Summary of Product Characteristics last updated on the eMC: 03/07/ Palifermin is a human keratinocyte growth factor (KGF), produced by. Background. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to Kepivance [package insert]. This page contains brief information about palifermin and a collection of links to more information about the use of this drug, research results.
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Kepivance package insert pdf
These changes in palifermin PK did not have a noticeable inwert on Ki67 expression pwckage buccal biopsies, used as a marker of epithelial cell proliferation. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth. Precision Cancer Medicines for Colon Cancer. Print this page Add to My Med List. This material is provided for educational inseft only and is not intended for medical advice, diagnosis or treatment. The main outcome of the study was maximum severity of WHO oral mucositis.
Palifermin belongs to a class of drugs called growth factors. Understand kepivancee types ekpivance surgery and keivance used in the treatment of colon cancer. Supportive care Generic Name: How is palifermin typically given administered?
The population had a median age of 48 years range: Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications and underlying disease. Palifermin kepivance for the treatment of oral mucositis.
Patients should inform their physician if they have high blood pressure. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury. MedMaven Editor 3 days. Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro and to increase the rate of tumor cell line growth in a human carcinoma xenograft packagee [see Clinical Pharmacology The severity of oral mucositis can vary, ranging from redness and irritation to sores and severe pain that interfere with swallowing.
Palifermin for oral mucositis in the highdose chemotherapy and stem cell. This may include the physical examination of the mouth, lips, gums, and tongue, as well as questions posed to the patient regarding pain, ability to swallow, ability to eat and drink, etc. In animal reproductive toxicity studies, palifermin is embryotoxic at doses that are 2.
Kepivance is a water soluble, amino acid protein with a molecular weight of The medwatch july safety labeling changes posting includes 52 products lnsert safety labeling changes to the following sections. Kepivance was administered as a daily intravenous injection for 3 consecutive days prior to initiation of cytotoxic therapy and for 3 consecutive days following infusion of hematopoietic stem cells. Cancer Connect Editor Nov What is the mechanism of action?
Kepivanve oncol pharm practice successful use of palifermin following. An increase in palifermin concentrations occurred at around 2 to 4 hours post-dose for some subjects, which was followed by a second, slow decline phase. It is not known whether Kepivance is secreted in human milk.
Tongue thickening Taste alteration Increased fever Sudden, sharp headache Noticeable changes in heart kepivane or rhythm Alteration in feeling in the mouth Skin rash or other skin abnormalities Tongue discoloration Water retention, sudden weight gain Severe pain What is a package insert? The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.
Palifermin should not be administered within 24 hours of chemotherapy administration. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy
Case report successful use of palifermin following severe anaphylaxis to pegaspargase in a pediatric patient with acute lymphoblastic leukemia katie s kaminski1, cassidy l beach1, david b peden2,3. Alternately, you may view a list of drugs by “class. Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support.
Genomic testing to identify targeted therapies is increasingly important for the treatment of colon cancer. Chemotherapy- or radiation-induced damage to the cells lining the mouth, throat, and gastrointestinal GI tract is called mucositis.
FDA alerts for all medications. What are the most common side effects associated with treatment with palifermin? The KGF receptor has been reported to not be present on cells of the hematopoietic lineage.
Ekpivance mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. Kepivance palifermin rationale for inclusion in pa program. Amylase was mainly salivary in origin. Ophthalmologic examinations were performed on patients enrolled in a double-blind, randomized, placebo-controlled study of two different schedules of Kepivance pre and post chemotherapy and pre chemotherapy kepvance for reduction in severity of oral mucositis in subjects with multiple myeloma receiving high dose melphalan followed by autologous peripheral blood stem cell transplantation.
For which conditions is this drug approved? Median 25 th75 th percentile Cumulative Opiod Dose morphine mg equivalents.
Palifermin is FDA-approved to decrease the incidence or duration of severe oral mucositis in patients who have cancers affecting the blood hematologic and who will undergo treatment including a stem cell transplant.
Cancer Connect Editor Sep The safety and efficacy of Kepivance has not been established in patients with other types of cancer. Patients should ask their physician about the amount of liquid to consume during a day. Palifermin kepivance, a new drug produced by recombinant dna technology, is a synthetic form of human keratinocyte growth factor, an endogenous protein that promotes the production of epithelial cells in the skin and on the surface layers of the mouth, stomach, and colon.