Kepivance (palifermin) is the first and only approved medication used to help with serious mouth sores in people with blood cancer going through high-dose chemotherapy given before a stem cell (bone marrow) transplant. This medication is injected into a vein by a healthcare provider. Common side effects of Kepivance (palifermin) include skin reactions, such as rash, itching, and redness.
To lower occurrence and length of time of having severe mouth sores in people with blood cancer receiving high-dose anticancer treatments and a stem cell transplant
Kepivance (palifermin) is a chemoprotective agent, or a medication that protects your cells from the effects of chemotherapy. It's a lab-made version of a human protein called keratinocyte growth factor (KGF). Human KGF attaches to certain cells in the lining of different body parts, such as the mouth, stomach, and intestines. When it's attached, it helps these healthy cells grow and protects them from damage. In doing so, Kepivance (palifermin) can reduce harm to mouth tissue caused by certain anticancer treatments.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Rare
Skin rash (severe)
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Bad, unusual, or unpleasant (after) taste
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in taste
difficulty with moving
discoloration of the tongue
dizziness
flushing or redness of the skin
headache
increased sensitivity to pain
increased sensitivity to touch
itching skin
muscle pain or stiffness
nervousness
pain in the joints
pounding in the ears
rash (mild)
slow or fast heartbeat
swelling
thickening of the tongue
tingling in the hands and feet
unusually warm skin
Incidence not known
redness or swelling of the vagina
redness, swelling, or pain of the skin
scaling of the skin on the hands and feet
ulceration of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Doesn't interact with many medications
Can use in children and adults
The first FDA-approved medication of its kind
Can commonly cause skin reactions (e.g., rash, itching, redness)
Only available as an injection through the vein
Not recommended while breastfeeding
You'll typically receive Kepivance (palifermin) at a hospital or an infusion center. This medication needs to be given by a healthcare provider who's trained to use the proper tools and techniques to prepare and give the medication safely.
Most commonly, you'll finish the first 3 doses of Kepivance (palifermin) at least 24 hours before your anticancer treatment and then start your last 3 doses at least 24 hours after your anticancer treatment. Receiving this medication within 24 hours of chemotherapy can sometimes worsen your mouth sores.
Tell your provider if you experience any changes in weight during the period of time you're receiving Kepivance (palifermin). Your dose depends on your weight. So if there are changes to your weight, your dose might need to be changed. Let your provider know if you have nausea, vomiting, or diarrhea that won’t go away since this can affect your weight.
If you're getting high-dose Evomela (melphalan) as preparation for your transplant for your blood cancer, Kepivance (palifermin) might not work well to help with mouth sores. If this is the case for you, talk to your provider to see what the best option for mouth sores is for you.
This medication is an intravenous (IV) injection that's administered by a healthcare provider. Your provider will calculate the dose based on your body weight each time you receive treatment. In general, the typical dose is 60 mcg/kg of body weight injected into a vein once a day.
Kepivance (palifermin) treatment is made up of 6 doses. The first 3 doses are given as one dose once a day for 3 days in a row before you receive chemotherapy. The last 3 doses are given after you complete chemotherapy as one dose once a day for 3 days in a row, starting on the day of your stem cell transplant.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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American Cancer Society. (n.d.). Stem cell or bone marrow transplant.
American Cancer Society. (2021). Mouth sores and pain.
American Cancer Society. (2023). Types of stem cell and bone marrow transplants.
Amgen, Inc. (2004). FDA approves Kepivance for severe oral mucositis in cancer patients undergoing bone marrow transplant; pivotal phase 3 study published in this week's New England Journal of Medicine. Business Wire.
Lauritano, D., et al. (2014). Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: A case-control study. International Journal of Oral Science.
National Cancer Institute. (n.d.). Autologous stem cell transplant.
National Cancer Institute. (n.d.). Palifermin.
Swedish Orphan Biovitrum AB (publ). (2023). Kepivance- palifermin injection, powder, lyophilized, for solution [package insert]. DailyMed.
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