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Important Safety Information

Compounded Semaglutide

Active ingredient: semaglutide (compounded)

Boxed Warning

Risk of Thyroid C-cell Tumors

In rodent studies, this medication and other GLP-1 receptor agonists caused thyroid C-cell tumors at clinically relevant exposures. It is unknown whether this medication causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of the rodent finding could not be determined. This medication 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 potential risk for MTC and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

About Compounded Semaglutide

Compounded Semaglutide is prepared by U.S.-licensed 503A or 503B compounding pharmacies under prescription. It uses the same active molecule — semaglutide — as the branded products Wegovy® and Ozempic®.

Compounded medications are NOT FDA-approved. The FDA does not evaluate compounded products for safety, effectiveness, or quality. Prescription products require a licensed provider's evaluation.

Contraindications

Do not use if you have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use if you have a known serious hypersensitivity reaction to the medication or any of its components.

Warnings & Precautions

Risk of thyroid C-cell tumors: See Boxed Warning. Monitor for signs of thyroid tumors. Compounded Semaglutide is contraindicated in patients with a personal or family history of MTC or MEN 2.

Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed. If pancreatitis is suspected, discontinue promptly. Do not resume if pancreatitis is confirmed.

Acute gallbladder disease: Cholelithiasis and cholecystitis have been reported. Evaluate for gallbladder disease in patients who develop suggestive symptoms.

Hypoglycemia with concomitant use of insulin or insulin secretagogues: When combined, lower doses of the secretagogue or insulin may be needed.

Acute kidney injury: There have been reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis, in patients treated with GLP-1 receptor agonists. Most events occurred in patients with nausea, vomiting, diarrhea, or dehydration. Monitor renal function in patients with renal impairment.

Severe hypersensitivity reactions: Anaphylaxis and angioedema have been reported. Discontinue and seek medical advice if a severe reaction is suspected.

Diabetic retinopathy complications (in patients with type 2 diabetes): Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy. Monitor patients with a history of diabetic retinopathy for progression.

Suicidal behavior and ideation: Monitor patients for the emergence or worsening of depression, suicidal thoughts, or any unusual changes in mood or behavior. Discontinue if symptoms develop.

Most Common Adverse Reactions

The most common adverse reactions, reported in ≥5% of patients treated, are nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.

Gastrointestinal side effects are typically dose-dependent and tend to occur during dose initiation and dose escalation, decreasing over time as treatment continues.

Use in Specific Populations

Pregnancy: May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for the recommended period after the last dose. Discontinue at least 2 months before a planned pregnancy due to the long washout period.

Lactation: There are no data on the presence of this medication in human milk or its effects on the breastfed infant or on milk production. Weigh developmental and health benefits of breastfeeding against the mother's clinical need.

Pediatric use: Safety and effectiveness in pediatric patients have not been established (refer to product-specific labeling for any approved pediatric indications).

Geriatric use: Greater sensitivity in older patients cannot be ruled out. In clinical trials, no overall differences in safety or efficacy were observed between elderly and younger patients.

Hepatic / renal impairment: No dose adjustment is recommended; however, monitoring is advised in patients with severe renal impairment, given the increased risk of acute kidney injury when dehydration occurs.

Compounded Product Disclosure

† Prices reflect medication only. Bon Health charges no membership fee — the per-month price for your chosen commitment tier is what you pay, billed monthly or quarterly depending on the plan you select. Medication is dispensed only following an online consultation with a licensed healthcare provider, who determines whether a prescription is clinically appropriate based on their independent clinical judgment.

Compounded Semaglutide and Compounded Tirzepatide are not FDA-approved. The FDA does not evaluate compounded medications for safety, effectiveness, or quality. These preparations are dispensed by U.S.-licensed 503A and 503B compounding pharmacies. Prescription products require a licensed provider's evaluation.

Semaglutide is the active ingredient in Ozempic® and Wegovy®, FDA-approved products of Novo Nordisk A/S. Tirzepatide is the active ingredient in Mounjaro® and Zepbound®, FDA-approved products of Eli Lilly and Company. Bon Health is not affiliated with, sponsored by, or endorsed by Novo Nordisk A/S or Eli Lilly and Company. Ozempic®, Wegovy®, Mounjaro®, and Zepbound® are registered trademarks of their respective owners.

Availability varies from state to state. Prescription required. Weight Loss by Bon Health is a doctor-guided program that includes ongoing clinical support, direct messaging with your care team, and medications prescribed based on what your provider determines is medically appropriate and necessary for you.

This page is a layperson summary of publicly available safety information and is provided for general education. It does NOT replace the full prescribing information or the judgment of a licensed clinician. Always speak with your healthcare provider before starting, changing, or stopping any medication.

Medical emergency?Call 911 or go to the nearest emergency room. If you are in crisis, call or text 988 for the Suicide and Crisis Lifeline.