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Important safety information

Important Safety Information for Wegovy (semaglutide) injection

Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is not known if Wegovy will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your 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.

• Do not use Wegovy if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Wegovy?

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

• 30 kg/m2 or greater (obesity) or

• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use:

• Wegovy should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist

• The safety and efficacy of coadministration with other products for weight loss have not been established

• Wegovy has not been studied in patients with a history of pancreatitis

Who should not use Wegovy?

Do not use Wegovy if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You have a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).

How should Wegovy be administered?

You can take Wegovy with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Ro-affiliated provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking Wegovy as prescribed without discussing with your provider first.

What should I tell my Ro-affiliated provider before using Wegovy?

• Wegovy has certain drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)

• Wegovy causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.

• Other GLP-1 medications, including Ozempic, Saxenda, Victoza, Byetta, or Bydureon

• If you’re using other products for weight loss, including dietary supplements

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes

• Thyroid cancer

• Pancreatitis

• Kidney disease

• Diabetic retinopathy

• Depression

• Suicidal thoughts or behavior

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

• If you are pregnant: Wegovy should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Wegovy during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

• If you are a female or male of reproductive potential: Discontinue Wegovy at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

• If you are breastfeeding: Wegovy was found in the milk of lactating rats. Tell your Ro-affiliated provider if you are breastfeeding before you start Wegovy.

Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Wegovy and Ozempic) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking Wegovy?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Wegovy. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Wegovy causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Wegovy is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your 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.

• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

• Acute Gallbladder Disease: Wegovy may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

• Low Blood Sugar (hypoglycemia): Wegovy lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

• Acute Kidney Injury: 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 plenty of water to help reduce your chance of dehydration.

• Serious Allergic Reactions: Stop using Wegovy right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects of Wegovy?

• Nausea

• Diarrhea

• Vomiting

• Constipation

• Abdominal pain

• Headache

• Fatigue

• Dyspepsia

• Dizziness

• Abdominal distension

• Eructation

• Hypoglycemia in patients with type 2 diabetes

• Flatulence

• Gastroenteritis

• Gastroesophageal reflux disease

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891

• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

 

Important Safety Information for Ozempic (semaglutide) injection

Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide (the active ingredient in Ozempic and Wegovy) caused thyroid tumors, including thyroid cancer. It is not known if Ozempic will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your 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.

• Do not use Ozempic if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Ozempic?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist that is used:

• with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

• to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

• Ozempic has not been studied in patients with a history of pancreatitis.

• Ozempic is not for treatment of type 1 diabetes mellitus.

Your Ro-affiliated provider may recommend the use of Ozempic as treatment for chronic weight management (obesity or overweight).

Who should not use Ozempic?

Do not use Ozempic if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You have a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).

__How should Ozempic be administered? __

You can take Ozempic with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Ro-affiliated provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking Ozempic as prescribed without discussing with your provider first.

What should I tell my Ro-affiliated provider before using Ozempic?

• Ozempic has certain drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)

• Ozempic causes a delay in gastric emptying so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.

• Other GLP-1 medications, including Wegovy, Saxenda, Victoza, Byetta, or Bydureon

• If you’re using other products for weight loss, including dietary supplements

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes

• Thyroid cancer

• Pancreatitis

• Kidney disease

• Diabetic retinopathy

• Depression

• Suicidal thoughts or behavior

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

• If you are pregnant: Ozempic should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

• If you are a female or male of reproductive potential: Discontinue Ozempic at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

• If you are breastfeeding: Ozempic was found in the milk of lactating rats. Tell your Ro-affiliated provider if you are breastfeeding before you start Ozempic.

Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Ozempic and Ozempic) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

__What are the most serious side effects that I or a caregiver should monitor for when taking Ozempic? __

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Ozempic. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Ozempic and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Ozempic causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Ozempic is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your 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.

• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

• Never Share a Pen: Pen-sharing poses a risk of infection.

• Low Blood Sugar (hypoglycemia): Ozempic lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

• Acute Kidney Injury: 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 plenty of water to help reduce your chance of dehydration.

• Serious Allergic Reactions: Stop using Ozempic right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

• Acute Gallbladder Disease: Ozempic may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

What are the most common side effects of Ozempic?

• Nausea

• Vomiting

• Diarrhea

• Stomach pain

• Constipation

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891

• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.