Navigation Links
Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

may be at increased risk for developing severe VOD.

Death from liver failure and from VOD has been reported in patients who receive Mylotarg (gemtuzumab ozogamicin for Injection).  Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD.  These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes.  However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity.

Mylotarg may cause fetal harm when administered to a pregnant woman.  The reported rates of Grades 3 and 4 thrombocytopenia, neutropenia, anemia, and bleeding were 99%, 98%, 47%, and 15%, respectively. Twenty-eight percent of patients experienced severe infections, including sepsis (16%) and pneumonia (7%). The most common adverse events were fever (85%), chills (73%), nausea (70%), vomiting (63%), asthenia (44%), diarrhea (38%), abdominal pain (37%), headache (35%), stomatitis (32%), dyspnea (32%), epistaxis (31%), hypokalemia (31%), anorexia (29%), sepsis (25%), constipation (25%), local reaction (25%), nonspecific rash (22%), herpes simplex (22%), and neutropenic fever (21%).

Mylotarg can produce a postinfusion symptom complex of fever and chills and less commonly hypotension and dyspnea during the first 24 hours after administration.  Patients should receive diphenhydramine 50 mg po and acetaminophen 650-1000 mg po one hour before Mylotarg (gemtuzumab ozogamicin for Injection) administration.  Two additional doses of acetaminophen 650-1000 mg po every four hours may be given.  Vital signs should be monitored during infusion and for four hours following infusion.  

Please see full prescribing information at:

SOURCE Pfizer Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6

Related medicine technology :

1. Pfizer And Epocrates Partner To Give Healthcare Providers Access To Medical Information Specialists For Medication Questions
2. Pfizer Appoints Mikael Dolsten President of Worldwide Research and Development
3. Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference
4. Pfizer Reigns Supreme After Patent Cliff as Humira Kicks Avastin off Top Spot
5. Gelesis Unveils Novel Non-Invasive Capsulated Device for Obesity and Presents Clinical Data; Appoints Former Pfizer R&D President to Board
6. Pfizers Jeffrey Kindler Becomes PhRMA Board Chairman; Christopher Viehbacher, John Lechleiter Assume New Posts
7. President of Pfizer Vaccines, Mark Swindell, Named as the Healthcare Businesswomens Associations 2010 Honorable Mentor
8. VetCentric Announces Partnership With Pfizer Animal Health
9. Pfizer Selects ChemAxons Markush Platform
10. Pfizer Whistleblower Named Years Most Influential Person In Business Ethics
11. Majority of Surveyed Pharmacy Directors Expect To Cover Pfizers Tanezumab If It Is Approved for the Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... , May 17, 2013  ConvaTec today announced that it will report ... Ken Berger , CEO, and Ed Borkowski , ... live via telephone. To participate in the conference call ... To participate in the conference call outside the U.S. and ... conference ID is 72195398. Participants should dial in 10 minutes ...
(Date:5/17/2013)... May 17, 2013  Serving a region of 650,000 inhabitants ... , Caribbean Imaging and Radiation Therapy (CIRT, Ponce ... with the acquisition of an Elekta Versa HD™ system, the ... offers clinicians the versatility to deliver conventional therapies to treat ... enabling treatment of highly complex cancers that require extreme targeting ...
(Date:5/17/2013)... Conn. , May 17, 2013  Boehringer ... in respiratory disease at the American Thoracic Society ... PA , May 17 – 22. ... product approved for the treatment of chronic obstructive ... powder)], as well as investigational compounds for asthma, ...
Breaking Medicine Technology:Puerto Rico's Caribbean Imaging and Radiation Therapy Center Orders Elekta's New Versa HD System for Treatment of Cancer Patients 2Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 2Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 3Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 4Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 5Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 6Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 7Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 8
... Cardinal Health today announced that the Federal Trade ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for ... distributor serving the New York metropolitan area. Cardinal Health ... About Cardinal Health Headquartered ...
... Weiss, president and founder of Breastcancer.org and a breast ... the U.S. Food and Drug Administration prior to the ... for Avastin,s use in metastatic HER2-negative breast cancer.  In ... removing Avastin,s approval to treat breast cancer, Breastcancer.org is ...
Cached Medicine Technology:Cardinal Health Receives Regulatory Clearance for Kinray Acquisition 2Cardinal Health Receives Regulatory Clearance for Kinray Acquisition 3Non-Profit Breastcancer.org Shares Concerns with FDA on Avastin Breast Cancer Recommendation 2Non-Profit Breastcancer.org Shares Concerns with FDA on Avastin Breast Cancer Recommendation 3
(Date:5/19/2013)... Buenos Aires, Argentina: Yoga classes ( clases ... Aires, Argentina by the Sivananda Yoga Vedanta Center. ... - (Barrio Norte). Classes are 90 minutes and are ... offered in a calm environment, allowing visitors to enjoy ... vegetarian food, among others. , The Yoga classes follow ...
(Date:5/19/2013)... May 19, 2013 HealthEconomics.Com , ... is pleased to unveil a new and exciting service: ... provides a powerful array of real-time communication tools to ... US and abroad. , HE-Xpo is powered by ... the look and feel of being at a physical ...
(Date:5/19/2013)... The legal team at Pulaski & Middleman, ... effort to connect women and families coping with the ... Yasmin & Ocella with the legal representation they need. ... notorious birth control drugs as well as news and ... Yasmin & Ocella were very popular birth control medications ...
(Date:5/18/2013)... Cambridge House of Maryville , a BMA affordable ... is hosting a Memorial Day Weekend Barbecue from 11 a.m. ... which is located at 6960 State Rte. 162 in Maryville, ... Medicaid, who need some help to maintain their independence. , ... homemade ice cream for dessert,” says Tracy Skaer-Henry, Administrator of ...
(Date:5/18/2013)... Daily Gossip issued a press release last week ... page. John Colston, Daily Gossip’s spokesperson, told the press that ... 14-Day Rapid Fat Loss Plan . , Shaun Hadsall ... at a time when nutritionists and fat loss gurus constantly ... , The diet is based on the Macro-Patterning scheme, ...
Breaking Medicine News(10 mins):Health News:Clases de Yoga in Buenos Aires, Argentina (Yoga Classes) Now Offered by Sivananda Yoga Vedanta Center 2Health News:HealthEconomics.Com Announces HE-Xpo, a New Virtual Trade Show Devoted to Healthcare Value and Market Access 2Health News:HealthEconomics.Com Announces HE-Xpo, a New Virtual Trade Show Devoted to Healthcare Value and Market Access 3Health News:Yazsideeffects.com Connects Yaz Side Effects Sufferers With Yaz Side Effects Lawyers 2Health News:Metro East Affordable Assisted Living Community to Host Memorial Day Weekend Barbecue 2
... Healthcare to Offer Unique and Cost-Effective Approach to Engage ... Patients and ... Life:WIRE(TM) Corp, a,dynamic mobile communications and health information ... agreement with Action,Healthcare Management, Inc. (AHM), a national medical ...
... Jan. 30 More than 100 local VIPS,physicians and ... of America (DCA) Delray Beach medical facility to commemorate ... imaging, enabling physicians to obtain clearer images of the ... without the need for beta blockers., Mayor Rita ...
... 30 The next generation of,elderly people will ... different,expectations regarding healthcare than their predecessors. This, according,to ... Wireless Healthcare,will increase the take up of telecare ... the elderly., In the report, "Health 2.0 ...
... Perdue AgriBusiness,has announced it will be contracting low linolenic ... season to support the,marketplace demand for healthier foods., ... bring to both,soybean growers on the Eastern Shore and ... trans fat content of their products," said John Ade,Perdue ...
... 2008) -- A new study from the Monell ... for the nausea and vomiting that often afflict ... the development of new approaches to combat these ... what causes the nausea and vomiting that accompany ...
... Alliance of Its Kind in the Delaware Valley, ... University School of Medicine and Crozer-Keystone Health System,recently ... transplant,services. The Temple-Crozer Kidney Transplant Alliance has created ... Delaware and,Chester counties with end-stage kidney disease who ...
Cached Medicine News:Health News:Life:WIRE(TM) to Provide Action Healthcare Management with Innovative Mobile Health Management Solution for Patients with Chronic Conditions 2Health News:Delray Beach Mayor Commemorates Diagnostic Centers of America (DCA) $2 Million Purchase from Siemens to Become Only Medical Facility in South Florida with World's Most Advanced Cardiac Scanner. 2Health News:Increase in IT Skills Amongst the Elderly Will Boost Telecare Market 2Health News:Perdue AgriBusiness Announces Low Linolenic Soybean Contracting Opportunities with DuPont Business Pioneer Hi-Bred 2Health News:Perdue AgriBusiness Announces Low Linolenic Soybean Contracting Opportunities with DuPont Business Pioneer Hi-Bred 3Health News:Explaining chemotherapy-associated nausea 2Health News:Temple University Hospital, Temple University School of Medicine and Crozer-Keystone Health System Collaborate to Provide Comprehensive Kidney Care 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: