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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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.
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 a water soluble, amino acid protein with a molecular weight of Three age groups were studied: Pregnant rabbits received intravenous palifermin during organogenesis at doses equivalent to 1. Patients will undergo assessments for oral mucositis.
Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy
Kepivance is a watersoluble, amino acid protein with a molecular weight of No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8.
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Other analyses included the incidence, duration, and severity of oral mucositis and the use of opioid analgesia. Tongue thickening Taste alteration Increased fever Sudden, sharp headache Noticeable changes in heart rate or kepivancf Alteration in feeling in the mouth Skin rash or other skin abnormalities Tongue discoloration Water retention, sudden weight gain Severe pain What is a package insert?
When should patients notify their physician? Grade 3 and 4.
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 The safety and efficacy of Kepivance have not been kepicance in patients with non-hematologic malignancies.
Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions kepivxnce nursing infants from Kepivance, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. There was no dose limiting toxicity identified at any dose level. Palifermin belongs to a class of drugs called growth factors.
The study assigned 48 sarcoma patients to receive either placebo or Kepivance prior to each cycle of chemotherapy. Cancer Connect Editor Sep If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
By clicking Subscribe, I agree to the Drugs. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin hair follicles and sebaceous glandand the lens of the eye.
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Kepivance is a water soluble, amino acid protein with a molecular weight of 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 The population had a median age of 48 years range: The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen.
Timing of palifermin dosing according to the package insert, palifermin should not be given within hours before receiving myelotoxic therapy. Our drug dictionary is organized by alphabet, including both generic and trade names.
Ixempra is a prescription medicine used to treat locally advanced or metastatic breast cancer when certain other medicines have not worked or no longer work.
In reproductive toxicology studies, increased post-implantation loss and decrease in fetal body weight were observed in both rabbit 2. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to help protect patients with haematologic malignancies undergoing highdose chemotherapy andor radiation followed by bone marrow transplant from severe oral mucositis.
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. What are the most common side effects associated with treatment with palifermin? Patients should ask their physician about the amount of liquid to consume during a day.
Specific treatment for colon cancer is based on the stage and genomic profile of each persons unique colon cancer. Patients should inform their physician of any other medication they are taking whether prescription or over-the-counter, including vitamins, herbs, etc. See Clinical Studies [ 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.
Highlights of prescribing information these highlights do not. Palifermin is embryotoxic in rabbits and rats. Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past. Typically, when a drug is first approved by the FDA for clinical use, the tradename selected by the manufacturer is used.
Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug.