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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Kepivance Rating No reviews – Add your review. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. For example, the webpage stated the effect of kepivance.
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.
Our drug dictionary is organized by alphabet, including both generic and trade names. Kepivance, a human keratinocyte growth factor, decreases the incidence and duration of severe oral mucositis in patients who have hematologic cancer and who receive myelotoxic therapy and need. In general, peak increases were observed during the period of cytotoxic therapy and returned to baseline by the day of hematopoietic stem cell infusion. Adverse events were similar to those reported in adult studies.
A subset of subjects kepivxnce in the multiple myeloma study were included in an evaluation for the risk of cataract development in patients receiving Kepivance treatment. There are no adequate and well-controlled studies of Kepivance in pregnant woman. Timing of palifermin dosing according to the package insert, palifermin should not be inserg within hours before receiving myelotoxic therapy.
Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. With cancer treatment success comes a downsidemore disability and pain. 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. The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity.
Precision Cancer Medicines for Colon Cancer. Palifermin is given in 3 doses prior to therapy and 3 doses following therapy. Multiple conditioning regimens were used. Print this page Add to My Med List. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. See Clinical Studies [ No accumulation was observed following 3 consecutive doses of Kepivance.
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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. No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8. Sobi cycle bike ride from mainz to brussels raises funds, awareness for haemophilia. The prespecified primary analysis was a comparison between the Kepivance pre-post and pre arms to placebo.
Sometimes these manufacturers will market the generic form under a new tradename to help identify it in the marketplace. Administer the first 3 doses prior to myelotoxic therapy. In a randomized, double-blind, placebo-controlled packaeg study designed to determine the efficacy of Kepivance with a high-dose melphalan preparative regimen, kepigance incidence of treatment-emergent infections was significantly greater in patients treated with Kepivance compared to placebo.
Finally, the actual chemical name of the compound is sometimes used by medical professionals rather than the tradename or generic name.
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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, inssrt, bladder, mammary gland, skin hair follicles and sebaceous glandand the lens of the eye.
The mean half-life range was 2. 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 Subscribe to free Drugs.
Surgery, chemotherapy, biomarker testing and precision cancer medicines all part of stage III colon cancer treatment. Three age groups were studied: Each single-dose vial of Kepivance contains palifermin 6.
Kepivance is supplied pavkage a lyophilized powder in single-dose vials containing 6. Pregnant rabbits received intravenous palifermin during organogenesis at doses equivalent to 1.
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. For which conditions is this drug approved? Part 4 of this fourpart series on cancer pain will discuss painful complications of chemotherapy andor radiation therapy.
In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. Particle contamination of parenteralia and inline filtration. In animal reproductive toxicity studies, palifermin is embryotoxic at doses that keoivance 2. The elimination half-life was similar between healthy subjects and cancer patients average 4. Palifermin belongs to a class of drugs called growth factors.
Patients will undergo assessments for oral mucositis. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular onsert, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice.
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.
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.