Usual Adult Dose for Diabetes Type 2

Oral Tablets:
Initial dose: 3 mg orally once a day for 30 days; then 7 mg orally once a day

• Titration: If additional glycemic control is needed after receiving 7 mg/day for at least 30 days, may increase to 14 mg orally once a day

Maintenance dose: 7 to 14 mg orally once a day
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended)

Subcutaneous Administration:
Initial dose: 0.25 mg subcutaneously once a week for 4 weeks, then 0.5 mg subcutaneously once a week

• If additional glycemic control is needed after at least 4 weeks receiving 0.5 mg dose subcutaneously once a week, may increase to 1 mg subcutaneously once a week

Maintenance dose: 0.5 to 1 mg subcutaneously once a week
Maximum dose: 1 mg/week

Switching between Subcutaneous Administration and Oral Tablets:

• Patients receiving 14 mg orally once a day can be transitioned to 0.5 mg subcutaneously once a week; subcutaneous administration should start after last oral dose
• Patients receiving 0.5 mg subcutaneously once a week can be transitioned to 7 or 14 mg orally once a day; oral therapy should start up to 7 days after last subcutaneous injection
• No equivalent oral dose is recommended to replace a subcutaneous dose of 1 mg weekly

Comments:

• Doses of 0.25 mg subcutaneously once a week and 3 mg orally once a day are intended for treatment initiation and are not effective doses for glycemic control.
• This drug has not been studied in patients with a history of pancreatitis; other antidiabetic therapies should be considered in these patients.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

Usual Adult Dose for Cardiovascular Risk Reduction

Oral Tablets:
Initial dose: 3 mg orally once a day for 30 days; then 7 mg orally once a day

• Titration: If additional glycemic control is needed after receiving 7 mg/day for at least 30 days, may increase to 14 mg orally once a day

Maintenance dose: 7 to 14 mg orally once a day
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended)

Subcutaneous Administration:
Initial dose: 0.25 mg subcutaneously once a week for 4 weeks, then 0.5 mg subcutaneously once a week

• If additional glycemic control is needed after at least 4 weeks receiving 0.5 mg dose subcutaneously once a week, may increase to 1 mg subcutaneously once a week

Maintenance dose: 0.5 to 1 mg subcutaneously once a week
Maximum dose: 1 mg/week

Switching between Subcutaneous Administration and Oral Tablets:

• Patients receiving 14 mg orally once a day can be transitioned to 0.5 mg subcutaneously once a week; subcutaneous administration should start after last oral dose
• Patients receiving 0.5 mg subcutaneously once a week can be transitioned to 7 or 14 mg orally once a day; oral therapy should start up to 7 days after last subcutaneous injection
• No equivalent oral dose is recommended to replace a subcutaneous dose of 1 mg weekly

Comments:

• Doses of 0.25 mg subcutaneously once a week and 3 mg orally once a day are intended for treatment initiation and are not effective doses for glycemic control.
• This drug has not been studied in patients with a history of pancreatitis; other antidiabetic therapies should be considered in these patients.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

Usual Adult Dose for Weight Loss

Initial Dose Escalation Schedule:

• Weeks 1 through 4: 0.25 mg subcutaneously once a week
• Weeks 5 through 8: 0.5 mg subcutaneously once a week
• Weeks 9 through 12: 1 mg subcutaneously once a week
• Weeks 13 through 16: 1.7 mg subcutaneously once a week

Maintenance Dose:

• Week 17 and onward: 2.4 mg subcutaneously once a week

Dosing Considerations:

• If dose escalation is not tolerated, consider delaying dose escalation for 4 weeks
• If the maintenance dose of 2.4 mg once a week is not tolerated, the dose can be temporarily decreased to 1.7 mg once a week for a maximum of 4 weeks
• After 4 weeks, increase dose back to 2.4 mg once a week; discontinue therapy if the patient cannot tolerate the maintenance dose of 2.4 mg once a week

Comments:

• For patients with type 2 diabetes, blood glucose should be monitored at baseline and during treatment.
• This drug should not be coadministered with other semaglutide-containing products or with any other GLP-1 receptor agonist.
• The safety and effectiveness of using this drug in combination with other weight loss products have not been established.
• This drug has not been studied in patients with a history of pancreatitis.

Uses: 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 or greater, OR 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Concomitant use of an insulin secretagogue (e.g., sulfonylurea) or insulin increases the risk of hypoglycemia, including severe hypoglycemia

• A reduced dose of insulin secretagogue or insulin may be needed

Precautions

US BOXED WARNING: Risk of Thyroid C-Cell Tumors:

• In rodents, this drug causes dose-dependent and treatment-duration dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether this drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance has not been determined.
• This drug is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Counsel patients regarding the risk of MTC and inform them of symptoms of thyroid tumors (e.g., 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 receiving this drug.

CONTRAINDICATIONS:

• A prior serious hypersensitivity reaction to semaglutide or to any product excipients; serious

hypersensitivity reactions including anaphylaxis and angioedema have been reported (subcutaneous formulation)

• Hypersensitivity to active substance or any product components (oral formulation)
• Personal or family history of medullary thyroid carcinoma (MTC)
• Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended with ESRD; however, no specific data is available for dialysis

Other Comments

Administration advice:
Oral Tablets:

• Take orally with no more than 4 ounces of plain water at least 30 minutes before the first food, beverage, or other oral medications of the day; waiting less than 30 minutes or taking with food, beverages other than plain water will decrease the absorption of this drug; waiting more than 30 minutes to eat may increase the absorption of this drug
• Swallow tablet whole, do not split, crush or chew
• Taking two 7 mg tablets to achieve a 14 mg dose is not recommended

MISSED DOSE: If a dose is missed, skip the missed dose and resume regular schedule

Subcutaneous Injection:

• Administer subcutaneously once a week into the abdomen, thigh, or upper arm; use a different injection site each week when injecting in the same body region
• Administer on the same day each week; may give at any time of the day, with or without meals
• When administering with insulin, administer as separate injections; it is okay to give in the same body region, but the injections should not be adjacent to each other
• Never share a pen between patients, even if the needle is changed; do not reuse or share needles or syringes between patients as this presents a risk for transmission of blood-borne pathogens

MISSED DOSE for TYPE 2 DIABETES:

• If a dose is missed, administer as soon as possible within 5 days after the missed dose; if more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day, resume regular once a week dosing
• Day of weekly administration may be changed as long as the time between doses is greater than 48 hours

MISSED DOSE for WEIGHT LOSS:

• If 1 dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer as soon as possible
• If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose.; resume dosing on the regularly scheduled day of the week
• If more than 2 consecutive doses are missed, resume dosing as scheduled or, reinitiate following the dose escalation schedule, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment

Storage requirements:
Oral:

• Dispense and store in original carton; store tablets in original blister card until use to protect from moisture; store in dry place away from moisture

Parenteral:

• OZEMPIC (type 2 diabetes indication): Refrigerate prior to first use (36F to 46F; 2C to 8C); do not freeze and do not use if has been frozen; after first use, may store at controlled room temperature (59F to 86F; 15C to 30C) or refrigerate; use within 56 days
• WEGOVY (weight loss indication): Refrigerate prior to first use (36F to 46F; 2C to 8C); do not freeze and do not use if has been frozen; If needed, prior to cap removal, may store at 8C to 30C (46F to 86F) for up to 28 days
• Always remove and safely discard needle after use; store pen without needle attached
• Keep pen cap on when not in use; protect from excessive heat and sunlight

Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. Product labeling may be consulted for full instructions.

• Prefilled dial-a-dose pen: Use Novofine(R) and Novofine(R) Plus disposable needles up to 8 mm length; use a new needle for each injection

Compatibility: Do not mix with other products.

General:

• This drug lowers fasting and postprandial blood glucose; weight loss has occurred in clinical trials.
• This drug has not been studied in patients with a history of pancreatitis and other therapies should be considered in patients with a history of pancreatitis.
• In the SUSTAIN (subcutaneous semaglutide) and PIONEER (oral semaglutide) trials across subgroups of varying cardiovascular risk, semaglutide showed consistent effects on reduction in major adverse cardiovascular events (MACE) versus comparators; however, no effect was observed in subjects with prior heart failure.
• This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective.

Monitoring:

• Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy; patients with type 2 diabetes taking Wegovy should have blood glucose monitored baseline and during therapy
• Monitor renal function in patients experiencing severe gastrointestinal events
• Monitor heart rate
• Observe for signs and symptoms of pancreatitis
• Monitor for worsening diabetic retinopathy
• Monitor for symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness)
• Monitor for suicidal behavior and ideation in patients taking this drug for weight loss

Patient advice:

• Patients should be advised to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients receiving subcutaneous therapy should be advised to never share a pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens.
• Patients should be instructed to report symptoms of thyroid tumors such as a lump in their neck, persistent hoarseness, dysphagia, or dyspnea; patients should be instructed to report any changes in vision.
• Patients should be aware of the potential for gastrointestinal (GI) adverse reactions and take measures to avoid dehydration; patients should be instructed to seek medical advice if they suspect they are becoming dehydrated or for persistent and severe GI events.
• Patients should be advised of the potential for pancreatitis and instructed to stop treatment promptly and contact their healthcare provider if pancreatitis is suspected.
• Patients with diabetes should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change; patients should be aware of signs and symptoms of hypoglycemia and how it should be managed, and they should be advised to take precautions to avoid hypoglycemia while driving and using machines.
• Women of childbearing potential should speak to their healthcare provider if they are pregnant or intend to become pregnant; there may be a potential risk to the fetus.

Frequently asked questions

• Mounjaro vs Ozempic: How do they compare?
• How long does it take for Ozempic to work?
• How long does it take to lose weight on Wegovy?
• Ozempic vs Wegovy: What's the difference between them?
• How does Ozempic (semaglutide) help with weight loss?
• What is Ozempic face?
• Where and how should Ozempic be injected?
• How does semaglutide work for weight loss?
• Does Rybelsus help with weight loss?
• How long does it take for Rybelsus to start working?
• What is Rybelsus used for and how does it work?