Patient Information
BONIVA
®
[bon-EE-va] (ibandronate sodium)
TABLETS
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 the end
of this leaflet for “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 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 leaflet 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
•
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
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 drink other
than
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
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 2.5 mg once-daily:
•
Take one BONIVA 2.5 mg
tablet once a day first thing
in
the morning
at least 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 miss 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 miss
a dose, contact your health care provider who
w
ill be able to advise you.
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 morning
of your
chosen day (see “How
should I take BONIVA?”).
What to do if I miss 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
ith
in
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 miss 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 60 m
inutes after you take it.
•
Do not lie
down
for at least 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 (which
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
allergic and
skin
reactions.
Contact your health
care provider if you develop any
symptoms of an
allergic reaction
including
skin rash
(w
ith
or w
ithout blisters), hives, wheezing, or swelling
of
the face, lips, tongue or throat. Get medical help
right
away if you have trouble breathing, swallow
ing
or feel
light-headed.
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, 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
symptoms,
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 thin
•
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
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
Co-promoted
by
Roche Laboratories Inc. and
GlaxoSmithKline
G
laxoSm
ithKline
Research
Triangle
Park, NC 27709
27899611
27899614
Revised: November 2008
Copyright © 2006-2008 by Roche Laboratories Inc.
All rights reserved.
