Compounded Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)

Please see: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf and https://www.drugs.com/semaglutide.html

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 Provider may recommend certain doses of Compound Semaglutide based on your medical evaluation.

Semaglutide (sem-a-GLOO-tide)

Indications and Use:
Compound Semaglutide is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.
Semaglutide is a glucagon-like-peptide-1 (GLP-1) receptor agonist.
• It may be used for weight management in overweight or obese patients.
• It may be used for blood sugar management in overweight or obese patients.
• It may help regulate appetite and food reward signaling in the brain.
• It may also be used for other conditions as determined by your doctor.

Cyanocobalamin is a synthetic form of B12 converted to methylcobalamin in the body.
• It can be used to supplement B12 deficiency or malabsorption.
• It may be used for other conditions as determined by your doctor.

Compounded Drug Forms: Subcutaneous injectables
Compound Semaglutide should not be used with other Semaglutide-containing products or any GLP-1 receptor agonist medicines. It is not known if Semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Semaglutide can be used in people who have had pancreatitis. It is not known if Semaglutide is safe and effective for use in children under 18 years of age.

What products are available?
These blends are available in 1mL and 5 mL fill volume in an amber vial.
• Cyanocobalamin/Semaglutide 1mg/1mg per 1 mL
• 1 mL fill volume in 5 mL vial
• 5 mL fill volume in 10 mL vial

What should the injectable product look like?
Upon visual inspection, the vial contents should appear as a clear red solution with no visible particles.

What should I tell my health care provider before I take this medicine?
• Allergy to Semaglutide
• History of medullary thyroid cancer or other thyroid C-cell cancer
• History of pancreatitis
• History of tachyarrhythmias
• Pregnant or breastfeeding

How should I use this medicine?
Follow the package directions provided by the pharmacy and by your prescriber. Your dosage is based on your medical condition and response to therapy. Follow the dosing schedule provided carefully.
• For Injectable — This medication should be given by subcutaneous injection. A subcutaneous injection (SQ) delivers medicine into the fatty layer between skin and muscle, used to give a small quantity of certain kinds of medications.
• Rotating your injection site is recommended. Commonly used injection sites include: the outer area of the upper arm, the abdomen (avoiding a 2-inch circle around the navel), or the front of the thigh.
• Wash hands and sanitize the injection site with alcohol prior to administration. Do not use the solution if it becomes cloudy, has particles, or changes color. Dispose of used needles in a Sharps container. Do not use past the beyond use date indicated on the prescription label.
• Keep medication refrigerated and discard 28 days after initial puncture.

What if I miss a dose?
• If you miss a dose within 5 days of scheduled dose, administer it as soon as possible.
• If more than 5 days has passed since missed dose, skip the missed dose, and continue with your regular dosing schedule.
• Do not take double the dose at once.

What should I watch for while using this medicine?
• Signs of an allergic reaction: hives blistering, swelling of the mouth, face, lips tongue throat, trouble breathing.
• Signs of injection site reaction: redness or itching around the administration site.
• Blood levels monitored for B12 and CBC are advised before treatment and ongoing as your prescriber deems necessary.
• Regular check-ups with your provider are recommended.

What may interact with this medicine?
• Due to the nature of the medication, Semaglutide may slow gastric emptying. This could interfere with the breakdown of other medications.
• Drug interactions exist with this medication.
• Discuss your medication regimen with your health care provider to determine the best therapy for you.

What side effects may I notice from receiving this medicine?
Possible side effects that may occur and may go away as your body gets used to the medication include:
• Gastrointestinal issues, such as
• Abdominal pain or stomach upset
• Constipation or diarrhea
• Nausea or vomiting
• Dyspepsia
• Headache
• Fatigue
• Dizziness

What serious side effects prompt immediate attention?
Contact your doctor immediately or seek medical attention if you experience:
• Neck mass
• Trouble breathing or swallowing
• Vocal hoarseness that will not go away
• Kidney problems or urinary complications
• Gallbladder problems
• Rapid heartbeat
• Eyesight changes
• Severe dizziness
• Signs of low blood sugar
• Pancreas problems
• Worsening behavioral or mood changes like depression or thoughts of self-harm You may experience side effects not listed. Contact your doctor with questions.
An allergic reaction to this medication is unlikely but seek medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, and/or trouble breathing.

Contraindications:
Hypersensitivity to Semaglutide, vitamin B12, or any component of the formulation. Semaglutide is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Where should I keep my medicine?
• Follow the storage recommendations found on your prescription label.
• Store injectable Semaglutide at refrigeration, between 36 to 46 degrees F, unless otherwise specified on the packaging.
• Protect injectables from light.

Additional Information:
• Do not share this medication with others to whom it was not prescribed.
• Keep out of reach from children and pets.
• If an overdose is suspected contact your local poison control center at 1-800-222-1222 or go to the nearest emergency room.
If you have any questions concerning this or any of your medications, contact your doctor or the pharmacy during normal business hours to answer your questions.
You may report side effects to the FDA at 1-800-FDA-1088.

**Patient Education Resources**

Understanding Obesity:
– CDC on Obesity (https://www.cdc.gov/obesity/)
– National Institute of Diabetes and Digestive and Kidney Diseases (https://www.niddk.nih.gov/health-information/weight-management)

Healthy Lifestyle Tips:
– ChooseMyPlate (https://www.choosemyplate.gov/)
– American Heart Association (https://www.heart.org/en/healthy-living)

Weight Loss Support:
– Choosing a Safe & Successful Weight Loss Program (https://www.niddk.nih.gov/health-information/weight-management/choosing-a-safe-successful-weight-loss-program)
– Obesity Action Coalition(https://www.obesityaction.org/)

**Prescriber/Doctor Information**
Melanie Maltese, NP: Extensive experience in managing chronic conditions like obesity. Committed to providing personalized and evidence-based care to each patient.

**Contact Information**
For any questions or concerns, please reach out to us:
– Phone: 208-887-4872
– Email: info@healthyhabitswc.com
– Physical Address: 14 S Baltic Pl, Meridian, ID 83642

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medication or any other medication. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does not include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. For questions about the source of any of the information provided herein, pharmacists at Belmar Pharmacy are available. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of this medicine.
This website and its content comply with FDA regulations and guidelines for prescription drug advertising. All information regarding Semaglutide is presented in a balanced manner, highlighting both benefits and risks, in accordance with the FDA’s requirements. The safety information is clearly linked to ensure that patients are fully informed about the medication they are considering.

References:
1. Clinical Resource, Comparison of GLP-1 Agonists. Pharmacist’s Letter/Prescriber’s Letter. August 2019.
1. Semaglutide. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.lexi.com. Accessed December 2022