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.
|Published (Last):||7 January 2007|
|PDF File Size:||18.1 Mb|
|ePub File Size:||1.18 Mb|
|Price:||Free* [*Free Regsitration Required]|
Kepivance has been studied in murine models of chemotherapy and radiation-induced gastrointestinal injury. As with all therapeutic proteins, there is a potential for immunogenicity. In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population.
California Cancer Care
A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics packqge metabolism of the specific drug.
Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. We are providing this information solely as a courtesy and, as such, it inserf in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice.
Median 25 th75 th percentile Cumulative Opiod Dose morphine mg equivalents. Kepivance palifermin description kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli.
For example, the webpage stated the effect of kepivance. In a post approval study, designed to packabe the efficacy of Kepivance in decreasing the incidence of severe acute graft versus host disease ;ackage in patients with hematologic malignancies undergoing allogeneic transplantation, the incidenceduration and severity of oral mucositis was also measured.
Typically, when a drug is first approved by kepivancr FDA for clinical use, the tradename selected by the manufacturer is used. In reproductive toxicology studies, increased post-implantation loss and decrease in fetal body weight were observed in both rabbit 2.
Kepivance – FDA prescribing information, side effects and uses
J oncol pharm practice successful use of palifermin following. Historically, treatment for mucositis has consisted of supportive therapies, such as mouthwashes, aimed at reducing discomfort until the cells regenerate themselves, which takes about seven to 14 days. What is the mechanism of action? Site Created By CancerConsultants. Cancer Connect Editor Sep Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.
Genomic testing to identify targeted therapies is increasingly important for the treatment of colon cancer. Kepivance palifermin rationale for inclusion in pa program. 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 package insert pdf
Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury. 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Kepivance is supplied as a lyophilized powder in single-dose vials containing 6.
There was no significant effect of palifermin on pacmage activity with respect to activated partial thromboplastin time aPTT. 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.
However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions. Our drug dictionary is organized by alphabet, including both generic and trade names. Nipent pentostatin for injection r x only warning nipent should be administered under the supervision jnsert a physician qualified and experienced in the use of cancer chemotherapeutic agents. Understand the types of surgery and ostomies used in the treatment of colon cancer.
It is important that patients inform their physician of any pre-existing conditions chicken pox, heart disease, kidney disease, liver disease, lung disease, etc. The pharmacokinetics of Kepivance were studied in healthy subjects and patients with hematologic malignancies. The easiest way to lookup drug information, identify kepivajce, check interactions and set up your own personal medication records.
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 Ixempra is a prescription medicine used to treat kepivsnce advanced or metastatic breast cancer when certain other medicines have not worked or no kepivvance work.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed insegt 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. Results from a pharmacokinetics study in 24 subjects with varying degrees of renal impairment demonstrated that renal impairment has little or no influence on Kepivance pharmacokinetics.
A chemotherapy drug or packae care agent may be referred to by different names. Istodax is a histone deacetylase hdac inhibitor indicated for. Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in insdrt with. The most common adverse reactions attributed to Kepivance were skin toxicities rash, erythema, edema, pruritusoral toxicities dysesthesia, tongue discoloration, tongue thickening, alteration of tastepain, arthralgias, and dysesthesia.
A total of patients were randomized to 3 arms: Other analyses included the incidence, duration, and severity of oral mucositis and the use of opioid analgesia. Kepivance is indicated as supportive care for preparative regimens predicted to result in.
Boxed warning, contraindications, warnings, inwert, adverse reactions, or patient package insert medication guide.