Semaglutide is a medication gaining prominence in both diabetes management and weight loss. This article provides a comprehensive overview of semaglutide, covering its mechanism of action, approved uses, potential side effects, and important considerations for those considering or currently using this drug.
What is Semaglutide?
Semaglutide is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist. It functions by mimicking the GLP-1 hormone, which is naturally released in the body after eating.
How Semaglutide Works
Semaglutide imitates the GLP-1 hormone, prompting the body to produce more insulin, which reduces blood sugar (glucose). Semaglutide interacts with the brain to suppress appetite and increase the feeling of fullness. These combined actions help you feel full longer, eat less, and maintain better control over blood sugar levels.
Semaglutide Brand Names and Uses
Semaglutide is marketed under various brand names, each approved by the FDA for specific conditions:
- Ozempic: Primarily used to control blood sugar in type 2 diabetes and help protect the kidneys.
- Rybelsus: An oral tablet also used for managing type 2 diabetes.
- Wegovy: Prescribed for long-term weight management and certain forms of liver disease.
It's important to note that while Ozempic and Rybelsus are approved for diabetes management, healthcare professionals may prescribe them off-label for weight loss.
Read also: Semaglutide Without Diet Changes
Dosage and Administration
The method of administration and dosage varies depending on the specific brand of semaglutide:
Ozempic
- Administration: Subcutaneous injection (under the skin) once weekly.
- Starting Dose: 0.25 mg for 4 weeks.
- Maintenance Dose: Can be increased to 1 mg or 2 mg once weekly if needed for additional glycemic control after at least 4 weeks on the 1 mg dosage.
- Missed Dose: Administer as soon as possible within 5 days of the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
Rybelsus
- Administration: Oral tablet taken once daily.
- Administration Instructions: Take at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. After 30 minutes, you may eat, drink, or take other oral medicines. Swallow tablets whole.
- Starting Dose: 3 mg once daily for 30 days.
- Alternative Starting Dose: 1.5 mg once daily for 30 days.
- Transitioning: Patients treated with Rybelsus 14 mg daily can be transitioned to Ozempic subcutaneous injection 0.5 mg once weekly. Patients treated with once weekly Ozempic 0.5 mg subcutaneous injection can be transitioned to Rybelsus 7 mg or 14 mg. Patients can start Rybelsus up to 7 days after their last injection of Ozempic.
Wegovy
- Administration: Subcutaneous injection (under the skin) once weekly.
- Missed Dose: Use the medicine as soon as you can and then go back to your regular schedule. Call your doctor if you miss more than 2 doses in a row of Wegovy.
- Maintenance Dosage: If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly.
Important Note: Always follow the specific instructions provided by your healthcare provider and the medication guide.
Storage Instructions
Proper storage is crucial to maintain the efficacy of semaglutide:
Ozempic
- Prior to First Use: Store in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.
- After First Use: Store the pen with the needle removed in a refrigerator or at room temperature (59°F to 86°F; 15°C to 30°C) for 56 days. Protect from heat and light. Keep the pen cap on when not in use. Always remove and safely discard the needle after each injection and store the Ozempic pen without an injection needle attached.
- Store the single-dose pen in the refrigerator from 2°C to 8°C (36°F to 46°F). If needed, prior to cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) for up to 28 days.
Wegovy
- Store in the refrigerator from 2°C to 8°C (36°F to 46°F). Protect Wegovy from light. Wegovy must be kept in the original carton until time of administration. Store at 68° to 77°F (20 to 25°C); excursions permitted to 59° to 86°F (15° to 30°C).
Rybelsus
- Store tablets in the original bottle until used to protect tablets from moisture.
Effectiveness of Semaglutide
Weight Loss
Semaglutide has demonstrated significant effectiveness in promoting weight loss. Studies have shown that individuals using semaglutide in conjunction with diet and exercise experienced substantial weight reduction compared to those who only made lifestyle changes.
- In one study, half of the participants using semaglutide lost 15% of their body weight, and nearly a third lost 20% after 68 weeks.
- Participants who incorporated only lifestyle changes lost about 2.4% of their weight.
However, it's important to note that weight regain is possible when discontinuing semaglutide. Maintaining a healthy lifestyle with diet and exercise is crucial for long-term weight management.
Read also: The Hoxsey Diet
Diabetes Management
Semaglutide is also highly effective in managing type 2 diabetes by:
- Stimulating insulin production when blood sugar levels are high.
- Slowing the emptying of the stomach, which can help regulate blood sugar levels.
Potential Side Effects
Like all medications, semaglutide can cause side effects. Most side effects tend to be mild and temporary, but it's important to be aware of potential risks.
Common Side Effects
- Gastrointestinal issues: Nausea, vomiting, diarrhea, constipation, gassiness, stomach pain, and distension (bloat).
- Other: Dizziness, fatigue, headache.
These side effects are often more pronounced when starting semaglutide and can be minimized by starting with a lower dose and gradually increasing it.
Serious Warnings and Precautions
Semaglutide carries warnings for several potential complications:
- Pancreatitis: Inflammation of the pancreas.
- Diabetic Retinopathy Complications: Worsening of pre-existing diabetic retinopathy.
- Hypoglycemia: Severely low blood sugar, especially when used with other diabetes treatments.
- Acute Kidney Injury: Sudden loss of kidney function.
- Acute Gallbladder Disease: Problems with the gallbladder.
- Hypersensitivity Reactions: Allergic reactions.
- Pulmonary Aspiration: Risk of inhaling stomach contents into the lungs during general anesthesia or deep sedation.
- Heart Rate Increase: (Specifically for Wegovy)
- Suicidal Behavior or Ideation: (Specifically for Wegovy)
- Thyroid Tumors or Thyroid Cancer: Observed in animal studies. It is not yet known whether these effects would occur in people.
Symptoms Requiring Immediate Medical Attention
Contact your doctor immediately if you experience any of the following:
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- A lump or swelling in the neck.
- Hoarseness.
- Difficulty swallowing.
- Shortness of breath.
- Severe stomach pain.
- Vision changes.
- Yellowing of the skin or eyes.
- Symptoms of low blood sugar (anxiety, blurred vision, confusion, cool, pale skin, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness).
- Signs of an allergic reaction (rash, itching, swelling, difficulty breathing).
- Decreased urination or swelling in the legs, ankles, or feet.
Who Should Avoid Semaglutide?
Semaglutide is not suitable for everyone. You should avoid semaglutide if you have:
- History of medullary thyroid cancer.
- History of gallbladder disease.
- History of pancreatitis.
- Multiple endocrine neoplasia syndrome type 2 (MEN2).
- Allergy to semaglutide or any of its ingredients.
The FDA recommends Wegovy for weight loss if you meet one of the following criteria:
- Have a body mass index (BMI) of 27kg/m2 or greater and at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.
- Have a BMI of 30kg/m2 or greater.
Special Considerations
- Pregnancy and Breastfeeding: Men and women should stop using semaglutide at least 2 months before they plan to get pregnant. Controlling diabetes is very important during pregnancy, as is gaining the right amount of weight. It is not known whether semaglutide passes into breast milk.
- Surgery: Inform your doctor or dentist if you are using semaglutide before any surgery, including dental surgery.
Drug Interactions
Semaglutide can interact with other medications, including prescription and over-the-counter drugs, vitamins, and herbal products. It is crucial to inform your doctor about all medications you are currently taking. Particular caution should be exercised when using semaglutide with other diabetes medications, such as insulin and sulfonylureas, as this can increase the risk of hypoglycemia.
Cost of Semaglutide
The cost of semaglutide can vary depending on the brand, dosage, and insurance coverage. Without insurance or manufacturer's copay cards, the approximate costs are:
- Wegovy (semaglutide injection for weight loss): About $1418 per month.
- Ozempic (semaglutide injection for type 2 diabetes): About $1051 per month.
- Rybelsus (semaglutide oral tablets for type 2 diabetes): About $1051 per month for 30 tablets.
Insurance coverage for brand-name GLP-1 medications varies and typically requires patients to meet specific medical criteria such as a qualifying BMI or related health condition.
Compounded Semaglutide
The FDA has raised concerns regarding compounded versions of semaglutide, emphasizing that these versions are not FDA-approved and may not undergo the same rigorous safety and quality reviews.
Risks of Compounded Semaglutide
- Lack of FDA Approval: Compounded drugs are not reviewed for safety, effectiveness, or quality before being marketed.
- Quality Issues: Improper storage during shipping may lead to quality issues.
- Fraudulent Products: Some products may contain false information on the label or be produced by non-existent pharmacies.
- Dosing Errors: Reports of adverse events related to dosing errors with compounded semaglutide products.
- Use of Salt Forms: Some compounders may use salt forms of semaglutide, which are different active ingredients than those used in FDA-approved drugs. The FDA does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.
FDA Recommendations
- Obtain a Prescription: Get a prescription from your doctor and fill it at a state-licensed pharmacy.
- Check Labels Carefully: Look for warning signs such as spelling errors or incorrect addresses.
- Verify Pharmacy Information: If you suspect a fraudulent product, contact the pharmacy listed on the label to verify its authenticity.
Additional Considerations
- Lifestyle Changes: Semaglutide is most effective when used in conjunction with lifestyle changes, including diet and exercise.
- Muscle Loss: Clinical trials have shown that GLP-1 agonist drugs like semaglutide can lead to a loss of lean muscle mass during treatment.
- Injection Site Rotation: When using injectable forms of semaglutide, rotate injection sites (abdomen, thigh, or upper arm) to prevent skin irritation.
- Medical Identification: Wear a medical identification bracelet or carry an ID card indicating that you are taking semaglutide.
- Travel: Keep a recent prescription and your medical history with you when traveling.
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