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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Study 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance. There was no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance as compared to patients who received placebo.

Timing of palifermin dosing according to the package insert, palifermin should not be given within hours before receiving myelotoxic therapy. Do not administer Kepivance within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy [see Dosage and Administration 2. Kepivance exhibited linear pharmacokinetics with extravascular distribution. Kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli.

For these reasons, comparison of the incidence of antibodies to Kepivance with the incidence of antibodies to other products may be misleading. 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.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.

Each single-dose vial of Kepivance contains palifermin 6. The elimination half-life was similar between healthy subjects and cancer patients average 4. Non Hodgkin’s lymphoma NHL was the most common malignancy followed by Hodgkin’s disease, multiple myeloma, and leukemia.

The effect of palifermin on chemotherapyand radiation. The Safety Committee attributed the safety finding to Kepivance having been administered within 24 hours of chemotherapy, which resulted in an increased sensitivity of the rapidly dividing epithelial cells in the immediate post-chemotherapy period [see Dosage and Administration 2.

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J oncol pharm practice successful use of palifermin. Use our drug profile search engine to review information about current FDA appproved cancer drugs. FDA alerts for all medications. The pharmacokinetics of Kepivance were studied in healthy subjects and patients with hematologic malignancies.

Palifermin concentrations declined in the first 30 minutes after dosing. Administer the first 3 doses prior to myelotoxic therapy.

The main outcome of the study was maximum severity of WHO oral mucositis. In animal reproductive toxicity studies, palifermin is embryotoxic at doses that are 2. By clicking Subscribe, I agree to the Drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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. The population had a median age of 48 years range: Our drug dictionary is organized by alphabet, including both generic and trade names.

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Amifostine precautions dosage for use in xerostomia relatively low, generally well tolerated monitoring consideration. The results of Study 1 are presented in Table 2 and Figure 1. 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 patients with hematologic malignancies undergoing allogeneic transplantation, the incidenceduration and severity of oral mucositis was kepivancs measured.

The data described in Table 1 and the discussion below reflect exposure to Kepivance in patients with hematologic malignancies who were enrolled in 3 randomized, placebo-controlled clinical trials and a pharmacokinetic study. 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. What is the mechanism of action?

Kepivance package insert pdf

Multiple conditioning regimens were used. A slight increase or plateau in concentration occurred at approximately 1 to 4 hours, followed by a terminal decline phase.

The mean half-life range was 2. Protein drug products play an important role in the treatment of severe diseases. Fda medwatch july safety labeling changes includes Palifermin stimulates cells, called epithelial cells, to grow and divide. However, the same agent may also be referred to by its chemical name. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage.

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Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.

Inhospital pharmacy published a list of oral medications that require protection from light. However, use of Kepivance in pediatric patients ages 1 to paxkage 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.

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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. Understand the types of surgery and ostomies used in the treatment of colon cancer. However, due to the instability of these complex molecules, protein aggregates can form which unsert compromise drug safety and efficacy including immunogenic reactions.

Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro and to increase the rate of tumor cell line growth in a human carcinoma xenograft model [see Clinical Pharmacology To evaluate Kepivance among patients receiving multiple cycles of chemotherapy for sarcoma, researchers conducted a small randomized, double-blind, placebo-controlled trial. Alternately, you may view a list of drugs by “class. Kepivznce easiest way to lookup drug information, identify pills, check interactions and set inert your own personal medication records.

There are no adequate and well-controlled studies of Kepivance in pregnant woman. Annals of Internal Medicine. This side effect of pacckage treatment can significantly affect patient quality of life and may cause delays in treatment.