Indications
For Diabetes: Potenza is recommended for the following uses:
- As an adjunct to diet and exercise, Potenza helps improve glycemic control in adults with type 2 diabetes mellitus.
- To decrease the risk of major cardiovascular events in adults with type 2 diabetes mellitus who also have established cardiovascular disease.
For Obesity: Potenza is used alongside a reduced-calorie diet and increased physical activity to manage chronic weight loss in adults with an initial body mass index (BMI) of:
- 30 kg/m² or more (Obesity), or
- 27 kg/m² or more (Overweight), with at least one related comorbid condition (such as hypertension, type 2 diabetes, or dyslipidemia).
Use Potenza only under the supervision of a registered healthcare provider.
Pharmacology
Semaglutide, a GLP-1 analogue, closely mirrors human GLP-1 with a 94% sequence similarity. As a GLP-1 receptor agonist, it selectively binds to and activates GLP-1 receptors, thereby enhancing insulin secretion and reducing glucagon secretion when blood glucose levels are high. Additionally, Semaglutide helps control blood sugar by slightly delaying gastric emptying. In hypoglycemic conditions, it suppresses insulin secretion while maintaining glucagon release. It also reduces body weight and fat by decreasing appetite.
Dosage & Administration
For Diabetes:
Semaglutide Tablet:
Take the tablet at least 30 minutes before your first meal, beverage, or other oral medications, using no more than 4 ounces (118 ml) of plain water.
- Starter Dose: 3 mg once daily for the first 30 days.
- Maintenance Dose: After 30 days, increase to 7 mg once daily.
- For Further Glycemic Control: If needed, increase to 14 mg once daily after at least 30 days on 7 mg.
Semaglutide Injection:
Start with 0.25 mg once a week for the first 4 weeks. After 4 weeks, increase to 0.5 mg weekly. If further glycemic control is necessary, increase to 1 mg weekly after at least 4 weeks on 0.5 mg. Weekly doses above 1 mg are not recommended. Administer the injection subcutaneously (in the abdomen, thigh, or upper arm). The weekly administration day can be changed as long as there is a 72-hour gap between doses.
Switching Between Semaglutide Tablet and Injection:
- Patients on the 0.5 mg weekly Semaglutide injection can transition to the 7 mg or 14 mg daily tablet.
- Patients on the 14 mg tablet can switch to the 0.5 mg weekly injection the day after their last tablet dose.
For Obesity:
Start with a 0.25 mg dose weekly for the first 4 weeks. If patients experience intolerance, the dose escalation may be delayed. The maintenance dose is 2.4 mg once weekly, but if patients cannot tolerate this, a temporary reduction to 1.7 mg is possible for up to 4 weeks. Doses higher than 2.4 mg are not recommended. Administer the injection weekly at any time, with or without meals, into the abdomen, thigh, or upper arm.
Use Potenza according to the guidance of a registered healthcare provider.
Interactions
- With Medications: Potenza may delay gastric emptying, potentially affecting the absorption of other oral medications.
- With Food: The absorption of Potenza can be reduced when taken with food.
Contraindications
- Potenza is contraindicated in patients with known hypersensitivity to Semaglutide or any of its components, including inactive ingredients or packaging materials.
- It should not be used in patients with a personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Not suitable for use during pregnancy or breastfeeding.
Side Effects
- Common: Nausea, stomach upset, indigestion, reflux, heartburn (GERD), abdominal pain, bloating, constipation, altered taste, fatigue, reduced appetite, flatulence, and elevated pancreatic enzymes (lipase and amylase).
- Rare: Severe allergic reactions (anaphylaxis). Seek immediate medical attention if you experience breathing difficulty, swelling of the face or throat, wheezing, rapid heartbeat, pale skin, dizziness, or weakness.
Pregnancy & Lactation
- Pregnancy: Limited exposure during clinical trials means Semaglutide should not be used during pregnancy. Discontinue use at least two months before planning to conceive.
- Lactation: Due to unknown risks of side effects on a breastfeeding infant, it is advised to discontinue Semaglutide before breastfeeding. Alternative formulations of Semaglutide are available for use during lactation.
Precautions & Warnings
- Not suitable for patients with type 1 diabetes or diabetic ketoacidosis.
- Potenza can increase heart rate, so use with caution in patients with cardiac conditions, such as tachyarrhythmias.
- Hypoglycemia risk may increase when used with insulin secretagogues (e.g., sulfonylureas). Reduce doses of insulin or secretagogues when starting treatment with Potenza.
Use in Special Populations
- Pediatrics: Safety and efficacy in children and adolescents under 18 have not been established.
- Elderly: No dose adjustments based on age.
- Renal Impairment: No dose adjustment is necessary for mild to severe renal impairment, but avoid use in patients with end-stage renal disease.
- Hepatic Impairment: No dose adjustments are required, but caution is advised.
Overdose Effects
- Overdose: Overdoses up to 4 mg have been reported, with nausea being the most common adverse reaction. There is no antidote for overdose; supportive treatment should be initiated based on clinical signs.
Dose Adjustment & Missed Dose
- Dose Adjustment: Continue current doses of metformin and thiazolidinediones when Potenza is added. If combining with sulfonylureas or insulin, dose reduction may be required to prevent hypoglycemia.
- Missed Dose: If a dose is missed, take it within 5 days. If more than 5 days have passed, skip the dose and return to the regular schedule.
Therapeutic Class
GLP-1 receptor agonists
Storage Conditions
Store the injection between 2°C and 8°C (in a refrigerator). Do not freeze. Keep out of light and out of reach of children.
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