Brand names: Ozempic, Rybelsus, Wegovy
Drug class: Incretin Mimetics

Medically reviewed by Drugs.com on Apr 10, 2025. Written by ASHP.

Introduction

Antidiabetic agent; glucagon-like peptide-1 (GLP-1) agonist (incretin mimetic).

Uses for Semaglutide

Type 2 Diabetes Mellitus

Glycemic Control

Used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Various preparations of semaglutide are available; Rybelsus oral tablets and Ozempic sub-Q injection are specifically FDA-labeled for use in the management of diabetes mellitus.

Used alone or in combination with one or more antidiabetic agents (e.g., metformin, a sulfonylurea, a thiazolidinedione, a dipeptidyl peptidase [DPP]-4 inhibitor, a sodium-glucose cotransporter 2 [SGLT2] inhibitor, basal insulin) as an adjunct to diet and exercise for the management of type 2 diabetes mellitus.

Guidelines from the American Diabetes Association (ADA) and other experts generally recommend the use of SGLT2 inhibitors or GLP-1 receptor agonists in patients with type 2 diabetes and established/high risk of atherosclerotic cardiovascular disease (ASCVD), heart failure, and/or chronic kidney disease. When selecting a treatment regimen, consider factors such as cardiovascular and renal comorbidities, drug efficacy and adverse effects, hypoglycemic risk, presence of overweight or obesity, cost, access, and patient preferences. Weight management should be included as a distinct treatment goal and other healthy lifestyle behaviors should also be included in treatment plan.

Not indicated for type 1 diabetes mellitus.

Patients with Type 2 Diabetes and Established Cardiovascular Disease

Used to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Various preparations of semaglutide are available; Ozempic sub-Q injection is specifically FDA-labeled for this use.

Oral^{† [off-label]} semaglutide also has been evaluated in a cardiovascular outcome trial in patients with type 2 diabetes mellitus and demonstrated noninferiority to placebo in time to first MACE. Some data suggest that cardiovascular benefits of semaglutide may be independent of route of administration.

For the treatment of patients with type 2 diabetes mellitus and established ASCVD, current clinical practice guidelines generally recommend the use of a GLP-1 receptor agonist with proven efficacy in cardiovascular outcome trials.

Patients with Type 2 Diabetes and Chronic Kidney Disease

Used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

Various preparations of semaglutide are available; Ozempic sub-Q injection is specifically FDA-labeled for this use.

For the treatment of patients with type 2 diabetes mellitus and chronic kidney disease, current clinical practice guidelines generally recommend the use a GLP-1 receptor agonist with proven benefit in reducing adverse renal outcomes.

Overweight and Obesity

Weight Reduction

Used in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients ≥12 years of age with obesity, or in adults with overweight and at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia).

Various preparations of semaglutide are available; Wegovy sub-Q injection is specifically FDA-labeled for this use.

Do not use in combination with any other semaglutide-containing products or any other GLP-1 receptor agonist.

Clinical practice guidelines recommend that patients with excess body weight and associated health risks be treated for obesity. Essential component of therapy is a comprehensive lifestyle intervention; may consider pharmacologic therapy as an adjunct in patients who fail to achieve or sustain clinically meaningful weight loss (generally defined as loss of >4–5% of total body weight) with behavioral modification alone. Evaluate response to drug therapy after 3–4 months; if clinically meaningful weight loss not achieved, consider new treatment plan because patient is likely not responding to the drug.

Reduction in Risk of Major Adverse Cardiovascular Events

Used in combination with a reduced-calorie diet and increased physical activity to reduce the risk of MACE (cardiovascular death, nonfatal MI, or nonfatal stroke) in adults with established cardiovascular disease and either obesity or overweight.

Various preparations of semaglutide are available; Wegovy sub-Q injection is specifically FDA-labeled for this use.

Do not use in combination with any other semaglutide-containing products or any other GLP-1 receptor agonist.

Semaglutide Dosage and Administration

General

Pretreatment Screening

• In patients with type 2 diabetes mellitus receiving semaglutide for chronic weight management, monitor blood glucose prior to initiating therapy.

Patient Monitoring

• Periodically monitor blood glucose and glycosylated hemoglobin (hemoglobin HbA_1c) to determine therapeutic response in patients with type 2 diabetes mellitus.

• In patients with type 2 diabetes mellitus receiving semaglutide for chronic weight management, monitor blood glucose during therapy.

• Monitor patients with a history of diabetic retinopathy for disease progression while receiving semaglutide.

• Monitor renal function when initiating semaglutide or escalating dosage in patients reporting severe adverse GI effects. Monitor renal function in patients with renal impairment reporting any adverse effect that could lead to volume depletion.

• Monitor heart rate regularly.

• Monitor for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior.

• Monitor patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting).

Administration

Administer orally or by sub-Q injection.

Oral Administration

Rybelsus

There are 2 formulations of oral semaglutide (Rybelsus). Formulation R1 includes the following dose strengths: 3 mg, 7 mg, and 14 mg. Formulation R2 includes the following dose strengths: 1.5 mg, 4 mg, and 9 mg. These formulations are not substitutable on a mg per mg basis. Use either Formulation R1 or Formulation R2; do not use both formulations at the same time.

Administer tablets on an empty stomach in the morning with water (up to 4 ounces); do not use any other liquids. After administration, wait at least 30 minutes before eating food, drinking beverages, or taking other oral medications.

Swallow tablets whole; do not cut, crush, or chew.

If a dose is missed, omit the missed dose and take the next dose the following day.

Sub-Q Administration

Ozempic

Administer by sub-Q injection into abdomen, thigh, or upper arm using a prefilled, single patient-use injection pen.

Administer once weekly at any time of day without regard to meals.

If a dose is missed, take the dose as soon as possible within 5 days after the missed dose. If >5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients may resume their regular once-weekly dosing schedule.

Administer semaglutide and insulin as separate injections in patients receiving both drugs for diabetes mellitus; do not mix insulin and semaglutide. May inject semaglutide and insulin in the same body region; however, do not administer injections adjacent to each other.

Wegovy

Administer by sub-Q injection into abdomen, thigh, or upper arm using a prefilled, single-use, disposable injection pen.

If a dose is missed and the next scheduled dose is more than 2 days (48 hours) away, administer the missed dose as soon as possible; if the next scheduled dose is less than 2 days (48 hours) away, do not administer the missed dose. Resume dosing on the regularly scheduled day of the week. If 2 or more consecutive doses are missed, resume dosing as scheduled or, if needed, reinitiate therapy and follow the dose escalation schedule.

Administer injections once weekly, on the same day each week, at any time of day without regard to meals.

Dosage

Pediatric Patients

Overweight or Obesity

Sub-Q

Pediatric patients ≥12 years of age: Initially, 0.25 mg once weekly; escalate dosage according to the schedule in Table 2 to minimize adverse GI effects.

If patient does not tolerate dose escalation, consider delaying the escalation for 4 weeks.

The maintenance dosage is 2.4 mg (recommended) or 1.7 mg once weekly.

Adults

Type 2 Diabetes Mellitus

Glycemic Control in Patients with Type 2 Diabetes Mellitus

Oral

RybelsusFormulation R1: Initially 3 mg once daily for 30 days. The 3-mg dosage is for initiation of treatment only to reduce GI intolerance and is not effective for glycemic control. After 30 days, increase dosage to 7 mg once daily. If patient requires additional glycemic control after receiving 7 mg of semaglutide once daily for at least 30 days, dosage may be increased to 14 mg once daily.

RybelsusFormulation R2:Initially 1.5 mg once daily for 30 days. The 1.5-mg dosage is for initiation of treatment only to reduce GI intolerance and is not effective for glycemic control. After 30 days, increase dosage to 4 mg once daily. If patient requires additional glycemic control after receiving 4 mg of semaglutide once daily for at least 30 days, dosage may be increased to 9 mg once daily.

Switching between Rybelsusformulations: Do not switch between Rybelsus formulations during the initiation phase (Days 1-30). After 30 days of treatment (after the initiation phase), patients may switch between the formulations (see Table 1). When switching between formulations, initiate the other Rybelsus formulation the day after discontinuing the previous formulation.

Switching from subcutaneous semaglutide (Ozempic) to oral semaglutide (RybelsusFormulation R1): Start with 7 mg or 14 mg of Rybelsus Formulation R1 orally once daily 1 week after discontinuing 0.5 mg of sub-Q Ozempic. Switching recommendations for patients taking Ozempic 0.25 mg, 1 mg, or 2 mg sub-Q once weekly to Rybelsus Formulation R1 are not available.

Switching from subcutaneous semaglutide (Ozempic) to oral semaglutide (Rybelsus Formulation R2): Start with 4 mg or 9 mg of Rybelsus Formulation R2 orally once daily 1 week after discontinuing 0.5 mg of sub-Q Ozempic. Switching recommendations for patients taking Ozempic 0.25 mg, 1 mg, or 2 mg sub-Q once weekly to Rybelsus Formulation R2 are not available.

Glycemic Control in Patients with Type 2 Diabetes Mellitus

Sub-Q

Initially, 0.25 mg once weekly for 4 weeks. The 0.25 mg once-weekly dosage is not effective for glycemic control; intended only as a starting dose to reduce GI intolerance.

After 4 weeks, increase dosage to 0.5 mg once weekly. The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg subcutaneously once weekly based on glycemic control. After an additional 4 weeks or more, if needed, may increase dosage to 1 mg once weekly. If additional glycemic control is needed after at least 4 weeks on the 1 mg dosage, may increase to a maximum of 2 mg once weekly.

Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease

Sub-Q

Initially 0.25 mg once weekly for 4 weeks. The 0.25 mg dose is intended for treatment initiation only; intended only as a starting dose to reduce GI intolerance.

After 4 weeks, increase dosage to 0.5 mg once weekly. The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg once weekly based on glycemic control. If additional glycemic control is needed, may increase to 1 mg once weekly after patient has received the 0.5 mg dose for at least 4 weeks. If additional glycemic control is needed after at least 4 weeks on the 1 mg dosage, may increase to a maximum of 2 mg once weekly.

Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease

Sub-Q

Initially 0.25 mg once weekly for 4 weeks. After 4 weeks, increase to 0.5 mg once weekly. After at least 4 weeks on a dosage of 0.5 mg once weekly, increase to recommended maintenance dosage of 1 mg once weekly.

Overweight or Obesity

Weight Reduction or Reduction in Risk of MACE

Sub-Q

Initially, 0.25 mg once weekly; escalate dosage according to the schedule in Table 2 to minimize adverse GI effects.

If patient does not tolerate dose escalation, consider delaying the escalation for 4 weeks.

Maintenance dosage is 2.4 mg (recommended) or 1.7 mg once weekly. Consider treatment response and tolerability when selecting the maintenance dosage.

Special Populations

Hepatic Impairment

No dosage adjustment is recommended.

Renal Impairment

No dosage adjustment is recommended.

Geriatric Patients

Manufacturer makes no specific recommendations.

Cautions for Semaglutide

Contraindications

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

• Prior serious hypersensitivity reaction to semaglutide or any ingredient in the formulation.

Warnings/Precautions

Warnings

Risk of Thyroid C-Cell Tumors

In rodents, semaglutide (at clinically relevant exposures) causes thyroid C-cell tumors that were dose- and duration-dependent. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the relevance of the findings in rodents to humans has not been determined. (See Boxed Warning.) Cases of MTC reported in patients receiving liraglutide, another GLP-1 receptor agonist, during postmarketing experience; data insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

Significantly elevated serum calcitonin values may suggest MTC; such values generally exceed 50 ng/L in patients with MTC. Uncertain value of routine monitoring of serum calcitonin or thyroid ultrasound examinations; further evaluate patients if serum calcitonin is elevated or thyroid nodules noted on physical examination or neck imaging.

Other Warnings and Precautions

Pancreatitis

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported.

Observe patients carefully for manifestations of pancreatitis after initiation and dosage increases. Symptoms may include persistent severe abdominal pain that sometimes radiates to the back and that may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue semaglutide and initiate appropriate management.

Diabetic Retinopathy Complications

Diabetic retinopathy complications reported in patients with type 2 diabetes mellitus receiving oral or sub-Q semaglutide. Rapid improvement in glycemic control has been associated with a temporary worsening of diabetic retinopathy. Data are lacking on the effect of long-term glycemic control with semaglutide on diabetic retinopathy. Monitor patients with a history of diabetic retinopathy for progression of this condition.

Sharing of Injection Pens

Do not share semaglutide (Ozempic) injection pens among patients, even if the needle has been changed; sharing poses risk for transmission of blood-borne pathogens.

Hypoglycemia

Semaglutide lowers blood glucose and can cause hypoglycemia.

Patients with diabetes mellitus receiving semaglutide in combination with an insulin secretagogue (e.g., a sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Caution and educate patients about risks and about signs and symptoms of hypoglycemia; reduction in sulfonylurea or insulin dosage may be necessary.

Renal Effects

Acute kidney injury and worsening of chronic renal failure (sometimes requiring hemodialysis) reported. Patients with baseline renal impairment may be at greater risk; however, some patients did not have known underlying renal disease.

Other factors (nausea, vomiting, diarrhea, or dehydration) were present in most patients. Because such adverse GI effects may worsen renal function, use caution and monitor renal function when initiating semaglutide or escalating dosage in patients reporting severe adverse GI effects.

Monitor renal function in patients with renal impairment reporting any adverse effect that could lead to volume depletion.

Severe GI Adverse Reactions

Use of GLP-1 agonists, including semaglutide, associated with adverse GI effects such as nausea, vomiting, and delayed gastric emptying; such effects can sometimes be severe.

Not recommended in patients with severe gastroparesis.

Hypersensitivity Reactions

Serious hypersensitivity reactions (anaphylaxis, angioedema) reported. If hypersensitivity reaction occurs, discontinue semaglutide; treat and monitor patient according to standard of care.

Use with caution in patients with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.

Elevated Heart Rate

Increases in heart rate reported.

Monitor heart rate regularly. Advise patients to inform their clinician if palpitations or feelings of a racing heartbeat occur while at rest during semaglutide therapy; if a sustained increase in resting heart rate occurs, discontinue therapy.

Suicidality

Suicidal behavior and ideation reported with other weight management products.

Manufacturer of semaglutide (Wegovy) states to monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior during treatment with the drug.

If a patient experiences suicidal thoughts or behaviors while receiving semaglutide, discontinue the drug. Avoid semaglutide in patients with a history of suicidal attempts or active suicidal ideation.

Acute Gallbladder Disease

Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported with GLP-1 receptor agonists. In patients receiving semaglutide injection for weight loss management, incidence of cholelithiasis and cholecystitis was higher in pediatric patients than in adults.

If cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Risks During General Anesthesia and Deep Sedation

GLP-1 agonists can delay gastric emptying, which can increase risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation. Pulmonary aspiration reported rarely during postmarketing experience in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Manufacturers state that available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking semaglutide. Instruct patients to inform their healthcare providers prior to any planned surgeries or procedures if they are taking semaglutide.

The American Society of Anesthesiologists (ASA) Task Force on Preoperative Fasting has issued a consensus-based guidance for management of GLP-1 receptor agonists prior to elective surgery. The task force suggests that for patients on daily GLP-1 agonist dosing (irrespective of indication, dose, or type of surgery), consider holding the drug on the day of procedure/surgery. For patients on weekly dosing (irrespective of indication, dose, or type of surgery), consider holding the GLP-1 agonist a week prior to procedure/surgery. If GLP-1 agonists prescribed for diabetes management are held for longer than the dosing schedule, consider consulting an endocrinologist for bridging the antidiabetic therapy to avoid hyperglycemia. These recommendations are based on limited evidence only (case reports).

For patients requiring urgent or emergent procedures, the task force states to proceed and treat the patient as ‘full stomach’ and manage accordingly.

Immunogenicity

Potential risk of immunogenicity. The presence of these antibodies has the potential to increase the risk of local skin reactions, hypersensitivity, or anaphylactic reactions and may also neutralize the therapeutic effects of GLP-1 receptor agonists; however, clinical importance appears to be low in most patients. The in vitro neutralizing activity of the antibodies is unknown.

Specific Populations

Pregnancy

Data are lacking on the use of semaglutide in pregnant women. Reproduction studies in animals have shown teratogenic effects (e.g., mortality, structural abnormalities, growth alterations, early pregnancy loss).

Poorly controlled diabetes mellitus during pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortion, preterm delivery, and delivery complications and also increases risk of major fetal birth defects, stillbirth, and macrosomia-related morbidity.

Manufacturer of the semaglutide preparations used for diabetic management states to use semaglutide during pregnancy only if the potential benefit justifies the potential risk to the fetus. Manufacturer of the semaglutide preparation used for weight control management states that weight loss offers no benefit to a pregnant patient and may cause fetal harm; if a patient becomes pregnant while receiving the drug, discontinue treatment.

A pregnancy exposure registry has been established to monitor pregnancy outcomes in women exposed to Wegovy; encourage pregnant women exposed to the drug to contact 1-800-727-6500.

Females and Males of Reproductive Potential

Discontinue semaglutide at least 2 months before a pregnancy is planned to account for the long half-life of the drug.

Lactation

Semaglutide is distributed into milk in rats; not known whether distributed into milk in humans.

Consider benefits of breast-feeding and importance of semaglutide to the woman along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Manufacturer states that breast-feeding is not recommended during treatment with oral semaglutide. Salcaprozate sodium (SNAC), an absorption enhancer in the oral formulation has been detected in milk of lactating rats at levels 2–12 times higher than in maternal plasma following a single maternal administration.

Pediatric Use

Safety and efficacy of semaglutide for type 2 diabetes mellitus (Ozempic, Rybelsus) not established in children or adolescents <18 years of age.

Safety and efficacy of semaglutide (Wegovy) for chronic weight management established in pediatric patients ≥12 years of age with BMI corresponding to ≥95th percentile standardized for age and sex. Insufficient data in pediatric patients with type 2 diabetes treated with Wegovy for obesity to determine if there is an increased risk of hypoglycemia with the drug similar to that reported in adults. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

When initiating Wegovy in pediatric patients ≥12 years of age with type 2 diabetes, consider reducing dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Hepatic Impairment

No substantial differences in the pharmacokinetics of semaglutide administered orally or sub-Q have been observed in patients with mild, moderate, or severe hepatic impairment.

Exposure of SNAC, an absorption enhancer in the oral formulation, increased with increasing hepatic impairment; not considered clinically relevant. Data lacking on the long-term safety of SNAC in patients with hepatic impairment.

Renal Impairment

No substantial differences in the pharmacokinetics of semaglutide administered orally or sub-Q have been observed in patients with mild, moderate, or severe renal impairment, including patients with ESRD.

Exposure of SNAC, an absorption enhancer in the oral formulation, increased with increasing renal impairment; not considered clinically relevant. Data lacking on the long-term safety of SNAC in patients with renal impairment. No effects of hemodialysis on pharmacokinetics of orally administered semaglutide or SNAC.

Disease of the Upper GI Tract

No clinically important pharmacokinetic differences between patients with type 2 diabetes mellitus with or without upper GI disease (chronic gastritis and/or gastroesophageal reflux disease) who received oral semaglutide once daily for 10 consecutive days.

Common Adverse Effects

Oral administration (≥5%): Nausea, abdominal pain, diarrhea, decreased appetite, vomiting, constipation.

Sub-Q administration with Ozempic (≥5%): Nausea, vomiting, diarrhea, abdominal pain, constipation.

Sub-Q administration with Wegovy (≥5%): 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, nasopharyngitis.

Drug Interactions

Low potential to inhibit or induce CYP enzymes or to inhibit drug transporters.

Orally Administered Drugs

Possible decreased rate and extent of absorption of concomitantly administered oral drugs; use caution with concomitantly administered oral drugs. In clinical pharmacology trials, sub-Q semaglutide did not affect the absorption of orally administered drugs (e.g., atorvastatin, digoxin, metformin, ethinyl estradiol, levonorgestrel, warfarin) to any clinically important extent.

No clinically important effects of oral semaglutide on absorption of other drugs (e.g., digoxin, ethinyl estradiol, levonorgestrel, furosemide, levothyroxine, lisinopril, metformin, omeprazole, rosuvastatin, warfarin) in drug interaction studies. Advise patients receiving oral semaglutide concomitantly with other oral drugs to closely follow oral semaglutide administration instructions. Consider increased clinical or laboratory monitoring in patients receiving concomitant therapy with drugs that have a narrow therapeutic index or that require clinical monitoring.

Specific Drugs

Semaglutide Pharmacokinetics

Absorption

Bioavailability

Sub-Q administration: 89–94% (absolute); exposure similar with administration in abdomen, thigh, or upper arm.

Oral administration (coformulated with salcaprozate sodium [SNAC] to facilitate absorption): 0.4–1% (absolute).

Peak plasma concentration achieved in 1 hour (oral administration) or 1–3 days (sub-Q administration). Steady state achieved after 4–5 weeks with oral or sub-Q dosing.

Distribution

Plasma Protein Binding

>99%.

Elimination

Metabolism

Mainly proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain.

Elimination Route

Mainly excreted in urine and feces. Approximately 3% of a dose is excreted in urine as unchanged drug.

Half-life

Elimination half-life is approximately 1 week.

Stability

Storage

Oral

20–25°C in original container; may expose to 15–30°C. Protect from moisture.

Parenteral

Injection

Ozempic: Before first use, store in refrigerator (2–8°C); do not freeze. After first use, can be stored at room temperature (15–30ºC) or refrigerated (2–8°C). Do not freeze and do not use if frozen; protect from excessive heat and light. When refrigerated, do not place injection pens directly next to the cooling element. Discard injection pen 56 days after first use.

Wegovy: Refrigerate between 2–8°C; do not freeze and protect from light. If needed, the pen can be stored at 8–30°C for up to 28 days prior to cap removal,. Store in the original carton until time of administration. Discard single-use prefilled pens after use.

Actions

• Long-acting GLP-1 receptor agonist; 94% amino acid sequence homology to endogenous human GLP-1.

• Stimulates insulin release in the presence of elevated glucose concentrations, suppresses glucose-dependent glucagon release, and slows gastric emptying, resulting in lower fasting and postprandial blood glucose concentrations and weight loss in patients with type 2 diabetes mellitus.

• Long-acting GLP-1 receptor agonists (e.g., albiglutide [no longer commercially available in the US], dulaglutide, exenatide extended-release, liraglutide, semaglutide) induce marked reductions in fasting plasma glucose (by stimulating insulin secretion) and modest reductions in postprandial glucose, while short-acting GLP-1 receptor agonists (e.g., exenatide, lixisenatide), have less of an effect on fasting plasma glucose concentrations and more of an effect on reducing postprandial glucose concentrations (by slowing gastric emptying and inhibiting glucagon secretion).

• Does not appear to be associated with clinically important prolongation of the corrected QT interval (QT_c).

Advice to Patients

• Advise patients to read the medication guide and instructions for use prior to initiating therapy and each time prescription is refilled.

• Inform patients that semaglutide causes thyroid C-cell tumors in rats and that the relevance of this finding in humans is unknown. Advise patients receiving semaglutide to report symptoms such as a lump in the neck, hoarseness, dysphagia, or dyspnea, which may be suggestive of thyroid cancer.

• Inform patients of the possibility of pancreatitis with semaglutide therapy. Inform patients about signs and symptoms of pancreatitis, including persistent severe abdominal pain sometimes radiating to the back that may or may not be accompanied by vomiting; stress importance of patient discontinuing semaglutide and promptly notifying clinician if such signs or symptoms occur.

• Inform patients to contact a clinician if changes in vision are experienced during treatment with semaglutide.

• Inform patients that they should never share injection pens containing semaglutide with another person, even if the needle is changed; sharing of the pen may pose a risk of transmitting or acquiring infection.

• Inform patients of the potential risk of dehydration due to adverse GI effects; advise patients to drink fluids to avoid dehydration. Inform patients of the potential risk for worsening renal function, which in some cases may require dialysis.

• Inform patients of the possibility of serious allergic or hypersensitivity reactions (e.g., anaphylaxis). Instruct patients to discontinue semaglutide and promptly seek medical advice if symptoms of a serious hypersensitivity reaction (e.g., swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or itching; fainting or feeling dizzy; very rapid heart rate) occur.

• Provide information regarding the potential risks and advantages of semaglutide therapy and of alternative modes of treatment.

• If the drug is being used as an antidiabetic agent, instruct the patient regarding diabetes self-management practices, such as regular physical activity, adhering to meal planning, periodic blood glucose monitoring, HbA_1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of other diabetic complications. Advise patients to seek medical advice promptly during periods of stress (e.g., fever, trauma, infection, surgery) as medication requirements may change.

• Advise patients that the most common adverse effects of oral semaglutide are nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation and that the most common adverse effects of sub-Q semaglutide therapy are nausea, vomiting, diarrhea, abdominal pain, and constipation. Advise patients that nausea, vomiting, and diarrhea are most common when first initiating oral or sub-Q semaglutide therapy but these effects decrease over time in most patients.

• Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during semaglutide treatment.

• Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or behaviors, they should stop taking the drug.

• Advise patients to inform clinicians if they are or plan to become pregnant or plan to breast-feed. Breast-feeding is not recommended during treatment with oral semaglutide due to the unknown potential for serious adverse effects from accumulation of salcaprozate sodium (SNAC), an absorption enhancer in the oral formulation, in milk; alternative formulations of semaglutide (i.e., injection) are available for use during lactation. Advise patients who are exposed to the Wegovy preparation during pregnancy to contact the manufacturer at 1-800-727-6500.

• Stress importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

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