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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What is a package insert? Median 25 th75 th percentile Cumulative Opiod Dose morphine mg equivalents. A chemotherapy drug or supportive care agent may be referred to by different names. Palifermin for oral mucositis in the highdose chemotherapy and stem cell. Binding of KGF to its receptor has been reported to result keplvance proliferation, differentiation, and migration of epithelial cells.
However, the same agent may also be referred to by its chemical name.
How are patients monitored? The following adverse reactions have been identified during postapproval use of Kepivance in the stem cell transplant setting. By clicking Subscribe, I agree to the Drugs. For the primary cataract endpoint of incidence of cataract development or cataract progression at Month 12, there was a greater proportion of subjects that experienced cataract development in the Kepivance group: Kepivance fda prescribing information, side effects and uses.
Six more hot drugs for today and beyond american nurse today. Kepivance, a human keratinocyte growth factor, decreases the incidence and duration of severe oral mucositis in patients who have hematologic cancer and who receive myelotoxic therapy and need.
A similar trend has been observed in adult patients.
Three age groups were studied: Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Kepivance, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. However, use of Kepivance in pediatric patients ages 1 to 16 years is supported by evidence from adequate and well-controlled studies of Kepivance in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Drug Dictionary Details Use our drug profile search engine to review information about current FDA appproved cancer drugs.
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Supportive care Generic Name: For example, the webpage stated the effect of kepivance. Ixempra is a prescription medicine used to treat locally advanced or metastatic breast cancer when certain other medicines have not worked or no longer work.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to. Cancer Connect Editor Sep Medically reviewed on Jul 2, Palifermin is given in 3 doses prior to therapy and 3 doses following therapy.
The mean half-life range was 2. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician. Kepivance exhibited linear pharmacokinetics with extravascular distribution. In a post approval study, designed to determine the efficacy of Kepivance in decreasing the incidence of severe acute graft versus host disease aGVHD in lackage with hematologic malignancies undergoing allogeneic transplantation, the inssrtduration and severity of oral mucositis was also measured.
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, onsert. This kepviance may cause birth defects. The effect of palifermin on chemotherapyand radiation therapy.
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. This side effect of cancer treatment can significantly affect patient quality of life and may cause delays in treatment. The medwatch july safety labeling changes posting includes 52 products with safety labeling changes to the following sections.
Kepivance – FDA prescribing information, side effects and uses
A slight increase or plateau in concentration occurred at approximately 1 to 4 hours, followed by a terminal decline phase. The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. The results of Study 1 are presented in Table 2 and Figure 1.
Submit your questions about the treatment of ovarian, colorectal and small intestine cancers to Dr John Hays M. In reproductive toxicology studies, increased keipvance loss and decrease in fetal body weight were observed in both rabbit 2. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
Study 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury. Palifermin exposure did not increase linearly with increasing doses. packabe
In mice and rats, Kepivance enhanced proliferation of epithelial cells as measured by Ki67 immunohistochemical staining and BrDU uptake and demonstrated an increase in tissue thickness of the tongue, buccal mucosa, and gastrointestinal tract. Subscribe to receive email notifications whenever new articles are published. Tongue thickening Taste alteration Increased fever Sudden, sharp headache Noticeable changes in heart rate 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?
Understand treatment options for recurrent colon cancer and the role of clinical trials. Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis. Palifermin belongs to a class of drugs called growth factors. Kepivance is a watersoluble, amino acid protein with a molecular weight of Print this page Add to My Med List.
Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see Drug Interactions 7 ]. Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with.