Xolair Clinical Trials

Genentech, Inc. XOLAIR- Omalizumab Injection, Solution
Clinical trials with Xolair in pediatric patients 6 to 11 years of age have been conducted [see Use in Specific Populations (8.4)] XOLAIR omalizumab injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-040 ... Return Document

XOLAIR® Omalizumab For Subcutaneous Use DESCRIPTION
CLINICAL STUDIES The safety and efficacy of Xolair were evaluated in three randomized, double-blind, placebo controlled, multicenter trials. The trials enrolled patients 12 to 76 years old, with moderate to severe persistent (NHLBI ... Fetch Document

Omalizumab (XOLAIR) Criteria For Use In Asthma
Omalizumab (XOLAIR) Criteria for Use in Asthma VA Pharmacy Benefits Management Services, Medical Advisory Panel, More recently, a pooled analysis of all clinical trials and EXCELS, a FDA-required Phase 4 safety study (prospective ... Fetch Full Source

XOLAIR™ (omalizumab) - AZBlue
XOLAIR™ (omalizumab) Coverage for services, procedures, medical devices and drugs are dependent upon benefit *** The pivotal clinical trials that established the safety and efficacy of Xolair in asthma excluded patients ... Read Here

Drug Monograph: Omalizumab (XOLAIR - Ampoule.org.hk
Drug Monograph: Omalizumab (XOLAIR clinical trials demonstrate a higher rate of malignancies, especially solid / organ cancer in the omalizumab exposed group. Clinicians should be aware of the potential risk of malignancy [2]. ... Access Full Source

FDA Drug Safety Communication Xolair
Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Xolair compared with non-Xolair-treated patients. ... Fetch Doc

Q4 And Q2 Week Dosing Tables For XOLAIR
Q4 and Q2 Week Dosing Tables for XOLAIR Intended for U.S. healthcare professionals only Clinical trials with Xolair in pediatric patients less than 6 years of age have not been conducted [see Use in Specific Populations (8.4)] ... Fetch Here

Injection Site Reaction - All About An Injection Site Reaction
An injection site reaction is one of the most common side effects you may experience after a Xolair injection. An injection site reaction following a Xolair injection occurred in 45% of patients involved in clinical trials. ... Read Article

DOSAGE FORMS AND STRENGTHS XOLAIR - Xolair Pregnancy Registry
Anaphylaxis has been reported to occur after administration of Xolair in premarket-ing clinical trials and in postmarketing spontaneous reports. Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, ... Retrieve Full Source

Beta2-adrenergic Agonist - Wikipedia, The Free Encyclopedia
Beta2-adrenergic agonist. This article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. (December 2008) β 2 Clinical trials: ... Read Article

Xolair. South San Fransisco, CA. Genentech, Inc. 2007.
Anaphylaxis has been reported to occur after administration of Xolair in premarketing clinical trials and in postmarketing spontaneous reports. Signs and symptoms in these reported cases . Page 12 – BLA 103976/5102 ... View Doc

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food And Drug ...
265 least one dose of Xolair in the three clinical trials, including 684 patients exposed for 12 266 weeks and 427 exposed for 24 weeks. This Medication Guide has been approved by the U.S. Food and Drug Administration. 851 . ... Retrieve Here

Omalizumab (Xolair
Omalizumab (Xolair ) Criteria for *Approximately 25% of refractory patients treated with cyclosporine in clinical trials remain in remission once treatment is stopped while symptoms return to near baseline after treatment with omalizumab is discontinued. ... View Doc

XOLAIR - Novartis.com.au
In the clinical trials of Xolair, all subjects had a positive skin test or serum IgE RAST to a relevant aeroantigen. The efficacy of Xolair in subjects who are negative for these tests is unknown. Quality of life ... Doc Viewer

Pediatric Focused Safety Review: Xolair
7. Pediatric Clinical Studies (continued) Xolair ® (Omalizumab) Safety Results. 6 to less than 12 years. In clinical trials: • No new or unusual safety trends ... Access Doc

Clinical Research Changed My Life - YouTube
Clinical Research Changed My Life East TN Center For Clinical Research. Xolair For Asthma - Duration: 2:17. by VanderbiltHealthNews 6,482 views. Clinical Trials 101: How do we develop and test new drugs? - Duration: ... View Video

Xolair™ (Omalizumab) - M.bcbsal.org
Clinical trials of Omalizumab had moderate-or-severe persistent asthma incompletely controlled . Page 9 of 14 and omalizumab (Xolair™). Several randomized trials have demonstrated the efficacy of omalizumab in CIU not responsive ... Read Document

Cromoglicic Acid - Wikipedia, The Free Encyclopedia
Cromoglicic acid (also referred to as cromolyn , cromoglycate (former BAN), or cromoglicate) is traditionally described as a mast cell stabilizer, and is commonly marketed as the sodium salt sodium cromoglicate or cromolyn sodium. This drug Clinical trials: ... Read Article

Page 1 July 2010 - XOLAIR
Xolair® (omalizumab) for subcutaneous use – Genentech, Inc. Page 1 July 2010 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Xolair ... Access Full Source

PATIENT INFORMATION LETTER: XOLAIR (OMALIZUMAB) What Is ...
What is Xolair (omalizumab), and why is it being prescribed? The allergic person makes too much of a certain protein in the body, called IgE antibody. The clinical studies performed for the FDA suggest that Xolair is very safe. So far, ... Fetch Full Source

Qualitative And Quantitative Composition Pharmaceutical Form ...
5 Anaphylaxis Anaphylaxis has been reported to occur after administration of Xolair in premarketing clinical trials and in postmarketing spontaneous reports. ... Content Retrieval

Xolair (omalizumab) - Wellmark Blue Cross Blue Shield
Xolair ® (omalizumab) inhaled steroids, and during steroid tapering phases of clinical trials. Improved asthma control was reflected by fewer symptoms, less need for medications, and fewer exacerbations. Of note, data from rescue ... Visit Document

Learn The Basics Of Clinical Trials - About.com Health
Understand the basics of clinical trials, including the reasons clinical trials are conducted, the types of trials, the phases of trials, and the protocols. ... Read Article

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Clinical trials have demonstrated that it takes at least In clinical studies Xolair was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers, ... View Full Source

Xolair - European Medicines Agency
Xolair . Procedural steps taken and scientific information after the authorisation . Application number Scope Opinion/ clinical trials, there is no indication that Xolair treatment is associated with an overall increased risk of malignancies. ... Retrieve Document

Xolair For Asthma - All About Xolair (Omalizumab)
Learn what you need to know about Xolair (omalizumab) including indications, how it works and important side effects. ... Read Article