Frequently Asked Questions About Kepivance™ (Palifermin)
Class: Supportive care
Generic Name: Palifermin (pa-li-FER-min)
Trade Name: Kepivance™
For which conditions is Kepivance approved for? Kepivance 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. Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth. 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. Patients who 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.
What is the mechanism of action? Kepivance belongs to a class of drugs called growth factors. Kepivance stimulates cells, called epithelial cells, to grow and divide. Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis.
How is Kepivance typically given (administered)? Kepivance is administered intravenously (into a vein) and the dose depends on the size or weight of the patient. Kepivance is given in 3 doses prior to therapy and 3 doses following therapy. Kepivance should not be administered within 24 hours of chemotherapy administration.
How are patients monitored? Patients will undergo assessments for oral mucositis. This may include the physical examination of the mouth, lips, gums, and tongue, as well as questions posed to the patient regarding pain, ability to swallow, ability to eat and drink, etc.
What are the most common side effects associated with treatment with Kepivance?
- Rash/Skin irritation
- Altered taste
- Water retention
- Mouth or tongue thickness or discoloration
- High blood pressure
- Abnormal sensations related to the nervous system
- Muscle aches
- Changes in laboratory results regarding the digestive system
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician if they have high blood pressure.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.), as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
- 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? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may 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. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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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.