Important Safety Information Regarding Compounded Sermorelin
Compounded Medication Disclaimer
Compounded medications, including Sermorelin, are not approved by the U.S. Food and Drug Administration (FDA) and do not undergo the same clinical studies as FDA-approved drugs to evaluate safety or efficacy. Compounded medications may still be legally prescribed when determined appropriate by a licensed healthcare provider following a medical consultation.
Eligibility
Sermorelin may be considered for adults with symptoms consistent with growth hormone deficiency, such as fatigue, decreased strength, reduced recovery, or sleep disturbances. Eligibility is determined on a case-by-case basis. A licensed healthcare provider will review your intake to confirm eligibility and ensure treatment is safe and appropriate for you.
Indication
Sermorelin is a synthetic analog of growth hormone–releasing hormone (GHRH). It is used to stimulate the pituitary gland to naturally increase growth hormone production, which may support energy, sleep quality, recovery, lean body mass, and overall vitality.
Contraindications
Do not use Sermorelin if you:
- Have a known hypersensitivity to Sermorelin or any of its components.
- Have active cancer or evidence of tumor growth.
- Are pregnant or breastfeeding.
Warnings and Precautions
Potential risks and side effects include:
- Injection site reactions: Pain, redness, or swelling.
- Hormonal effects: Headaches, flushing, or water retention.
- Allergic reactions: Rash, itching, or difficulty breathing.
- Unmasking of latent conditions: Sermorelin may accelerate the growth of pre-existing tumors or malignancies.
Precautions Before Use
Inform your healthcare provider if you:
- Have a history of cancer, especially hormone-sensitive cancers.
- Have endocrine or pituitary disorders.
- Are pregnant, planning pregnancy, or breastfeeding.
- Are taking other medications, including prescriptions, over-the-counter drugs, vitamins, or supplements.
Administration
- Sermorelin is administered as a subcutaneous injection, typically once daily at bedtime.
- Follow the dosing instructions provided by your healthcare provider.
- Do not adjust or discontinue Sermorelin without consulting your provider.
Common Side Effects
The most common side effects include:
- Injection site irritation.
- Headache, flushing, dizziness.
- Nausea or mild stomach upset.
This list does not include all possible side effects. Consult your healthcare provider regarding any adverse effects you may experience.
Important Notes
- Sermorelin treatment should only be initiated and monitored by a licensed healthcare provider.
- If you experience a medical emergency, call 911 immediately.
- For additional safety information, contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Commitment to Safety
Yucca Health is committed to providing safe, transparent, and high-quality care. We encourage patients to discuss all concerns openly with their provider to ensure the best possible treatment outcomes.