From the FDA Drug Label
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
The usage guidelines for Sermorelin (Growth Hormone-Releasing Hormone (GHRH)) therapy are to use it only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection. Precautions include:
- Monitoring for adverse reactions such as febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
- Discontinuing the infusion and evaluating the patient if an adverse reaction occurs.
- Following the instructions of the manufacturer of the drug to be administered 1, 1.
From the Research
Sermorelin therapy should be administered as a subcutaneous injection, typically at a dosage of 100-300 mcg once daily before bedtime to align with the body's natural growth hormone release patterns. The medication requires refrigeration and should be reconstituted with bacteriostatic water immediately before use. Treatment duration varies but often continues for 3-6 months initially, with periodic breaks recommended to prevent desensitization of growth hormone receptors. Patients should be aware that Sermorelin requires a prescription and medical supervision, as it stimulates the pituitary gland to naturally produce growth hormone rather than directly replacing it. Common side effects include injection site reactions, headache, dizziness, and flushing, which are typically mild and transient. Sermorelin is contraindicated in patients with active malignancy, intracranial lesions, or hypersensitivity to GHRH peptides. Blood glucose levels should be monitored, particularly in diabetic patients, as growth hormone can affect insulin sensitivity. For optimal results, Sermorelin therapy should be combined with adequate sleep, proper nutrition, and regular exercise, as these factors enhance natural growth hormone production. Treatment effectiveness should be assessed through clinical improvement and, when appropriate, measurement of IGF-1 levels rather than direct growth hormone levels due to the pulsatile nature of growth hormone release, as supported by studies such as 2.
Some key points to consider when using Sermorelin include:
- The importance of medical supervision due to potential side effects and interactions, such as those noted in 3 regarding orthopaedic complications in children with growth hormone therapy.
- The need for monitoring of blood glucose levels, especially in diabetic patients, as discussed in 4 regarding the effects of growth hormone replacement therapy on adrenal androgen secretion.
- The potential for Sermorelin to stimulate natural growth hormone production, making it a valuable alternative to direct growth hormone replacement, as indicated in studies like 5 and 6.
- The consideration of individual patient factors, such as the presence of active malignancy or intracranial lesions, which may contraindicate the use of Sermorelin, as would be the case in any medical treatment decision.
Given the information available and the focus on minimizing morbidity, mortality, and maximizing quality of life, the most appropriate approach to Sermorelin therapy is one that balances potential benefits with careful monitoring and management of potential risks, as informed by the highest quality and most recent evidence available, such as the studies referenced here 2, 3, 5, 4, 6.