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palifermin |
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palifermin Kepivance Pharmacologic class: Keratinocyte growth factor (KGF) (rDNA origin) Therapeutic class: Biologic and immunologic agent Pregnancy risk category C ActionProduced by recombinant DNA technology in Escherichia coli; binds to KGF receptor on cell surface, resulting in epithelial cell proliferation, differentiation, and migration AvailabilityPowder for injection (lyophilized): 6.25 mg in single-use vials ⊘Indications and dosages ➣ To decrease incidence and duration of severe oral mucositis in patients with hematologic malignancies who are receiving myelotoxic therapy requiring hematopoietic stem cell support Adults: 60 mcg/kg/day I.V. bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of six doses. Give first three doses before myelotoxic therapy, with third dose given 24 to 48 hours before such therapy. Administer last three doses after myelotoxic therapy, with first of these given after (but on same day of) hematopoietic stem cell infusion and at least 4 days after most recent palifermin dose. Contraindications• Hypersensitivity to drug, its components, or E. coli-derived proteins PrecautionsUse cautiously in: Administration• Reconstitute powder with 1.2 ml sterile water for injection to yield final concentration of 5 mg/ml.
Adverse reactionsCNS: dysesthesia CV: hypertension EENT: tongue discoloration or thickening Musculoskeletal: pain, arthralgias Skin: rash, pruritus, skin toxicities, erythema Other: altered taste, edema, fever InteractionsDrug-drug. Heparin: possible binding Drug-diagnostic tests. Amylase, lipase: increased Patient monitoring• Monitor serum amylase and lipase levels frequently. Patient teaching• Instruct patient to report adverse reactions, including rash, itching, skin redness, swelling, discolored tongue, and altered taste. How to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit webmaster's page for free fun content. |
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| In Lacey's earlier role as Amgen's director of pathology, he initiated the clinical studies of palifermin, now marketed as Kepivance, the first product of its type to treat painful mouth sores known as oral mucositis that often afflict patients with mouth cancers. Thousand Oaks, CA, announced the US Food and Drug Administration (FDA) has approved Kepivance (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. Kineret, Kepivance and Stemgen generated combined sales of nearly $70 million in 2007. |
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