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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By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug.
Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.
Highlights of prescribing information these highlights do not. The pharmacokinetics of Kepivance was evaluated in the phase 1 study. In keepivance randomized, double-blind, placebo-controlled kepivande study designed to determine the efficacy of Kepivance with a high-dose melphalan preparative regimen, the incidence of treatment-emergent infections was significantly greater in patients treated with Kepivance compared to placebo.
Additional studies are warranted to determine the role of Kepivance kepivancee the management and prevention of chemotherapy-induced mucositis in this and other tumor types. Palifermin concentrations declined in the first 30 minutes after dosing. The severity of oral mucositis can vary, ranging from redness and irritation to sores and severe pain that interfere with swallowing.
A chemotherapy drug or supportive care agent may be referred to by different names. Surgery, chemotherapy, biomarker testing and precision cancer medicines all part of stage III colon cancer treatment. There was no significant effect of palifermin on heparin activity with respect to activated partial thromboplastin time aPTT. It is important that patients inform their physician of any pre-existing conditions chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.
This side effect of cancer treatment can significantly affect patient quality of life and may cause delays in treatment. By submitting your email, you are opting in to receiving information from healthcom media and affiliates. Clinical studies of Kepivance did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently from younger subjects. No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8.
The medwatch july safety labeling changes posting includes 52 products with safety labeling changes to the following sections. Patients will undergo assessments for oral mucositis.
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The effect of palifermin on chemotherapyand radiation therapy. Kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli.
FDA alerts for all medications. Treatment of cutaneous tcell lymphoma ctcl in patients who have received at least one prior systemic therapy. The researchers concluded that single-dose Kepivance prior to chemotherapy in sarcoma patients effectively reduced mucositis incidence as well as severity. The results for Study 1 were supported by results observed in the subset of patients in Study 2 who received the same dose and schedule of Kepivance administered in Study 1.
There were no significant differences between either of kepivane Kepivance regimens and the placebo arm in the incidence of severe oral mucositis. Subscribe to free Drugs. Specialty pharmacy clinical policy bulletins aetna non.
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Palifermin is FDA-approved to decrease paclage 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. Kepivance palifermin description kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli. In a post approval study, Study 3, designed to determine the efficacy of Kepivance with a high dose melphalan preparative regimen, patients with multiple myeloma were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial.
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.
Kepivance – FDA prescribing information, side effects and uses
The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity. 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 insfrt days.
Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions.
Each single-dose vial of Kepivance contains palifermin 6. The prescribing physician is kepivqnce responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care. Genomic testing to identify targeted therapies is increasingly important for the treatment of colon cancer. Non Hodgkin’s lymphoma NHL was the most common malignancy followed by Hodgkin’s disease, kepivancs myeloma, and leukemia.
Kepivance, a human keratinocyte growth factor, decreases the incidence and kepivabce of severe oral mucositis in patients who have hematologic cancer and who receive myelotoxic therapy and need.
The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to.
Patients should inform their physician of any kepivanec medication they are taking whether prescription or over-the-counter, including vitamins, herbs, etc. Patients should inform their physician if they have high blood pressure. The effects of Kepivance on stimulation of KGF receptor-expressing, non-hematopoietic tumors in patients are not known. Six more hot drugs for today and beyond american nurse today.
What is a package insert? It is important to use pac,age kind of birth control while undergoing treatment. The population had a median age of 48 years range: The KGF kepivabce, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin hair follicles and sebaceous glandand the lens of the eye.