Medication package insert for compounded semaglutide

IMPORTANT: HOW TO USE THIS INFORMATION 

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.


SEMAGLUTIDE (WEIGHT LOSS) - COMPOUNDED INJECTION (SEM-a-GLOOtide)


WHAT IS COMPOUNDED SEMAGLUTIDE? 

Semaglutide is a type of medication called a glucagon-like peptide 1 (GLP-1) receptor agonist, or “GLP-1” for short, used for the treatment of obesity and diabetes. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. The compounded semaglutide you have been prescribed uses the same active pharmaceutical ingredient as brand-name forms of semaglutide.


USES 

This medication is used with a provider-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Semaglutide is similar to a natural hormone in your body (incretin). It works by controlling your appetite.


HOW DOES SEMAGLUTIDE WORK? 

Semaglutide acts like a hormone your body naturally makes to regulate blood sugar and appetite. Like other GLP-1s, semaglutide is believed to help with weight management by slowing down how quickly food leaves your stomach, making you feel full faster and satiated for longer; and talking directly to the part of your brain in charge of feeling full, helping you regulate how much you eat. These two effects, when combined with an appropriate diet and exercise, make semaglutide an excellent tool to support healthy weight management.


HOW IS COMPOUNDED SEMAGLUTIDE PRESCRIBED? 

Compounded semaglutide typically starts at a low dose that is gradually increased over time. The typical dosing schedule of compounded semaglutide is:

Weeks 1–4: 0.25 mg once a week

Weeks 5–8: 0.5 mg once a week

Weeks 9–12: 1 mg once a week

Weeks 13–16: 2 mg once a week

Once you have reached a dose of 2 mg once a week for at least four weeks, you may remain at that dose or may transition to a higher dose of brand-name semaglutide, if available. Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.


WHAT IF YOU HAVE A PREVIOUS PRESCRIPTION? 

In the event you happen to have a previous prescription for brand-name semaglutide or another GLP-1 in addition to your compounded semaglutide, do not take both medications simultaneously. Taking two or more of these medications together increases potentially severe side effects.


HOW DO I INJECT COMPOUNDED SEMAGLUTIDE? 

Compounded semaglutide is injected once a week using the supplied syringes and needles. You may inject into your abdomen (at least two inches away from your navel), upper thigh, or upper arm. Follow the instructions under How to Use below and reach out to your healthcare team if you need more help. It may be used with or without food. The dosage is based on your medical condition and response to treatment. Your provider will start you on a low dose first to decrease your risk of stomach/abdominal side effects, and gradually increase your dose.


WHAT ARE THE SIDE EFFECTS OF COMPOUNDED SEMAGLUTIDE?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING) that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined. For a complete list of side effects, including the Boxed Warning and less common side effects like ileus, see the Side Effects

section below or your Treatment Plan.


WARNING

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). While using this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness


HOW TO USE

Read the Medication Guide and Instructions for Use provided before you start using compounded semaglutide and each time you get a refill. Learn all preparation and usage instructions. If you have questions, ask your provider or pharmacist. Each combination of syringe and needle is meant to be used only once. Do not reuse a needle or syringe.


WHEN YOUR MEDICATION ARRIVES 

The medication must be stored in the prescription bottle it comes in and placed in your refrigerator as soon as you receive it. The packaging is designed to keep your medication within

safe temperature ranges for up to 2 days. If you haven’t refrigerated your medication within 2 days of receiving it, contact us at support@carevalidate.com 


HOW TO STORE YOUR MEDICATION

Refrigerate your medication as soon as it arrives. Store the vial of medication in the prescription bottle it came in. Keep it in your refrigerator at 36º–46º F (2º–8º C). Discard any unused medication 28 days after first using the vial, or when the expiration date has passed, whichever comes first.


WHAT TO DO IF YOU HAVE A PREVIOUS PRESCRIPTION 

In the event you happen to have a previous prescription for brand-name semaglutide or another GLP-1 in addition to your compounded semaglutide, do not take both medications simultaneously. Instead, discard your previously prescribed medication. Taking two or more of these medications together increases potentially severe side effects.


WHEN TO TAKE YOUR DOSE 

Administer one dose each week, on the same day each week, at any time of day, with or without food.


WHAT TO HAVE READY

  • one (1) vial of medication
  • one (1) sterile syringe with needle
  • two (2) alcohol wipes
  • one (1) vial seal sticker
  • hard plastic resealable container to dispose of used needle and syringe


BEFORE YOU START 

Wash your hands with soap and water. Double-check the information on the vial, including the dose amount and expiration date. The medication should be clear and colorless. If it’s not, don’t use the medication and instead contact your provider for further guidance.


FILLING THE SYRINGE

  1. Gently shake the vial. If this is a new vial, remove the plastic cap. If not, remove the seal sticker you previously placed on the top. Now, clean the top of the vial with an alcohol wipe.
  2. On the syringe, remove the caps from the plunger and the needle. It’s important to keep the needle sterile, so do not touch it. 
  3. While holding the syringe with the needle pointed up, pull the plunger down to the correct dose. 
  4. Insert the needle into the rubber part of the vial top and press down on the plunger completely to inject all of the air from the syringe into the vial. Injecting the air into the medication vial makes the next step easier!
  5. While the needle is still in the vial, turn the vial upside down. Make sure the needle tip is surrounded by liquid. Pull back the plunger past your dose amount. For example, if your dose is 10 units of medication, pull the plunger back beyond the 10 units mark.
  6. Remove any air bubbles by tapping the syringe with your finger.
  7. Push the plunger to the prescribed dose level on the syringe. For example, if your prescribed dose is 10 units, push the plunger to the 10 units mark.
  8. Turn the vial upright and then remove the needle.
  9. Do not put the needle cap back on the needle. You can put the syringe down by resting it on the needle cap so the tip of the needle doesn’t touch anything.
  10. Apply a new vial seal sticker to the cap of the vial after each use. Press firmly to ensure adherence to the cap to prevent contamination.


ADMINISTERING THE INJECTION

  1. Clean the area you want to inject with an alcohol wipe and allow the skin to dry. Your abdomen (at least two inches away from your belly button), thigh (front or outer thigh), or upper arm are all good injection sites, but choose a spot that is at least one finger’s width away from the last injection spot.
    1. Change where you give the injection each time. You can inject in the same area of your body each time—just make sure it’s not in the exact same spot every time. Moving injection spots is important to minimize the formation of permanent, fatty nodules that can arise and decrease efficacy of your treatment.
  2. Hold the syringe with the needle facing toward the ceiling. Push the plunger slightly until a drop of liquid forms at the end of the needle.
  3. Pinch and hold the skin that you will inject.
  4. Holding the syringe pointing directly at the pinched skin, quickly push the needle through the skin into the fat tissue, making sure to insert the entire length of the needle. Then, slowly push the plunger to inject all of the medication.
  5. Pull the needle out and clean the skin with an alcohol wipe or tissue. It’s normal to see a drop of blood at the injection spot. Press gently on the site for a few seconds for the bleeding to stop.


DISCARDING THE SYRINGE

Discard the syringe in a sharps container or a heavy plastic container with a tight-fitting lid, like an empty detergent bottle. Do not throw away the syringe in your household trash.


Under certain circumstances, chemical degradation of drugs may occur.


Information last revised January 2024.


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