Kepivance
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.
What is Kepivance (palifermin)?
What is Kepivance (palifermin) used for?
- 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
How Kepivance (palifermin) works
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.
Drug facts
Side effects of Kepivance (palifermin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Rash (62%)
- Fever (39%)
- Itching (35%)
- Skin redness (32%)
- Swelling (28%)
Less Common Side Effects
- Changes in mouth or tongue color or thickness
- Changes in taste
- Changes in skin sensitivity
- General pain
- Joint pain
- Cataracts (blurry or cloudy vision, seeing faded colors)
The following Kepivance (palifermin) side effects have also been reported
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.
Pros and cons of Kepivance (palifermin)
Pros
- Doesn't interact with many medications
- Can use in children and adults
- The first FDA-approved medication of its kind
Cons
- Can commonly cause skin reactions (e.g., rash, itching, redness)
- Only available as an injection through the vein
- Not recommended while breastfeeding
Pharmacist tips for Kepivance (palifermin)
- 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.
Common questions about Kepivance (palifermin)
A clinical study looked at how well Kepivance (palifermin) worked for severe mouth sores in people with blood cancer going through certain high-dose anticancer treatments (chemotherapy and radiation) and a stem cell transplant. Results showed that 63% of people who took Kepivance (palifermin) had severe mouth sores compared to 98% of people who took a placebo. If you experience mouth sores at any point in your cancer treatment, eating soft foods that are easy to swallow or chilled foods that numb your mouth (e.g., popsicles, ice chips) can help. Avoid fizzy drinks or very spicy, salty, or sugary foods to prevent further mouth irritation. Follow up with your provider about whether Kepivance (palifermin) can help with your mouth sores or for recommendations on how to manage them.
Currently, Kepivance (palifermin) is only FDA approved to lower the number of severe mouth sores and how long they last in people with blood cancer getting high-dose chemotherapy and undergoing a stem cell transplant. It's not known whether this medication is safe or works well for people with other cancers. Some studies showed that Kepivance (palifermin) might cause certain tumors to grow faster in the lab. There are some treatments available to manage severe mouth sores(), each with its own safety risks. Discuss with your provider to see what the best option is for you for mouth sores from chemotherapy.
There are two types of stem cell transplants: autologous (using stem cells coming from the same person who has the cancer) and allogeneic (using stem cells coming from another donor). Currently, studies show that Kepivance (palifermin) can work to lower the occurrence of severe mouth sores in people with blood cancer who are preparing for the autologous type of stem cell transplant. In fact, one study showed that people who got an allogeneic stem cell transplant and received this medication were more likely to have severe mouth sores than those who received placebo. If you have questions regarding whether Kepivance (palifermin) is right for you, talk to your provider.
If you’re pregnant, planning on becoming pregnant, or breastfeeding, talk to your provider about the risks of using Kepivance (palifermin). There isn't enough information to know if Kepivance (palifermin) is safe in human pregnancy. But animal studies showed that it can cause serious and life-threatening harm to unborn babies, such as growth problems. Similarly, it's not clear whether Kepivance (palifermin) is safe to use while breastfeeding. Because of the potential risks to breastfed babies, it's recommended that you don't breastfeed your baby during treatment and for at least 2 weeks after the last dose of medication. Discuss with your provider about safe options for you and your baby.
The effect of Kepivance (palifermin) on human fertility (the ability to have children) hasn't been studied. But animal studies showed that this medication lowered the ability of female and male rats to have babies. While animal studies don’t always represent what happens in humans, it’s possible that Kepivance (palifermin) might lower your ability to have children as well. If you plan to have children, please talk with your provider about the benefits and risks of taking this medication.
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Kepivance (palifermin) dosage
Typical dosage for Kepivance (palifermin)
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.
Interactions between Kepivance (palifermin) and other drugs
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.
- Heparin