HORSHAM, Pa., May 15 /PRNewswire/ -- JOM Pharmaceutical Services, Inc. (JOM), a service coordinator that provides delivery services and customer support to Centocor, Inc. and Ortho Biotech, L.P., was notified May 6, 2008, that a transport trailer carrying DOXIL(R) (doxorubicin HCl liposome injection), PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was stolen while the driver was traveling from a distribution center in Kentucky to a specialty distributor. This incident has been reported to local and federal law enforcement offices, as well as the U.S. Food and Drug Administration; however, the transport trailer and product have not yet been recovered.
To ensure patient safety, Centocor and Ortho Biotech are voluntarily withdrawing products with lot numbers matching those of the stolen product from the market and communicating this action to all authorized distributors and all prescribing physicians, healthcare providers, and patients.
If the stolen product were to be reintroduced into distribution channels, the companies cannot guarantee that products were stored at appropriate temperatures, nor can the companies guarantee the products were not damaged. A voluntary withdrawal of products with lot numbers corresponding to that of the stolen product minimizes the possibility of inadvertent use of stolen product by physicians and, therefore, the overall risk to patients.
On May 7, 2008, JOM discontinued shipment of products with lot numbers matching those of the stolen product. Healthcare providers and patients that did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients that are concerned about products shipped after this date with the following NDC and lot numbers can return the product by contacting the companies at (888) 626-5660:NDC Description Lot Number Expiration
Date
59676-3100-1 Cartons containing six (6)D091534 07/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
10,000 U/mL
59676-3200-4 Cartons containing four (4) P113612 09/2010
multidose vials of
PROCRIT(R) (epoetin alfa)
20,000 U/mL
59676-3400-1 Cartons containing four (4) P106803 06/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
40,000 U/mL
17314-9600-1 Cartons containing 1 0717124 03/2009
DOXIL(R) (doxorubicin HCl
liposome injection) 20mg in
10mL (2 mg/mL) single use vial.
17314-9600-2 DOXIL(R) (doxorubicin HCl 0715423 02/2009
liposome injection) 50mg in
25mL (2mg/mL) single use vial
57894-0300-1 Cartons containing one (1)8AM26021P1 01/2011
vial of REMICADE(R)
(infliximab) 100mg
57894-0300-1 Cartons containing one (1)8BK35014P1 02/2011
vial of REMICADE(R)
(infliximab) 100mg
No other lot numbers of product are impacted by this incident. All three of these products have tamper-evident features that can be used to authenticate the package. Healthcare professionals and patients who have concerns about any product they possess may contact the number below for assistance with the identification of these features.
The amount of stolen and withdrawn product represents a very small proportion of the total product within the distribution channel; therefore the companies do not anticipate a disruption in product availability for patients.
JOM, Centocor, and Ortho Biotech will continue to work closely with healthcare providers and authorized distribution partners to identify and isolate product with lot numbers corresponding to those of the stolen product, and ask that anyone report any questionable activities to the appropriate authorities. Healthcare professionals, distributors or patients are asked to direct questions related to this voluntary withdrawal to the companies by calling (888) 626-5660.
Please see Important Safety Information for REMICADE(R) (infliximab), PROCRIT(R) (epoetin alfa), and DOXIL(R) (doxorubicin HCl liposome injection) at their respective websites.
About JOM Pharmaceutical Services, Inc.
JOM Pharmaceutical Services, Inc. is a service provider that is dedicated to providing safe and on-time delivery of pharmaceutical products for Ortho Biotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.
About Ortho Biotech, 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 www.orthobiotech.com.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.
Showing posts with label infliximab. Show all posts
Showing posts with label infliximab. Show all posts
Thursday, May 15, 2008
Tuesday, May 6, 2008
Crohn's Disease Patients Should Limit Their Exposure to Radiation!
Specialist centres must take steps to reduce the amount of radiation people with Crohn's disease are exposed to from diagnostic imaging, radiologists have urged [1]. Patients with Crohn's disease may be particularly vulnerable to radiation owing to their young age at presentation and an elevated risk of some intestinal malignancies such as small bowel lymphoma.
Researchers estimated the cumulative effective dose (CED) of diagnostic radiation of 354 patients with Crohn’s disease treated at a tertiary centre.They found that 55 patients, 15.5 per cent, had a 'high' CED – defined as greater than 75mSv.Less than six imaging studies were performed per patient over the first five years of the 15-year study. During this period the mean CED was 7.9mSv, with CT accounting for 46.3 per cent of radiation exposure.During the last five years, these figures had increased to almost seven images per patient and a mean CED of 25.1mSv. CT accounted for 84.7 per cent of radiation exposure at this time.
The likelihood of having a high CED was increased by an earlier diagnosis, upper gastrointestinal tract disease, the use intravenous steroids or infliximab, and multiple surgical procedures.The authors said: "Strategies to reduce the effective dose of radiation incurred by patients undergoing CT imaging can be employed without sacrificing image quality and should be considered for all patients, particularly those who are likely to require multiple examinations."
Researchers estimated the cumulative effective dose (CED) of diagnostic radiation of 354 patients with Crohn’s disease treated at a tertiary centre.They found that 55 patients, 15.5 per cent, had a 'high' CED – defined as greater than 75mSv.Less than six imaging studies were performed per patient over the first five years of the 15-year study. During this period the mean CED was 7.9mSv, with CT accounting for 46.3 per cent of radiation exposure.During the last five years, these figures had increased to almost seven images per patient and a mean CED of 25.1mSv. CT accounted for 84.7 per cent of radiation exposure at this time.
The likelihood of having a high CED was increased by an earlier diagnosis, upper gastrointestinal tract disease, the use intravenous steroids or infliximab, and multiple surgical procedures.The authors said: "Strategies to reduce the effective dose of radiation incurred by patients undergoing CT imaging can be employed without sacrificing image quality and should be considered for all patients, particularly those who are likely to require multiple examinations."
Thursday, October 4, 2007
Remicade Allergy - Remicade For Crohn's Disease Stories
I have gotten some feedback from those that have gotten Remicade infusions for their Crohn's. It reminds me the second time I got remicade. I guess there is a high chance for an allergic reaction if you start on remicade and then stop before you have had a certain number of treatments. I want to say it is four. Anyways, I went to the infusion center in Winter Park (Florida) and got hooked up. I was fine after the test dose, so they turned up the drip. Ooops, I had a pretty severe allergic reaction, breaking out in hives and experiencing shortness of breath. I got loaded up with bendedryl, steroids and antibiotics through my IV. I was unable to return to work and went home extremely doped up.
Here is an interesting article on the success or Humira when Remicade fails:
ROCHESTER, Minn., May 2 (UPI) -- Adalimumab -- sold as Humira -- works on Crohn's disease for those adults who fail on infliximab, sold as Remicade, say Mayo Clinic scientists in Minnesota.
A study of 325 subjects with the disorder who were treated with Humira or placebo, showed that after four weeks 21 percent of the Humira group were in complete remission and 52 percent noted an improvement in their symptoms.
In contrast, only 7 percent of the placebo group went into remission and just 34 percent had fewer symptoms.
The study was done at 52 centers in the United States, Canada, and Europe on patients with moderate to severe Crohn's disease whose symptoms persisted on Remicade or who had developed an allergic reaction to the medication.
"Approximately 50 percent of Crohn's disease patients ... will eventually develop an allergic reaction (to Remicade), need higher doses, or stop responding to the therapy," said researcher William Sandborn. "This study demonstrates that, in the short term, Humira can be safely administered ... to these patients (for) a second chance at remission and a significant improvement in quality of life."
Crohn's disease is an inflammatory, autoimmune disorder of the gastrointestinal tract that produces abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Currently there is no known cure.
A report on the research was published May 2, 2007 in the online issue of the Annals of Internal Medicine.
UPI May 2, 2007
Another great Remicade Story -
Thirty-two years ago Ginger Gray walked into her doctor's office complaining of abdominal pain, diarrhea, severe weight loss, and overwhelming joint pain. At 19, she hadn't grown an inch since the sixth grade. But her doctor said there was nothing physically wrong with her, and even suggested she seek psychiatric counseling. Fortunately for Gray, she sought another physician's opinion. Based on tests he conducted, the doctor recommended the 4-foot-11-inch Pennsylvania resident begin full-time treatment for Crohn's disease.
"Crohn's disease robbed me of my stamina," Gray says. "It took two years for me to fully regain my strength and weight so that I could begin working again."
Until now, treatment for Crohn's has relied on surgery and anti-inflammatory and other drugs also used to treat other conditions. In August 1998, the Food and Drug Administration licensed the first treatment specifically for Crohn's disease, an incurable and sometimes debilitating inflammation of the bowel.
Remicade (infliximab) is a genetically engineered antibody that blocks inflammation caused by a protein called tumor necrosis factor. After clinical trials showed benefit from Remicade treatment within a two-to-four week period following a single dose, FDA approved the drug for patients with moderate to severe Crohn's disease who have not found relief with other treatments.
"We recognized that [Remicade] had such a dramatic effect on patients," says Barbara Matthews, M.D., a medical officer in FDA's Center for Biologics Evaluation and Research, "that it was given accelerated approval."
Remicade, which is taken intravenously, can decrease the amount of inflammation along the lining of the intestine. Clinical trials also show that Remicade is effective in closing fistulas (abnormal passages or sores between the bowel and skin). Although not a cure, the drug reduces the symptoms in patients who have not responded well to traditional treatments.
"This is an exciting development for two reasons," says R. Balfour Sartor, M.D., professor of medicine, microbiology and immunology at the University of North Carolina, and chairman of the National Scientific Advisory Committee for the Crohn's & Colitis Foundation of America (CCFA). "It is the first therapy for Crohn's disease derived by molecular techniques, and it has the possibility of improving the quality of life for [Crohn's] patients."
But Sartor also cautions that the long-term toxic effects of Remicade are unknown and that the drug is not needed by every Crohn's disease patient. "Two-thirds of the people will have near immediate results," he says, "but only those patients who do not respond to other therapies" are eligible to take the drug. The next step is to maintain a patient's remission after the drug's initial effect has worn off.
Currently, studies are being done to better define the risks and longer-term benefits of Remicade because drug reactions and potential adverse effects from suppressing tumor necrosis factor require further clarification.
- by Carol Lewis, FDA Consumer
Here is an interesting article on the success or Humira when Remicade fails:
ROCHESTER, Minn., May 2 (UPI) -- Adalimumab -- sold as Humira -- works on Crohn's disease for those adults who fail on infliximab, sold as Remicade, say Mayo Clinic scientists in Minnesota.
A study of 325 subjects with the disorder who were treated with Humira or placebo, showed that after four weeks 21 percent of the Humira group were in complete remission and 52 percent noted an improvement in their symptoms.
In contrast, only 7 percent of the placebo group went into remission and just 34 percent had fewer symptoms.
The study was done at 52 centers in the United States, Canada, and Europe on patients with moderate to severe Crohn's disease whose symptoms persisted on Remicade or who had developed an allergic reaction to the medication.
"Approximately 50 percent of Crohn's disease patients ... will eventually develop an allergic reaction (to Remicade), need higher doses, or stop responding to the therapy," said researcher William Sandborn. "This study demonstrates that, in the short term, Humira can be safely administered ... to these patients (for) a second chance at remission and a significant improvement in quality of life."
Crohn's disease is an inflammatory, autoimmune disorder of the gastrointestinal tract that produces abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Currently there is no known cure.
A report on the research was published May 2, 2007 in the online issue of the Annals of Internal Medicine.
UPI May 2, 2007
Another great Remicade Story -
Thirty-two years ago Ginger Gray walked into her doctor's office complaining of abdominal pain, diarrhea, severe weight loss, and overwhelming joint pain. At 19, she hadn't grown an inch since the sixth grade. But her doctor said there was nothing physically wrong with her, and even suggested she seek psychiatric counseling. Fortunately for Gray, she sought another physician's opinion. Based on tests he conducted, the doctor recommended the 4-foot-11-inch Pennsylvania resident begin full-time treatment for Crohn's disease.
"Crohn's disease robbed me of my stamina," Gray says. "It took two years for me to fully regain my strength and weight so that I could begin working again."
Until now, treatment for Crohn's has relied on surgery and anti-inflammatory and other drugs also used to treat other conditions. In August 1998, the Food and Drug Administration licensed the first treatment specifically for Crohn's disease, an incurable and sometimes debilitating inflammation of the bowel.
Remicade (infliximab) is a genetically engineered antibody that blocks inflammation caused by a protein called tumor necrosis factor. After clinical trials showed benefit from Remicade treatment within a two-to-four week period following a single dose, FDA approved the drug for patients with moderate to severe Crohn's disease who have not found relief with other treatments.
"We recognized that [Remicade] had such a dramatic effect on patients," says Barbara Matthews, M.D., a medical officer in FDA's Center for Biologics Evaluation and Research, "that it was given accelerated approval."
Remicade, which is taken intravenously, can decrease the amount of inflammation along the lining of the intestine. Clinical trials also show that Remicade is effective in closing fistulas (abnormal passages or sores between the bowel and skin). Although not a cure, the drug reduces the symptoms in patients who have not responded well to traditional treatments.
"This is an exciting development for two reasons," says R. Balfour Sartor, M.D., professor of medicine, microbiology and immunology at the University of North Carolina, and chairman of the National Scientific Advisory Committee for the Crohn's & Colitis Foundation of America (CCFA). "It is the first therapy for Crohn's disease derived by molecular techniques, and it has the possibility of improving the quality of life for [Crohn's] patients."
But Sartor also cautions that the long-term toxic effects of Remicade are unknown and that the drug is not needed by every Crohn's disease patient. "Two-thirds of the people will have near immediate results," he says, "but only those patients who do not respond to other therapies" are eligible to take the drug. The next step is to maintain a patient's remission after the drug's initial effect has worn off.
Currently, studies are being done to better define the risks and longer-term benefits of Remicade because drug reactions and potential adverse effects from suppressing tumor necrosis factor require further clarification.
- by Carol Lewis, FDA Consumer
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