Entocort for Crohn's Disease

Entocort (Entocort CR 3mg capsules) 

About Side effects

Overview

Information specific to: Entocort CR 3mg capsules when used in Crohn's disease.

Entocort (ent-o-kort) is a medicine which is used in Crohn's disease. Entocort contains budesonide. It is supplied by AstraZeneca UK Limited.

The information in this Medicine Guide for Entocort varies according to the condition being treated and the particular preparation used.

Your medicine

Entocort is a corticosteroid. Entocort works by preventing or reducing inflammation. It is used to treat Crohn's disease.

People who take corticosteroids for a long period of time are prone to infections as their immune system can become weak. These infections may be much more severe than they usually would be and the symptoms that would usually be used to identify such infections can be hidden. For this reason people who take Entocort must be careful to avoid exposure to infections such as chickenpox and measles whenever possible. If you have been exposed to chickenpox or measles, you must get immediate medical advice. You should continue to take your medicine unless your prescriber advises you to stop taking it.

Other information about Entocort:

if you have been given a steroid warning card, make sure you carry it with you at all times while you are taking corticosteroids. These cards are normally given to you by your prescriber or by your pharmacist. If you are currently taking corticosteroids, or have taken them in the last year, you must tell everyone involved in prescribing you medicines and giving you medical treatment. This includes your doctor, dentist, nurse and pharmacist. You must make sure that they all know about your corticosteroid treatment.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Whether this medicine is suitable for you

Entocort is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

are about to have surgeryare allergic or sensitive to or have had a reaction to any of the ingredients in the medicineare elderlyhave a condition that becomes worse during steroid treatmenthave a peptic ulcerhave an infectionhave been exposed to chickenpox or measles while you are using Entocorthave cataractshave diabetes or have a family history of diabeteshave fructose intolerancehave glaucoma or have a family history of glaucomahave glucose-galactose malabsorption problemshave had psychoses caused by steroidshave high blood pressurehave liver problemshave or have had affective disorders or have a family history of affective disordershave or have had depressionhave osteoporosishave recently taken other steroidshave sucrase-isomaltase deficiency

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

to check that this medicine is not having any undesired effects

Over time it is possible that Entocort can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Entocort has become unsuitable, it is important that the prescriber is contacted immediately.

Alcohol

Alcohol can interact with certain medicines.

In the case of Entocort:

there are no known interactions between alcohol and EntocortDiet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Entocort:

this medicine interacts with grapefruit or grapefruit juice. Grapefruit or grapefruit juice increases the level of Entocort in your blood

If your diet includes any of the above, speak to your prescriber or pharmacist for further advice.

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Entocort:

this medicine is unlikely to affect driving ability or the ability to operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Entocort:

you should only take this medicine during pregnancy if your doctor thinks that you need ittaking this medicine during pregnancy may harm your baby. This can happen if it is taken repeatedly or for long periods of time

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Entocort, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Entocort:

this medicine passes into breast milk. Taking this medicine at high doses while breastfeeding may affect your baby

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Entocort:

carbamazepinecimetidinecolestyramineitraconazoleketoconazole

The following types of medicine may interact with Entocort:

contraceptive steroidscytochrome P450 enzyme inducerscytochrome P450 enzyme inhibitorsoestrogensprotease inhibitors

If you are taking Entocort and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Entocort.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

Entyvio and Crohn’s Disease

FDA Approves Takeda’s Entyvio™ (vedolizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

May 21, 2014

Deerfield, Ill., May 20, 2014, and Osaka, Japan, May 21, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food and Drug Administration (FDA) simultaneously approved a new biologic therapy, Entyvio™ (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).

“Entyvio is a new option that works to block important contributors to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease,” said Stephen B. Hanauer, M.D., medical director, Digestive Health Center, Northwestern University Feinberg School of Medicine. “The clinical trial program evaluated the efficacy and safety profile of Entyvio and demonstrated that Entyvio has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease.”

Entyvio is now approved for inducing and maintaining clinical response and remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Entyvio is also approved for achieving clinical response and remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.

“Patients with moderately to severely active ulcerative colitis or Crohn’s disease, and the healthcare professionals who care for them, need additional new treatment options,” said Douglas Cole, president,
Takeda Pharmaceuticals U.S.A., Inc. “Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders.”
The Entyvio dose regimen is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter. Patients should be observed during infusion and until the infusion is complete. See dosage and administration section in full prescribing information.

In March, Entyvio received a positive Opinion for the treatment of adults with moderately to severely active UC and CD from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and Takeda is awaiting response from the European Commission on approval for Marketing Authorisation.

Clinical Trial Program
The Biologics License Application filing with the FDA was supported by the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both UC and CD patient populations in four clinical studies involving 2,700 patients in nearly 40 countries. Three of these studies were randomized, double-blind, placebo-controlled trials – GEMINI I (UC Trials I and II), GEMINI II (CD Trials I and III) and GEMINI III (CD Trial II). GEMINI I, II and III evaluated adult patients with moderately to severely active UC or CD who had an inadequate response or intolerance to immunomodulator therapy; inadequate response, loss of response, or intolerance to a TNF blocker; or were corticosteroid dependent or had an inadequate response or intolerance to corticosteroids.

Adverse reactions were reported in 52 percent of patients treated with Entyvio and 45 percent of patients treated with placebo (UC Trials I and II: 49 percent with Entyvio and 37 percent with placebo; CD Trials I and III: 55 percent with Entyvio and 47 percent with placebo). Serious adverse reactions were reported in 7 percent of patients treated with Entyvio compared to 4 percent of patients treated with placebo (UC Trials I and II: 8 percent with Entyvio and 7 percent with placebo; CD Trials I and III: 12 percent with Entyvio and 9 percent with placebo).
The most common adverse reactions reported with Entyvio (incidence greater than or equal to 3 percent and greater than or equal to 1 percent higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

About Entyvio™ (vedolizumab)

Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does not bind to or inhibit function of the alpha4beta1 and alpha E beta 7 integrins and does not antagonize the interaction of alpha4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.

INDICATIONS: ENTYVIO™ (vedolizumab)
Adult Ulcerative Colitis (UC)

Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids:
• inducing and maintaining clinical response
• inducing and maintaining clinical remission
• improving endoscopic appearance of the mucosa
• achieving corticosteroid-free remission
Adult Crohn's Disease (CD)

Adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids:
• achieving clinical response
• achieving clinical remission
• achieving corticosteroid-free remission

IMPORTANT SAFETY INFORMATION
• ENTYVIO (vedolizumab) is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
• Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
• Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections.
• Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
• There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
• Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
• Most common adverse reactions (incidence greater than or equal to 3% and greater than or equal to 1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
Please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.
More information will also be available soon at www.ENTYVIOHCP.com andwww.ENTYVIO.com.

©2015 Crohn's & Colitis Foundation of America