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 effect of palifermin on chemotherapyand radiation therapy. An increase in palifermin concentrations occurred at around 2 to 4 hours post-dose for some subjects, which was followed by a second, slow decline phase.

Kepivance – FDA prescribing information, side effects and uses

The study assigned 48 sarcoma patients to receive either placebo or Kepivance prior to each cycle of chemotherapy. 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, randomized, double-blind, placebo-controlled trial.

The clinical component of this study was funded by aesgen, inc. Specific treatment for colon cancer is based on the stage and genomic profile of each persons unique colon cancer. Ophthalmologic examinations were performed on patients enrolled in a double-blind, randomized, placebo-controlled study of two different schedules of Kepivance pre and post chemotherapy and pre chemotherapy only for reduction in severity of oral mucositis in subjects with multiple myeloma receiving high dose melphalan followed by autologous peripheral blood stem cell transplantation.

In animal reproductive toxicity studies, palifermin is embryotoxic at doses that are 2. Available for Android and iOS devices. Palifermin is FDA-approved to decrease the incidence or duration of severe oral mucositis in patients who have cancers affecting the blood hematologic and who will undergo treatment including a stem cell transplant.

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

Three age groups were studied: Once the original manufacturers patent on the drug has expired, other manufacturers, with FDA approval, are allowed to produce and market the same chemical compound which is typically referred to as a “generic” form of the original.

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Boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert medication guide. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see Drug Interactions 7 ]. In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. 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.

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Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth. Use our drug profile search engine to review information about current FDA appproved cancer drugs.

In a postmarketing safety kepivajce, the incidence of cataracts was numerically higher among patients receiving Kepivance inseft in the control population. Understand the types of surgery and ostomies used in the treatment of colon cancer.

Other analyses included the incidence, duration, and severity of oral mucositis and the use of opioid analgesia. 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.

Additional studies are warranted to determine the role of Kepivance in the packafe and prevention of chemotherapy-induced mucositis in this and other tumor types. A total of patients were randomized to 3 arms: The details, including your email addressmobile number, may be used to keep you informed about future products and services.

In patients receiving Kepivance, dysesthesia including hyperesthesia, hypoesthesia, and paresthesia was usually localized to the perioral region, whereas in patients receiving placebo dysesthesias were more likely to occur in extremities.

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

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Are there any special precautions patients should be aware of before starting treatment? For which conditions is this drug approved? The population had a median age of 48 years range: Each single-dose vial of Kepivance contains palifermin 6. Kepivance is the first fdaapproved systemic drug for treating and preventing mucositis from chemotherapy or radiation therapy.

No clastogenic or mutagenic effects of palifermin were observed in mammalian chromosomal aberration or Ames genotoxicity assays. Our drug dictionary is organized by alphabet, including both generic and trade names.

Insret medwatch july safety labeling changes includes Patients should ask their physician about the amount of liquid to consume during a day. The dose intensity inseert this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen. 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.

Kepivance palifermin rationale for inclusion in pa program.

Palifermin

Tongue ineert 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 ,epivance Tongue discoloration Water retention, sudden weight gain Severe pain What is a package insert?

Patients kepiivance inform their physician if they are pregnant, breastfeeding or planning a family in the near future. What is a package insert? Kepivance Rating No reviews – Add your review. Kepivance fda prescribing information, side effects and uses. The Safety Committee attributed the safety finding to Kepivance having been administered within 24 hours of chemotherapy, which resulted in an increased sensitivity of the rapidly dividing epithelial cells in the immediate post-chemotherapy period [see Dosage and Administration 2.

If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration [see Clinical Pharmacology