Staples Out

Im at urgent care getting the staples in my head taken out. Im incredibly nauseous still and im having hot flashes bad...hate this.

On a better note, I had a few friends over last night and had an absolute blast!  :)

Babysitting

My best friend needed to take her husband to the ER. Fortunately,  it's just a virus. I got to stay with her baby girl :) absolutely love that little girl! Had a great talk with my friend's mom too. I needed it and I'm so blessed to have great people like them in my life! They are so genuine and amazing listeners. They hear what's in my heart and give me incredible support. They are blessings!

Head Injury

Im going to refrain from the details because I didn't do anything to deserve it and you probably wouldn't understand how it happened or believe me if I told you lol but I have 4 staples in my head. As if I haven't been in the hospital enough! And it hurts! And im concussed and sleepy and nauseous! Ugh!
And now I have to wear a hat...glad its cold!

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

Followup With GI

I went to my post hospital followup visit with my GI doctor.  He said I need to continue on disability for a while, if not permanently. He is keeping me on prednisone for the full course and then may be trying a new crohn's medication.  I can't remember the name but I promise to post about it and any info I get as soon as I know!

Thanks for keeping in your thoughts and prayers!

Low Residue Diet

I've been trying to diet and lose weight lately and I ended up losing sight of what I could and couldn't eat due to my Crohn's disease. I want to eat like everyone else trying to diet. Unfortunately,  eating raw veggies is just not a realistic plan and I ended up with a small bowel obstruction because of my poor choices. So I'm heading back towards a low residue/fiber diet and I wanted to share a bit of information for everyone!

Should You Try a Low-Residue Diet?

If a doctor has diagnosed you or a loved one with an inflammatory bowel disease (IBD) -- like Crohn's disease or ulcerative colitis -- or with diverticulitis, your doctor may suggest you follow a low-residue diet.

Never heard of it? The basic idea is that you'll eat foods that are easy to digest, and you'll limit those that aren't. 

What Is a Low-Residue Diet?

It's a diet that limits high-fiber foods, such as whole-grain breads and cereals, nuts, seeds, raw or dried fruits, and vegetables.

New Way to Ease Ulcerative Colitis?

"Residue" refers to undigested food, including fiber, that make up stool. The goal of the diet is to have fewer, smaller bowel movements each day, in order to ease symptoms such as diarrhea, bloating, gas, and stomach cramping.

Your doctor may recommend that you go on a low-residue diet for a short time when you're having a flare, or after surgery to help with recovery. But it's not a general eating plan for all people with IBD. 

Crohn's can make it harder for your body to absorb nutrients from food. Ask your doctor for a referral to a nutritionist who can make sure your diet plan is right for you and let you know if you need any vitamin supplements.

On a low-residue diet, you can eat:

Grains

Refined or enriched white breads and plain crackers, such as saltines or Melba toast (no seeds)Cooked cereals, such as farina, cream of wheat, and gritsCold cereals, such as puffed rice and corn flakesWhite rice, noodles, and refined pasta

Fruits and Vegetables

The skin and seeds of many fruits and vegetables are loaded with fiber, so peeling skin and avoiding seeds is part of a low-residue diet. You can eat the following vegetables on the diet:

Well-cooked fresh vegetables or canned vegetables without seeds, such as asparagus tips, beets, green beans, carrots, mushrooms, spinach, squash (no seeds), and pumpkinCooked potatoes without skinTomato sauce (no seeds)

Fruits include:

Ripe bananasSoft cantaloupeHoneydewCanned or cooked fruits without seeds or skin, such as applesauce or canned pearsAvocado

Milk and Dairy

Milk products are OK to eat in moderation. Milk has no fiber, but it may trigger symptoms such as diarrhea and cramping if you have lactose intolerance. You could use lactase supplements or eat lactose-free products.

Reviewed by Jennifer Robinson, MD on November 18, 2014

© 2014 WebMD, LLC. All rights reserved.

Back to ER, Round 3 of Stricture

Ended up coming back to the ER. I haven't eaten in days. I have no appetite at all and im nauseous.  I forced myself to eat a little soft food but couldnt keep it down. The pain is just as bad too. I came to the ER around 830pm and its 130am now and I JUST got meds and an iv.  And then I waited this entire time for the dr to not even bother doing a ct scan or xray,  only blood work and thats pointless considering my labs have been looking great this entire time but I still had a small bowel obstruction!  This is why I didn't want to come back to begin with. Theres always a chance I get a dr who doesnt take anything seriously. I have a GI appointment Thursday so looks like im going to be waiting to find out more.  On a lighter note, I had a hot nurse lol.

Waiting to be discharged now. Praying it'll happen quickly!

Finally Home, Still Sick

I was discharged friday after 5 days in the hospital again. Got home and in still sick. I have no appetite.  Im throwing up everything I get down. Im in pain. I called my GI last night and he said I could wait until Monday and go in to the office or go to the er and let them do a ct scan. He recommended the er, but I dont want to be admitted again so I tried to sleep it off. Im so so right now. Hopefully ill be feeling better by tomorrow and won't need to go in at all. Ugh!! Not fun!!

New Crohn's Research: Looking for a Cure

Closing in on a cure for Crohn's

By: Maureen McFadden - Email
Updated: Tue 6:52 PM, Jan 27, 2015
Home / Headlines List / Article

More than 750,000 Americans suffer from Crohn's disease, a painful, chronic inflammation of the gastrointestinal tract that causes abdominal cramps and diarrhea.

Prescription medications may give some patients relief, but so far there is no cure.

Now, however, researchers say they have identified the bacteria that causes inflammation in some patients, helping them close in on a cure.

Eric Prado, 20, was a college freshman when he developed what he thought was a stomach bug.

"It feels like a stabbing pain, kind of all around," says Prado.

Doctors diagnosed Prado with Crohn's disease, a serious inflammation of the small bowel and colon.

Saleh Naser is a microbiologist from the University of Central Florida College of Medicine who specializes in Crohn's research. Naser says patients with severe cases can be virtually housebound.

"They have a chair next to the bathroom door where they have to go to the bathroom 15 to 20 times a day,” says Naser.

Naser has identified bacteria called MAP that could hold the key.

"This bacteria is known for a long time now to be responsible for the same symptoms we see in Crohn's disease, but in cows," says Naser.

As part of a clinical trial, Naser's lab is testing blood and tissue samples from Crohn's patients for the presence of MAP.

Patients are being given what Naser calls anti-MAP therapy; for one year, they take three antibiotics known to kill the MAP bacteria in the lab.

"If the bacteria is gone, then the symptoms should be gone," says Naser.

Prado is thankful his symptoms are mild and mostly controlled with medication.

“You don't know the future, sometimes you just have to be positive and keep doing what you do," says Prado.

65 clinical sites in three countries are participating in the MAP trial of the antibiotic therapy.

Naser says it's his goal to learn more about the bacteria and why some people are more at risk for Crohn's than others.

BACKGROUND: Crohn's disease is part of a group of conditions known as Inflammatory Bowel Disease (IBD). It can affect the entire thickness of the bowel wall and can "skip" areas, meaning there can be normal areas in-between patches of intestine. Since Crohn's is a chronic condition, the disease will have symptoms that flare up followed by periods of remission. Symptoms may include: fatigue, fever, diarrhea, abdominal pain/cramping, blood in stool, loss of appetite followed by weight loss, mouth sores and perianal disease (pain or drainage near the anus).
(Sources: http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/, http://www.mayoclinic.org/diseases-conditions/crohns-disease/basics/symptoms/con-20032061)

DIAGNOSIS/TREATMENT: There is no singular test that can diagnose Crohn's; however it is a combination of information that doctors will use to determine the cause of symptoms. Physical examination, blood work, stool samples, and X-rays of G.I. tract are early tests and exams that can help determine diagnosis. An endoscopy can examine the colon and a biopsy can examine the tissue of the colon or affected area. The goal of treating Crohn's is to reduce the inflammation that causes symptoms. Anti-inflammatory drugs, immune system suppressors, and antibiotics are standards-of-care; as well as anti-diarrheals, pain relievers, iron and calcium supplements, and vitamin B-12 shots. Nutrition therapy, involving a low-fiber diet, may also be used to compliment medications; this will reduce the size and number of bowel movements. Surgery is also an option; however the effect is usually temporary because the disease can occur near the reconnected tissue.
(Sources: http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/crohns-diagnosis-testing.html, http://www.mayoclinic.org/diseases-conditions/crohns-disease/basics/treatment/con-20032061)

NEW DISCOVERY: Mycobacterium avium subspecies paratuberculosis, or MAP, has been known for a long time to be responsible for the symptoms of Crohn's disease, but in cows, sheep and goats. Not all human cases of Crohn's are caused by MAP. Now, a simple blood test can identify the DNA of the MAP, allowing doctors to quickly diagnose or rule out Crohn's. A clinical trial is now underway, testing anti-MAP therapy which consists of three antibiotics known to kill the MAP bacteria. Saleh Naser, Ph.D., Microbiologist and Professor of Infectious Disease at University of Central Florida told Ivanhoe, "These antibiotics do kill the underlying cause of Crohn's which is MAP. If MAP is eradicated, the patient should be without any symptoms." Dr. Naser's team, as well as teams in several other countries, are conducting ongoing trials and hope to publish their findings within the next couple of years. For information on the clinical trial and recruitment locations, click here.
(Source: Interview with Dr. Naser)

Hospitalized

I was discharged monday and less than a week later, im admitted again.  I started throwing up this morning and havent stopped. My best friend brought me to the er and they admitted me. The xray didnt show an obstruction but the dr said it may be that I threw up so much it decompressed it. My veins suck so bad ive been stuck 8 times and the iv I had has slipped out and they're calling ICU to try to put in a new one...until then no pain or nausea meds and its been 2 hrs since nausea meds and 5 hours since pain meds. Needless to say, im miserable.