On January 4, 2024, the FDA announced they were investigating counterfeit semaglutide products that had been distributed and dispensed to patients. Use of these products have led to side effects. The FDA is advising that all pharmacies, patients and healthcare providers check the lot and serial number on their semaglutide product before using it. If the lot number is NAR0074 and serial number 430834149057, do not use the medicine and call your pharmacy right away. If you are concerned about your semaglutide product and want to know if its ok, please call your local pharmacy or Novo Nordisk at 1-800-727-6500. If you think you are experiencing a side effect from semaglutide, call you local pharmacy or doctor and you can report your side effect to FDA Medwatch at https://www.accessdata.fda.gov/scripts/medwatch/
Semaglutide injection may increase the risk that you will develop tumors of the thyroid gland, including medullary thyroid carcinoma (MTC; a type of thyroid cancer). Laboratory animals who were given semaglutide developed tumors, but it is not known if this medication increases the risk of tumors in humans. Tell your doctor if you or anyone in your family has or has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to use semaglutide injection. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to semaglutide injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with semaglutide injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using semaglutide injection.
Why is this medication prescribed?
Semaglutide injection (Ozempic) is used along with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications did not control the sugar levels well enough. Semaglutide injection (Ozempic) is also used to reduce the risk of a stroke, heart attack, or death in adults who have type 2 diabetes along with heart and blood vessel disease. It is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Semaglutide injection is not used instead of insulin to treat people with diabetes who need insulin. Semaglutide injection (Wegovy) is used along with an individualized low-calorie, low-fat diet and exercise program to help with weight loss in obese adults or overweight adults who may also have high blood pressure, diabetes, or high cholesterol. Semaglutide injection (Wegovy) is also used along with an individualized low-calorie, low-fat diet and exercise program to help with weight loss in obese children 12 years of age or older. Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Semaglutide injection also works by slowing the movement of food through the stomach and may decrease appetite and cause weight loss.
Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
How should this medicine be used?
Semaglutide injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected once a week without regard to meals. Use semaglutide injection on the same day each week at any time of day. You may change the day of the week that you use semaglutide as long as it has been 2 or more days (48 or more hours) since you used your last dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use semaglutide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of semaglutide injection and increase your dose after 4 weeks. Your doctor may increase your dose again after another 4 weeks based on your body's response to the medication.
Semaglutide injection helps to control diabetes and weight loss, but it is not a cure. Continue to use semaglutide injection even if you feel well. Do not stop using semaglutide injection without talking to your doctor.
Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of semaglutide injection. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.
Always look at the semaglutide solution before you inject it. It should be clear, colorless, and free of particles. Do not use semaglutide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.
Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.
You can inject semaglutide in your upper arm, thigh, or stomach area. Change (rotate) the injection site with each injection. You can inject semaglutide and insulin in the same body area, but you should not give the injections right next to each other. Allow the pen to warm to room temperature before injecting if the pen was stored in the refrigerator.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking semaglutide injection,
- tell your doctor and pharmacist if you are allergic to semaglutide (Rybelsus, Ozempic, Wegovy), albiglutide (Tanzeum; no longer available in the US), dulaglutide (Trulicity), exenatide (Bydureon, Byetta), liraglutide (Saxenda, Victoza), lixisenatide (Adlyxin, in Soliqua), any other medications, or any of the ingredients in semaglutide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It is especially important to tell your doctor about all the medications you take by mouth because semaglutide may change the way your body absorbs these medications.
- tell your doctor if you have or have ever had pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eyes caused by diabetes), gallbladder disease, or kidney disease. Also tell your doctor if you have recently had diarrhea, nausea, or vomiting or if you cannot drink liquids by mouth, which may cause dehydration (loss of a large amount of body fluids).
- tell your doctor if you plan to become pregnant. Your doctor may tell you to stop using semaglutide injection for 2 months before a planned pregnancy.
- tell your doctor if you are pregnant or are breastfeeding. If you become pregnant while using semaglutide injection, call your doctor.
- ask your doctor what to do if there is a large change in your diet, exercise, or weight; or if you get sick, develop an infection or fever, experience unusual stress, or are injured. These changes and conditions can affect your blood sugar and the amount of semaglutide injection you may need.
- you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are using semaglutide injection for weight loss. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: depression; talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
What special dietary instructions should I follow?
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.
What should I do if I forget a dose?
If you are using semaglutide injection (Ozempic), inject the missed dose as soon as you remember it. However, if more than 5 days passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.
If you are using semaglutide injection (Wegovy) and the next dose is more than 2 days away (48 hours), use the missed dose as soon as possible. If you miss a dose of semaglutide injection (Wegovy) and the next scheduled dose is less than 2 days away (48 hours), skip the missed dose and continue your regular dosing schedule. If you miss a dose of semaglutide injection (Wegovy) for more than 2 weeks, call your doctor or pharmacist.
What side effects can this medication cause?
Semaglutide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- abdominal pain
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:
- ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
- rash; itching; swelling of the eyes, face, mouth, tongue, or throat; or difficulty breathing or swallowing
- decreased urination; or swelling of legs, ankles, or feet
- vision changes
- fainting or dizziness
- pain in upper stomach; yellowing of skin or eyes; fever; or clay-colored stools (in those receiving semaglutide [Wegovy] for management of weight loss)
- rapid heartbeat
- dizziness, light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety or irritability or mood changes, hunger, weakness, or feeling jittery
Semaglutide injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in and out of reach of children. Store it away from light and heat, with the pen cap on.
Store unused semaglutide pens (Ozempic) in the refrigerator (36°F to 46°F [2°C to 8°C]) but do not place them near the refrigerator cooling element. Once a semaglutide pen is in use you can store it at room temperature (59°F to 86°F [15°C to 30°C]) or in the refrigerator. Do not freeze. Do not use semaglutide if it has been frozen. When traveling, pens that are in use can be stored at room temperature (59°F to 86°F [15°C to 30°C]) (not in a car glove compartment or other hot place). Make a note of the date you first use a semaglutide pen, and dispose of the pen after 56 days, even if there is some solution left in the pen.
Store semaglutide pens (Wegovy) in the refrigerator (36°F to 46°F [2°C to 8°C]). Before removing the cap, it can be stored or from 46°F to 86°F [8°C to 30°C]) in the original carton for up to 28 days. Do not freeze. Do not use semaglutide if it has been frozen.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What other information should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.