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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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Grade 3 and 4. Study 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance. Patients should inform their physician of any other medication they inesrt taking whether prescription or over-the-counter, including vitamins, herbs, etc.

Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic kepivane stem cell support [See Clinical Studies Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis.

A similar trend has been observed in adult patients. Kepivance exhibited linear pharmacokinetics with extravascular distribution. Administer the first 3 doses prior to myelotoxic therapy.

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A subset of subjects enrolled in the multiple myeloma study were included in an evaluation for packagr risk of cataract development in patients receiving Kepivance treatment. 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.

In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population. Patients who have received a prescription of this drug for a condition insett than which it is approved may wish to discuss this issue with their physician.

Palifermin should not be administered within 24 hours of chemotherapy administration.

The elimination half-life was similar between healthy subjects and cancer patients average 4. There was no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance as compared to patients who received placebo. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA.

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Indications kepivance is a mucocutaneous epithelial human growth pakage indicated to decrease the incidence and duration of severe oral mucositis in patients with. Palifermin is embryotoxic in rabbits and rats. Kepivance is supplied as a sterile, white, preservative-free, lyophilized powder for intravenous injection after reconstitution with 1.

There was no dose limiting toxicity identified at any dose level. The prescribing physician is solely responsible inseert making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care. Palifermin is given in 3 doses prior to therapy and 3 doses following therapy.

Kepivance – FDA prescribing information, side effects and uses

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. As with all therapeutic proteins, there is a potential for immunogenicity. Multiple conditioning regimens were used. It is not known whether Kepivance is secreted in human milk.

Fda medwatch july safety labeling changes includes An increase in palifermin concentrations occurred at around 2 to 4 hours post-dose for some subjects, which was followed by a second, slow decline phase. Medically reviewed on Jul 2, Pregnant rabbits received intravenous palifermin during organogenesis at doses equivalent to 1.

By submitting your email, you are opting in to receiving information from healthcom media and affiliates. Patients will undergo assessments for oral mucositis.

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Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy

Kepivance is a water soluble, amino acid protein with a molecular weight of In patients receiving Kepivance, dysesthesia including hyperesthesia, hypoesthesia, and paresthesia was usually localized to the perioral region, whereas in patients receiving placebo dysesthesias were more likely to occur in extremities.

The safety and efficacy of Kepivance in decreasing the incidence and duration kepibance severe oral mucositis in patients with hematologic malignancies NHL, Hodgkin’s disease, acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma receiving psckage therapy requiring hematopoietic stem cell support, were established in a randomized placebo-controlled clinical trial of patients Study 1 and a randomized, schedule-ranging, placebo-controlled clinical trial of patients Study 2.

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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. This drug may cause birth kkepivance. When should patients notify their physician?

Palifermin stimulates cells, called epithelial cells, to grow and divide. No accumulation was observed following 3 consecutive doses of Kepivance. Kepivance palifermin rationale for inclusion in pa program.

By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. 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.

How are patients monitored? What is the mechanism of action? Timing of palifermin dosing according to the package insert, palifermin should not be given within hours before receiving myelotoxic therapy.

Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. In reproductive toxicology studies, increased post-implantation loss and decrease in fetal body weight were observed in both rabbit 2. However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions.

Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to. Finally, the actual chemical name of the compound is sometimes used by medical professionals rather than the tradename or generic name.

The KGF receptor has been reported to not be present on cells of the hematopoietic lineage. Istodax is a histone deacetylase hdac inhibitor indicated for. Cancer Connect Editor Nov The researchers concluded that single-dose Kepivance prior to chemotherapy in sarcoma patients effectively reduced mucositis incidence as well as severity.