Download COMMON QUESTIONS ABOUT BUNAVAIL

COMMON
QUESTIONS
ABOUT
BUNAVAIL
A B O U T B U N AVA I L
2
BUNAVAIL.COM
Q
HOW IS BUNAVAIL
DIFFERENT FROM
OTHER BUPRENORPHINE
MEDICATIONS LIKE
SUBOXONE®?
A: B
UNAVAIL contains buprenorphine, the same medicine
found in other medications designed for the treatment of
opioid dependence.
Unlike some medications you may take, BUNAVAIL does
not go under your tongue. It is the only medication that uses
special film technology to stick to the inside of your cheek
to deliver buprenorphine. It’s discreet so no one knows
you’re taking it and you can speak and swallow normally
as it dissolves.
The unique technology in BUNAVAIL includes a backing
layer, which helps to direct medication into your
bloodstream and stop it from flowing back into your
mouth where you might swallow it. In fact, with
BUNAVAIL, you get the same amount of medication
as you do with Suboxone but from a smaller total dose.*
*Relative bioavailability determined with Suboxone tablets.
INDICATION
BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription
medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL
should be used as part of a complete treatment plan to include counseling and
psychosocial support.
Prescription use of this product is limited under the Drug Addiction
Treatment Act (DATA).
A B O U T B U N AVA I L
Q
WHAT IS A
BUCCAL FILM?
A: B
UNAVAIL is called a buccal film because it adheres to
the buccal mucosa. ‘Buccal mucosa’ is a scientific term
for the surface of your cheek inside your mouth. So, rather
than holding BUNAVAIL under your tongue, it sticks to the
inside of your cheek.
BUNAVAIL buccal film is made of two layers: the top
layer and the backing layer. The top layer contains the
dose of buprenorphine. It sticks against the cheek and
begins to deliver medication right away. The backing
layer helps to direct the flow of buprenorphine into your
bloodstream and stops some of it from flowing back
into your mouth where you might swallow it.
BUNAVAIL
buccal film
Top layer
BN4
Backing layer
The two layers in the BUNAVAIL buccal film allow for
a more efficient delivery of medication. In the end, you
get the same effect as you do from Suboxone® from
half the amount of buprenorphine.
As the film dissolves, it will remain fixed to your cheek
so you can speak and swallow normally.
4
BUNAVAIL.COM
Q
THE DOSES OF
BUNAVAIL ARE LESS
THAN WHAT I’M
USED TO GETTING.
DOES THAT MEAN
I’M GETTING LESS
MEDICATION?
A: B
UNAVAIL has about half the overall dose of Suboxone
because its unique route of administration and
two-layer design allows it to deliver buprenorphine
more efficiently. The same amount of buprenorphine
gets into your bloodstream through your cheek
and less flows back into the mouth where it could
be swallowed.
As a result, BUNAVAIL can have a lower dose while
giving you the same amount of buprenorphine
as Suboxone.*
*Relative bioavailability determined with Suboxone tablets.
Please see Important Safety Information, and full
Prescribing Information and Medication Guide
at BUNAVAIL.com.
5
TA K I N G B U N AVA I L
Q
WHICH SIDE OF
THE FILM SHOULD
I PLACE AGAINST
MY CHEEK?
A: The side with the dose strength, eg, BN4, printed on
it should be placed against your cheek. This side is
designed to stick to your cheek when it comes into
contact with moisture and deliver buprenorphine
as it dissolves.
If you place the wrong side of the film against your cheek,
BUNAVAIL will not stick.
6
BUNAVAIL.COM
Q
WHAT SHOULD I
DO IF I CAN’T GET
BUNAVAIL TO STICK
TO MY CHEEK, OR
IT STICKS TO MY
TEETH OR FOLDS
OVER ITSELF?
A: If you encounter any problems while applying BUNAVAIL,
don’t panic. First, readjust the film on your finger and
try to reapply the film to the inside of your cheek. If the
film won’t adhere, properly dispose of it and try again with a
new film. Remember to make sure your mouth is moist.
Try not to get frustrated if your first few attempts at applying
BUNAVAIL feel awkward. You’ll get used to it with some
practice. Try it with the practice films included in your
starter kit. Ask your doctor for more practice films if
you need them.
For more practical advice, watch
the How to Take BUNAVAIL
video on BUNAVAIL.com.
Please see Important Safety Information, and full
Prescribing Information and Medication Guide
at BUNAVAIL.com.
7
TA K I N G B U N AVA I L
8
BUNAVAIL.COM
Q
IS MY FILM SUPPOSED
TO FEEL GUMMY
AFTER IT HAS STARTED
TO DISSOLVE?
A: Some patients say that BUNAVAIL film feels sticky or
gummy as it dissolves. This can be considered normal
and is due to the materials in BUNAVAIL that cause
it to stick to the inside of the cheek and efficiently
deliver buprenorphine into the bloodstream.
9
TA K I N G B U N AVA I L
Q
HOW LONG DOES
BUNAVAIL TAKE TO
DISSOLVE?
A: BUNAVAIL begins to dissolve as soon as it’s placed
against the cheek. The time it takes to dissolve varies
by person. You should leave it in your mouth until it
is fully dissolved.
During this time, you can speak and swallow normally
and interact with others without them knowing you’re
taking your medication.
The BUNAVAIL film is made of two layers, each with a
different thickness. The backing layer is thicker than
the top layer, and since it’s thicker, it will take more
time to dissolve. This design allows the backing layer
to stop some of the buprenorphine from flowing back
into your mouth where it can be swallowed.
10
BUNAVAIL.COM
Q
CAN I EAT AND
DRINK WHILE
TAKING BUNAVAIL?
CAN I SMOKE?
A: You can speak and swallow normally while taking
BUNAVAIL. However, you shouldn’t eat or drink
as that may cause the film to come off your
cheek before it’s fully dissolved.
Do not drink alcohol while using BUNAVAIL,
as this can lead to loss of consciousness or
even death.
There are no restrictions regarding smoking
when taking BUNAVAIL.
Please see Important Safety Information, and full
Prescribing Information and Medication Guide
at BUNAVAIL.com.
11
B U N AVA I L A N D Y O U R T R E AT M E N T
Q
WHERE IS THE RIGHT
PLACE TO PUT
BUNAVAIL?
A: BUNAVAIL should be applied comfortably to the
middle of the inside of your cheek. Once BUNAVAIL
adheres, try not to play with it with your tongue as
this can cause it to move. As you continue to apply
BUNAVAIL, you’ll find a spot that works best for you.
If you are applying more than one film at a time,
make sure you put them on opposite cheeks.
12
BUNAVAIL.COM
Q
HOW LONG DO I HAVE
TO TAKE BUNAVAIL?
A: BUNAVAIL is a maintenance medication. That
means it should be taken on a regular basis for
the treatment of opioid dependence. Work with
your doctor on coming up with a treatment plan
that’s right for you. Make sure you take BUNAVAIL
as prescribed by your doctor.
Q
WHAT SHOULD I
DO IF I STILL HAVE
CRAVINGS OR THINK
I MAY BE EXPERIENCING
WITHDRAWAL SYMPTOMS?
A: Continue to take your medication as prescribed and
call your doctor to discuss your symptoms.
Please see Important Safety Information, and full
Prescribing Information and Medication Guide
at BUNAVAIL.com.
13
B U N AVA I L A N D Y O U R T R E AT M E N T
Q
IS A FILM ON MY
CHEEK GOING TO
IRRITATE MY MOUTH?
A: In a scientific study, 249 people who took Suboxone
switched to BUNAVAIL for 12 weeks. Before they
switched to BUNAVAIL, up to 6.8% of people had oral
abnormalities over 2 examinations. During the 12
weeks of the study, researchers conducted more than
1000 examinations of people’s mouths. They found
that 2.4% of people had an oral abnormality but no
abnormalities were seen in the last 4 weeks of the
study.
If you do have any side effects, call your doctor
right away.
14
BUNAVAIL.COM
Q
ARE THERE ANY
PROGRAMS TO
HELP ME PAY FOR
MY MEDICATION?
A: The BUNAVAIL Savings Program is available to help
eligible patients pay for their medication. Whether
you have commercial insurance or are paying cash
for your medication, the BUNAVAIL Savings Program
can help reduce the cost of your medication.
Visit BunavailSavingsCard.com for more information
and to print a card.
Please see Important Safety Information, and full
Prescribing Information and Medication Guide
at BUNAVAIL.com.
15
INDICATION
BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription medicine
indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used
as part of a complete treatment plan to include counseling and psychosocial support.
Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).
IMPORTANT SAFETY INFORMATION
Keep BUNAVAIL (buprenorphine and
naloxone) buccal film (CIII) out of the
sight and reach of children. Ingestion of
BUNAVAIL by a child may cause severe
breathing problems and death. If a child
takes BUNAVAIL, get emergency help
right away.
Do not take BUNAVAIL if you are allergic
to buprenorphine or naloxone, as serious
negative effects including anaphylactic
shock, have been reported.
Do not take BUNAVAIL before the effects
of other opioids (e.g., heroin, methadone,
oxycodone, morphine) have lessened as
you may experience withdrawal symptoms.
Do not drive, operate heavy machinery,
or perform any other dangerous activities
until you know how BUNAVAIL affects you.
BUNAVAIL contains buprenorphine, an
opioid that can cause physical dependence.
Your doctor can tell you more about the
difference between physical dependence
and drug addiction. Do not stop taking
BUNAVAIL without talking to your doctor.
You could become sick with uncomfortable
withdrawal symptoms because your
body has become used to this medicine.
16
BUNAVAIL.COM
Do not switch from BUNAVAIL to other
medicines that contain buprenorphine
without talking with your doctor. The
amount of buprenorphine in a dose of
BUNAVAIL is not the same as the amount
of buprenorphine in other medicines.
Your doctor will prescribe a dose of
BUNAVAIL that may be different than
other buprenorphine-containing
medicines you may have been taking.
BUNAVAIL can cause serious
life-threatening breathing problems,
overdose and death, particularly when
taken by the intravenous (IV) route in
combination with benzodiazepines,
sedatives, tranquilizers or alcohol. You
should not drink alcohol while taking
BUNAVAIL, as this can lead to loss of
consciousness or even death.
Like other opioids (e.g., heroin, methadone,
oxycodone, morphine), BUNAVAIL may
produce orthostatic hypotension
(‘dizzy spells’) in ambulatory individuals.
Common side effects of BUNAVAIL
include headache, drug withdrawal
syndrome, lethargy (lack of energy),
sweating, constipation, decrease in
sleep (insomnia), fatigue and sleepiness.
Because BUNAVAIL contains naloxone,
injecting BUNAVAIL may cause serious
withdrawal symptoms such as pain,
cramps, vomiting, diarrhea, anxiety,
sleep problems, and cravings.
BUNAVAIL can be abused in a manner
similar to other opioids, legal or illicit.
Keep BUNAVAIL in a safe place. Do not
give your BUNAVAIL to other people, it
can cause them harm or even death.
Selling or giving away this medicine
is against the law.
BUNAVAIL is not recommended in
patients with severe hepatic impairment.
BUNAVAIL may be used with caution
for maintenance treatment in patients
with moderate hepatic impairment.
Before taking BUNAVAIL, tell your doctor
if you are pregnant or plan to become
pregnant. If you become pregnant
while taking BUNAVAIL, tell your doctor
immediately as there may be significant
risks to you and your baby; your baby may
have symptoms of withdrawal at birth.
Before taking BUNAVAIL, talk to your
doctor if you are breast-feeding or plan
to breast-feed your baby. BUNAVAIL can
pass into your breast milk and may harm
your baby. Monitor your baby for increased
sleepiness and breathing problems. Your
doctor should tell you about the best way to
feed your baby if you are taking BUNAVAIL.
This is not a complete list of potential
adverse events associated with BUNAVAIL
buccal film. Please see full Prescribing
Information for a complete list.
To report negative side effects associated
with taking BUNAVAIL buccal film, please
call 1-800-469-0261. You are encouraged
to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or
call 1-800-FDA-1088.
For more information, please see full Prescribing Information and Medication Guide
for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) at www.BUNAVAIL.com.
17
For more information on using
BUNAVAIL correctly, watch the
How to Take BUNAVAIL video at
bunavail.com.
The information provided here is intended only for residents of the United States.
BUNAVAIL® is a registered trademark of BioDelivery Sciences International, Inc.
The BUNAVAIL and buccal film logos and BioDelivery Sciences logo are
trademarks owned by BioDelivery Sciences International, Inc.
All other trademarks and trade names are the property of their respective owners.
© 2016 BioDelivery Sciences International, Inc. All rights reserved. 01/16 BUN-0099.1