Navigation Links
Updated Analysis of 2001 Epoetin Alfa Study Posted
Date:12/4/2007

BRIDGEWATER, N.J., Dec. 4 /PRNewswire/ -- An updated analysis from a 2001 study conducted by the Gynecologic Oncology Group evaluating Epoetin alfa in 109 patients with cervical cancer has been posted online (http://dx.doi.org/10.1016/j.ygyno.2007.10.011). The study (GOG-191) was terminated in 2003 due to potential concerns of thromboembolic events (TE) in the group treated with Epoetin alfa. The U.S. Food and Drug Administration (FDA) was notified at that time.

GOG-191 was a randomized phase III trial designed to evaluate the efficacy of maintaining hemoglobin levels above 12 grams per deciliter of blood (g/dL) with Epoetin alfa in subjects with advanced cervical cancer undergoing chemoradiotherapy. The updated analysis, expected to be published in the journal, Gynecologic Oncology, found a statistically non-significant trend toward decreased progression-free and overall survival in the patients treated with Epoetin alfa.

The updated analysis provides further evidence supporting the recent ESA class label change to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 g/dL.

Ortho Biotech has informed FDA of this updated analysis, and will continue to work with the agency and the GOG to ensure that these data are shared expeditiously with the medical community.

The safety and effectiveness of Epoetin alfa in its approved uses has been established in well-controlled studies and substantiated clinically over the past 20 years in more than four million patients worldwide for approved indications.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with advanced breast, head and neck,

lymphoid, and non-small cell lung malignancies when dosed to target a

hemoglobin of greater than or equal to 12 g/dL.

-- The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

-- To minimize these risks, as well as the risk of serious cardio- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

-- Use only for treatment of anemia due to concomitant myelosuppressive

chemotherapy.

-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

-- The dose of PROCRIT should be titrated for each patient to achieve and

maintain the following hemoglobin levels:

-- Chronic renal failure patients - hemoglobin levels between 10 to 12

g/dL. If a patient does not attain hemoglobin levels of 10 to 12

g/dL despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and

ADMINISTRATION in the PROCRIT Prescribing Information.

-- Cancer or HIV patients - the lowest hemoglobin level sufficient to

avoid transfusion and not to exceed 12 g/dL.

-- Monitor hemoglobin regularly during therapy, more frequently following

a dosage adjustment or until hemoglobin becomes stable.

-- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or

without other cytopenias, associated with neutralizing antibodies to

erythropoietin have been reported in patients with chronic renal

failure receiving PROCRIT by subcutaneous administration. If any

patient develops a sudden loss of response to PROCRIT, accompanied by

severe anemia and low reticulocyte count, and anti-erythropoietin

antibody-associated anemia is suspected, withhold PROCRIT and other

erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-

888-227-5624) to perform assays for binding and neutralizing

antibodies. If erythropoietin antibody-mediated anemia is confirmed,

PROCRIT should be permanently discontinued and patients should not be

switched to other erythropoietic proteins.

-- The safety and efficacy of PROCRIT therapy have not been established in

patients with a known history of a seizure disorder or underlying

hematologic disease (e.g., sickle cell anemia, myelodysplastic

syndromes, or hypercoagulable disorders).

-- In some female patients, menses have resumed following PROCRIT therapy;

the possibility of pregnancy should be discussed and the need for

contraception evaluated.

-- Prior to and regularly during PROCRIT therapy monitor iron status;

transferrin saturation should be greater than or equal to 20% and

ferritin should be greater than or equal to 100 ng/mL. During therapy

absolute or functional iron deficiency may develop and all patients

will eventually require supplemental iron to adequately support

erythropoiesis stimulated by PROCRIT.

-- During PROCRIT therapy, blood pressure should be monitored carefully

and aggressively managed, particularly in patients with an underlying

history of hypertension or cardiovascular disease.

-- In studies, the most common side effects included fever (pyrexia),

diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or

loss of strength or weakness (asthenia, fatigue), shortness of breath,

high blood pressure, headache, joint pain (arthralgias), abnormal skin

sensations (as tingling or tickling or itching or burning;

paresthesia), rash, constipation, and upper respiratory infection.

Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com.


'/>"/>
SOURCE Ortho Biotech Products, L.P.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Updated GOLD report presents new understandings in diagnosis, treatment and prevention of COPD
2. Updated Brochure on Gynecologic Cancer Treatments Now Available
3. Medifast Announces Updated Full Year 2007 Guidance
4. Updated: National Infertility Awareness Week Nov. 4-10; Infertility Affects Significant Number of Couples
5. Long-term pharmacotherapy for obesity and overweight: updated meta-analysis
6. inVentiv Health Provides Updated Information on December 11th Investor Day
7. UPDATED: Evalve(R) Completes $60 Million Series D Financing
8. Study, meta-analysis examine factors associated with death from heatstroke
9. Latest DES Analysis Stresses Importance of Physicians Well-Trained in Implantation Technique and Patient Follow-Up
10. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
11. Takeda statement on ACTOS meta-analysis published in the Journal of the American Medical Association
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Rob Lowe acts as host and helps educate ... is on hiking in American. Viewers can reconnect with America as it explores some ... , Many consumers have looked for an inventive new place for a family vacation, ...
(Date:5/26/2017)... , ... May 26, 2017 , ... “THE FLINTHILLS FAMILY-Our Journey to the Cross”: the ... Journey to the Cross” is the creation of published authors, Bob and Margaret Massey. ... to say, he is "panther quick and leather tough." His love for others is ...
(Date:5/26/2017)... ... ... “Cactus Jack: Against All Odds”: the story of Coach Cactus Jack and the ... is the creation of published author, Walter Hubbard, a retired wildlife and fisheries biologist ... Jane. Walter. Walter and Jane have three adult children and a granddaughter. ...
(Date:5/24/2017)... ... May 24, 2017 , ... In modern research, success depends ... instruments for research and understanding the basic principles that were designed to drive ... innovations in stereo microscopy for brightfield and fluorescence typically used in laboratories working ...
(Date:5/24/2017)... San Diego, California (PRWEB) , ... May 24, ... ... patient care through innovative medical image management and interpretation, has received U.S. Food ... technology. , Nucleus.io is a web-based, scalable and secure cloud platform for ...
Breaking Medicine News(10 mins):
(Date:5/11/2017)... , May 11, 2017  Thornhill Research ... has been awarded an $8,049,024 USD five-year, firm-fixed-priced, ... through the Canadian Commercial Corporation (CCC) ( ... Anesthesia Systems to administer general anesthesia to patients ... "The US Marine Corps have been ...
(Date:5/10/2017)... 10, 2017 CSSi, the global leader in ... research industry, is proud to announce the launch of ... website features both enriched content and a customized layout ... the company,s already well-established position as the top global ... "After many months of hard work, we are delighted ...
(Date:5/8/2017)... -- MACRA replaces the outdated sustainable growth rate ... Black Book Research crowdsource-surveyed 8,845 physician practices from February ... for MIPS Compliance Technology is Booming ... or more clinicians seek to buy Merit-Based Incentive Payment ... of the changes, the hunt is on for the ...
Breaking Medicine Technology: