Navigation Links
Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
Date:9/11/2007

GAITHERSBURG, Md., Sept. 11 /PRNewswire/ -- As the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) and Drug Safety and Risk Management Advisory Committee (DSRMAC) meet today to discuss questions related to erythropoiesis-stimulating agents (ESA's), Ortho Biotech reiterates its position on the following key issues that will be discussed:

* The studies being examined by the FDA Advisory Committees evaluated

hemoglobin targets above 13 grams per deciliter of blood (g/dL). In

March 2007, label guidance for all ESAs was revised to reflect a maximum

hemoglobin of 12 g/dL. When patients are treated according to the

label, PROCRIT(R) (Epoetin alfa) is a safe and effective therapeutic

option in the management of anemia in patients with chronic renal

failure (CRF).

* The weight of clinical evidence suggests that patients experience the

greatest benefit from a hemoglobin of between 10-12 g/dL, and that

patients who fall below a hemoglobin of 10 g/dL experience greater

morbidity and mortality, and are more likely to require a blood

transfusion.

* The company agrees that additional data are needed to determine how to

best identify and treat "ESA hyporesponders," or those patients who do

not respond adequately to ESA therapy.

PROCRIT represents a revolutionary treatment option in anemia management. ESAs, including PROCRIT, continue to be the only viable alternative to blood transfusions for the treatment of anemia in CRF patients. ESAs provide clear clinical benefit in CRF patients with regard to transfusion avoidance and improvements in physician-assessed and patient-reported outcomes. The benefits and risks of PROCRIT have been established in well-controlled clinical trials and observed in clinical experience over the past 18 years in four million patients worldwide across approved indications.

Ortho Biotech looks forward to working closely with the FDA to help ensure that healthcare professionals have the information they need to continue to use PROCRIT safely and effectively.

About PROCRIT (Epoetin alfa)

PROCRIT can be 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

From the Boxed Warnings

* Use the lowest dose of PROCRIT that will gradually increase the

hemoglobin (Hb) concentration to the lowest level sufficient to avoid

the need for red blood cell (RBC) transfusion.

* PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased the

risk for death and for serious cardiovascular events (including serious

arterial and venous thromboembolic events, myocardial infarction,

stroke, congestive heart failure) when administered to target a Hb of

greater than 12 g/dL. A rate of hemoglobin rise of greater than 1 g/dL

over 2 weeks may also contribute to these risks.

* Cancer patients: Use of ESAs:

-- Shortened the time to tumor progression in patients with advanced

head and neck cancer receiving radiation therapy when administered

to target a Hb of greater than 12 g/dL.

-- Shortened overall survival and increased deaths attributed to

disease progression at 4 months in patients with metastatic breast

cancer receiving chemotherapy when administered to target a Hb of

greater than 12 g/dL.

-- Increased the risk of death when administered to target a Hb of

12 g/dL in patients with active malignant disease receiving neither

chemotherapy nor radiation therapy. ESAs are not indicated for this

population.

* Patients receiving PROCRIT pre-operatively for reduction of allogeneic

RBC transfusions: A higher incidence of deep venous thrombosis was

documented in patients receiving PROCRIT who were not receiving

prophylactic anticoagulation. Antithrombotic prophylaxis should be

strongly considered when PROCRIT is used to reduce allogeneic RBC

transfusions.

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

* Monitor Hb regularly during therapy, more frequently following a dosage

adjustment or until Hb 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 (eg, 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.

* 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 Warning.

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 technology :

1. Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology
2. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ESMO Conference
3. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
4. Beike Biotechnology Study Suggests Adult Stem Cells Show Promise for Peripheral Vascular Disease
5. ConjuChem Biotechnologies Reports PC-DAC:Exendin-4 Albumin Conjugate Data Presented at American Diabetes Association Annual Meeting
6. Active Biotech presents new pre-clinical data for the 57-57 project at the 8th World Congress on Inflammation
7. New Positive Pre-clinical Data for Active Biotechs RA Project I-3D
8. Prana Biotechnology Presents New Key Findings on PBT2
9. Oncolytics Biotech Inc. Announces Positive Clinical Data from U.S. Phase I REOLYSIN Trial
10. News from the Battlefield of Metastatic Cancer: Epeius Biotechnologies Draws the Sword of Targeted Gene Delivery (Rexin-G) from the Stone of Chemistry and Physics
11. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ASCO Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... PUNE, India , May 4, 2016 /PRNewswire/ ... report spreads across 154 pages, profiling 09 key ... It is a professional and in-depth study on ... providing a basic overview of the industry including ... Insulin Needles market analysis is provided for the ...
(Date:5/3/2016)... 3, 2016  Axiogenesis has acquired a major investment from Sino-German High-Tech Fund to further expand product development, strengthen ... http://photos.prnewswire.com/prnh/20160503/362921 ... ... ... ...
(Date:5/3/2016)... , May 3, 2016   BIOTRONIK , ... today announced Food and Drug Administration (FDA) approval ... that provides heart failure patients with access to ... also have remote monitoring with daily automatic transmission ... heart rate in response to physiological demands. ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... May 05, 2016 , ... Tim ... program serving families of greater Dubuque, IA. The current campaign fundraises for Veteran’s ... discharged veterans. Donations to Veteran’s Freedom Center may now be made here: ...
(Date:5/5/2016)... ... 05, 2016 , ... Dr. Benjamin Stong of Kalos Facial Plastic Surgery, LLC ... Stong is double board certified and the only facial plastic surgeon in Atlanta to ... Non-surgical therapies such as stem cells can be used to provide stabilization to hair ...
(Date:5/5/2016)... , ... (PRWEB) May 05, 2016 , ... Talent ... acquisition startup, HireNurses, on the eve of National Nurses Week (May 6-12). ... and healthcare employers. With their enrollment into the Talent Tech Lab Virtual Incubation program, ...
(Date:5/5/2016)... ... May 05, 2016 , ... VisualDx ... Android devices. VisualDx is the first point of care diagnostic support system ... medicine. The system speeds diagnosis, therapy decisions and patient education for emergency ...
(Date:5/5/2016)... ... May 05, 2016 , ... ACLS ... to announce its new referral program, giving participants incentive for spreading the word ... community, and we know many professionals share resources with their friends and colleagues,” ...
Breaking Medicine News(10 mins):