Prepare your body for severe
oral mucositis before it starts
Kepivance® has been proven to help decrease the
incidence and duration of severe oral mucositis
Indication
Kepivance® is a prescription medication used
to decrease the incidence and duration of
severe inflammation and ulceration of the
lining of the mouth and throat (mucositis)
in people suffering from cancers of the bone
marrow, while receiving chemotherapy and/
or radiotherapy to prepare the bone marrow
for a stem cell transplant. It is supportive
care for chemotherapy and/or radiation
that is predicted to cause severe mucositis
in the majority of patients. The safety and
effectiveness of Kepivance® have not been
proven in patients suffering from cancers other
than bone marrow cancers. Kepivance® is not
recommended when high dose melphalan is
used as the conditioning regimen.
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Understanding oral mucositis, a
possible side effect of chemotherapy
and radiation therapy
High-dose chemotherapy and/or radiation therapy can be
effective in treating cancers of the bone marrow. The high doses
used can rid the body of cancer cells in the bone marrow. A stem
cell transplant is then performed to put healthy stem cells back
into the bone marrow. Chemotherapy and/or radiation therapy,
however, may also damage some healthy cells in the body,
including cells lining the mouth and the throat—a potentially
painful and debilitating side effect known as oral mucositis. While
the stem cell transplant puts healthy cells back into the bone
marrow, it cannot put healthy cells back into the mouth or throat.
Oral mucositis consists of swelling and ulceration (sores) in the
lining of the mouth and throat. It can cause pain and disability,
ranging from mild to severe.
The World Health Organization (WHO) defines 5 grades of oral mucositis
Patients consider oral mucositis
the most debilitating effect of
chemotherapy and radiation therapy
Severe oral mucositis can lead to complications,
including:
Severe pain
Increased risk of infections
The need for nutrition through an IV
Increased length of hospital stay
In one study, research showed that 98%
of people who received total body irradiation
for bone marrow cancer developed severe
oral mucositis
WHO mucositis scale
Oral mucositis
Grade 0
No evidence
of mucositis
Grade 1
Grade 2
Severe mucositis
Grade 3
Grade 4
Discomfort and
possible redness
Redness, sores
Redness, sores
No sores
Able to swallow
solid food
Not able to
swallow solid
Not able to
swallow solid food food or liquids
Important Safety Information
The safety and effectiveness of Kepivance®
have not been proven in patients suffering from
cancers other than bone marrow cancers. Tumor
growth of cancers other than bone marrow
cancers in cell culture and animal models has
been seen.
Redness, sores
Predicting severe oral mucositis is difficult,
and there’s no way of knowing how severe
it will be if you get it. Kepivance® can be
prescribed by your healthcare professional
as a way to help reduce the effects of severe
oral mucositis. To be effective, Kepivance®
must be administered before you begin your
chemotherapy and/or radiation therapy.
Important Safety Information
In clinical studies, bone marrow recovery
was similar between patients who received
Kepivance® or placebo. There were no differences
seen in cancer progression or patient survival.
Please see accompanying full Prescribing Information.
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Kepivance® has been proven
to decrease the incidence and
duration of severe oral mucositis
Kepivance® is administered intravenously
for 3 consecutive days before and after
treatment—taking approximately
30 seconds to administer
Kepivance® dosing for patients receiving stem cell transplantation*
Before Chemotherapy/
Radiotherapy Treatment
Kepivance® works by building up the lining in your
mouth and throat. The added layers of cells can help
reduce the sores and pain associated with severe
oral mucositis.
In a study among people undergoing total body
irradiation for a stem cell transplant, 63% receiving
Kepivance® developed grade 3 or 4 (severe)
oral mucositis compared to 98% of those not
receiving Kepivance®
In the same study, of people who developed
grade 3 or 4 (severe) oral mucositis while
receiving Kepivance®, it lasted an average
of 3 days compared to 9 days in those not
receiving Kepivance®
Dose 1–
Day 1
Dose 2– Dose 3–
Day 2
Day 3
During Chemotherapy/
Radiotherapy Treatment
At least 4 days
After Chemotherapy/
Radiotherapy Treatment
Dose 4–
After but
on same
day
Dose 5–
1st day
after
Dose 6–
2nd day
after
• The first 3 doses of Kepivance® are usually administered in an outpatient setting
This dosing schedule is important because Kepivance®
needs time to prepare the body for chemotherapy and/or
radiation therapy by building up the lining in the mouth in
order to reduce the effects of severe oral mucositis.
Some of the most common side effects reported in people
receiving Kepivance® were:
Rash
Fever
Itching
Fluid retention
Redness of the skin
Increase of the enzyme
amylase in the blood
Please tell your healthcare professional if you experience rashes,
reddening of the skin, itchiness, swelling of the tongue, changes
in mouth and tongue sensation, and/or alteration in taste.
Important Safety Information
Important Safety Information
Kepivance® is not recommended
when high dose melphalan is
used as the conditioning regimen.
This brochure does not include all possible side effects you
might experience with Kepivance®. Please see accompanying
full Prescribing Information and Important Safety Information
included in this brochure.
Kepivance® should not be administered during the 24 hours
before receiving chemotherapy and/or radiotherapy.
*Dosing schedule represents patients receiving myeloablative therapy.
Please see accompanying full Prescribing Information.
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Frequently Asked Questions
What other drugs will affect Kepivance®?
What information should I tell my healthcare professional
before I start on Kepivance®?
Kepivance® has been shown to interact with heparin.
If heparin is used to maintain your IV line, your IV line
must be rinsed with saline prior to and after Kepivance®
administration.
Before you start receiving Kepivance®, tell your healthcare
professional if you are allergic to other products made from E. coli.
What should I be aware of as I start my treatment
with Kepivance®?
Inform your healthcare professional about any other
medication you may be taking.
The safety and efficacy of Kepivance® have not been proven
in patients with cancers other than bone marrow cancers.
Growth of cancer tumors that are not related to bone marrow
cancer has been seen in laboratory and animal research.
Where can I get more information?
You can call 1-866-773-5274 for more information on
Kepivance® or you can visit www.Kepivance.com.
The most common adverse reactions are rash, fever, increase
of the enzyme amylase in the blood, itching, redness of the
skin and fluid retention.
Where will Kepivance be administered?
®
Kepivance® is given through an IV injection by a trained nurse
or healthcare professional and takes about 30 seconds to
administer. The first 3 doses are usually administered in an
outpatient setting. The last 3 doses are administered inpatient
after completion of your stem cell transplant.
T:9”
Typically, oral mucositis symptoms develop 5 to 8 days following
the administration of chemotherapy or radiation therapy and
last approximately 7 to 14 days. It is important to note that
Kepivance® works as a preventative therapy and needs to be
administered before starting chemotherapy or radiation therapy.
B:9.25”
When does oral mucositis typically appear?
S:8.75”
Please tell your healthcare professional if you experience
rashes and reddening of the skin, itchiness, swelling of
the tongue, changes in mouth and tongue sensation,
or an alteration in taste while taking Kepivance®.
Questions to ask your
healthcare professional
When will I undergo a stem cell transplant?
What kind of stem cell transplant will I be undergoing?
What should I do to prepare for a stem cell transplant?
Will I be undergoing total body irradiation?
How often will I be receiving chemotherapy?
What are some common side effects I should expect with
chemotherapy/radiation therapy?
Will my treatment put me at a high risk for severe oral
mucositis?
What therapies are available to prevent or protect me from
severe oral mucositis?
Please see accompanying full Prescribing Information.
When you can’t predict, prepare. Talk to your
healthcare professional about Kepivance®
and whether it’s right for you.
To learn more about Kepivance®,
please visit www.Kepivance.com.
Indication and Usage
Kepivance® is a prescription medication used to decrease the
incidence and duration of severe inflammation and ulceration of
the lining of the mouth and throat (mucositis) in people suffering
from cancers of the bone marrow, while receiving chemotherapy
and/or radiotherapy regimens to prepare the bone marrow for
a stem cell transplant. It is supportive care for those regimens
predicted to cause severe mucositis in the majority of patients.
The safety and efficacy of Kepivance® have not been proven
in patients with cancers other than bone marrow cancers.
Kepivance® is not recommended when high dose melphalan is
used as the conditioning regimen.
Important Safety Information
The safety and efficacy of Kepivance® have not been proven in
patients with cancers other than bone marrow cancers. Tumor
growth of cancers other than bone marrow cancers in cell culture
and animal models has been seen.
The most common adverse reactions are rash, fever, increase of
the enzyme amylase in the blood, itching, redness of the skin
and fluid retention.
Please tell your healthcare professional if you experience rashes
and reddening of the skin, itchiness, swelling of the tongue,
changes in mouth and tongue sensation, or an alteration in taste
while taking Kepivance®.
Kepivance® has been shown to interact with heparin. If heparin
is used to maintain your IV line, your IV line must be rinsed with
saline prior to and after Kepivance® administration.
Kepivance® should not be administered during the 24 hours
before receiving chemotherapy and/or radiotherapy.
Kepivance is a registered trademark, licensed by Swedish
Orphan Biovitrum AB (publ) and is marketed by Sobi, Inc.
KEP_12819 © 2014 Swedish Orphan Biovitrum. All rights reserved.