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Gonadorelin: Info & Anecdotal Observations

Gonadorelin: Medication Info & Anecdotal Observations Possible Uses Testicular atrophy, as an alternative to hCG Overview Recently, the FDA reclassified the hCG molecule from a drug to a biologic. Under federal regulations all compounding pharmacies cannot compound biologics. Prescribers who use hCG as a part of testosterone therapy treatment for testicular atrophy are exploring the use of gonadorelin as a substitute for off-label use in men. hCG stimulates production of gonadal steroid hormones by causing production of by the testes and the development of secondary sex characteristics in males. Gonadorelin is similar to releasing hormone which can have an effect on the testes per the axis.

Dosage and Vial Size 5mL vial 0.2mg/mL inject SQ 5mL (100mcg) twice per week. Technically that vial will last 5 weeks.

Medication Dating APS Belmar has 90-day dating. This is at room temperature and in liquid form. We are working on method suitability currently and it should be completed in the in early Fall to meet California requirements. Chris Pasa, your California Engineer can assist you with any questions, his email is [email protected].

Suggested Patient Monitoring Subjective change in appearance of testicles (fullness or atrophy). • Check LH and FSH levels pre-and-post therapy • Testosterone levels • levels Pricing for a 5ml Vial Advantage pricing: $23.00. Ask your Solutions Engineer for volume pricing, additional forms and strengths.

Sample Sig Gonadorelin Injectable Written as: Gonadorelin Acetate 0.2mg/ml 5ml vial Inject 0.5ml Subcutaneously (100mcg) twice a week

www.apsmeds.com Tel: 727-787-4137 | Rx Fax: 866-739-4750 01/07/21 Anecdotal Prescriber Feedback Gonadorelin has not been tested for in clinical trials, but several of our prescribers have shared feedback on off-label gonadorelin prescribing. Below is a summary of their findings. Integrative Clinic This clinic tested its patients on gonadorelin and their LH and FSH levels were elevated. Men’s Clinics Several large, men’s Testosterone clinics have prescribed it for: “Testicular Atrophy”. They have reported a “very good” response to the 100mcg twice-a-week dosing. Their “good” response is SOLEY based on lab results showing LH levels increasing and subjective reports from a limited number of patients indicating a visible increase in testicular size.

Information Use and Disclaimer: This information should not be used to decide whether or not to prescribe this medicine or any other medicine. 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 anecdotal 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. This information is not specific medical advice.

34911 US Highway 19 N Online: www.apsmeds.com Suite 600 Palm Harbor, FL 34684 Phone: (727) 787-4137 to learn more or speak to a pharmacist

Your APS | Belmar Engineer:

The information provided herein is for prescriber reference only and nothing herein should be construed as making a claim about the safety or effectiveness of compounded products, including any products compounded by Belmar Pharmacy and/or APS Pharmacy. Nothing herein is intended to replace or influence the independent judgment of any licensed professional. Patients interested in any products compounded by Belmar Pharmacy and/or APS Pharmacy are encouraged to speak to a medical professional about their medical options and before seeking treatment.