What is the most important
information I should know
about RYBELSUS®?
RYBELSUS® may cause
serious side effects,
including:
•Possible thyroid tumors,
including cancer. Tell your
healthcare provider if you
get a lump or swelling in
your neck, hoarseness,
trouble swallowing, or
shortness of breath. These
may be symptoms of thyroid
cancer. In studies with
rodents, RYBELSUS® and
medicines that work like
RYBELSUS® caused thyroid
tumors, including thyroid
cancer. It is not known if
RYBELSUS® will cause
thyroid tumors or a type of
thyroid cancer called
medullary thyroid carcinoma
(MTC) in people
Do not use RYBELSUS® if:
•you or any of your family
have ever had MTC, or if you
have an endocrine system
condition called Multiple
Endocrine Neoplasia
syndrome type 2 (MEN 2)
•you have had a serious
allergic reaction to
semaglutide or any of the
ingredients in RYBELSUS®.
See symptoms of serious
allergic reaction in “What
are the possible side
effects of RYBELSUS®?”
Before using RYBELSUS®,
tell your healthcare
provider if you have any
other medical conditions,
including if you:
•have or have had problems
with your pancreas or
kidneys
•have a history of vision
problems related to your
diabetes
•are pregnant or plan to
become pregnant. It is not
known if RYBELSUS® will
harm your unborn baby. You
should stop using
RYBELSUS® 2 months before
you plan to become
pregnant. Talk to your
healthcare provider about
the best way to control your
blood sugar if you plan to
become pregnant or while
you are pregnant
•are breastfeeding or plan to
breastfeed. Breastfeeding is
not recommended during
treatment with RYBELSUS®
Tell your healthcare
provider about all the
medicines you take,
including prescription and
over-the-counter medicines,
vitamins, and herbal
supplements. RYBELSUS® may
affect the way some
medicines work and some
medicines may affect the way
RYBELSUS® works.
How should I take
RYBELSUS®?
•Take RYBELSUS® exactly as
your healthcare provider
tells you to
•Take RYBELSUS® by mouth
on an empty stomach when
you first wake up with a sip
of plain water (no more than
4 ounces)
•Do not split, crush, or chew.
Swallow RYBELSUS® whole
•After 30 minutes, you can
eat, drink, or take other oral
medicines
•If you miss a dose of
RYBELSUS®, skip the missed
dose and go back to your
regular schedule
What are the possible side
effects of RYBELSUS®?
RYBELSUS® may cause
serious side effects,
including:
•inflammation of your
pancreas (pancreatitis).
Stop using RYBELSUS® and
call your healthcare provider
right away if you have severe
pain in your stomach area
(abdomen) that will not go
away, with or without
vomiting. You may feel the
pain from your abdomen to
your back
•changes in vision. Tell your
healthcare provider if you
have changes in vision
during treatment with
RYBELSUS®
•low blood sugar
(hypoglycemia). Your risk
for getting low blood sugar
may be higher if you use
RYBELSUS® with another
medicine that can cause low
blood sugar, such as a
sulfonylurea or insulin.
Signs and symptoms of
low blood sugar may
include: dizziness or
lightheadedness, blurred
vision, anxiety, irritability or
mood changes, sweating,
slurred speech, hunger,
confusion or drowsiness,
shakiness, weakness,
headache, fast heartbeat,
and feeling jittery
•kidney problems (kidney
failure). In people who have
kidney problems, diarrhea,
nausea, and vomiting may
cause a loss of fluids
(dehydration), which may
cause kidney problems to
get worse. It is important for
you to drink fluids to help
reduce your chance of
dehydration
•serious allergic reactions.
Stop using RYBELSUS® and
get medical help right away,
if you have any symptoms of
a serious allergic reaction,
including swelling of your
face, lips, tongue, or throat;
problems breathing or
swallowing; severe rash or
itching; fainting or feeling
dizzy; or very rapid
heartbeat
The most common side
effects of RYBELSUS® may
include nausea, stomach
(abdominal) pain, diarrhea,
decreased appetite, vomiting,
and constipation. Nausea,
vomiting, and diarrhea are
most common when you first
start RYBELSUS®.
What is RYBELSUS®?
RYBELSUS® (semaglutide)
tablets 7 mg or 14 mg is a
prescription medicine used
along with diet and exercise
to improve blood sugar
(glucose) in adults with type 2
diabetes.
•RYBELSUS® is not
recommended as the first
choice of medicine for
treating diabetes
•It is not known if RYBELSUS®
can be used in people who
have had pancreatitis
•RYBELSUS® is not for use in
people with type 1 diabetes
•It is not known if RYBELSUS®
is safe and effective for use
in children under 18 years of
age
RYBELSUS® is a registered
trademark of
Novo Nordisk A/S.
Novo Nordisk is a registered
trademark of
Novo Nordisk A/S.
© 2021 Novo Nordisk
All rights reserved.
US21RYB00695
November 2021