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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Kepivance is a water soluble, amino acid protein with a. To view content sources and attributions, please refer to our editorial policy. In vitro and in vivo data showed that palifermin interacts with unfractionated as well as low molecular weight heparins with no noticeable effect on the pharmacodynamics of either drug. 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 clinical trials of another drug and may not reflect the rates observed in clinical practice.
Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support [See Clinical Studies 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 effect of palifermin on chemotherapyand radiation. See Clinical Studies [ Specific treatment for colon cancer is based on the stage and genomic profile of each persons unique colon cancer. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see Drug Interactions 7 ]. Palifermin is embryotoxic in rabbits and rats.
After completion of the phase iii clinical study, aesgen, inc.
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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. The dose intensity of this preparative regimen is comparable to the dose intensity of the Study 1 preparative regimen. Kepivance is a watersoluble, amino acid protein with a molecular weight of Subscribe to receive email notifications whenever new articles are published. For these reasons, comparison of the incidence of antibodies to Kepivance with the incidence of antibodies to other products may be misleading.
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. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to. Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth.
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. Tongue thickening 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 abnormalities Tongue discoloration Water retention, sudden weight gain Severe pain What is a package insert? By submitting your email, you are opting in to receiving information from healthcom media and affiliates.
The researchers concluded that single-dose Kepivance prior to chemotherapy in sarcoma patients effectively reduced mucositis incidence as well as severity. Request pdf on researchgate palifermin kepivance for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support objective.
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.
By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
There were no significant differences between either of the Kepivance regimens and the placebo arm in the incidence of severe oral mucositis. Pregnant rabbits received intravenous palifermin during organogenesis at doses equivalent to 1. Because many drugs 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 drug, taking into account the importance of the drug to the mother.
Drink plenty of fluids.
Study 2 was a randomized, multi-center, placebo-controlled trial comparing varying schedules of Kepivance. Patients kepivancd have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician. The elimination half-life was similar between healthy subjects and iinsert patients average 4. Inesrt package insert is required by the FDA and contains kepivznce summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.
Kepivance palifermin description kepivance palifermin is a human keratinocyte growth factor kgf produced by recombinant dna technology in escherichia coli e coli. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth.
If you do not pzckage the package insert for the drug you are using, your pharmacist or physician may be able to provide knsert with a copy. Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to help protect patients with hematologic malignancies undergoing highdose chemotherapy andor radiation followed by autologous bone marrow transplant from severe oral mucositis.
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. Kepivance is a water soluble, amino acid protein with a molecular weight of Clinical studies of Kepivance did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently from younger subjects.
Information on the dosing and safety of Kepivance in the pediatric population is limited.
The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity. Part 4 of this fourpart ppackage on cancer pain will discuss painful complications of chemotherapy andor radiation therapy. Treatment of cutaneous tcell lymphoma ctcl in patients who have received at least one prior systemic therapy. J oncol pharm practice successful use of palifermin following.
Kepivance – FDA prescribing information, side effects and uses
Other analyses included the incidence, duration, and severity of oral mucositis and the use of opioid analgesia. The information provided above on the drug you have selected is provided for your information only and is insfrt a substitute for consultation with an appropriate medical doctor.
Kepivance exhibited linear pharmacokinetics with extravascular distribution. As with any printed reference, the use of particular drugs, regimens and drug dosages lnsert become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.