semaglutide (Rx)

Brand and Other Names:Ozempic, Rybelsus, more...Wegovy

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, prefilled, single-dose pen (Ozempic)

  • 2mg/1.5mL (1.34mg/mL); delivers doses of 0.25mg or 0.5mg per injection
  • 4mg/3mL (1.34mg/mL); delivers 1mg per injection
  • 8mg/3mL (2.68 mg/mL); delivers 2mg per injection

injection, prefilled, single-dose pen (Wegovy)

  • 0.25mg/0.5mL
  • 0.5mg/0.5mL
  • 1mg/0.5mL
  • 1.7mg/0.75mL
  • 2.4mg/0.75mL

oral tablet (Rybelsus)

  • 3mg
  • 7mg
  • 14mg

Type 2 Diabetes Mellitus

SC (Ozempic)

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM)
  • Also indicated to reduce risk of major adverse cardiovascular events (MACE) (eg, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with T2DM and established cardiovascular disease
  • 0.25 mg SC qWeek for 4 weeks initially; THEN increase to 0.5 mg qWeek
  • If glycemic control not achieved after at least 4 weeks on 0.5-mg dose, can increase to 1 mg qWeek
  • If glycemic control not achieved after at least 4 weeks on 1-mg dose, may increase to 2 mg qWeek; not to exceed 2 mg/week
  • Note: The initial 0.25-mg dose is intended for treatment initiation and is not effective for glycemic control

Oral (Rybelsus)

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Initial: 3 mg PO qDay x30 days; the 3-mg dose is intended for treatment initiation and is not effective for glycemic control
  • After 30 days on 3 mg/day: Increase to 7 mg PO qDay
  • After 30 days on 7 mg/day: May increase dose to 14 mg PO qDay if additional glycemic control needed
  • Note: Taking two 7-mg tablets to achieve 14 mg dose is not recommended

Switching between Ozempic (SC) and Rybelsus (PO)

  • Taking 14 mg/day PO: Transition to 0.5 mg SC qWeek on day after last PO dose
  • Taking 0.5 mg/week SC: Transition to 7mg or 14 mg PO starting up to 7 days after last SC injection
  • There is no equivalent PO dose for the 1-mg SC dose

Weight Management

Wegovy only

Indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia)

Initiate with low dose and gradually escalate to maintenance dose of 2.4 mg/week SC to minimize GI adverse reactions

If unable to tolerate a dose during escalation, consider delaying dose escalation for 4 weeks

If unable to tolerate maintenance dose of 2.4 mg once-weekly, may temporarily decreased to 1.7 mg once weekly, for a maximum of 4 weeks; after 4 weeks, increase back to maintenance 2.4 mg once-weekly; discontinue if not tolerated after second attempt

In patients with type 2 diabetes, monitor blood glucose before initiating and during treatment

Once weekly SC dose escalation schedule

  • Weeks 1-4: 0.25 mg
  • Weeks 5-8: 0.5 mg
  • Weeks 9-12: 1 mg
  • Week 13-16: 1.7 mg
  • Week 17 and onward: 1.7 mg or 2.4 mg (maintenance)

Dosage Modifications

Renal or hepatic impairment

  • No dosage adjustment required

Upper GI tract disease

  • PO: No dosage adjustment required

Dosing Considerations

Limitations of use

  • Not studied in patients with a history of pancreatitis
  • Ozempic, Rybelsus (T2DM)
    • SC semaglutide is not a substitute for insulin
    • Not indicated for type 1 diabetes mellitus or for treatment of diabetic ketoacidosis, as it would not be effective in these settings
  • Wegovy (weight management)
    • Contains semaglutide and should not be coadministered with other semaglutide-containing products or with any other GLP-1 receptor agonist
    • Safety and effectiveness in combination with other products intended for weight loss, including prescription drugs, OTC drugs, and herbal preparations, have not been established

Dosage Forms & Strengths

injection, prefilled, single-dose pen (Wegovy)

  • 0.25mg/0.5mL
  • 0.5mg/0.5mL
  • 1mg/0.5mL
  • 1.7mg/0.75mL
  • 2.4mg/0.75mL

Weight Management

Wegovy only

Indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged ≥12 years with an initial BMI at ≥95th percentile standardized for age and sex (obesity)

Refer to prescribing information for BMI cut-offs for obesity by sex and age for pediatric patients aged ≥12 years (CDC Criteria)

Once weekly SC dose escalation schedule

  • Weeks 1-4: 0.25 mg SC qWeek
  • Weeks 5-8: 0.5 mg SC qWeek
  • Weeks 9-12: 1 mg SC qWeek
  • Week 13-16: 1.7 mg SC qWeek

Maintenance dosage

  • Week 17 and onward: 2.4 mg SC qWeek
  • Unable to tolerate maintenance 2.4 mg once-weekly dosage: May reduce maintenance dosage to 1.7 mg SC qWeek
  • Unable to tolerate 1.7 mg-dose: Discontinue treatment

Dosage Modifications

Renal impairment

  • All severities, including end-stage renal disease: No dosage adjustment necessary

Hepatic impairment

  • All severities: No dosage adjustment necessary

Dosing Considerations

Limitations of use

  • Wegovy
    • Do NOT combine with other semaglutide-containing products or with any other GLP-1 receptor agonist
    • Safety and effectiveness in combination with other products intended for weight loss, including prescription drugs, OTC drugs, and herbal preparations, not established
    • Not studied in patients with a history of pancreatitis
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Interactions

Interaction Checker

and semaglutide

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (25)

                • chlorpropamide

                  semaglutide, chlorpropamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk.

                • glimepiride

                  semaglutide, glimepiride. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • glipizide

                  semaglutide, glipizide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • glyburide

                  semaglutide, glyburide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • ifosfamide

                  ifosfamide, semaglutide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Monitor renal function.

                • insulin aspart

                  semaglutide, insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin aspart protamine/insulin aspart

                  semaglutide, insulin aspart protamine/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin degludec

                  semaglutide, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin detemir

                  semaglutide, insulin detemir. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin glargine

                  semaglutide, insulin glargine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin glulisine

                  semaglutide, insulin glulisine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin inhaled

                  semaglutide, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin isophane human/insulin regular human

                  semaglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin lispro

                  semaglutide, insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin lispro protamine/insulin lispro

                  semaglutide, insulin lispro protamine/insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin NPH

                  semaglutide, insulin NPH. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • insulin regular human

                  semaglutide, insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.

                • lonapegsomatropin

                  lonapegsomatropin decreases effects of semaglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.

                  lonapegsomatropin decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.

                • nateglinide

                  semaglutide, nateglinide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • repaglinide

                  semaglutide, repaglinide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • somapacitan

                  somapacitan decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.

                • somatrogon

                  somatrogon decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.

                • somatropin

                  somatropin decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.

                • tolazamide

                  semaglutide, tolazamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                • tolbutamide

                  semaglutide, tolbutamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin secretagogues with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin secretagogue dose may reduce hypoglycemia risk. .

                Minor (0)

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                  Adverse Effects

                  >10%

                  (SC, Ozempic)

                  • Nausea (15.8-20.3%)
                  • Documented symptomatic hypoglycemia, adjunctive therapy [≤70 mg/dL glucose threshold] (16.7-29.8%)
                  • Severe or symptomatic hypoglycemia, adjunctive therapy [≤56 mg/dL glucose threshold] (8.3-10.7%)

                  (SC, Wegovy)

                  • Nausea (44%)
                  • Diarrhea (30%)
                  • Vomiting (24%)
                  • Constipation (24%)
                  • Abdominal pain (20%)
                  • Headache (14%)
                  • Fatigue (11%)

                  (PO)

                  • Nausea (11-20%)
                  • Abdominal pain (10-11%)

                  1-10%

                  (SC, Ozempic)

                  • Vomiting (5-9.2%)
                  • Diarrhea (8.5-8.8%)
                  • Abdominal pain (5.7-7.3%)
                  • Constipation (3.1-5%)
                  • Dyspepsia (2.7-3.5%)
                  • Eructation (1.1-2.7%)
                  • Documented symptomatic hypoglycemia, monotherapy [≤70 mg/dL glucose threshold] (1.6-3.8%)
                  • Flatulence (0.4-1.5%)
                  • GERD (1.5-1.9%)

                  (SC, Wegovy)

                  • Dyspepsia (9%)
                  • Dizziness (8%)
                  • Abdominal distension (7%)
                  • Eructation (7%)
                  • Retinal disorders (6.9%)
                  • Hypoglycemia in T2DM (6%)
                  • Flatulence (6%)
                  • Gastroenteritis (6%)
                  • GERD (5%)
                  • Gastritis (4%)
                  • Gastroenteritis viral (4%)
                  • Hair loss (3%)
                  • Cholelithiasis (1.6%)
                  • Injection site reactions (1.4%)

                  (PO)

                  • Diarrhea (9-10%)
                  • Decreased appetite (6-9%)
                  • Vomiting (6-8%)
                  • Constipation (5-6%)
                  • Abdominal distension (2-3%)
                  • Dyspepsia (0.6-3%)
                  • GERD (2%)
                  • Gastritis (2%)
                  • Eructation (0.6-2%)
                  • Flatulence (1-2%)
                  • Cholelithiasis (1%)

                  <1%

                  (SC, Ozempic)

                  • Gastritis (0.4-0.8%)
                  • Cholelithiasis (0.4%)
                  • Fatigue (>0.4%)
                  • Dysgeusia (>0.4%)
                  • Dizziness (>0.4%)
                  • Injection site reaction (0.2%)

                  (SC, Wegovy)

                  • Hypotension and syncope
                  • Appendicitis
                  • Acute kidney injury
                  • Cholecystitis

                  Frequency Not Defined

                  PO

                  • Increased amylase and lipase
                  • Increased HR
                  • Hypersensitivity: Anaphylaxis, angioedema, rash, urticaria

                  Postmarketing Reports

                  Gastrointestinal disorders: Ileus, acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death

                  Hypersensitivity: Anaphylaxis, angioedema, rash, urticaria

                  Renal and urinary disorders: Acute kidney injury

                  Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy

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                  Warnings

                  Black Box Warnings

                  In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures; unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined

                  Contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2

                  Advise patients of the potential risk for MTC with semaglutide and the possible symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness)

                  Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with semaglutide

                  Contraindications

                  Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2

                  Known hypersensitivity to semaglutide or to any of the product components

                  Cautions

                  Based on findings in rats and mice, semaglutide may cause thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined

                  In control trials, acute pancreatitis was reported (0.3 events [SC] and 0.1 events [PO] per 100 patient years); after initiating treatment, monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting); if pancreatitis suspected, discontinue semaglutide and do not restart if confirmed

                  Patients treated with semaglutide showed an increased risk of diabetic retinopathy complications compared with placebo/comparator; rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy

                  Semaglutide pens must never be shared between patients, even if the needle is changed; pen-sharing poses a risk for transmission of blood-borne pathogens

                  Postmarketing reports describe acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists; a majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration; monitor renal function when initiating or escalating doses of semaglutide in patients reporting severe adverse GI reactions

                  Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists; if hypersensitivity reactions occur, discontinue treatment, treat promptly, and monitor until signs and symptoms resolve

                  Acute gallbladder disease events (eg, cholelithiasis, cholecystitis) reported in GLP-1 receptor agonist trials and postmarketing surveillance; if suspected, gallbladder studies and appropriate clinical follow-up are indicated

                  Wegovy only

                  • Cholelithiasis reported; substantial or rapid weight loss can increase risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in treated patients than in placebo-treated patients, even after accounting for the degree of weight loss; if suspected, gallbladder studies and appropriate clinical follow-up are indicated
                  • Can cause hypoglycemia
                  • Heart rate increased (mean 1-4 bpm); 10-19 bpm (41%); 20 bpm (26%)
                  • Suicidal behavior and ideation reported in clinical trials with other weight management products; monitor for emergence or worsening depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior; discontinue if suicidal thoughts or behaviors experienced; avoid with history of suicidal attempts/ideation

                  Drug interactions overview

                  • Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin may increase the risk of hypoglycemia; consider a lower dose of the secretagogue or insulin to reduce risk of hypoglycemia in this setting; inform patients using concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia
                  • Exercise caution when semaglutide is concomitantly administered with oral medications; semaglutide causes a delay of gastric emptying, thereby potentially impacting oral absorption of such medications
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                  Pregnancy & Lactation

                  Pregnancy

                  Data are insufficient regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

                  Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy; should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

                  Discontinue treatment in women at least 2 months before a planned pregnancy, owing to the long washout period for semaglutide

                  Ozempic, Rybelsus: Use during pregnancy only if potential benefit justifies potential risk to fetus

                  Wegovy: May cause fetal harm; advise patients to inform healthcare provider of known or suspected pregnancy; advise patients exposed to this drug during pregnancy to contact Novo Nordisk at 1-877- 390-2760 or www.wegovypregnancyregistry.com

                  Clinical Considerations

                  • Ozempic, Rybelsus
                    • Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes; poorly controlled diabetes during pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications
                    • Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
                  • Wegovy
                    • Appropriate weight gain based on prepregnancy weight is currently recommended for all pregnant patients, including those who already are overweight or obese, because of the obligatory weight gain that occurs in maternal tissues during pregnancy

                  Animal data

                  • In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal clinical exposure based on AUC
                  • In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the MRHD (monkey); these findings coincided with marked maternal body weight loss in both animal species

                  Lactation

                  There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production

                  In lactating rats, semaglutide was detected in milk at levels 3- to 12-fold lower than in maternal plasma

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Glucagon-like peptide-1 (GLP-1) agonist

                  Diabetes type 2: Incretins, such as GLP-1, enhance glucose-dependent insulin secretion by pancreatic beta-cells, suppress inappropriately elevated glucagon secretion, and slow gastric emptying

                  Weight management: GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation

                  Absorption

                  SC

                  • Bioavailability: 89%
                  • Peak plasma time: 1-3 days
                  • Plasma concentration, steady-state
                    • 65 ng/mL (0.5 mg/week); 123 ng/mL (1 mg/week); similar exposure is achieved with SC administration of semaglutide in the abdomen, thigh, or upper arm
                    • Wegovy: 75 nmol/L; increases proportionally with doses up to 2.4 mg/week

                  PO

                  • Absolute bioavailability: 0.4-1%
                  • Peak plasma time: 1 hr
                  • Plasma concentration, steady-state: 6.7 nmol/L (7 mg/day); 14.6 nmol/L (14 mg/day)
                  • Steady-state: 4-5 weeks

                  Distribution

                  Vd: 12.5 L (SC); 8 L (PO)

                  Protein binding: >99% (bound to plasma albumin)

                  Metabolism

                  Primary route: Proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain

                  Excretion

                  Half-life: ~1 week

                  Clearance: 0.05 L/hr (SC); 0.04 L/hr (PO)

                  Excretion: Primary excretion routes are urine and feces; ~3% of absorbed dose is excreted in urine unchanged

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                  Administration

                  SC Administration (Ozempic)

                  Administer SC to abdomen, thigh, or upper arm

                  Administer once weekly, on the same day each week, at any time of the day, with or without meals

                  Day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 2 days (>48 hours)

                  Use a different injection site each week when injecting in the same body region

                  Visually inspect before use; drug should appear clear and colorless

                  Do not use semaglutide if particulate matter and coloration observed

                  When used with insulin, administer as separate injections and never mix the products; it is acceptable to inject semaglutide and insulin in the same body region but injections should not be adjacent to each other

                  Missed SC dose (Ozempic)

                  • If missed dose is ≤5 days: Administer dose as soon as possible
                  • If missed dose >5 days: Skip missed dose and administer next dose on the regularly scheduled day; patients can then resume their regular once weekly dosing schedule

                  SC Administration (Wegovy)

                  Administer SC to abdomen, thigh, or upper arm

                  The time of day and the injection site can be changed without dose adjustment

                  Administer once weekly, on the same day each week, at any time of day, with or without meals

                  Visually inspect before use; drug should appear clear and colorless

                  Do not use semaglutide if particulate matter and coloration observed

                  Missed SC dose (Wegovy)

                  • If 1 dose is missed and the next scheduled dose is >2 days away (48 hr), administer missed dose as soon as possible
                  • If 1 dose is missed and the next scheduled dose is <2 days away (48 hr), do not administer the dose; resume dosing on regularly scheduled day of the week
                  • If >2 consecutive doses are missed, resume dosing as scheduled or, if needed, reinitiate and follow dose escalation schedule, which may reduce the occurrence of GI symptoms associated with reinitiating treatment

                  Oral Administration (Rybelsus)

                  Take at least 30 minutes before first food, beverage,

                  Missed SC dose (Wegovy)

                  If 1 dose is missed and next scheduled dose is >2 days (48 hr) away, administer missed dose as soon as possible

                  If 1 dose is missed and next scheduled dose is <2 days (48 hr) away, do not administer dose; resume dosing on regularly scheduled day of the week

                  If >2 consecutive doses are missed, resume dosing as scheduled or, if needed, reinitiate, and follow dose escalation schedule to reduce the incidence of GI symptoms associated with reinitiating treatment

                  or other oral medication of the day with no more than 4 oz of plain water only

                  Waiting <30 minutes, or taking with food, beverages (other than plain water), or other oral medications decrease efficacy by decreasing semaglutide absorption

                  Waiting to take after 30 minutes to eat may increase semaglutide absorption

                  Swallow tablets whole; do not split, crush, or chew

                  Missed oral dose (Rybelsus)

                  • If dose missed, the missed dose should be skipped, and the next dose should be taken the following day

                  Storage

                  SC (Ozempic)

                  • Unused SC pens
                    • Refrigerate at 36-46ºF (2-8ºC)
                    • Do not store in freezer or directly adjacent to the refrigerator cooling element
                    • Do not freeze and do not use if frozen
                  • After first SC use
                    • Store at room temperature, 59-86°F (15-30°C) or refrigerate at 36-46ºF (2-8ºC) for up to 56 days
                    • Do not freeze
                    • Keep pen cap on when not in use
                    • Protect from excessive heat and sunlight

                  SC (Wegovy)

                  • Refrigerate at 2-8ºC (36-46ºF)
                  • If needed, prior to cap removal, the pen can be kept at 8-30ºC (46-86ºF) up to 28 days
                  • Do not freeze
                  • Protect from light; keep in original carton until time of administration
                  • Discard pen after use

                  Oral tablets

                  • Store at 68-77ºF (20-25ºC); excursions permitted to 59-86ºF (15-30ºC)
                  • Store and dispense in the original carton
                  • Store tablet in the original blister card until use to protect tablets from moisture
                  • Store product in a dry place away from moisture
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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Rybelsus oral
                  -
                  3 mg tablet
                  Rybelsus oral
                  -
                  14 mg tablet
                  Rybelsus oral
                  -
                  7 mg tablet
                  Rybelsus oral
                  -
                  7 mg tablet
                  Ozempic subcutaneous
                  -
                  2 mg/dose (8 mg/3 mL) injection
                  Ozempic subcutaneous
                  -
                  1 mg/dose (2 mg/1.5 mL) injection
                  Ozempic subcutaneous
                  -
                  1 mg/dose (4 mg/3 mL) injection
                  Ozempic subcutaneous
                  -
                  0.25 mg or 0.5 mg(2 mg/1.5 mL) injection
                  Ozempic subcutaneous
                  -
                  1 mg/dose (4 mg/3 mL) injection

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                  Additional Offers
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.