### SEMAGLUTIDE MED (semaglutide) for Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use SEMAGLUTIDE MED safely and effectively. See full prescribing information for SEMAGLUTIDE MED.
SEMAGLUTIDE MED injection, for subcutaneous use
**INDICATIONS AND USAGE**
SEMAGLUTIDE MED is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for investigational use in promoting weight loss, appetite suppression, and metabolic health in bodybuilding settings. Not approved for all indications in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer subcutaneously using a prefilled dosing pen.
– Adults (males and females): 0.25 mg to 2.4 mg per week, titrated gradually (2.1).
– Cycle duration: As needed for weight management, typically 12-16 weeks.
**DOSAGE FORMS AND STRENGTHS**
Solution: Variable dosing pen (0.25 mg to 2.4 mg) (3).
**CONTRAINDICATIONS**
– Hypersensitivity to semaglutide or any component of the formulation (4).
– Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (4).
– Pregnancy (4).
**WARNINGS AND PRECAUTIONS**
– Gastrointestinal effects: May cause nausea or diarrhea; monitor patient comfort (5.1).
– Hypoglycemia: Risk with concurrent insulin use; monitor glucose (5.2).
– Thyroid tumors: Monitor for thyroid abnormalities (5.3).
– Pancreatitis: Discontinue if suspected (5.4).
**ADVERSE REACTIONS**
Common adverse reactions include nausea, diarrhea, and injection site reactions (6).
**DRUG INTERACTIONS**
– Insulin or oral hypoglycemics: May enhance effects; monitor glucose (7.1).
– Oral medications: May delay absorption; adjust timing (7.2).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Monitor for organ dysfunction (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
SEMAGLUTIDE MED is indicated for investigational use in adults to promote significant weight loss, suppress appetite, improve insulin sensitivity, enhance cardiovascular health, and boost metabolic rate. It is commonly used in bodybuilding for fat reduction during cutting phases while preserving muscle mass. This product is not approved for all indications and should be used under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer subcutaneously using a prefilled dosing pen, preferably in the abdomen, thigh, or upper arm. Start at a low dose and titrate gradually to minimize gastrointestinal side effects.
– Adults (males and females): Initiate at 0.25 mg once weekly for 4 weeks, then increase as tolerated to 0.5 mg, 1 mg, 1.7 mg, or up to 2.4 mg weekly.
– Cycle duration: Typically 12-16 weeks for weight management, adjusted based on response and tolerance. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Use sterile technique for administration. Inspect solution for clarity; do not use if discolored or particulate matter is present. Store pens as per instructions.
**3 DOSAGE FORMS AND STRENGTHS**
Supplied as a prefilled dosing pen delivering 0.25 mg to 2.4 mg semaglutide per dose.
**4 CONTRAINDICATIONS**
SEMAGLUTIDE MED is contraindicated in:
– Patients with known hypersensitivity to semaglutide or excipients.
– Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 due to thyroid tumor risk.
– Pregnant women (Category X).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Gastrointestinal Effects**
May cause nausea, vomiting, or diarrhea, particularly during dose escalation. Monitor patient comfort and reduce dose or discontinue if severe.
**5.2 Hypoglycemia**
Risk of hypoglycemia when used with insulin or sulfonylureas, particularly in patients with diabetes. Monitor blood glucose levels and adjust antidiabetic therapy as needed.
**5.3 Thyroid Tumors**
Animal studies suggest a risk of thyroid C-cell tumors; monitor for thyroid abnormalities, such as neck masses or dysphagia, and discontinue if suspected.
**5.4 Pancreatitis**
May cause acute pancreatitis; monitor for symptoms like severe abdominal pain. Discontinue immediately if pancreatitis is suspected.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Gastrointestinal: Nausea, vomiting, diarrhea, constipation.
– General: Fatigue, headache.
– Local: Injection site reactions (pain, erythema, swelling).
– Metabolic: Hypoglycemia (with insulin or sulfonylureas).
Serious reactions may include pancreatitis, thyroid tumors, or hypersensitivity responses.
**7 DRUG INTERACTIONS**
**7.1 Insulin or Oral Hypoglycemics**
Concurrent use with insulin or sulfonylureas may increase hypoglycemia risk. Monitor glucose levels closely and adjust doses as needed.
**7.2 Oral Medications**
May delay gastric emptying, affecting absorption of oral medications. Administer oral drugs at least 1 hour before semaglutide or adjust timing.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm based on animal data. Contraindicated in pregnant women.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Limited data available; monitor for age-related organ dysfunction, particularly gastrointestinal or renal issues.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with semaglutide, but misuse for weight loss may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include severe nausea, vomiting, or hypoglycemia. Treat symptomatically, including glucose administration if needed, and discontinue use.
**11 DESCRIPTION**
SEMAGLUTIDE MED contains semaglutide, a long-acting GLP-1 receptor agonist. Supplied as a prefilled dosing pen for subcutaneous injection. Half-life: Approximately 7 days. Note: Ethyl oleate and ricinus oil are not used in this formulation, as it is water-based.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Semaglutide activates GLP-1 receptors, promoting insulin secretion, suppressing appetite,
