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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A chemotherapy drug or supportive care agent may be referred to by different names.

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Cancer Connect Editor Nov In a randomized, double-blind, placebo-controlled post-approval study designed to determine the efficacy of Kepivance with a high-dose melphalan preparative regimen, the incidence of treatment-emergent infections was significantly oepivance in patients treated with Kepivance compared to placebo.

Submit your questions about the treatment of ovarian, colorectal and small intestine cancers to Dr John Hays M. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA.

No dose adjustment is recommended for the geriatric population [see Use in Specific Populations 8. Request pdf on researchgate palifermin kepivance for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support objective.

The safety and efficacy of Kepivance has not been established in patients with other types of cancer. 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.

In a post approval study, designed to determine the efficacy of Kepivance in decreasing the incidence of severe acute graft versus host disease aGVHD in patients with hematologic malignancies undergoing allogeneic transplantation, the incidenceduration and severity of oral mucositis was also measured. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the packagr trials of another drug and may not reflect the rates observed in clinical practice.

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Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis. To evaluate Kepivance among patients receiving multiple cycles of chemotherapy for sarcoma, researchers conducted kdpivance small randomized, double-blind, placebo-controlled trial.

Ixempra is a prescription medicine used to treat locally advanced or kepivancce breast cancer when certain other medicines have not worked or no longer work.

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. Timing of palifermin dosing according to the package insert, palifermin should not be given within hours before receiving myelotoxic therapy.

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. Palifermin kepivance for the treatment of oral mucositis. Patients were treated with up to six cycles of chemotherapy with doxorubicin. Multiple conditioning regimens were used. There was no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance as compared to patients who received placebo.

By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. The prescribing physician is solely responsible for making all decisions pafkage to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care. Patients will undergo assessments for oral mucositis. A similar trend has been observed in adult patients. Kepivance has been studied in murine models of chemotherapy and radiation-induced gastrointestinal injury.

Palifermin

Surgery, chemotherapy, biomarker testing and precision cancer medicines all part of stage III colon cancer treatment. The main outcome of the study was maximum severity of WHO oral mucositis. Kepivance is a water soluble, amino acid protein with a molecular weight of 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.

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In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population.

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Understand treatment options for recurrent colon cancer and the role of clinical trials. What is a package insert? However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions.

Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects. Kepivance is a watersoluble, amino acid protein with a molecular weight of In animal reproductive toxicity studies, palifermin is embryotoxic at doses that are 2.

As with all therapeutic proteins, there is a potential for immunogenicity.

Patients should inform their physician kepivancs they are pregnant, breastfeeding or planning a family in the near future. Palifermin exposure did not increase linearly with increasing doses. 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.

Kepivance should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert medication guide.

Cancer Connect Editor Jul Drink plenty kepivancs fluids. 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 following adverse reactions have been identified during postapproval use of Kepivance in the stem cell transplant setting. Palifermin is embryotoxic in rabbits and rats. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells.