liraglutide (rDNA origin) injection
Im portant Patient Inform ation
This is a BRIEF SUM M ARY of im portant inform ation about
Victoza®. This inform ation does not take the place of
talking w ith your doctor about your medical condition or
your treatm ent. If you have any questions about Victoza®,
ask your doctor. Only your doctor can determ ine if
Victoza® is right fo r you.
WARNING
During the drug testing process, the medicine in Victoza®
caused rats and mice to develop tum ors of the thyroid
gland. Some of these tum ors w ere cancers. It is not
know n if Victoza® w ill cause thyroid tum ors or a type of
thyroid cancer called m edullary thyroid cancer (MTC) in
people. If MTC occurs, it m ay lead to death if not detected
and treated early. Do not take Victoza® if you or any of
your fam ily members have MTC, or if you have M ultiple
Endocrine Neoplasia syndrome type 2 (MEN 2). This is
a disease w here people have tum ors in more than one
gland in the body.
W hat is Victoza® used for?
•
Victoza® is a glucagon-like-peptide-1
(GLP-1) receptor
agonist used to improve blood sugar (glucose) control in
adults with type
2
diabetes mellitus, when used with a diet
and exercise program.
•
Victoza® should not be used as the first choice of medicine
for treating diabetes.
•
Victoza® has not been studied in enough people with a
history of pancreatitis (inflammation of the pancreas).
Therefore, it should be used with care in these patients.
•
Victoza® is not for use in people with type 1
diabetes
mellitus or people with diabetic ketoacidosis.
•
It is not known if Victoza® is safe and effective when used
with insulin.
W ho should not use Victoza®?
•
Victoza® should not be used in people with a personal or
family history of MTC or in patients with MEN 2.
W hat is the most im portant inform ation I should know
about Victoza®?
•
In animal studies, Victoza® caused thyroid tumors. The
effects in humans are unknown. People who use Victoza®
should be counseled on the risk of MTC and symptoms of
thyroid cancer.
•
In clinical trials, there were more cases of pancreatitis in
people treated with Victoza® compared to people treated
with other diabetes drugs. If pancreatitis is suspected,
Victoza® and other potentially suspect drugs should
be discontinued. Victoza® should not be restarted if
pancreatitis is confirmed. Victoza® should be used with
caution in people with a history of pancreatitis.
•
Serious low blood sugar (hypoglycemia) may occur when
Victoza® is used with other diabetes medications called
sulfonylureas. This risk can be reduced by lowering the
dose of the sulfonylurea.
•
Like all other diabetes medications, Victoza® has not been
shown to decrease the risk of large blood vessel disease
(i.e. heart attacks and strokes).
W h at are the side effects of Victoza®?
•
Tell your healthcare provider if you get a lump or swelling
in your neck, hoarseness, trouble swallowing, or shortness
of breath while taking Victoza®. These may be symptoms
of thyroid cancer.
•
The most common side effects, reported in at least 5%
of people treated with Victoza® and occurring more
commonly than people treated with a placebo (a non-
active injection used to study drugs in clinical trials) are
headache, nausea, diarrhea, and resistance to liraglutide
(antibody formation).
•
Immune system related reactions, including hives, were
more common in people treated with Victoza® (0.8% )
compared to people treated with other diabetes drugs
(0.4% ) in clinical trials.
•
This listing of side effects is not complete. Your health care
professional can discuss with you a more complete list of
side effects that may occur when using Victoza®.
W h at should I know about taking Victoza® w ith other
medications?
•
Victoza® slows emptying of your stomach. This may impact
how your body absorbs other drugs that are taken by
mouth at the same time.
Can Victoza® be used in children?
•
Victoza® has not been studied in people below 18 years of
age.
Can Victoza® be used in people w ith kidney or liver
problems?
•
There is limited data on using Victoza® in people with
kidney or liver problems. Victoza® should be used with
caution in these types of people.
Still have questions?
This is only a summary of important information. Ask your
doctor for more complete product information, or
•
call 1-877-4VICTOZA (1-877-484-2869)
•
visit victoza.com
V i c t o z a
®
i s a r e g i s t e r e d t r a d e m a r k o f
N o v o N o r d i s k A / S .
Date of Issue: Jan 2010
Version 1
© 2010 Novo Nordisk A/S.
141826
June 2010
novo nordisk
