KEPIVANCE PACKAGE INSERT PDF

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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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 packsge stem cell transplant.

Sobi cycle bike ride from mainz to brussels raises funds, awareness for haemophilia. Kepivance palifermin rationale for inclusion in pa program. Inhospital pharmacy published a list of oral medications that require protection from light. There were no significant differences between either of the Kepivance regimens and the placebo arm in the incidence of severe oral mucositis. Palifermin exposure did not increase linearly with increasing doses. 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.

What is the mechanism of action? Drink plenty of fluids. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.

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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.

Our drug insdrt is organized by alphabet, including both generic and trade names. A chemotherapy drug or supportive care agent may be referred to by different names. 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. Kepivance Rating No reviews – Add your review.

Understand treatment options for recurrent colon cancer and the role of clinical trials. For these reasons, comparison of the incidence of antibodies to Kepvance with the incidence of antibodies to other products may be misleading.

We comply with kepviance HONcode standard for trustworthy health information – verify here. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury.

Palifermin

When should patients notify their physician? Subscribe to receive email notifications whenever new paxkage are published.

The prespecified primary analysis was a comparison between the Kepivance pre-post and pre arms to placebo. Fda medwatch july safety labeling changes includes Once the original manufacturers patent on the drug has expired, other manufacturers, with FDA approval, are allowed to produce and market the same chemical compound which is typically referred to as a “generic” form of the original.

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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.

J oncol pharm practice successful use of palifermin following. A slight increase or plateau in concentration occurred at approximately 1 to 4 packagf, followed by a terminal decline phase.

Palifermin for oral mucositis in the highdose chemotherapy and stem cell.

California Cancer Care

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 kepivance, a new drug produced by recombinant dna technology, is a synthetic form of human keratinocyte growth factor, an endogenous protein that promotes kepivanxe production of epithelial cells in the skin and on the surface layers of the mouth, stomach, and colon.

Kepivance is a water soluble, amino acid protein with a.

Multiple conditioning regimens were used. There inxert no adequate and well-controlled studies of Kepivance in pregnant woman. Treatment of peripheral tcell lymphoma ptcl in patients who have received at least one prior therapy.