Wegovy (Semaglutide) Injection

Wegovy carries a risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). Patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use this medication. Regular monitoring for symptoms of thyroid tumors, such as a lump in the neck or hoarseness, is recommended.

Your healthcare provider should show you how to use Wegovy™ before you use it for the first time.

• Wegovy™ should be visually inspected prior to injection. Use only if the solution is clear, colorless, and particle-free.
• Take Wegovy™ once a week, on the same day every week, with or without meals.
• Wegovy™ can be administered subcutaneously in the abdomen, thigh, or upper arm. It is possible to change the time of day and the site of injection without adjusting the dose.
• Change (rotate) your injection site with each injection. Do not use the same site for each injection.

• Wegovy™ pens are intended for one-time use only. Your pen already contains the Wegovy™ dose.
• The needle cover conceals the needle, so the needle cannot be seen. Make sure you don’t remove the pen cap until you’re ready to inject. The needle cover should not be touched. It is possible to get a needle stick injury. As soon as the needle cover is pressed against your skin, your Wegovy™ injection will begin.
• Do not remove the pen from your skin before the yellow bar in the pen window stops moving. You may not receive the full dose of Wegovy™ if the needle is removed earlier. Contact your healthcare provider or Novo Nordisk at 1-833-934-6891 if the yellow bar does not move or stops during the injection.
• When you remove the pen from your skin, the needle cover will lock. Injections cannot be stopped and restarted.
• People who are blind or have vision problems should not use the Wegovy™ pen without the assistance of someone trained in using the pen.

Please note: dosing instructions will be given to you by your healthcare professional. Always follow the advice from your prescriber when dosing.

• Initiate Wegovy™ with a dose of 0.25 mg injected subcutaneously once-weekly and follow the dose escalation schedule:

• Consider delaying dose escalation for 4 weeks if you are not tolerating a dose during dose escalation.
• The maintenance dose of Wegovy™ is 2.4 mg subcutaneously injected once-weekly.
• If you cannot tolerate the maintenance dose of 2.4 mg once-weekly, you can temporarily reduce the dose to 1.7 mg once-weekly, for a maximum of 4 weeks. Wegovy™ should be increased to 2.4 mg once a week after 4 weeks. If you cannot tolerate 2.4 mg of Wegovy™, consider discontinuing it and speak to your healthcare professional.
• Monitor blood glucose levels (possibly with a meter) before and during treatment with Wegovy™ if you have type 2 diabetes.

Speak to your healthcare provider about the warnings and precuations of any medication you have been prescribed.

Risk of Thyroid C-Cell Tumors

After lifetime exposure to semaglutide at clinically relevant plasma exposures, semaglutide increased the incidence of thyroid C-cell tumors (adenomas and carcinomas) in mice and rats. In humans, Wegovy™ has not been shown to cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), since human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Post-marketing reports of MTC in patients treated with liraglutide (such as Saxenda) are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use. If you have a personal or family history of MTC or MEN 2, Wegovy™ is contraindicated. Inform patients about the potential risk for MTC associated with the use of Wegovy™ and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

People treated with Wegovy™ may benefit from routine serum calcitonin monitoring or thyroid ultrasound to detect MTC early. Due to the high prevalence of thyroid disease and a low-test specificity for serum calcitonin, such monitoring may increase the risk of unnecessary procedures. Individuals with MTC usually have serum calcitonin values of more than 50 ng/L, which indicates significantly elevated serum calcitonin levels. Please get further evaluation if serum calcitonin is elevated. A physical examination or neck imaging should also be performed for individuals with thyroid nodules.

Acute Pancreatitis

Patients treated with GLP-1 receptor agonists, including semaglutide, have experienced acute pancreatitis, including hemorrhagic and necrotizing pancreatitis. Clinical trials with Wegovy™ showed acute pancreatitis in patients. Watch for signs and symptoms of acute pancreatitis following the initiation of Wegovy™ (including persistent severe abdominal pain, sometimes radiating to the back, and sometimes accompanied by vomiting). Wegovy™ should be discontinued immediately if acute pancreatitis is suspected. Wegovy™ should not be restarted if acute pancreatitis is confirmed. Patients with a history of pancreatitis have not been studied with Wegovy™. Wegovy™ has not been studied in patients with a history of pancreatitis to determine whether they are at higher risk of developing pancreatitis.

Acute Gallbladder Disease

Patients treated with Wegovy™ reported cholelithiasis at a rate of 1.6% compared to 0.7% of patients treated with placebo. Wegovy™-treated patients reported 0.6% cholecystitis, while placebo-treated patients reported 0.2%. Even after accounting for weight loss, Wegovy™-treated patients reported a greater incidence of acute gallbladder disease than placebo-treated patients. It is recommended to perform gallbladder studies and follow up clinically if cholelithiasis is suspected.

Hypoglycemia

It is possible to experience hypoglycemia after taking Wegovy™. Hypoglycemia (defined as plasma glucose less than 54 mg/dL) was reported in 6.2% of Wegovy™-treated patients compared with 2.5% of placebo-treated patients with type 2 diabetes and BMI greater than 27 kg/m2. Only one Wegovy™-treated patient developed severe hypoglycemia (requiring assistance from another person). Wegovy™ is associated with an increased risk of hypoglycemia, including severe hypoglycemia, in patients with type 2 diabetes mellitus taking combination drugs (e.g., sulfonylurea) or insulin. Patients taking semaglutide in combination with insulin have experienced hypoglycemia. Wegovy™ has not been evaluated in patients receiving insulin. Educate yourself on the signs and symptoms of hypoglycemia because there is a risk of hypoglycemia. People with type 2 diabetes should monitor their blood glucose before and during treatment with Wegovy™. Consult your healthcare provider about reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin when starting Wegovy™.

Acute Kidney Injury

Post-marketing reports have described acute kidney injury and worsening chronic renal failure in patients treated with semaglutide, requiring hemodialysis in some cases. Acute kidney injury is more likely to occur in patients with renal impairment, but some of these events have occurred in patients without underlying renal disease. Many of the reported events were associated with nausea, vomiting, or diarrhea, leading to volume depletion. In patients who experience severe adverse gastrointestinal reactions, monitor renal function when initiating or increasing Wegovy™ doses. Report any adverse reactions that may lead to volume depletion in patients with renal impairment.

Hypersensitivity

With semaglutide, serious hypersensitivity reactions have been reported (e.g., anaphylaxis, angioedema). In the event of hypersensitivity reactions, discontinue use of Wegovy™, contact your healthcare professional and monitor until signs and symptoms disappear. Do not use this medication if you have had a history hypersensitivity to semaglutide or any of the excipients in Wegovy™. Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. It is unknown whether patients who have experienced anaphylaxis or angioedema with another GLP-1 receptor agonist will be predisposed to these reactions with Wegovy™.

Diabetic Retinopathy Complications (Diabetes)

Diabetes retinopathy was reported by 4.0% of Wegovy™-treated patients and 2.7% of placebo-treated patients with type 2 diabetes and BMI greater than or equal to 27 kg/m2. In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in patients with type 2 diabetes and high cardiovascular risk, diabetic retinopathy complications (3.0%) were more common in patients treated with semaglutide injection than those treated with placebo (1.8%). In patients with diabetic retinopathy at baseline, the risk of diabetic retinopathy complications was higher (semaglutide injection 8.2%, placebo 5.2%) than in patients without known diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%). A temporary worsening of diabetic retinopathy has been associated with rapid improvements in glucose control. Long-term glycemic control with semaglutide has not been studied for diabetic retinopathy complications. The progression of diabetic retinopathy should be monitored in patients with a history of the disease.

Heart Rate Increase

In clinical trials, Wegovy™-treated patients showed mean increases in resting heart rate of 1 to 4 beats per minute (bpm) compared with placebo patients. Patients treated with Wegovy™ had more significant changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively). Keep an eye on your heart rate in accordance with your usual clinical practice. During Wegovy™ treatment, patients should notify their healthcare providers if they experience palpitations or a racing heartbeat. Wegovy™ should be discontinued if a sustained increase in resting heart rate occurs.

Suicidal Behavior and Ideation

There have been reports of suicidal behavior and ideation in clinical trials of other weight management products. Wegovy™ treatment should be monitored for the appearance or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Wegovy™ if you experience suicidal thoughts or behaviors. If you have a history of suicide attempts or active suicidal thoughts, you should not take Wegovy™.

Delayed Gastric Emptying

Wegovy™ and other GLP-1 agonist medications directly act on the gastrointestinal system causing delayed gastric emptying and decreased intestinal motility. This is the reason why GI upset is a common side effect of this medication. Studies have shown that food takes significantly longer to move through the stomach of patients taking Wegovy™, which can make undergoing anesthesia for surgical procedures unsafe. If you have an upcoming surgical procedure, tell your surgeon and anesthesiologist about the medicines you are taking and your Wegovy™ should be held for at least one week per the most recent guidelines.

In addition to tablets, capsules, and liquid solutions, Wegovy™ can affect drugs taken orally. During Wegovy™ treatment, your doctor may adjust the dosage of any drugs you take by mouth.

Tell your doctor and pharmacist about all medications you take before starting Wegovy™ treatment. Over-the-counter weight loss supplements and products are included here. You may be advised to stop taking other weight loss products or medications if they prescribe Wegovy™.

Concomitant use with an Insulin Secretagogue (e.g., Sulfonylurea) or Insulin Wegovy™ lowers blood glucose and can cause hypoglycemia. The risk of hypoglycemia is increased when Wegovy™ is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. The addition of Wegovy™ in patients treated with insulin has not been evaluated. When initiating Wegovy™, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia

Oral medications causes a delay of gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials with semaglutide 1 mg, semaglutide did not affect the absorption of orally administered medications. Nonetheless, monitor the effects of oral medications concomitantly administered with Wegovy™.

There are 245 known drugs that interact with Wegovy™ (semaglutide). The two major being; bexarotene and gatlifloxacin.

As with most drugs, Wegovy™ can cause mild or serious side effects. There are a number of side effects associated with Wegovy™, as shown with the information below. All possible side effects are not included in this description.

Depending on your age, health conditions, and current medications, the side effects of a drug may vary.

Wegovy™ side effects can be discussed with your doctor or pharmacist.

The most common side effects of Wegovy™ may include: nausea, stomach (abdomen) pain, dizziness , stomach flu, diarrhea, headache, feeling bloated, heartburn, vomiting, tiredness (fatigue), belching,  constipation, upset stomach and gas.

Some of the more uncommon side effects include:

Pancreatitis

Stop using Wegovy™ 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

Wegovy™ 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 and clay-colored stools

Hypoglycemia

Low blood sugar in patients with type 2 diabetes who receive Wegovy™ can be both a serious and common 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 Wegovy™ and while you take Wegovy™.

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 and feeling jittery.

Kidney Problems

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.

Increased Heart Rate

Wegovy™ can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take Wegovy™. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

Depression

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.

Stop using Wegovy™ 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 Wegovy™.

Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue Wegovy™. Available pharmacovigilance data and data from clinical trials with Wegovy™ use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the MRHD (rabbit) and greater than or equal to 2-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There are no data on the presence of semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Wegovy™ and any potential adverse effects on the breastfed infant from Wegovy™ or from the underlying maternal condition.

There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to Wegovy™ and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

Overdoses have been reported with other GLP-1 receptor agonists. Effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Wegovy™ of approximately 1 week.

Immediately contact your doctor if you believe you have injected too much Wegovy™. Alternatively, you can contact the American Association of Poison Control Centers by calling 800-222-1222 or by using its online resource. However, if you experience severe symptoms, call 911 or your local emergency number immediately. Visit an emergency room if necessary.

If you miss a dose of Wegovy™ 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 Wegovy™ 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 Wegovy™ 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.

Wegovy™ pens should be stored between 2°C and 8°C (36°F and 46°F). For up to 28 days, Wegovy™ may be stored from 8°C to 30°C (46°F to 86°F) in the original carton after removing the cap. It is recommended that Wegovy™ be kept in the original carton in order to keep it protected from light. Keep out of the freezer.

Wegovy™ pens should be disposed of in FDA-cleared sharps disposal containers immediately after use. Do not throw away (dispose of) the pen in your household garbage.

You may use a household container if you do not have a sharps disposal container that is FDA-cleared: made of heavy-duty plastic, able to be closed with a tight-fitting, puncture-resistant lid, without sharps coming out, upright and stable when used, leak-proof, and properly labeled to indicate hazardous wastes inside.

Your sharps disposal container must be disposed of according to the guidelines in your community when it is almost full. Useful needles and syringes may be disposed of according to state or local laws. Visit the FDA’s website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, as well as specific sharps disposal in your state.

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