Medically reviewed by Drugs.com. Last updated on Nov 27, 2019.
Applies to the following strengths: 2 mg/1.5 mL; 3 mg; 7 mg; 14 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
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 at least 30 days at 7 mg/day, may increase to 14 mg orally once a day
Maintenance dose: 7 to 14 mg/day
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended)
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 at 0.5 mg/week, may increase dose 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 their 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 their last subcutaneous injection
-No equivalent oral dose is recommended to replace a subcutaneous dose of 1 mg weekly
-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 is not recommended as a first-line therapy due to the uncertain relevance of rodent C-cell tumor findings to humans.
-This drug has not been studied in patients with a history of pancreatitis; other antidiabetic therapies should be considered in these patients.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Concomitant Use of an Insulin Secretagogue (e.g., Sulfonylurea) or Insulin:
-Risk of hypoglycemia may be lowered by a reducing the dose of the insulin secretagogue or insulin
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.
-Hypersensitivity to active substance or any product components
-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.
No adjustment recommended with ESRD; however, no specific data is available for dialysis
-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 whole, do not split, crush or chew tablets
-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
-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
-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 administration may be changed if the time between doses is greater than 48 hours
-Dispense and store in original carton; store tablets in original blister card until use to protect from moisture
-Refrigerate prior to first use (36F to 46F; 2C to 8C); do not freeze and do not use if it has been frozen
-After first use, may store at controlled room temperature (59F to 86F; 15C to 30C) or refrigerate; use within 56 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.
-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 antidiabetic therapies should be considered in patients with a history of pancreatitis.
-This drug is not recommended as a first-line therapy due to the uncertain human relevance of rodent C-cell tumor findings.
-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.
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy
-Monitor renal function in patients experiencing severe gastrointestinal events
-Observe for signs and symptoms of pancreatitis
-Monitor for worsening diabetic retinopathy
-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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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