KEPIVANCE PACKAGE INSERT PDF

This page contains brief information about palifermin and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. FDA label information for this drug is available at DailyMed. Palifermin is approved to prevent and treat:. Palifermin is also being studied in the treatment of common side effects in other types of cancer.

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Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support.

The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies ]. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies [see Warnings and Precautions 5. Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support.

Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support [See Clinical Studies Administer the first 3 doses prior to myelotoxic therapy. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy Administer the first 3 doses prior to myelotoxic therapy.

Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see Drug Interactions 7 ]. Administer the last 3 doses after myelotoxic therapy is complete; administer the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance [see Drug Interactions 7 ].

The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. The effects of Kepivance on stimulation of KGF receptor-expressing, non-hematopoietic tumors in patients are not known. 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 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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.

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.

Patients received Kepivance either before, or before and after, regimens of myelotoxic chemotherapy, with or without total body irradiation TBI , followed by hematopoietic stem cell support. The most common adverse reactions attributed to Kepivance were skin toxicities rash, erythema, edema, pruritus , oral toxicities dysesthesia, tongue discoloration, tongue thickening, alteration of taste , pain, arthralgias, and dysesthesia.

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. 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.

Cataracts: In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population.

Infections: In a randomized, double-blind, placebo-controlled post-approval 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.

In general, peak increases were observed during the period of cytotoxic therapy and returned to baseline by the day of hematopoietic stem cell infusion. Amylase was mainly salivary in origin. All MedLibrary. This site is provided for educational and informational purposes only, in accordance with our Terms of Use , and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

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