Efficacy and Safety of Exjade® ( Latest Developments )

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Offline nice friend

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Efficacy and Safety of Exjade® ( Latest Developments )
« on: December 04, 2008, 02:57:33 PM »
Hi Buddies ,
these are the latest news from novartis .... Latest development in llong-term studies .. here are the cutting of Exjade's trial abstract ... for more detail please visit novartis Pharma's official site for Exjade ..  www.exjade.com ...

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Exjade results at ASH to show benefits for chronically transfused patients by significantly reducing toxic iron that can damage key organs

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Exjade
•Efficacy and Safety of Deferasirox (Exjade®) in Patients with Transfusion-Dependent Anemias: 1-Year Results from the Large, Prospective, Multicenter EPIC Study.
•Efficacy and Safety of Deferasirox (Exjade®) during 1 Year of Treatment in Transfusion-Dependent Patients with Myelodysplastic Syndromes: Results from EPIC Trial

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About Exjade
Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over).  It is approved in 90 countries including the US, Switzerland, Japan and the countries comprising the European Union.  The approved indication may vary depending upon the individual country.
 
Exjade is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
 
There have been post-marketing reports of acute renal failure, hepatic failure and cytopenias in patients treated with Exjade. Monthly monitoring of serum creatinine, proteinuria, serum transaminases and blood counts is recommended, and the dose of Exjade should be modified or interrupted if necessary. More frequent creatinine monitoring is recommended in patients with an increased risk of renal complications. Upper gastrointestinal ulceration and hemorrhage have been reported and caution should be exercised when combined with drugs with ulcerogenic potential. Skin rashes, including hypersensitivity reactions, have been reported. Exjade should be interrupted if severe rash develops and discontinued if severe hypersensitivity reaction occurs. Auditory and ophthalmic testing should be conducted annually.
 
Exjade should not be taken with aluminium-containing antacids. Caution should be exercised when Exjade is combined with drugs metabolized through CYP3A4. 
 
The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, rash, non-progressive increase in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria and headache.
 
Please visit www.exjade.com for more information.
Sometimes , God breaks our spirit to save our soul.
Sometimes , He breaks our heart to make us whole.
Sometimes , He sends us pain so we can be stronger.
Sometimes , He sends us failure so we can be humble.
Sometimes , He sends us illness so we can take better care of our selves.
Sometimes , He takes everything away from us so we can learn the value of everything we have.

===========
Umair

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Offline Dori

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Re: Efficacy and Safety of Exjade® ( Latest Developments )
« Reply #1 on: December 05, 2008, 06:24:57 PM »
Lovely drug, isn'it?  :mouthshut

I dont have time to do my own research:

What are: Upper gastrointestinal ulceration and hemorrhage

I got almost all probs, but I keep standing in the storm

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Offline nice friend

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Re: Efficacy and Safety of Exjade® ( Latest Developments )
« Reply #2 on: December 05, 2008, 08:09:35 PM »
http://www.emedicine.com/radio/topic302.htm
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Upper gastrointestinal bleeding (UGIB) is defined as hemorrhage that emanates proximal to the ligament of Treitz. It is a common and potentially life-threatening condition. More than 350,000 hospital admissions are attributable to UGIB, which has an overall mortality rate of 10%. Although more than 75% of cases of bleeding cease with supportive measures, a significant percentage of patients require further intervention, which often involves the combined efforts of gastroenterologists, surgeons, and interventional radiologists.1, 2, 3, 4

The first decision point in managing GI bleeding is defining the site and cause of bleeding: is it an upper GI or a lower GI hemorrhage?5, 6

Clinically, UGIB often causes hematemesis (vomiting of blood) or melena (passage of stools rendered black and tarry by the presence of altered blood). The color of the vomitus depends on its contact time with the hydrochloric acid of the stomach. If vomiting occurs early after the onset of bleeding, it appears red; with delayed vomiting, it is dark red, brown, or black. Coffee-ground emesis results from precipitation of blood clots in the vomitus. Hematochezia (red blood per rectum) usually indicates bleeding distal to the ligament of Treitz. Occasionally, rapid bleeding from an upper GI source may result in hematochezia.

The rate and extent of hemorrhage, coupled with the patient's comorbidities, determine the clinical presentation of UGIB. Endoscopy is a critical early intervention that can be used to establish the source of bleeding, and it also offers therapeutic options. If bleeding cannot be controlled by means of endoscopy, further interventions with catheter-directed embolotherapy or surgery may be warranted.7

For excellent patient education resources, visit eMedicine's Esophagus, Stomach, and Intestine Center. Also, see eMedicine's patient education article Gastrointestinal Bleeding.
Sometimes , God breaks our spirit to save our soul.
Sometimes , He breaks our heart to make us whole.
Sometimes , He sends us pain so we can be stronger.
Sometimes , He sends us failure so we can be humble.
Sometimes , He sends us illness so we can take better care of our selves.
Sometimes , He takes everything away from us so we can learn the value of everything we have.

===========
Umair

*

Offline Dori

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  • 1443
Re: Efficacy and Safety of Exjade® ( Latest Developments )
« Reply #3 on: December 06, 2008, 08:50:16 AM »
Aha, let's hope we will never have it.

a friend of me has ulcerative colitis. Terrible disease  :(.

 

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