KEPIVANCE PACKAGE INSERT PDF

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 reproductive toxicology studies, increased post-implantation loss and decrease in fetal body psckage were observed in both rabbit 2. In general, peak increases were observed during the period of cytotoxic therapy and returned to baseline by the day of hematopoietic stem cell infusion. Patients should check with kepivacne physician before starting any new drug or nutritional supplement.

The prespecified primary analysis was a comparison between the Kepivance pre-post and pre arms to placebo. The clinical component of this study was funded by aesgen, inc. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications and underlying disease. By clicking Subscribe, I agree to the Drugs.

A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, indert, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.

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 drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice.

Maintain adequate rest and nutrition. For the primary cataract endpoint of incidence of cataract development or cataract progression at Month 12, there was a greater proportion of subjects that experienced cataract development in the Kepivance group: Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with. Each single-dose vial of Kepivance contains palifermin 6.

No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8. To evaluate Kepivance among patients receiving multiple cycles of chemotherapy for sarcoma, researchers conducted a small randomized, double-blind, placebo-controlled trial. 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 kelivance mouth, stomach, and colon.

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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 – FDA prescribing information, side effects and uses

Case report successful use of palifermin following severe anaphylaxis to pegaspargase in a pediatric patient with acute lymphoblastic leukemia katie s kaminski1, cassidy l beach1, david b peden2,3.

In clinical trials, serum samples from patients treated with Kepivance were tested for antibodies to Kepivance using an electrochemiluminescence-based binding assay. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in 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 kepivancf mother.

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.

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. 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. For patients with hematologic blood cancers that involve treatment with a stem cell transplant, a biological therapy called Kepivance appears kepkvance reduce mouth and throat soreness and improve function by stimulating cells that protect the lining of the mouth and GI tract.

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.

Kspivance 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance.

Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy

Treatment of peripheral tcell lymphoma ptcl in patients who have received at packags one prior therapy. Palifermin belongs to a class of drugs called growth factors. However, use of Kepivance in pediatric patients ages 1 to 16 years is supported by evidence from adequate and well-controlled studies of Kepivance in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant.

Kepivance is a watersoluble, amino acid protein with a molecular weight of The study assigned 48 sarcoma patients to receive either placebo or Kepivance prior to each cycle of chemotherapy. Tongue thickening Taste alteration Increased fever Sudden, sharp headache Noticeable changes in heart rate or rhythm 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?

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The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. Evaluation and treatment of chemo or radiationinduced. Understand treatment options for recurrent colon cancer inesrt the role of clinical trials. Palifermin is embryotoxic in rabbits and rats.

Kepivance is a water soluble, amino acid protein with a molecular weight of Kepivance is a water soluble, amino acid protein with a. Subscribe to free Drugs. Use our drug profile search engine to review information about current FDA lepivance cancer drugs. Six more hot drugs for today and beyond american nurse today. Important Limitations of Use The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

For these reasons, comparison of the incidence of antibodies to Kepivance with the incidence of antibodies to other products may be misleading. Istodax is a histone deacetylase hdac inhibitor indicated for. 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. Chemotherapy- or radiation-induced damage to the cells lining the mouth, throat, and gastrointestinal GI tract is called mucositis.

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In a post approval study, Study 3, designed to determine the efficacy of Kepivance with a high dose melphalan preparative regimen, patients with multiple myeloma were evaluated in a multicenter, kepivancee, double-blind, placebo-controlled trial. The mean half-life range was 2. Genomic testing to identify targeted therapies is increasingly important for the treatment of colon cancer.