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 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 muc ositis.

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Amifostine precautions dosage for use in xerostomia relatively low, generally well tolerated monitoring consideration. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to help protect patients with haematologic malignancies undergoing highdose keepivance andor radiation followed by bone marrow transplant from severe oral mucositis.

Because these reactions kkepivance reported voluntarily from a paxkage of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Six more hot drugs for today and beyond american nurse today. This side effect of cancer treatment can significantly affect patient quality of life and may cause delays in treatment. Drink plenty of fluids. 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.


Fda medwatch july safety labeling changes includes Supportive care Generic Name: After completion of the phase iii clinical study, aesgen, inc. Kepivance exhibited linear pharmacokinetics with extravascular distribution. The median time to onset of cutaneous toxicity was 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of 5 days. Evaluation and treatment of chemo or radiationinduced. Palifermin exposure did not increase linearly with increasing kepivabce.

Historically, treatment for mucositis has consisted of supportive therapies, such as mouthwashes, aimed at reducing discomfort until the cells regenerate themselves, kepivxnce takes about seven to 14 days.

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Palifermin for oral mucositis in the highdose chemotherapy and stem cell. For which conditions is this drug approved? Sometimes these manufacturers will market the generic form under a new tradename to help identify it in the marketplace. Additional studies are warranted to determine the role of Kepivance in the management and prevention of chemotherapy-induced mucositis in this and other tumor types.

What are the most common side effects associated with treatment with palifermin? A slight increase or plateau in concentration occurred at approximately 1 to 4 hours, followed by a terminal decline phase.

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It is not known whether Kepivance is secreted in human milk. Kepivance is a water soluble, amino acid protein with a molecular weight of When should patients notify their physician? Print this page Add to My Med List. 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 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.


Boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert medication guide. It is important to use some kind of birth control while undergoing treatment.

Inhospital pharmacy published a list of oral medications that require protection from light. Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and kfpivance of severe oral mucositis in patients with. 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.

Use our drug profile search engine to review information about current FDA appproved cancer drugs. Alternately, you may view a list of drugs by “class. Results from a pharmacokinetics study in 24 subjects with varying degrees of renal impairment demonstrated that renal impairment has little or no influence on Kepivance pharmacokinetics. Because clinical trials are kwpivance under widely varying conditions, adverse reaction rates inssrt 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.

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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. Kepivance is indicated as supportive care for preparative regimens predicted to result in.

Kepivance is ihsert recombinant human keratinocyte growth factor that works at the cellular level to.