Unlock Rapid Weight Loss with Semaglutide: Essential Prescription Guidelines You Need to Know!

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the FDA under brand names like Ozempic®, Wegovy®, and Rybelsus®. Each brand has specific indications, formulations, and dosages. Semaglutide promotes satiety, leading to reduced food intake and weight management. It is also used to maintain weight loss and may lower the risk of heart attack and stroke in individuals affected by excess weight.

Qualifying for Semaglutide

Qualifying for semaglutide isn't always straightforward, as different versions are approved for different uses. Healthcare providers consider these uses and other factors to determine eligibility.

BMI Requirements

Generally, to qualify for semaglutide for weight loss, individuals need to have a:

BMI of 30 or higher (obesity)
BMI of 27 or higher (overweight) with at least one weight-related health condition

Weight-related health conditions may include high blood pressure (hypertension), high cholesterol (dyslipidemia), type 2 diabetes, heart disease, sleep apnea, or PCOS.

Qualifying for Specific Semaglutide Brands

Ozempic®: FDA-approved for type 2 diabetes management. May be prescribed off-label for weight loss, even without type 2 diabetes, based on BMI and weight-related conditions.
Wegovy®: FDA-approved for weight loss. Typically requires a BMI of 30 or higher, or a BMI of 27 or higher with at least one weight-related condition. In March 2024, the FDA approved Wegovy® to reduce the risk of heart attack, stroke, and cardiovascular death in those with heart disease and overweight or obesity.
Rybelsus®: An oral form of semaglutide, FDA-approved for type 2 diabetes. Can be prescribed off-label for weight loss, with similar requirements to Wegovy®.
Compounded Semaglutide: Not FDA-approved, so there are no official qualifying standards. Healthcare providers may follow Wegovy® prescribing guidelines. Hers platform offers compounded GLP-1s from FDA-regulated pharmacies.

Semaglutide Dosage and Administration

Subcutaneous Injections

Subcutaneous semaglutide has a bioavailability of 89%, reaching peak concentration within 1-3 days. Steady-state exposure is achieved after 4-5 weeks of weekly administration, increasing proportionally with doses up to 2.4 mg.

Read also: Transformations with Ozempic

Administration Sites: The abdomen, thigh, or upper arm. Rotate injection sites within the same body region weekly.
Dosage Escalation: The 0.5 mg weekly dosage can be increased to 1 mg weekly if glycemic control is inadequate after 4 weeks.
Missed Dose: If a dose is missed by less than 5 days, administer it promptly and resume the regular schedule.

Oral Semaglutide

Oral semaglutide has minimal bioavailability (0.4% to 1%) due to the high homology to human GLP-1 peptide. It is co-administered with sodium N-(8-[2-hydroxybenzoyl]amino) caprylate (SNAC) to enhance absorption across the gastric mucosa.

Administration: Administer at least 30 minutes before the first food, beverage, or medication of the day, with no more than 4 ounces (120 mL) of water.
Semaglutide-naive: The recommended starting dose is 3 mg daily for 30 days, then increased to 7 mg daily. After 30 days on 7 mg, patients may consider escalating to 14 mg daily.
Converting from Ozempic®: Transitioning from semaglutide injection Ozempic® 0.5 mg weekly, one may consider switching to either 7 mg or 14 mg taken PO daily for up to 7 days after the last injection.
Missed Dose: Skip the missed dose and resume with the next scheduled dose.

Dosage Adjustments

Intolerance: If the 2.4 mg weekly dosage is not tolerated, consider reducing the dose to 1.7 mg weekly for a maximum of 4 weeks before increasing back to 2.4 mg. Discontinue if intolerance continues.
Missed Dose (Wegovy®): If the next scheduled dose is more than 2 days away, administer it as soon as possible. If less than 2 days away, skip the dose and resume the regular schedule. If 2 or more consecutive doses are missed, resume dosing as scheduled.
Renal Impairment: No dosage adjustment is necessary for mild-to-severe impairment, but caution should be exercised when initiating or escalating doses. The manufacturer advises against adjusting the dosage for patients undergoing three or more weekly hemodialysis sessions or peritoneal dialysis due to limited clinical evidence.

Efficacy of Semaglutide

STEP Trials

The Semaglutide Treatment Effect in People with Obesity (STEP) clinical trial program investigated the effects of weekly subcutaneous semaglutide (Wegovy®) on weight loss.

STEP 1: Lifestyle interventions consistent with increased physical activity were provided. Patients experienced a significant weight loss of -14.9% with semaglutide 2.4 mg, compared to -2.4% with placebo. 86.4% of patients treated with semaglutide 2.4 mg achieved a weight loss of 5% or more at 68 weeks.
STEP 4: Patients initially treated with semaglutide for 20 weeks were randomized to continue semaglutide or switch to placebo. At 68 weeks, those who continued semaglutide experienced a weight loss of -17.4%, compared to -15.2% with semaglutide vs. placebo.
STEP 8: Compared subcutaneous weekly semaglutide (Wegovy®) to subcutaneous daily liraglutide, revealing semaglutide's superiority in the primary outcome of mean percentage change in body weight.
STEP TEENS: Examined the efficacy and safety of semaglutide (Wegovy®) compared to placebo in adolescents aged 12 to less than 18 with obesity.

Weight Loss Results

In clinical trials, semaglutide 2.4 mg resulted in a significant weight loss of -14.9% compared to placebo.
86.4% of patients treated with semaglutide 2.4 mg achieved a weight loss of 5% or more at 68 weeks.
Patients continuing semaglutide therapy experienced a weight loss of -17.4% compared to -15.2% with semaglutide vs. placebo.
60-91% of patients had a weight loss of 5% or more depending on dose vs. placebo.
Semaglutide demonstrated superiority in weight loss compared with either placebo or liraglutide.

Safety and Precautions

Contraindications

You shouldn’t use semaglutide if:

You or someone in your family has had medullary thyroid carcinoma (a rare thyroid cancer).
You have multiple endocrine neoplasia syndrome type 2 (an inherited condition that causes tumors).
You’re allergic to any ingredients in semaglutide drugs.
You’re pregnant or want to try to conceive within the next two months.
You’re taking another semaglutide medication or another glucagon-like peptide-1 (GLP-1) receptor agonist.

Warnings and Precautions

Thyroid C-cell Tumors: The prescribing information includes a boxed warning regarding the potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
Gastrointestinal Adverse Reactions: Semaglutide can cause gastrointestinal issues like nausea, vomiting, diarrhea, abdominal pain, and constipation.
Hypoglycemia: GLP-1 agonists can lower blood glucose and may cause hypoglycemia, especially when used with other diabetes medications like insulin.
Pregnancy: Semaglutide is not recommended during pregnancy due to potential fetal risks. Discontinue semaglutide at least 2 months before attempting to conceive.
Breastfeeding: Insufficient data exists regarding semaglutide in human milk. The decision to use semaglutide while breastfeeding should consider the potential risk of infant exposure versus the benefits of breastfeeding.
Pediatric Patients: Wegovy® is approved for use in pediatric patients aged 12 and older with a BMI corresponding to ≥95th percentile standardized for age and sex.

Potential Side Effects

Common Side Effects: Nausea, vomiting, constipation, and diarrhea.
Serious Side Effects: Allergic reactions, change in vision, dehydration, fast or irregular heartbeat, gallbladder problems, kidney injury, pancreatitis, thoughts of suicide or self-harm, thyroid cancer.

Drug Interactions

Semaglutide may interact with insulin and other medications for diabetes, potentially increasing the risk of low blood sugar.

Compounded Semaglutide and Counterfeit Products

The FDA has issued warnings about compounded and counterfeit semaglutide preparations. Compounded drugs are not FDA-approved and may not be reviewed for safety, effectiveness, or quality.

Risks of Compounded Semaglutide

Lack of FDA Approval: Compounded drugs are not FDA-approved, meaning they haven't undergone rigorous testing for safety and efficacy.
Quality Concerns: There are concerns about the quality of compounded GLP-1 drugs, including improper storage during shipping and the use of salt forms of semaglutide.
Dosing Errors: Reports of adverse events related to dosing errors with compounded semaglutide products, resulting from patients measuring and self-administering incorrect doses.
Counterfeit Products: The FDA has identified counterfeit drugs claiming to be authentic but potentially containing the wrong ingredients or harmful substances.
Illegal Online Sales:Illegally marketed drugs may be counterfeit, contain the wrong ingredients, or have too little or too much active ingredient.

FDA Recommendations

Prescription from Licensed Provider: Only obtain drugs containing semaglutide with a prescription from a licensed health care provider.
State-Licensed Pharmacies: Obtain medicines only from state-licensed pharmacies or outsourcing facilities registered with the FDA.
Check Labels: Carefully check labels of compounded GLP-1 drugs for warning signs such as spelling errors or incorrect addresses.
Contact Pharmacy: If you receive a product with a licensed pharmacy name on the label that you think might be fraudulent, contact the pharmacy to ask if it is their product.

Mechanism of Action

Semaglutide operates as a GLP-1 receptor agonist, sharing 94% structural homology with human GLP-1. It enhances glucose-dependent insulin secretion, suppresses glucagon secretion, and slows gastric emptying. This promotes satiety, leading to a reduction in food intake.

Read also: Semaglutide Without Diet Changes

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