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Compounded Sermorelin Safety Information

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 Ivim Health provider may recommend certain doses of compounded sermorelin based on your medical evaluation.  

Indications and Use: 

Compounded sermorelin is a prescription medicine that may help adults with increasing muscle mass, energy and endurance and prevent sarcopenia, especially while on a reduced calorie diet and GLP-1 therapy. It may have anti-aging benefits and may also help to improve libido and sexual performance.   

Compounded sermorelin is a modified version of a naturally occurring substance that causes release of growth hormone from the pituitary gland. Growth hormones are naturally produced by the pituitary gland and are necessary for growth in children. Sermorelin is FDA approved in human growth hormone replacement therapy under the brand name Geref 

This medicine is available only with your doctor’s prescription. 

  • Important Safety Information for Compounded Sermorelin Sublingual: It is important to let your provider know of any medications and medical conditions. This way the provider can make sure the medication is right for you 
  • Underactive thyroid—This condition can interfere with the effects of sermorelin 

Is Compounded Sermorelin FDA-approved? 

  • Compounded sermorelin is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications. Compounded sermorelin is a modified version of a naturally occurring substance that causes release of growth hormone from the pituitary gland and has the same active pharmaceutical ingredient as the FDA approved brand name medication, Geref. 

Limitations of Use: 

  • Compounded sermorelin should not be used in combination with other sermorelin-containing or sermorelin-like products  
  • The safety and efficacy of coadministration with other products have not been established 
  • Tell your healthcare professional if you are taking any other prescription or non-prescription (over-the-counter (OTC)) medicine. 
  • There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. 

Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would. The above are suggestions for use of compounded sermorelin. 

Who should not use compounded sermorelin? 

 Do not use compounded sermorelin if: 

  • You have a known allergic reaction to sermorelin-containing products or products that include human Growth Hormone Releasing Peptides (hGHRPs) 
  • Breastfeeding 
  • Pregnant   
  • Current benign or cancerous tumor(s) 

How should compounded sermorelin be administered?  

  • You can take compounded sermorelin with or without food. The medication is a self-administered oral sublingual medication that is administered nightly (Monday-Friday). Your Ivím provider will guide you on a treatment regimen.  
  • You should not change your dosing regimen or stop taking compounded sermorelin as prescribed without discussing it with your provider first.  

What should I tell my Ivím provider before using compounded sermorelin? 

  • Compounded sermorelin has certain drug interactions. It’s important to tell your Ivím provider all the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.  

Some medications to watch out for include: 

  • Thyroid Medication 
  • Steroids 
  • Type 2 Diabetes—can affect glucose levels 
  • Chronic use of immunosuppressive therapy 
  • hGH medication  

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of: 

  • Type 1 or type 2 diabetes 
  • Thyroid Disease  
  • Cancer History 
  • Tumor history 
  • Autoimmune Disease(s)  

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.  

  • There are no adequate studies in women for determining infant risk when using this medication during breastfeeding.   
  • There are no adequate studies in women who are pregnant for determining fetal risk when using this medication during pregnancy.   

Note: Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death. 

What are the most serious side effects that I or a caregiver should monitor for when taking compounded sermorelin? 

If you are experiencing a medical emergency, call 911 or seek immediate medical attention. 

These serious side effects can occur with compounded sermorelin. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes. 

  • Anaphylaxis  
  • Trouble in swallowing 
  • Trouble breathing 

What are the most common side effects of compounded sermorelin? 

  • Itching  
  • Flushing 
  • Dizziness 
  • Flushing 
  • Headache 
  • Sleepiness 
  • Trouble sitting still 

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Before using compounded sermorelin 

  • Your healthcare provider should show you how to use compounded sermorelin before you use it for the first time. 
  • Tell your healthcare provider if you are taking medicines to treat diabetes or thyroid disease.  

Review these questions with your healthcare provider: 

  • Do you have any medical conditions? 
  • Do you take diabetes medicines, such as insulin or sulfonylureas? 
  • Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? 
  • Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Compounded sermorelin may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded sermorelin. It is not known if compounded sermorelin passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using compounded sermorelin. 

How to take 

  • Read the Instructions for Use that come with compounded sermorelin 
  • Use compounded sermorelin exactly as your healthcare provider says. 
  • Compounded sermorelin is in a dissolvable tablet or troche which is dissolved under the tongue or in the pocket of the cheek before bedtime 
  • Use compounded sermorelin nightly. 
  • Learn more 

Compounded sermorelin is a prescription medicine. For more information on sermorelin-containing products, please call 877-581-2210 to learn more or receive information regarding how to contact your pharmacy. 

This summary provides basic information about compounded sermorelin but does not include all the information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded sermorelin and how to take it. Your healthcare provider is the best person to help you decide if compounded sermorelin is right for you.