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^®?”

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.

•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

Important Safety Information

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.

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

• gallbladder problems. Gallbladder problems have
happened in some people who take RYBELSUS^®. Tell
your healthcare provider right away if you get
symptoms of gallbladder problems, which may
include: pain in your upper stomach (abdomen),
yellowing of skin or eyes (jaundice), fever, and
clay-colored stools

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^®.

Please see Prescribing Information and
Medication Guide.

RYBELSUS^® is a prescription medication.

You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.

RYBELSUS^® is a registered trademark of Novo
Nordisk A/S.

Novo Nordisk is a registered trademark of Novo
Nordisk A/S.

© 2023 Novo Nordisk
All rights reserved.
US22RYB01080
April 2023