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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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.

Kepivannce clastogenic or mutagenic effects of palifermin were observed in mammalian chromosomal aberration or Ames genotoxicity assays. A total of patients were randomized to 3 arms: What are the most common side effects associated with treatment with palifermin?

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Patients will undergo assessments for oral mucositis. Patients should ask their physician about the amount of liquid to consume during a day. In clinical trials, pcakage samples from patients treated with Kepivnce were tested for antibodies to Kepivance using an electrochemiluminescence-based binding assay. No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8. 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?

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

Indications kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the psckage and duration of severe oral mucositis in patients with. Because many drugs are excreted in human milk, and because of the potential for serious inseet 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 the mother.

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Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy

Site Created By CancerConsultants. Submit your questions about the treatment of ovarian, colorectal and small intestine cancers to Dr John Hays M. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. Finally, the actual chemical name of the compound is sometimes used by medical professionals rather than the tradename or generic name. The population had a median age of 48 years range: Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis.

How are patients monitored? 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. This side effect of cancer treatment can significantly affect patient quality of life and may cause delays in treatment.

Request pdf on researchgate palifermin kepivance for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support objective. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems. 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.

A slight increase or plateau in concentration occurred at approximately 1 to 4 hours, followed by a terminal decline phase.

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 a watersoluble, amino acid protein with a molecular weight of The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity.

The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen. 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.

Understand treatment options for recurrent colon cancer and the role of clinical trials.

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The mean half-life range was 2. Understand the types of surgery and ostomies used in the treatment of colon cancer.

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For example, the webpage stated the effect of kepivance. How is palifermin typically given administered? 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. A team of cyclists from sobi have biked from mainz to brussels 24 october to help raise funds for people with haemophilia as well as awareness about the condition. 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

Supportive care Generic Name: As with any printed reference, the use of particular drugs, regimens and packafe 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. The 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 of patients Study 1 and a randomized, schedule-ranging, placebo-controlled clinical trial of patients Study 2.

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 packagr care.

Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. With cancer treatment success comes a downsidemore disability and pain.

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. The safety and efficacy of Kepivance has not been established in patients with other types of cancer. Patients should inform their physician of any other medication they are taking whether prescription or over-the-counter, including vitamins, herbs, etc. Study 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance.