Important Safety Information — Sermorelin Acetate

About Sermorelin

Sermorelin acetate is a growth hormone-releasing hormone (GHRH) analog that signals the pituitary gland to produce and secrete growth hormone. Historically it was used in the clinical evaluation of growth hormone deficiency. Compounded sermorelin is prescribed only at a licensed physician's discretion and is not FDA-approved.

Contraindications

• Known hypersensitivity to sermorelin acetate or any of its components
• Active malignancy (cancer), as growth hormone can influence cell growth and proliferation
• Patients with closed epiphyses (in pediatric contexts) should not be treated for growth stimulation
• Acute critical illness (e.g., after major surgery, trauma, or severe infection)

Warnings and Precautions

• Thyroid function: Untreated hypothyroidism can jeopardize the response to sermorelin. Thyroid levels should be evaluated prior to initiation of therapy and monitored throughout treatment to ensure adequate levels.
• Antibody formation: As with any peptide, antibodies to sermorelin may develop. The presence of antibodies does not always reduce the response to treatment but should be monitored.
• Obesity: Obesity may blunt the growth hormone response to sermorelin.
• Glucose metabolism: Growth hormone may alter insulin sensitivity. Monitor blood glucose, especially in patients with diabetes or prediabetes.
• Intracranial lesions: Patients with pre-existing intracranial lesions should be monitored for progression or recurrence of the underlying disease.
• Fluid retention: Growth hormone stimulation may cause mild fluid retention, joint pain, or carpal tunnel symptoms.

Common Side Effects

• Injection site reactions (redness, swelling, itching, or tenderness)
• Facial flushing
• Headache
• Nausea
• Dizziness
• Sleepiness or drowsiness
• Taste changes
• Restlessness or difficulty sitting still
• Mild joint pain or stiffness

Serious Side Effects

Seek medical attention immediately if you experience any of the following:

• Signs of a serious allergic reaction: hives, difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat
• Severe or persistent headache
• Significant swelling in the extremities or carpal tunnel symptoms
• Signs of elevated blood sugar (increased thirst, frequent urination, blurred vision)
• Rapid heart rate or chest pain

Drug Interactions

• Glucocorticoids (e.g., prednisone, dexamethasone): May decrease the growth hormone response to sermorelin.
• Cyclooxygenase inhibitors (e.g., aspirin, indomethacin): May decrease the effectiveness of sermorelin.
• Insulin: May affect the growth hormone response. Monitor glucose levels closely.
• Thyroid-lowering medications (e.g., propylthiouracil): May impair the response to sermorelin.
• Somatostatin or somatostatin analogs (e.g., octreotide): May inhibit the growth hormone response to sermorelin.
• Muscarinic antagonists (e.g., atropine): May blunt the growth hormone response.
• Clonidine and levodopa: These agents may release somatostatin, potentially reducing the effectiveness of sermorelin.

Use in Specific Populations

• Pregnancy: Should be used during pregnancy only if clearly needed. The effects of sermorelin on fetal development have not been fully established.
• Lactation: It is unknown whether sermorelin is excreted in human breast milk. Use with caution in nursing mothers.
• Pediatric use: Has been studied in children for growth hormone deficiency. Should be used under close medical supervision.
• Geriatric use: No specific dose adjustments have been established. Older adults may require closer monitoring for fluid retention and glucose changes.
• Diabetes: Monitor blood glucose closely, as growth hormone stimulation may alter insulin sensitivity.