Patient Information
B O N I V A ® [bon-EE-va] (ib an d ro n ate so d iu m )
T A B L E T S
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 with your health care provider
about your condition or your treatment. Talk about
BONIVA with 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 swallowing,
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 will not work if you
stop taking it.
Who should not take BONIVA?
Do not take BONIVA if you:
• have low blood calcium (hypocalcemia)
•cannot sit or stand up for at least 60 minutes
• 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 milk and if it can harm your baby
• have swallowing problems or other problems with
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, vitamins
and supplements. Some medicines, especially certain
vitamins, 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 minutes before you eat. drink anything other than
plain water, or take any other oral medicine.
•Take BONIVA with 6 to 8 ounces (about 1 full cup)
of plain water. Do not take it with any drink other
than plain water. Do not take it with other drinks, such
as mineral water, sparkling water, coffee, tea. dairy
drinks (such as milk), 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 minutes 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 vitamins,
calcium, or antacids. Take your vitamins, 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 milk
and call your local poison control center or emergency
room right away. Do not make yourself vomit. Do not
lie down.
• Keep taking BONIVA for as long as your health
care provider tells you. BONIVA will not work if you
stop taking it.
• Your health care provider may tell you to exercise
and take calcium and vitamin 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 minutes 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
will 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 will 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 following 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 within 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 will 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 minutes after you take it.
• Do not lie down for at least 60 minutes 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 with swallowing
•chest pain
•very bad heartburn or heartburn that does not
get better
BONIVA MAY CAUSE:
• pain or trouble swallowing (dysphagia)
• heartburn (esophagitis)
• ulcers in your stomach or esophagus (the tube that
connects your mouth and stomach)
Common side effects with BONIVA are:
•diarrhea
• pain in extremities (arms or legs)
•dyspepsia (upset stomach)
Less common side effects with BONIVA are short-
lasting. mild 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
(with or without blisters), hives, wheezing, or swelling of
the face. lips, tongue or throat. Get medical help right
away if you have trouble breathing, swallowing or feel
light-headed.
Rarely, patients have reported severe bone, joint, and/or
muscle pain starting within one day to several months
after beginning to take, by mouth, bisphosphonate drugs
to treat osteoporosis (thin 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 with delayed healing
and infection, often following 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 with 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 with 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 with 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 following 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 family member with osteoporosis
• do not get enough calcium or vitamin 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 with
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, microcrystalline 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.
Distributed by:
Roche Laboratories Inc.
340 Kingsland Street
Nutley. New Jersey 07110-1199
Co-promoted by Roche Laboratories Inc. and
G la x o S m ith K lin e
GlaxoSmithKline
Research Triangle Park. NC 27709
27899611
27899614
Revised: November 2008
Copyright © 2006-2008 by Roche Laboratories Inc.
All rights reserved.
