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

•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^®.

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

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.
US22RYB01089
April 2023

Important Safety Information