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Science Forum Index » Medicine - Cancer Forum » Palifermin (marketed as Kepivance)
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 Posted: Mon Nov 13, 2006 1:00 pm |
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http://www.fda.gov/cder/drug/InfoSheets/patient/paliferminPIS.htm
Patient Information Sheet
Palifermin (marketed as Kepivance)
PDF Print Version
This is a summary of the most important information about Kepivance. For
details, talk to your healthcare professional.
What Is Kepivance?
* Kepivance is a prescription medicine used to reduce the chance of
developing painful sores and ulcers in the mouth (severe mucositis) and to
shorten the time with severe mucositis in patients with blood cancers who
receive high doses of chemotherapy and radiation therapy before bone
marrow transplants.
* Kepivance has not been shown to be safe and effective in patients
being treated for forms of cancer other than leukemia or lymphoma.
* Kepivance has not been studied in children.
* It has not been determined if patients age 65 years and over respond
to Kepivance differently than younger patients.
Who Should Not Use Kepivance?
Do not receive Kepivance if you are allergic to:
* Kepivance or any its ingredients
* other products made from E. coli proteins
What Are The Risks?
Kepivance can cause serious problems such as:
* Possible tumor growth if Kepivance is used for non-blood related
cancers.
* Skin and mucus membrane side effects such as rash, redness,
swelling, itching, unusual sensations in the mouth, tongue color change,
tongue thickening and changes in taste. Tell your healthcare professional
if you get any of these side effects.
* Fever
* Breathing problems
* Other common side effects include swelling, pain, joint pain,
increases in blood pancreas enzymes, high blood pressure, and protein in
the urine.
What Should I Tell My Healthcare Professional?
Before you start receiving Kepivance, tell your healthcare professional if
you are pregnant, planning to become pregnant, or are breast-feeding.
Are There Any Interactions With Drugs Or Foods?
Tell your healthcare professional about all the medicines you take
including prescription and nonprescription medicines, vitamins, and herbal
supplements.
Kepivance can interact with heparin. If heparin is used to maintain your
I.V., your I.V. must be flushed with saline before and after receiving
Kepivance.
How Should I Take Kepivance?
Kepivance is given as an infusion in the vein (I.V.) for 3 days before
you get chemotherapy and for 3 days after. Kepivance should not be given
to you within 24 hours of your chemotherapy treatment.
Kepivance FDA Approved 12/2004 Patient Information Sheet 07/2005
http://patient.cancerconsultants.com/news.aspx?id=38511
KepivanceŽ Reduces Mucositis in Colorectal Cancer Patients Receiving 5-FU
According to an early online publication in the Journal of Clinical
Oncology, KepivanceŽ (palifermin) can significantly reduce oral mucositis
among patients with colorectal cancer who are receiving chemotherapy
including fluorouracil plus leucovorin (FU/LV).
Colorectal cancer is the second leading cause of cancer-related deaths in
the U.S. Patients with colorectal cancer are often treated with
chemotherapy, including the agents fluorouracil and leucovorin.
Oral mucositis (OM) is a common side effect among patients undergoing
treatment with FU/LV. Oral mucositis refers to damage to the lining of the
mouth and digestive system caused by therapy. Damage can range from
irritation to severe pain and ulceration. If OM becomes severe, it can
cause so much pain that patients are not able to swallow and must receive
nutrition and hydration through a feeding tube or a tube placed in a vein
(total parenteral nutrition or TPN). Furthermore, OM can lead to a
full-body infection and/or a delay in treatment, which may prohibit
optimal outcomes.
Kepivance is an agent that is administered prior to chemotherapy and has
been shown to reduce the incidence and severity of OM in patients
undergoing high-dose therapy prior to a stem cell transplant. Researchers
continue to evaluate its effects in different patient populations.
Researchers from several medical institutions recently conducted a
clinical trial to evaluate the effectiveness of Kepivance in reducing or
preventing OM among patients with colorectal cancer who were receiving
treatment including two cycles of FU/LV. This trial included 28 patients
treated with Kepivance and 36 patients treated with placebo (inactive
substitute).
* In the first cycle of chemotherapy, OM occurred in 29% of patients
treated with Kepivance, compared to 61% of patients who received placebo.
* In the second cycle of chemotherapy, OM occurred in 11% of patients
treated with Kepivance, compared with 47 of patients who received placebo.
* OM was reportedly less severe among patients treated with
Kepivance.There were no significant differences in overall survival
between the two groups of patients.
The researchers concluded that Kepivance significantly reduces the
incidence and severity of OM among patients with colorectal treated with
FU/LV-based therapy. Patients with colorectal cancer who are to undergo
treatment with FU/LV may wish to speak with their physician regarding the
risks and benefits of participating in a clinical trial further evaluating
Kepivance or other novel treatment approaches. Two sources of information
regarding ongoing clinical trials include the National Cancer Institute
(www.cancer.gov) and www.cancerconsultants.com.
Reference: Rosen L, Abdi E, Davis I, et al. Palifermin Reduces the
Incidence of Oral Mucositis in Patients With Metastatic Colorectal Cancer
Treated With Fluorouracil-Based Chemotherapy. Journal of Clinical
Oncology. 2006. Early online publication October 30, 2006. DOI:
10.1200/JCO.2005.04.1152.
NCI Distionary
kepivance (KEH-puh-vants)
A form of keratinocyte growth factor (KGF) that is made in the
laboratory. KGF stimulates the growth of cells that line the surface of
the mouth and intestinal tract. Kepivance is used to prevent and treat
oral mucositis (mouth sores) caused by high-dose chemotherapy and
radiation therapy in leukemia and lymphoma. It is also being studied in
the prevention and treatment of oral mucositis and dysphagia (difficulty
swallowing) in other types of cancer. Kepivance belongs to the family of
drugs called recombinant human keratinocyte growth factors. Also called
palifermin. |
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