KEPIVANCE PACKAGE INSERT PDF

September 2, 2019 posted by

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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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. Patients should inform their physician if kepivanve are pregnant, breastfeeding or planning a family in the near future.

Kepivance – FDA prescribing information, side effects and uses

Amylase was mainly salivary in origin. Palifermin exposure did not increase linearly with increasing doses. Medically reviewed on Jul 2, Palifermin stimulates cells, called epithelial cells, to grow and divide. Available for Android and iOS devices.

Kepivance package insert pdf

Typically, when a drug is first approved by the FDA for clinical use, the tradename selected by the manufacturer is used. For patients with hematologic blood cancers that involve treatment with a stem cell transplant, a biological therapy called Kepivance appears to reduce mouth and throat soreness and improve function by stimulating cells that protect the lining of the mouth and GI tract.

Kepivance is the first fdaapproved systemic drug for treating and preventing mucositis from chemotherapy or radiation therapy.

No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8. Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects. The main outcome of the study was maximum severity of WHO oral mucositis.

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Kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli.

How are patients monitored? Cancer Connect Editor Sep However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions. See Clinical Studies [ As with all therapeutic proteins, there is a potential for immunogenicity.

No clastogenic or mutagenic effects of palifermin were observed in mammalian chromosomal aberration or Ames genotoxicity assays. After completion of the phase iii clinical study, aesgen, inc. Annals of Internal Medicine.

In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. Palifermin kepivance for the treatment of oral mucositis. Three age groups were studied: The results for Study 1 were supported by results observed in the subset of patients in Study 2 who received the same dose and schedule of Kepivance administered in Study 1.

Study 2 was a packave, multi-center, placebo-controlled trial comparing varying schedules of Kepivance. There are no adequate and well-controlled studies of Kepivance in pregnant woman.

The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen. Kepivance should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions that affect drug stability. 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.

Kepivance is a water soluble, amino acid protein with a molecular weight of Kepivance palifermin rationale for inclusion in pa program. The effect of palifermin on chemotherapyand radiation therapy. Palifermin is administered intravenously into a vein and the dose depends on the size or weight of the patient. 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.

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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. Treatment of peripheral tcell lymphoma ptcl in patients who have received at least one prior therapy.

Kepivance Rating No reviews – Add your review. Site Created By CancerConsultants. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Kepivance has been studied in murine models of chemotherapy and radiation-induced gastrointestinal injury.

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In reproductive toxicology studies, increased post-implantation loss and decrease in fetal body weight were observed in both rabbit 2. The study assigned 48 sarcoma patients to receive either placebo or Kepivance prior to each cycle of chemotherapy. The researchers concluded that single-dose Kepivance prior to chemotherapy in sarcoma patients effectively reduced mucositis incidence as well as severity.

Because many kepigance 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 kepivace, taking into account the importance of the drug to the mother.