Provided by You Health for patients

Compounded Semaglutide

for subcutaneous use

Following consultation, a You Health provider determined that Compounded Semaglutide is medically appropriate and necessary for your treatment.

Compounded semaglutide is not FDA-approved. The FDA does not verify the safety or effectiveness of compounded drugs.
The following provides a medication overview of compounded semaglutide and how to effectively and safely use it to support weight loss. You will also receive a physical document called a medication guide or patient drug information in the package with your medication when it arrives from the pharmacy, it contains full information about compounded semaglutide. Please read all of the information, specific to the medication(s) you were prescribed, before taking your medication. If you’re not sure which medication you were prescribed, please reference the label on your prescription bottle(s) or contact a member of your Care Team.
What is the most important information I should know about compounded semaglutide?
Compounded semaglutide may cause serious side effects, including:
  • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, compounded semaglutide and medicines that work like compounded semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Do not use compounded semaglutide if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Females and males of reproductive potential: Discontinue compounded semaglutide at least 2 months before a planned pregnancy because of the long half-life of compounded semaglutide.
What is compounded semaglutide?
Compounded semaglutide is an injectable prescription medicine that may help individuals with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off.
  • Compounded semaglutide should be used with a reduced-calorie diet and increased physical activity.
  • Compounded semaglutide should not be used with other semaglutide-containing products or any GLP-1 receptor agonist medicines.
  • It is not known if compounded semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
  • It is not known if compounded semaglutide can be used in people who have had pancreatitis.
  • It is not known if compounded semaglutide can be used in people who have had gastroparesis.
  • It is not known if compounded semaglutide is safe and effective for use in children under 12 years of age.
In this medication overview you will find more information for the following:
  1. Usage

    How to get the most out of your treatment

  2. Warnings

    Important safety information

  3. Side Effects

    What to look out for when using your treatment

Usage:

1. How should I use compounded semaglutide?

To get started, read the Instructions for Use AND follow your provider's dosing instructions that come with compounded semaglutide

You will begin treatment by slowly titrating up the dose of compounded semaglutide over a 3 to 4 month period, depending on the dosage plan you have been prescribed and the instructions given by your provider. All dosage schedules are shown in the table below. Once you reach your maximum dose, you will remain at this dose unless instructed otherwise.
The syringes included in your prescription shipment are marked in UNITS.
 Dosage Plan 1Dosage Plan 2Dosage Plan 3
Weeks 1 - 4Inject 8 units once per week (0.2mg)Inject 10 units once per week (0.25mg)Inject 8 units once per week (0.2mg)
Weeks 5 - 8Inject 16 units once per week (0.4mg)Inject 20 units once per week (0.5mg)Inject 16 units once per week (0.4mg)
Weeks 9 - 12Inject 30 units once per week (0.75mg)Inject 40 units once per week (1mg)Inject 30 units once per week (0.75mg)
Weeks 13+Inject 50 units once per week (1.25mg)Inject 40 units once per week (1mg)Inject 30 units once per week (0.75mg)
 
Use compounded semaglutide exactly as your healthcare provider prescribes you to use it. A healthcare provider will provide directions on how to prepare to inject your dose of compounded semaglutide before injecting the first time.
  • Compounded semaglutide is injected just under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject compounded semaglutide into a muscle (intramuscularly) or vein (intravenously). Please review this How to Inject video tutorial to learn how to successfully administer your Compound Semaglutide medication.
  • Use compounded semaglutide 1 time each week, on the same day each week, at any time of the day.
  • If you need to change the day of the week, you may do so as long as your last dose of compounded semaglutide was given 2 or more days before.
  • Do not use the same site for each injection. Change (rotate) your injection site with each weekly injection. You may use the same area of your body, but be sure to choose a different injection site in that area - the general rule is at least one inch difference.
  • You can take compounded semaglutide with or without food.
  • If you inject too much compounded semaglutide, you may have severe nausea, severe vomiting and severe low blood sugar. Go to the nearest hospital emergency room right away if you experience any of these symptoms. Once you have been evaluated, contact your provider.
2. What if I miss a dose of compounded semaglutide?
If you miss a dose of compounded semaglutide and the next scheduled dose is more than 2 days away (48 hours), take the missed dose as soon as possible. If you miss a dose of compounded semaglutide and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Take your next dose on the regularly scheduled day. If you miss your dose of compounded semaglutide for more than 2 weeks, take your next dose on the regularly scheduled day or message your care team to discuss how to restart your treatment.
3. What if I am having surgery?
It is important that you stop using compounded semaglutide 1 week before your planned procedure.
4. How should I store compounded semaglutide?
  • Store Compounded Semaglutide in the refrigerator between 36°F to 46°F (2°C to 8°C). Store Compounded Semaglutide in the original carton until use to protect it from light.
  • Do not freeze compounded semaglutide. Do not use compounded semaglutide if was frozen, if it has been exposed to light or temperatures above 86°F, or has been out of the refrigerator for 14 days or longer.
  • Keep compounded semaglutide and all medicines out of the reach of children
5. Can I drink alcohol while using compounded semaglutide?
  • Drinking alcohol while using compounded semaglutide is not strictly prohibited but while involved in a weight loss program, moderation of alcohol is recommended. Avoid driving a car or operating heavy machinery after consuming alcohol.
In case of overdose, get medical help or contact a Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.
Medication disposal
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.

If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:

  • Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
  • Place the mixture in a container such as a sealed plastic bag;
  • Throw away the container in your trash at home; and
  • Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.

How do I dispose of used syringes?

After use, discard the syringe immediately in a safe, hard-sided container with a lid, such as food storage boxes or an empty laundry detergent canister. Do not reuse a previously used syringe. Do not attempt to put the cap back on the syringe as you may poke yourself unintentionally. When your container is ¾ full, you can take the used materials to your local pharmacy or find an alternative disposal site near you for proper disposal. Syringes should never be thrown loosely into the trash, toilet or recycling bin.

Warnings

Important Safety Information
WARNING: RISK OF THYROID C-CELL TUMORS
In rodents, SEMAGLUTIDE causes thyroid C-cell tumors. It is unknown whether SEMAGLUTIDE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the 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 use compounded semaglutide if:
  • You or any of you family have ever had a type of thyroid cancer called Medullary Thyroid Carcinoma (MTC) or if you have an endocrine condition called Multiple Endocrine Neoplasia type 2 (MEN 2).
  • You have diabetes (Type 1 or 2)
  • You currently have pancreatitis or have had a history of pancreatitis
  • You have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
  • You have a history of suicidal attempts or active suicidal thoughts
  • You are allergic to compounded semaglutide, any other GLP-1 class drug, or any of the inactive ingredients in compounded semaglutide. Inactive ingredients include: di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.
Symptoms of a serious allergic reaction include:
  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat
Before using compounded semaglutide, tell your healthcare provider about all of your medical conditions, including if you:
  • Have or have had problems with your pancreas or kidneys.
  • Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • Have type 1 or type 2 diabetes, and a history of diabetic retinopathy.
  • Have or have had depression or suicidal thoughts, or mental issues.
  • Are pregnant or plan to become pregnant. Compounded semaglutide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded semaglutide. You should stop using compounded semaglutide 2 months before you plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known if compounded semaglutide passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using compounded semaglutide.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Compounded semaglutide may affect the way some medicines work, and some medicines may affect the way compounded semaglutide works.
  • Before using compounded semaglutide, tell your healthcare provider if you are taking medicines to treat diabetes, including insulin or sulfonylureas which could increase your risk of low blood sugar.
    • Compounded semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
    • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of compounded semaglutide?

Compounded semaglutide may cause serious side effects, including: In addition to the side effects listed below, please see the section titled “What is the most important information I should know about compounded semaglutide?”
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
  • Gallbladder problems. Compounded semaglutide may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
    • pain in your upper stomach (abdomen)
    • yellowing of skin or eyes (jaundice)
    • fever
    • clay-colored stools
  • Inflammation of your pancreas (pancreatitis). Stop using compounded semaglutide and get evaluated by a healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • Increased heart rate. Compounded semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
  • Serious allergic reactions. Stop using compounded semaglutide and get medical help right away by calling 911 or going to the Emergency Room if you have any symptoms of a serious allergic reaction including:
    • swelling of your face, lips, tongue or throat
    • fainting or feeling dizzy
    • problems breathing or swallowing
    • very rapid heartbeat
    • severe rash or itching
  • Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines to treat type 2 diabetes, such as sulfonylureas or insulin. Low blood sugar in patients with type 2 diabetes who receive compounded semaglutide can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking compounded semaglutide and while you take compounded semaglutide. Signs and symptoms of low blood sugar may include:
    • dizziness or light-headedness
    • blurred vision
    • anxiety, irritability, or mood changes
    • sweating
    • slurred speech
    • hunger
    • confusion or drowsiness
    • shakiness
    • weakness
    • headache
    • fast heartbeat
    • feeling jittery
  • Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with compounded semaglutide.
  • Increased heart rate. Compounded semaglutide can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take compounded semaglutide. Contact a healthcare provider right away if you feel your heart racing or pounding in your chest and it lasts for several minutes.
  • Depression or thoughts of suicide. You should pay attention to any changes in your mood, behaviors, feelings, or thoughts. Contact your healthcare provider right away if you have any changes to your mental health that are new, worse, or worry you.
The most common side effects of compounded semaglutide include: nausea, diarrhea, vomiting, stomach (abdominal pain), headache, indigestion, upset stomach, dizziness, feeling bloated, gas, stomach flu, runny nose or sore throat, belching, constipation, feeling tired (fatigue), heartburn.
These are not all the possible side effects of compounded semaglutide.
Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. Contact your healthcare provider for medical advice about side effects. You may report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
General information about the safe and effective use of compounded semaglutide.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use compounded semaglutide for a condition for which it was not prescribed. Do not give compounded semaglutide to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about compounded semaglutide that is written for health professionals.