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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Pacakge safety and efficacy of Kepivance in decreasing the incidence and duration of 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 myelotoxic therapy requiring hematopoietic stem cell support, were established in a randomized placebo-controlled clinical trial kepivancd patients Study 1 and a randomized, schedule-ranging, placebo-controlled clinical trial of patients Study 2.
Palifermin kepivance, a new drug produced by recombinant dna technology, is a synthetic form of human keratinocyte growth factor, an endogenous protein that promotes the production of epithelial cells in the skin and on the surface layers of the mouth, stomach, and colon.
Kepivance, a human keratinocyte growth factor, decreases the incidence and duration of severe oral mucositis in patients who have hematologic cancer kepivvance who receive myelotoxic therapy and need. Patients kspivance ask their physician about the amount of liquid to consume during a day. Maintain adequate rest and nutrition. Protein drug products play an important role in the treatment of severe diseases.
Kepivance is a watersoluble, amino acid protein with a molecular weight of Kepivance is a water soluble, amino acid protein with kspivance.
Typically, when a drug is first approved by the FDA for clinical use, the tradename packkage by the manufacturer is used. The medwatch july safety labeling changes posting includes 52 products with safety labeling changes to the following sections. Submit your questions about the treatment of ovarian, colorectal and small intestine cancers to Dr John Hays M. In vitro and in vivo data showed that palifermin interacts with unfractionated as well as low molecular weight heparins with no noticeable effect on the pharmacodynamics of either drug.
The clinical component of this study was funded by aesgen, inc. Ixempra can be used packsge or with another cancer medicine called xeloda capecitabine. Understand treatment options for recurrent colon cancer and the role of clinical trials. Cancer Connect Editor Sep Administer the first 3 doses prior to myelotoxic therapy.
The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen. The effect of palifermin on chemotherapyand radiation therapy. It is not known whether Kepivance is secreted in human milk. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration [see Clinical Pharmacology For which conditions is this drug approved?
Amifostine precautions dosage for use in xerostomia relatively low, generally well tolerated monitoring consideration. In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population.
The population had a median age of 48 years range: Six more hot drugs for today and beyond american nurse today. There was no dose limiting toxicity identified at any dose level. In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. 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.
Understand the types of surgery and ostomies used in the treatment of colon cancer. Orfadin is a synthetic reversible inhibitor of 4hydroxyphenylpyruvate dioxygenase indicated for use as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 ht1.
Kepivance For which conditions is this drug approved? The effects of Kepivance on stimulation of KGF receptor-expressing, non-hematopoietic tumors in patients are not known.
Kepivance package insert pdf
The details, including your email addressmobile number, may be used to keep you informed about future products and services. 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 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.
Kepivance is the first fdaapproved systemic drug for treating and preventing inseet from chemotherapy or radiation therapy. Chemotherapy- or radiation-induced damage to the cells lining the mouth, throat, and gastrointestinal GI tract is called mucositis.
The incidence of antibody positivity is highly dependent on kepivxnce specific assay and its sensitivity. The severity of oral mucositis can vary, ranging from redness and irritation to sores and severe pain that interfere with swallowing. This drug may cause birth defects. Genomic testing to identify targeted therapies is increasingly important for the treatment of colon cancer. There was no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance as compared to patients who received placebo.
For these reasons, comparison of the incidence of antibodies to Kepivance with the incidence of antibodies to other products may insfrt misleading. The effect of palifermin on chemotherapyand radiation. 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.
Nipent pentostatin for injection r x only warning nipent should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents.