Semaglutide-Pyridoxine® 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, Semaglutide-Pyridoxine® and medicines that work like Semaglutide-Pyridoxine® caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide-Pyridoxine® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not use Semaglutide-Pyridoxine® 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).

• Semaglutide-Pyridoxine® is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:
• to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
• that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.
• Semaglutide-Pyridoxine® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.
• It is not known if Semaglutide-Pyridoxine® is safe and effective for use in children under 12 years of age.

• 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 had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide-Pyridoxine®. See the end of this Medication Guide for a complete list of ingredients in Semaglutide-Pyridoxine®. Symptoms of a serious allergic reaction include:

swelling of your face, lips, tongue or throat
fainting or feeling dizzy
problems breathing or swallowing
very rapid heartbeat
severe rash or itching

• have or have had problems with your pancreas or kidneys.
• have type 2 diabetes and a history of diabetic retinopathy.
• have or have had depression or suicidal thoughts, or mental health issues.
• are pregnant or plan to become pregnant. Semaglutide-Pyridoxine® may harm your unborn baby. You should stop using Semaglutide-Pyridoxine® 2 months before you plan to become pregnant.
o Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who use Semaglutide-Pyridoxine® during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry or you may contact Novo Nordisk at 1-877-390-2760.
• are breastfeeding or plan to breastfeed. It is not known if Semaglutide-Pyridoxine® passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Semaglutide-Pyridoxine®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide-Pyridoxine® may affect the way some medicines work and some medicines may affect the way Semaglutide-Pyridoxine® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide-Pyridoxine® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• Read the Instructions for Use that comes with Semaglutide-Pyridoxine®.
• Use Semaglutide-Pyridoxine® exactly as your healthcare provider tells you to.
• Your healthcare provider should show you how to use Semaglutide-Pyridoxine® before you use it for the first time.
• Semaglutide-Pyridoxine® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Semaglutide-Pyridoxine® into a muscle (intramuscularly) or vein (intravenously).
• Change (rotate) your injection site with each injection. Do not use the same site for each injection.
• Use Semaglutide-Pyridoxine® 1 time each week, on the same day each week, at any time of the day.
• Start Semaglutide-Pyridoxine® with 0.25 mg per week in your first month. In your second month, increase your weekly dose to 0.5 mg. In the third month, increase your weekly dose to 1 mg. In the fourth month, increase your weekly dose to 1.7 mg. In the fifth month onwards, your healthcare provider may either maintain your dose at 1.7 mg weekly or increase your weekly dose to 2.4 mg.
• If you need to change the day of the week, you may do so as long as your last dose of Semaglutide-Pyridoxine® was given 2 or more days before.
• If you miss a dose of Semaglutide-Pyridoxine® and the next scheduled dose is more than 2 days away (48 hours), take the missed dose as soon as possible. If you miss a dose of Semaglutide-Pyridoxine® and the next schedule dose is less than 2 days away (48 hours), do not administer the dose. Take your next dose on the regularly scheduled day.
• If you miss doses of Semaglutide-Pyridoxine® for more than 2 weeks, take your next dose on the regularly scheduled day or call your healthcare provider to talk about how to restart your treatment.
• You can take Semaglutide-Pyridoxine® with or without food.
• If you take too much Semaglutide-Pyridoxine®, you may have severe nausea, severe vomiting and severe low blood sugar. Call your healthcare provider or go to the nearest hospital emergency room right away if you experience any of these symptoms.

Semaglutide-Pyridoxine® may cause serious side effects, including:
• See “What is the most important information I should know about Semaglutide-Pyridoxine®?”
• inflammation of your pancreas(pancreatitis). Stop using Semaglutide-Pyridoxine® 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.
• gallbladder problems. Semaglutide-Pyridoxine® may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms:
pain in your upper stomach (abdomen)
yellowing of skin or eyes (jaundice)
fever
clay-colored stools

• increased risk of low blood sugar (hypoglycemia), especially those who also take medicines to treat diabetes mellitus such as insulin or sulfonylureas. Low blood sugar in patients with diabetes who receive Semaglutide-Pyridoxine® can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking Semaglutide-Pyridoxine® and while you take Semaglutide-Pyridoxine®. Signs and symptoms of low blood sugar may include:
dizziness or light-headedness
sweating
shakiness
blurred vision
slurred speech
weakness
anxiety
hunger
headache
irritability or mood changes
confusion or drowsiness
fast heartbeat
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 Semaglutide-Pyridoxine® 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
severe rash or itching
very rapid heartbeat
problems breathing or swallowing
fainting or feeling dizzy

• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Semaglutide-Pyridoxine®.
• increased heart rate. Semaglutide-Pyridoxine® can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take Semaglutide-Pyridoxine®. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
• depression or thoughts of suicide. You should pay attention to any mental 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.

The most common side effects of Semaglutide-Pyridoxine® in adults or children aged 12 years and older may include:
• nausea
• stomach (abdomen) pain
• dizziness
• gas
• diarrhea
• headache
• feeling bloated
• stomach flu
• vomiting
• tiredness (fatigue)
• belching
• heartburn
• constipation
• upset stomach
• low blood sugar in people with type 2 diabetes
• runny nose or sore throat

Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of Semaglutide-Pyridoxine®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Semaglutide-Pyridoxine® for a condition for which it was not prescribed. Do not give Semaglutide-Pyridoxine® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Semaglutide-Pyridoxine® that is written for health professionals.