Patient Information
BONIVA
® [bon-EE-va] (ibandronate sodium)
TA BLETS
Rx only
Read this patient information carefully before you
start taking BONIVA. Read this patient information
each time you get a refill for BONIVA. There may be
new
information. This information is not everything
you need to
know
about BONIVA. It does not take
the place of talking w
ith
your health care provider
about your condition or your treatment. Talk about
BONIVA w
ith
your health care provider before you
start taking it, and at your regular check-ups.
What is the most important information
I should know
about BONIVA?
BONIVA may cause serious problems in
the stomach
and the esophagus (the tube that connects your
mouth
and stomach) such as trouble swallow
ing,
heartburn, and ulcers (see “What are the possible
side effects of BONIVA?”).
You must take BONIVA exactly as prescribed for
BONIVA to work for you and to
lower the chance
of serious side effects (see “How
should I take
BONIVA?”).
What is BONIVA?
BONIVA is a prescription medicine used to
treat or
prevent osteoporosis in
women after menopause
(see “What is osteoporosis?”).
BONIVA may reverse bone loss by stopping more
loss of bone and increasing bone mass in
most
women who
take it, even though they won't be able
to
see or feel a difference. BONIVA may help lower
the chances of breaking bones (fractures).
For BONIVA to
treat or prevent osteoporosis, you have
to
take it as prescribed. BONIVA w
ill not work if you
stop taking it.
Who should not take BONIVA?
Do not take BONIVA if you:
•
have low
blood
calcium
(hypocalcem
ia)
•
cannot sit or stand up
for at least 1 hour
(60
m
inutes)
•
have kidneys that work very poorly
•
are allergic to
ibandronate sodium
or any of the other
ingredients of BONIVA (see the end of this Patient
Information for a list of all the ingredients in
BONIVA)
Tell your health care provider before using BONIVA:
•
if you are pregnant or planning to
become pregnant. It
is not known
if BONIVA can harm
your unborn baby
•
if you are breast-feeding. It is not known
if BONIVA
passes into
your m
ilk and if it can harm
your baby
•
if you have swallow
ing problems or other problems w
ith
your esophagus (the tube that connects your mouth
and stomach)
•
if you have kidney problems
•
if you are planning a dental procedure such as tooth
extraction
Tell your health care provider (including your
dentist) about all the medicines you take including
prescription and non-prescription medicines, vitam
ins,
and supplements. Some medicines, especially certain
vitam
ins, supplements, and antacids can stop BONIVA
from
getting
to
your bones. This can happen if you take
other medicines too
close to
the time that you take
BONIVA (see “How
should I take BONIVA?”).
How
should I take BONIVA?
•
Take BONIVA exactly as instructed by your health
care provider.
•
Take BONIVA first thing in
the morning at least
1
hour
(60
m
inutes) before you eat, drink anything other than
plain water, or take any other oral medicine.
•
Take BONIVA w
ith
6
to
8
ounces (about
1
full cup)
of plain water. Do not take it w
ith
any other drink
besides plain water. Do not take it w
ith
other drinks,
such as m
ineral water, sparkling water, coffee, tea,
dairy drinks (such as m
ilk), or juice.
•
Swallow
BONIVA whole. Do not chew
or suck the
tablet or keep it in
your mouth
to
melt or dissolve.
•
After taking BONIVA you must wait at least
1
hour
(60
m
inutes) before:
- Lying down. You may sit, stand, or do normal
activities like read the newspaper or take a walk.
- Eating or drinking anything except for plain water.
- Taking other oral medicines including vitam
ins,
calcium
, or antacids. Take your vitam
ins, calcium
,
and antacids at a different time of the day from
the
time when you take BONIVA.
•
If you take too
much BONIVA, drink a full glass of m
ilk
and call your local poison control center or emergency
room
right away. Do not make yourself vom
it. Do not
lie down.
•
Keep taking BONIVA for as long as your health
care provider tells you. BONIVA w
ill not work if you
stop
taking it.
•
Your health care provider may tell you to
exercise
and take calcium
and vitam
in supplements to
help
your osteoporosis.
•
Your health care provider may do
a test to
measure
the thickness (density) of your bones or do
other
tests to
check your progress.
What is my BONIVA schedule?
Schedule for taking BONIVA
150
mg once monthly:
•
Take one BONIVA
150
-mg tablet once a month.
•
Choose one date of the month
(your BONIVA day)
that you w
ill remember and that best fits your
schedule to
take your BONIVA
150
-mg tablet.
•
Take one BONIVA
150
-mg tablet in
the morn
ing of your
chosen day (see “How
should I take BONIVA?”).
What to do if I m
iss a monthly dose:
•
If your next scheduled BONIVA day is more than
7
days away, take one BONIVA
150
-mg tablet in
the
morning follow
ing the day that you remember (see
“How
should I take BONIVA?”). Then return
to
taking one BONIVA
150
-mg tablet every month
in
the morning of your chosen day, according to
your
original schedule.
•
Do not take two
150
-mg tablets w
ithin
the same week.
If your next scheduled BONIVA day is only
1
to
7
days
away, wait until your next scheduled BONIVA day to
take your tablet. Then return to
taking one BONIVA
150
-mg tablet every month
in
the morning of your
chosen day, according to
your original schedule.
•
If you are not sure what to do if you m
iss
a dose, contact your health care provider who
w
ill be able to advise you.
Schedule for taking BONIVA
2.5
mg once daily:
•
Take one BONIVA
2
.
5
-mg tablet once a day first thing in
the morn
ing
at least 1 hour
(60
m
inutes) before you eat,
drink anything other than
plain water, or take any other
oral medicine (see “How
should I take BONIVA?”).
What to do if I m
iss a daily dose:
•
If you forget to
take your BONIVA
2
.
5
-mg tablet in
the
morning, do not take it later in
the day. Just return
to
your normal schedule and take 1 tablet the next
morning. Do not take two
tablets on
the same day.
•
If you are not sure what to do if you m
iss
a dose, contact your health care provider who
w
ill be able to
advise you.
What should I avoid while taking BONIVA?
•
Do
not take other medicines, or eat or drink anything
but plain water before you take BONIVA and for at
least 1 hour
(60
m
inutes) after you take it.
•
Do
not lie down for at least
1
hour
(60
m
inutes)
after you take BONIVA.
What are the possible side effects of BONIVA?
Stop taking BONIVA and call your health care
provider right away if you have:
•
pain or trouble w
ith swallow
ing
•
chest pain
•
very bad heartburn or heartburn that does not
get better
BONIVA MAY CAUSE:
•
pain or trouble swallow
ing (dysphagia)
•
heartburn (esophagitis)
•
ulcers in
your stomach or esophagus (the tube that
connects your mouth
and stomach)
Common side effects w
ith
BONIVA are:
•
diarrhea
•
pain in
extrem
ities (arms or legs)
•
dyspepsia (upset stomach)
Less common side effects w
ith
BONIVA are short-
lasting, m
ild
flu-like symptoms (usually improve after
the first dose). These are not all the possible side
effects of BONIVA. For more information ask your
health care provider or pharmacist.
Rarely, patients have reported
severe bone, jo
int, and/or
muscle pain starting w
ith
in
one day to
several months
after beginning to
take, by mouth, bisphosphonate drugs
to
treat osteoporosis (th
in
bones). This group
of drugs
includes BONIVA. Most patients experienced relief after
stopping the drug. Contact your health care provider if
you develop these symptoms after starting BONIVA.
Rarely, patients taking bisphosphonates have reported
serious jaw
problems associated w
ith
delayed healing
and infection, often follow
ing dental procedures such
as tooth
extraction. If you experience jaw
problems,
please contact your health care provider and dentist.
What is osteoporosis?
Osteoporosis is a disease that causes bones to
become
thinner. Thin bones can break easily. Most people think
of their bones as being solid like a rock. Actually, bone is
living tissue, just like other parts of the body, such as
your heart, brain, or skin. Bone just happens to
be a
harder type of tissue. Bone is always changing. Your
body keeps your bones strong and healthy by replacing
old
bone w
ith
new
bone.
Osteoporosis causes the body to
remove more bone
than it replaces. This means that bones get weaker.
Weak bones are more likely to
break. Osteoporosis
is a bone disease that is quite common in
women
after menopause. At first, osteoporosis has no
symp-
toms, but people w
ith
osteoporosis may develop loss of
height and are more likely to
break (fracture) their
bones, especially the back (spine), wrist, and hip
bones.
Osteoporosis can be prevented, and w
ith
proper
therapy it can be treated.
Who is at risk for osteoporosis?
Talk to
your health care provider about your chances
for getting osteoporosis.
Many things put people at risk for osteoporosis.
The follow
ing people have a higher chance of
getting osteoporosis:
Women who:
•
are going through or who
are past menopause
(“the change”)
•
are white (Caucasian) or Asian
People who:
•
are th
in
•
have a fam
ily member w
ith
osteoporosis
•
do
not get enough calcium
or vitam
in D
•
do
not exercise
•
smoke
•
drink alcohol often
•
take bone thinning medicines
(like prednisone) for a long time
General information about BONIVA
Medicines are sometimes prescribed for conditions that
are not mentioned in
patient information. Do not use
BONIVA for a condition for which it was not prescribed.
Do not give BONIVA to
other people, even if they have
the same symptoms you have. It may harm
them
.
Store BONIVA at
77
°F (
25
°C) or at room
temperature
between
59
°F and 86°F (
15
°C and
30
°C).
Keep BONIVA and all medicines out of the reach of
children.
This summarizes the most important information about
BONIVA. If you would
like more information, talk w
ith
your health care provider. You can ask your health care
provider or pharmacist for information about BONIVA
that is written
for health professionals.
For more information about BONIVA, call
1
-
888
-MY-BONIVA or visit www
.myboniva.com
.
What are the ingredients of BONIVA?
BONIVA (active ingredient): ibandronate sodium
BONIVA (inactive ingredients): lactose monohydrate,
povidone, m
icrocrystalline cellulose, crospovidone,
purified stearic acid, colloidal silicon dioxide, and
purified water. The tablet film
coating contains
hypromellose, titanium
dioxide, talc, polyethylene
glycol
6000
and purified water.
BONIVA is a registered trademark of Roche
Therapeutics Inc.
D
istributed by:
Roche Laboratories Inc
340
Kingsland Street
Nutley, New
Jersey
07110-1199
www
.rocheusa.com
Co-promoted by:
GlaxoSmithKline
GlaxoSm
ithKline
Research Triangle Park, NC
27709
www
.gsk.com
27899375
Revised: March
2007
Copyright
©2007
by Roche Laboratories Inc.
All rights reserved.
