an IV. After your first dose, you’ll get another IV dose at 2 weeks and 6 weeks. After that you’ll get a dose every 8 weeks.
Another drug that works in a different way blocks IL-12 and IL-23:
- Ustekinumab (Stelara). This is given as an IV for your first dose. After your first IV dose, you will receive an injection under your skin 8 weeks later and then every 8 weeks.
Crohn’s Disease Treatment
Several different medications, as well as surgical treatments, may help reduce Crohn’s disease symptoms.
Alternative therapies, medications, and surgery all help alleviate Crohn’s symptoms. Masterfile; Thinkstock; iStock
There’s no cure for Crohn’s disease, but there are several therapies available to help manage symptoms.
Most people with Crohn’s disease can lead a fairly normal life with treatment.
The treatments your doctor recommends will depend on the severity and type of symptoms you’re experiencing, as well as what parts of your digestive tract are affected.
The two main types of treatment for Crohn’s disease are medication and surgery.
Medications for Crohn’s Disease
There are a number of medicines available to treat Crohn’s disease.
Your doctor may recommend one or more drugs, depending on which parts of the digestive tract are causing your symptoms.
Most medications to treat Crohn’s disease reduce inflammation and suppress the immune system.
Some medicines are used to treat flares, when symptoms are at their worst. Other medicines help prevent the return of symptoms once they’ve gone away.
Common medicines for Crohn’s disease include:
Aminosalicylates (5-ASAs) These drugs help reduce inflammation in the digestive tract, especially in the colon. (1)
Aminosalicylates are generally prescribed for people with mild to moderate symptoms. According to the Crohn’s & Colitis Foundation, they’re most useful as a maintenance treatment to prevent relapses. (1)
Their effects are localized to the intestines, and they have fewer side effects than some of the other medications used to treat Crohn’s.
Apriso, Asacol, Delzicol, Lialda, or Pentasa (mesalamine) and Azulfidine (sulfasalazine) are the most commonly prescribed aminosalicylates used to treat Crohn’s disease. (2)
Corticosteroids Also known simply as steroids, these drugs help reduce inflammation and immune system activity.
They’re generally prescribed for people with moderate to severe symptoms, according to the National Institute of Diabetes and Digestive and Kidney Diseases. (3)
Deltasone (prednisone), Medrol (methylprednisolone), and Entocort EC (budesonide) are commonly prescribed corticosteroids for Crohn’s disease.
Corticosteroids suppress the entire immune system, not just in the digestive tract.
Because they can have significant side effects in both the long and short term, steroids are usually taken only for short periods of time to help control a Crohn’s disease flare. (1)
Immunomodulators These drugs help reduce inflammation by suppressing the body’s immune system.
Your doctor may recommend an immunomodulator if you have severe symptoms, or if you haven’t seen enough improvement in your symptoms with aminosalicylates and corticosteroids.
These drugs may help you stop taking corticosteroids or maintain remission when other drugs haven’t been effective for this purpose, according to the Crohn’s & Colitis Foundation. (1)
Immunomodulators may take between a few weeks and three months to start working. (3)
Biologic response modifiers (biologics) These drugs help prevent inflammation by targeting proteins made by the immune system.
Biologics are the newest class of drugs used to treat Crohn’s disease, and they’re usually reserved for people who haven’t responded well to more established treatments. (1)
They’re often taken in combination with other medications and are given intravenously (by IV) or by injection.
Some biologics can be taken at home, but others must be given in a doctor’s office.
Antibiotics These drugs can help treat or prevent Crohn’s complications that involve infection, such as abscesses and fistulas.
According to the Mayo Clinic, researchers believe that antibiotics may reduce the amount of harmful bacteria in the intestines, helping to reduce inflammation. (2)
Commonly prescribed antibiotics for Crohn’s disease include Cipro (ciprofloxacin) and Flagyl (metronidazole). (2)
Surgery for Crohn’s Disease
Your doctor may recommend surgery for your Crohn’s disease if your symptoms aren’t getting better with medicine.
About 70 percent of people with Crohn’s disease will need surgery at some point, according to the Crohn’s & Colitis Foundation. (1)
Surgery isn’t a cure for Crohn’s disease, but some people can live without symptoms for as long as several years after surgery.
According to the Mayo Clinic, taking medications after surgery can help prevent or delay recurrence of your disease. (2)
Commonly performed surgeries for Crohn’s disease include:
Resection and anastomis In this procedure, a surgeon removes the diseased part of your small intestine or colon and reconnects what remains. (4)
Strictureplasty This procedure may be used in certain cases to reopen an area of the bowel that has become blocked (usually part of the small intestine) without removing the section altogether. (5)
Colectomy, proctocolectomy, and ileostomy A simple colectomy removes the colon but preserves the rectum, allowing stool to pass through the anus normally.
A proctocolectomy removes the entire colon and rectum. It’s performed along with an ileostomy, which creates an opening in your abdomen (called a stoma) for waste to pass through.
Waste is then collected in an external bag or pouch, which can be emptied into a toilet and replaced whenever it fills up. (6)
Complementary and Alternative Treatments
There’s little scientific evidence that complementary or alternative therapies provide clear benefits for people with Crohn’s disease. (2)
Some people with Crohn’s disease use complementary therapies, together with conventional treatments such as medicine and surgery, to help reduce symptoms.
Complementary therapies for Crohn’s disease include:
Probiotics These preparations of “good bacteria” may help with digestion and improve some symptoms, such as bloating and gas.
There’s some evidence that certain probiotics may also help people with Crohn’s disease stay in remission, according to the Mayo Clinic. But research results are mixed, and more extensive studies are needed. (2)
A systematic review published in 2015 in the journal BioMed Research International found that probiotics can have a positive effect in the maintenance and remission periods of IBD, though the evidence is stronger in patients with ulcerative colitis. (7)
On the other hand, a review in the journal Frontiers in Medicine found that probiotics did not appear to provide any significant benefit to children with Crohn’s disease, and a 2016 review concluded that “there is insufficient evidence to support the use of probiotics in the management of Crohn’s disease at this time.” (8)(9)
Probiotics come in many different bacterial strains, preparations, and dosages. Some probiotics may help more than others, and some may not help at all.
Ask your doctor for a recommendation before starting on a probiotic.
Stress reduction techniques These include practices such as yoga, meditation, and tai chi.
While there are anecdotal reports of people reducing their symptoms through stress reduction or mind-body techniques, most studies have found little benefit or mixed results. (10)
Acupuncture This technique involves a practitioner inserting fine needles in various locations on your body.
A study published in the World Journal of Gastroenterology found that acupuncture — combined with herb burning, called moxibustion — led to significantly less Crohn’s disease activity, as shown by self-reporting. (11)
Herbal and plant-based remedies According to an April 2015 article in the journal Annals of Gastroenterology, herbal and plant remedies that have been shown in studies to reduce active Crohn’s disease include wormwood, cannabis, Boswellia serrata, and Tripterygium wilfordii. (12)
Tell your doctor if you use any complementary therapies, especially if you’re taking dietary supplements or vitamins.
These products may contain ingredients that could interact with other medications you’re taking, and some supplements may contain impurities or have dangerous side effects. (2)