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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Surgery, chemotherapy, biomarker testing and precision cancer medicines all part of stage III colon cancer treatment. Kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli. It is not known whether Kepivance is secreted in human milk. Cancer Connect Editor Jul Precision Cancer Medicines for Colon Cancer.
FDA alerts for all medications. 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. 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.
The effect of palifermin on chemotherapyand radiation therapy. The severity of oral mucositis can vary, ranging from redness and irritation to sores and severe pain that interfere with swallowing. Understand treatment options for recurrent colon cancer and the role of clinical trials. The results are presented in Figure 2. Are there any special precautions patients should be aware of before starting treatment? The researchers concluded that single-dose Kepivance prior to chemotherapy in sarcoma patients effectively reduced mucositis incidence as well as severity.
In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. By submitting your email, you are opting in to receiving information from healthcom media and affiliates. For patients with hematologic blood cancers that involve treatment with a stem cell transplant, a biological therapy called Kepivance appears to reduce mouth and throat soreness and improve function by stimulating cells that protect the lining of the mouth and GI tract.
Typically, when a drug is first approved by the FDA for clinical use, the tradename selected by the manufacturer is used. Other analyses included the incidence, duration, and severity of oral mucositis and the use of opioid analgesia.
J oncol pharm practice successful use of palifermin following.
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Available for Android and iOS devices. Kepivance is a watersoluble, amino acid protein with a molecular weight of Packagee not administer Kepivance within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy [see Dosage and Administration 2.
It is important to use some kind of birth control while undergoing treatment. Patients received Kepivance either before, or before and after, regimens of myelotoxic chemotherapy, with or without total body irradiation TBIfollowed by hematopoietic stem cell support.
The most common adverse reactions attributed to Kepivance were skin toxicities rash, erythema, paackage, pruritusoral toxicities dysesthesia, tongue discoloration, tongue thickening, alteration of tastepain, arthralgias, and dysesthesia.
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 kepviance only for reduction in severity of oral mucositis in subjects with multiple myeloma receiving high dose melphalan followed by autologous peripheral blood stem cell transplantation.
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.
Site Created By CancerConsultants. Patients should check with their physician inssrt starting any paxkage drug or nutritional supplement. To evaluate Kepivance among patients receiving multiple cycles of chemotherapy for sarcoma, researchers conducted a small randomized, double-blind, placebo-controlled trial. 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 ekpivance including a stem cell transplant.
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. Historically, treatment for mucositis has consisted of supportive therapies, such as mouthwashes, aimed at reducing discomfort until the cells regenerate themselves, which takes about seven to 14 days.
Palifermin is embryotoxic in rabbits and rats.
Kepivance package insert pdf
The pharmacokinetics of Kepivance were studied in healthy subjects and patients with hematologic malignancies. Sometimes these manufacturers will market the generic form under a new tradename to help identify it in the marketplace. Kepivance For which conditions is this drug approved? The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen.
These changes in palifermin PK did not have a noticeable effect on Ki67 expression in buccal biopsies, used as a marker of epithelial cell proliferation. Fda medwatch july safety labeling changes includes Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support [See Clinical Studies Palifermin for oral mucositis in the highdose chemotherapy and stem cell.
There was no dose limiting toxicity identified at any dose level. Treatment of peripheral tcell lymphoma ptcl in patients who have received at least one prior therapy. Patients should ask their physician about the amount of liquid to consume during a day. Kepivance fda prescribing information, side effects and uses. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. In general, peak increases were observed during the period of cytotoxic therapy and returned to baseline by the day of hematopoietic stem cell infusion.
Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.
Inhospital apckage published a list of oral medications that require protection from light. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration [see Clinical Pharmacology The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity.
Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to help protect patients with hematologic malignancies undergoing highdose chemotherapy andor radiation followed by autologous bone marrow transplant from severe oral mucositis.