WeightLossbyRugiet

Important Safety Information

Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used as a treatment for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obesity) or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Rugiet-affiliated provider may recommend certain doses of semaglutide based on your medical evaluation.

IMPORTANT: This is a summary and does not have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Limitations of Use:

  • Semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.
  • The safety and efficacy of coadministration with other products for weight management have not been established.
  • Semaglutide has not been studied in patients with a history of pancreatitis.

WARNING: RISK OF THYROID C-CELL TUMORS

See full prescribing information for complete boxed warning.

  • In rodents, semaglutide causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not take semaglutide if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
  • Have been diagnosed with insulin-dependent diabetes.
  • Have been diagnosed with pancreatitis or history of pancreatitis.
  • Have a known allergy to semaglutide/any other GLP-1 drug or any of the inactive ingredients in semaglutide. Inactive ingredients include: di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.
  • Have a history of suicidal attempts or active suicidal ideation.

WARNINGS AND PRECAUTIONS

  • Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
  • Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary.
  • Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of semaglutide in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
  • Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported post marketing. Discontinue semaglutide if suspected and promptly seek medical advice.
  • Females and males of reproductive potential: Discontinue semaglutide at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue semaglutide immediately.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
  • Heart Rate Increase: Monitor heart rate at regular intervals.
  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue semaglutide if symptoms develop.

Side Effects:

Most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS:

Semaglutide delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue semaglutide.
  • Females and Males of Reproductive Potential: Discontinue semaglutide at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
  • Lactation: There are no data on the presence of semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.