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About: Palifermin (Kepivance®)
Palifermin is a man-made version of a protein, naturally produced by the body, called keratinocyte growth factor (KGF). KGF stimulates the growth of tissues such as: skin and the lining of the mouth, stomach, and intestines. KGF also assists in the repair of the skin and gastrointestinal lining by stimulating cells to grow and develop. Palifermin, like the body’s own KGF, is also able to stimulate these cells to grow and develop.
Mucositis is inflammation of the lining of the mouth and gastrointestinal tract (throat, stomach, and intestines), frequently seen in patients undergoing bone marrow or stem cell transplant. Severe mucositis often includes sores and ulcers in the mouth and GI tract, making it difficult or impossible to eat, drink, talk or swallow. Palifermin is used to decrease the chance of developing severe mucositis or to shorten the duration of severe mucositis in cancer patients receiving chemotherapy and radiation therapy, and undergoing autologous or allogeneic transplant.
Properties and Characteristics of Palifermin
| Drug class | Human keratinocyte growth factors |
| Brand Names | Kepivance |
| Synonyms | 24-163 fibroblast growth factor 7 (human), Palifermin, Palifermina |
| Molecular Formula | C721H1142N202O204S9 |
| Molecular Weight | 16192.7 Da |
| Structural formula of main components |  |
| Pure active ingredient | Recombinant Human Keratinocyte Growth Factor |
| Excretion | Primary route of excretion for Palifermin (Kepivance) is through the kidneys via urine |
| Storage | Lyophilized powder should be stored in its carton and refrigerated at 2° to 8°C (36° to 46°F) |
| Available Forms | Injection, Powder for solution |
| Prescription | Doctor prescription is required |
Palifermin Uses
Palifermin is a medication used in certain medical situations to reduce the risk of severe oral mucositis in patients undergoing high-dose chemotherapy and radiation therapy followed by stem cell transplantation. Here are some key uses of palifermin:
Stem Cell Transplantation: Palifermin is primarily used to prevent and reduce the severity of oral mucositis in patients who are undergoing high-dose chemotherapy and total body irradiation (TBI) followed by stem cell transplantation. This is often done for conditions like leukemia, lymphoma, or other blood-related disorders.
Oral Mucositis Prevention: Oral mucositis is a common side effect of intensive cancer treatments, characterized by painful sores and ulcerations in the mucous membranes of the mouth and throat. Palifermin is used to mitigate the severity and duration of oral mucositis, which can significantly impact a patient’s quality of life and ability to eat and drink.
Hematologic Conditions: Palifermin may also be considered for patients with certain hematologic malignancies (cancers of the blood) who are undergoing aggressive treatment regimens, including high-dose chemotherapy, to help reduce the risk and severity of oral mucositis.
Treatment of Radiation-Induced Oral Mucositis: In some cases, palifermin may be used to manage oral mucositis caused by radiation therapy to the head and neck region when other measures are ineffective or not suitable.
It’s important to note that palifermin is not used for all cancer patients but is specifically indicated for those at high risk of developing severe oral mucositis due to the aggressive nature of their treatment. The medication works by stimulating the growth of cells in the oral mucosa, which can help protect the tissue from the damaging effects of chemotherapy and radiation.
What are side effects of Palifermin (Kepivance)?
Palifermin may cause serious side effects including:
- Hives,
- Difficulty breathing,
- Swelling of your face, lips, tongue, or throat,
- Blurred vision,
- Tunnel vision,
- Eye pain, and
- Seeing halos around lights
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Kepivance include:
- Skin irritation (rash, redness, swelling, itching)
- Burning or tingling sensation in the mouth
- Tongue discoloration
- Tongue thickening
- Changes in taste
- Swelling
- Pain
- Joint pain
- Increases in blood pancreas enzymes
- Increased blood pressure
- Protein in the urine.
Tell your doctor if you have any serious side effects of Kepivance including fever or breathing problems.
Seek medical care at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Mechanism of action
Palifermin has been shown to protect oral and intestinal epithelia from the effects of radiation and chemotherapy, though the exact mechanism is not well understood.1 As a recombinant keratinocyte growth factor (KGF), palifermin may promote cell proliferation, reducing the severity of oral mucositis in patients in the relevant treatment groups.1 Agonism of fibroblast growth factor 2 may be predominantly responsible for this effect.2 The endogenous form if palifermin is expressed in the kidney of rats.
Interaction with other drugs
Palifermin is a medication that is used to help reduce the risk of severe mouth sores in patients undergoing high-dose chemotherapy and stem cell transplant. It works by promoting the growth of cells in the mouth and gut lining. When taking palifermin, it’s important to be aware of potential drug interactions, as these can affect how palifermin works or how other medications are metabolized in the body. Here are some important considerations regarding palifermin interactions with other drugs:
Chemotherapy Drugs: Palifermin is typically used in conjunction with high-dose chemotherapy regimens. It does not interact with chemotherapy drugs in a way that reduces their effectiveness or causes harmful effects. In fact, it is specifically used to help reduce the side effects of chemotherapy.
Immunosuppressive Drugs: Palifermin may interact with immunosuppressive medications, such as corticosteroids or drugs used to prevent graft-versus-host disease (GVHD) after stem cell transplant. These interactions can affect the overall immune response in the body. Healthcare providers will carefully monitor the use of these drugs when palifermin is administered.
Drugs Metabolized by Cytochrome P450 Enzymes: Palifermin does not significantly affect the activity of cytochrome P450 enzymes, which are involved in the metabolism of many drugs. Therefore, it is less likely to have major interactions with medications that are substrates or inhibitors of these enzymes.
Other Growth Factors: Palifermin is a growth factor, and there may be theoretical concerns about potential interactions with other growth factors or cytokines. However, specific interactions of this nature have not been widely reported.
Herbal Supplements and Over-the-Counter Medications: It’s important to inform your healthcare provider about all medications, including herbal supplements and over-the-counter drugs, that you are taking while receiving palifermin. Some of these substances could potentially interact with palifermin or other medications you are receiving.
Inform Your Healthcare Provider: Always communicate openly with your healthcare provider about your medication history and any changes in your medication regimen. They will be able to provide you with specific guidance and monitor for potential interactions.
It’s important to note that drug interactions can be complex, and individual responses may vary. Your healthcare provider will consider your specific medical condition, treatment plan, and medications when assessing the potential for interactions. They can adjust your treatment plan or monitor you closely to ensure your safety and the effectiveness of your treatment. Never stop or adjust your medications without consulting your healthcare provider.
Recommended Dosage
The dosage of Palifermin (brand name Kepivance) is typically determined by your healthcare provider and is based on your individual medical condition and treatment regimen. Palifermin is used to prevent and reduce the severity of oral mucositis in patients undergoing high-dose chemotherapy and radiation therapy followed by stem cell transplantation.
The typical recommended dosage of Palifermin for adults is as follows:
- The recommended dose is 60 mcg per kilogram of body weight per day.
- Palifermin is administered as an intravenous (IV) infusion.
- The infusion is given for three consecutive days before conditioning therapy (chemotherapy and/or radiation) and for three consecutive days after stem cell transplantation.
The exact timing and duration of the treatment may vary depending on your specific treatment plan and the recommendations of your healthcare team. It’s essential to follow your healthcare provider’s instructions regarding the dosage and administration of Palifermin carefully.
Palifermin is typically administered by a healthcare professional in a clinical setting, such as a hospital or infusion center. It’s not something you would take on your own at home.
As with any medication, Palifermin can have potential side effects, and your healthcare team will monitor your condition closely during treatment to ensure your safety and well-being. If you have any questions or concerns about the dosage or administration of Palifermin, be sure to discuss them with your healthcare provider.
Overdose symptoms
Palifermin is typically administered as an intravenous (IV) infusion in a clinical setting under the supervision of healthcare professionals. Since it is administered by healthcare providers, the risk of overdose is minimal under normal circumstances.
However, if for some reason an overdose were to occur, it’s important to seek immediate medical attention. Overdose symptoms can vary, but they may include:
- Increased Risk of Mucositis: Palifermin stimulates the growth of cells in the oral mucosa, and an overdose could potentially lead to an increased risk of oral mucositis or more severe mucositis symptoms.
- Other Adverse Effects: Excessive administration of Palifermin could potentially lead to other adverse effects or complications, although specific overdose symptoms may not be well-defined.
- Systemic Effects: While Palifermin primarily acts locally in the oral mucosa, high doses could potentially lead to systemic effects or interactions with other medications.
It’s crucial to emphasize that Palifermin should only be administered by healthcare professionals who are experienced in its use and who follow the recommended dosing guidelines. Overdose is unlikely to occur when the medication is administered according to the prescribed dosage and under proper medical supervision.
If you suspect an overdose or experience any unusual symptoms or reactions during or after the administration of Palifermin, you should immediately contact your healthcare provider or seek medical attention. They will assess your condition and take appropriate measures to manage any potential complications.
Precautions
There are several precautions and considerations that should be taken into account when using Palifermin:
- Medical Supervision: Palifermin should only be administered by healthcare professionals who are experienced in its use and are familiar with the specific dosing guidelines and treatment protocols. It is typically given in a clinical setting, such as a hospital or infusion center, and not intended for self-administration.
- Risk of Allergic Reactions: Allergic reactions to Palifermin are rare but can occur. Patients should be monitored for any signs of an allergic reaction during and after the infusion, including rash, itching, swelling, dizziness, or difficulty breathing. Any such reactions should be reported to the healthcare team immediately.
- Preexisting Medical Conditions: Patients with a history of serious allergic reactions or other significant medical conditions should inform their healthcare provider before receiving Palifermin. The medication’s safety and suitability may need to be assessed in such cases.
- Concurrent Medications: Inform your healthcare provider about all medications, supplements, and herbal products you are taking. Palifermin is not known to have significant drug interactions, but it’s important to ensure that it won’t interfere with other treatments or medications you may be receiving.
- Pregnancy and Breastfeeding: The safety of Palifermin during pregnancy and breastfeeding has not been established. Patients who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits with their healthcare provider.
- Monitoring and Side Effects: Palifermin is generally well-tolerated, but it can have side effects, including fever, rash, and other less common adverse reactions. Your healthcare team will closely monitor you during treatment and manage any side effects that may arise.
- Oral Hygiene: While Palifermin can help reduce the severity of oral mucositis, it’s important to maintain good oral hygiene practices as recommended by your healthcare provider. This may include regular mouth rinsing and gentle oral care to minimize the risk of infection.
- Follow Medical Advice: Patients should follow their healthcare provider’s instructions regarding the dosing and administration of Palifermin. Do not make any changes to your treatment plan without consulting your healthcare team.
It’s essential to have open and honest communication with your healthcare provider about your medical history, any concerns you may have, and any changes in your health during Palifermin treatment.