Notice to Consumers

CONSULT WITH AN EXPERT – TALK TO YOUR PHARMACIST

Before leaving the pharmacy or using any medication, take these essential steps:

  • Verify the Patient Information: Confirm the name on the label matches the intended recipient.
  • Check the Medication: Ensure the medicine corresponds with the label description.
  • Understand Your Medication: Know its name, purpose, and benefits.
  • Usage Instructions: Learn when and how to take the medication, the recommended duration, and what to do if you miss a dose.
  • Side Effects: Be aware of potential reactions and the steps to take if they occur.
  • Drug Interactions: Confirm compatibility with other medications or supplements.
  • Diet and Lifestyle Considerations: Identify any foods, drinks, or activities to avoid during treatment.

KNOW YOUR RIGHTS

At Audeotherapy, we are dedicated to providing clear and transparent information to every patient. In line with regulations, you are entitled to the following:

  • Pharmacist Consultation: Speak with a pharmacist every time you receive a new prescription or experience a change in dosage, strength, or instructions.
  • Accessible Labels: Request prescription drug labels printed in 12-point font for improved readability.
  • Interpreter Services: Receive complimentary interpreter support if needed.

Medication Access and Safety:

  • Audeotherapy ensures all legally prescribed medications or devices are provided unless:
    • Payment for the drug or device cannot be secured; or
    • Dispensing the product would violate the law or endanger health.
  • If a product is temporarily unavailable, we will assist in securing timely access. You may also inquire about pricing or the availability of generic alternatives.

Important Reminder: Audeotherapy supplies medications and products solely for research purposes.


HOW TO FILE A COMPLAINT
If you have concerns about the pharmacy, contact:

California State Board of Pharmacy
2720 Gateway Oaks Drive, Suite 100
Sacramento, CA 95833
(916) 518-3100
www.pharmacy.ca.gov


SUPPORT HOURS
Monday–Friday: 9:00 AM – 6:00 PM PST
Saturday: 8:00 AM – 9:00 AM PST

Your well-being is our priority—reach out with any questions or concerns.

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Safety Information

Critical Details About Compounded Semaglutide

Compounded medications are legally allowed to be prescribed under federal law; however, they are not FDA-approved and do not undergo FDA evaluation for safety, efficacy, or production standards. At AudeoTherapy, compounded semaglutide is prescribed based on an individualized medical assessment.

WARNING: Potential Risk of Thyroid C-Cell Tumors
Research in animals has linked semaglutide, the active ingredient in some GLP-1 receptor agonists, to thyroid tumors, including medullary thyroid carcinoma (MTC). It is unclear if semaglutide causes similar tumors in humans. Notify your healthcare provider immediately if you notice symptoms of thyroid cancer, such as neck lumps or swelling, hoarseness, swallowing difficulties, or shortness of breath. Compounded semaglutide is not suitable for individuals with personal or family histories of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Uses of Compounded Semaglutide
Compounded semaglutide is intended for use alongside a reduced-calorie diet and increased physical activity to manage chronic weight in adults who meet the following criteria:

  • A body mass index (BMI) of 30 kg/m² or higher (classified as obesity), or
  • A BMI of 27 kg/m² or higher (overweight) with at least one weight-related condition, such as type 2 diabetes, hypertension, or abnormal cholesterol levels.

Usage Restrictions

  • Do not use compounded semaglutide in combination with other GLP-1 receptor agonists or semaglutide-containing products.
  • Its safety and effectiveness when combined with other weight management medications have not been established.
  • Patients with a history of pancreatitis or gastroparesis have not been studied for this treatment.

Avoid Use If You:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or MEN 2.
  • Are diagnosed with type 1 diabetes, pancreatitis, or gastroparesis.
  • Are allergic to semaglutide or any inactive ingredients.
  • Have a history of suicidal thoughts or behavior.

Precautions and Warnings:

  • Acute Pancreatitis: Stop using the medication if pancreatitis is suspected.
  • Gallbladder Issues: Monitor for symptoms of gallbladder disease, including gallstones, and seek medical advice as needed.
  • Low Blood Sugar: When combined with insulin or similar medications, there is an increased risk of hypoglycemia. Regularly monitor blood sugar and adjust doses as recommended by your provider.
  • Kidney Health: Monitor kidney function, particularly in patients with renal impairment or those experiencing severe gastrointestinal effects.
  • Mental Health Concerns: Watch for mood changes, depression, or suicidal thoughts, and discontinue use if these symptoms occur.

Pregnancy and Fertility Considerations
Semaglutide may harm an unborn child. Avoid use during pregnancy or if planning to become pregnant. Stop treatment at least two months before attempting to conceive.

Common Side Effects:
Frequently reported side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, fatigue, headaches, and low blood sugar in patients with type 2 diabetes.

Potential Drug Interactions:
Compounded semaglutide slows gastric emptying, which could impact the absorption of oral medications. Consult your healthcare provider to manage potential interactions effectively.

Medication Disclaimer

Essential Information on Medications: Saxenda®, Victoza®, Wegovy®, and Ozempic® are patented products of Novo Nordisk™, while Eli Lilly and Company™ produce Mounjaro™ and Zepbound. This website is not affiliated with, endorsed by, or connected to these companies or their products in any capacity. While these FDA-approved medications may be available through other sources, we do not provide them, and they are currently experiencing supply shortages. During such shortages, pharmacies might prepare compounded versions of these drugs, provided they comply with the Federal Food, Drug, and Cosmetic Act’s requirements. Compounded medications are valuable for patients with unique medical needs that FDA-approved drugs cannot address. However, it is important to note that compounded drugs are not FDA-approved, nor do they undergo premarketing evaluations for safety, effectiveness, or quality. The FDA has not assessed these medications for their intended uses, nor has the manufacturing process for compounded drugs been reviewed by the FDA.