KEPIVANCE PACKAGE INSERT PDF

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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The safety and efficacy of Kepivance has not been established in patients with other types of cancer. Supportive care Generic Name: Surgery, chemotherapy, biomarker testing and precision cancer medicines all part of stage III colon cancer treatment.

Palifermin kepivance for the treatment of oral mucositis. Kepivance is the first fdaapproved systemic drug for treating and preventing mucositis from chemotherapy or radiation therapy. However, due to the instability of these complex molecules, protein aggregates can form which can compromise drug safety and efficacy including immunogenic reactions. This pacjage is provided for educational purposes only and kepkvance not intended for medical advice, diagnosis or treatment. This side effect of cancer treatment can significantly affect patient quality of life and may cause delays in treatment.

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.

Patients should inform their physician of any other medication they are taking whether prescription or over-the-counter, including vitamins, herbs, etc.

As with all therapeutic proteins, there is a potential for immunogenicity. The elimination half-life was similar between healthy subjects and cancer patients average 4. Kepivance should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Finally, the actual innsert name of the compound is sometimes used by medical professionals rather than the tradename inserrt generic name.

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When should patients notify insrrt physician? Request pdf on researchgate palifermin kepivance for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support objective. Drug Dictionary Details Use our drug profile search engine to review information about current FDA appproved cancer drugs.

There were no significant differences between either of pzckage Kepivance regimens and the placebo arm in the incidence of severe oral mucositis. The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity. Protein drug products play an important role in the treatment of severe diseases.

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For example, the webpage stated the effect of kepivance. Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. 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.

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There was no significant effect of palifermin on heparin activity with respect to activated partial thromboplastin time aPTT.

A similar trend has been observed in adult patients. Understand treatment options for recurrent colon cancer and the role of clinical trials. J oncol pharm practice successful use of palifermin.

Cancer Connect Editor Sep Part 4 of this fourpart series on cancer pain will discuss painful complications of chemotherapy andor radiation therapy. However, the same agent kepivvance also be referred to by its chemical name. Each single-dose vial of Kepivance contains palifermin 6.

Kepivance Effective in Managing Mucositis in Patients Undergoing Chemotherapy

Patients who have received a prescription of this keoivance for a condition other than which it is approved may wish to discuss this issue with their physician. Grade 3 and 4. In animal reproductive toxicity studies, palifermin is embryotoxic at doses that are 2. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.

FDA alerts for all medications. Maintain adequate rest and nutrition. Site Created By CancerConsultants. The pharmacokinetics of Kepivance was evaluated in the phase 1 study. Palifermin is given in 3 doses prior to therapy and 3 doses following therapy.