Important Safety Information
Recommended Dosage (Adults)
Typical dosing ranges from 0.2 mg to 0.5 mg administered once daily by subcutaneous
injection.
Dosing is individualized based on:
• Baseline laboratory values
• Clinical response
• Tolerability
• Provider discretion
Administration Instructions
• Administer via subcutaneous injection.
• Common injection sites include abdomen or thigh.
• Often administered in the evening to align with physiologic GH pulsatility.
• Rotate injection sites to reduce risk of irritation.
• Reconstitute only as directed by pharmacy instructions.
CONTRAINDICATIONS
Sermorelin is contraindicated in patients with:
• Active malignancy
• History of cancer without provider clearance
• Known hypersensitivity to sermorelin acetate or excipients
• Pregnancy
• Breastfeeding
• Closed epiphyses in pediatric patients
• Untreated intracranial lesions
WARNINGS AND PRECAUTIONS
5.1 Neoplasms
Growth hormone–stimulating therapies may theoretically promote growth of existing
malignancies. Discontinue therapy if tumor progression occurs.
5.2 Glucose Intolerance
GH stimulation may affect insulin sensitivity. Monitor patients with:
• Diabetes mellitus
• Prediabetes
• Metabolic syndrome
Adjust antidiabetic medications as necessary.
5.3 Intracranial Hypertension
Symptoms may include:
• Headache
• Visual changes
• Nausea
• Vomiting
Discontinue therapy if papilledema is confirmed.
5.4 Fluid Retention
Patients may experience:
• Peripheral edema
• Arthralgia
• Carpal tunnel symptoms
Dose adjustment may be required.
5.5 Thyroid Function
Hypothyroidism may reduce response to therapy. Thyroid function should be evaluated
and treated appropriately prior to initiation.
6. ADVERSE REACTIONS
Most Common Adverse Reactions:
• Injection site redness, swelling, or irritation
• Headache
• Flushing
• Dizziness
• Nausea
• Fatigue
Less Common:
• Edema
• Joint discomfort
• Transient hyperglycemia
Serious Adverse Reactions (Rare):
• Severe allergic reaction
• Intracranial hypertension
• Tumor progression insusceptible individuals
Report adverse reactions to your prescribing provider immediately.
7. DRUG INTERACTIONS
Use caution when administered with:
• Insulin or oral hypoglycemic agents
• Corticosteroids
• Thyroid hormone replacement
Corticosteroids may blunt GH response.
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Sermorelin is contraindicated in pregnancy. There are no adequate and well-controlled
studies in pregnant women.
8.2 Lactation
It is unknown whether sermorelin is excreted in human milk. Discontinue use during
breastfeeding.
8.3 Geriatric Use
Older patients may require closer monitoring due to metabolic variability.
9. OVERDOSAGE
Limited data available. Excessive dosing may result in:
• Headache
• Flushing
• Nausea
• Dizziness
• Hypotension
Seek medical attention in case of suspected overdose.
10. DESCRIPTION
Sermorelin acetate is a synthetic peptide analog of growth hormone–releasing hormone (GHRH 1–29). It stimulates the anterior pituitary gland to release endogenous growth hormone.
Compounded sermorelin formulations are not FDA approved finished drug products but are prepared pursuant to a valid prescription in accordance with applicable federal and state compounding regulations.
11. CLINICAL PHARMACOLOGY
Mechanism of Action
Sermorelin binds to GHRH receptors in the anterior pituitary, stimulating pulsatile secretion of endogenous growth hormone.
Pharmacodynamics
Induces physiologic GH release, which stimulates production of insulin-like growth factor 1 (IGF-1).
Pharmacokinetics
Rapid onset of action following subcutaneous injection. Plasma half-life is short; effects are mediated via downstream IGF-1 production.
12. MONITORING REQUIREMENTS
Patients may require periodic evaluation of:
• IGF-1 levels
• Fasting glucose
• HbA1c
• Thyroid function
• Clinical symptom response
Monitoring frequency determined by prescribing provider.
13. STORAGE AND HANDLING
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Protect from light.
Do not freeze.
Follow pharmacy reconstitution and expiration instructions.
14. PATIENT COUNSELING INFORMATION
Advise patients:
• Use only as prescribed
• Do not exceed recommended dose
• Report persistent headaches, vision changes, swelling, or allergic reactions
• Maintain regular lab follow-up
Individual results vary.
This prescribing information is provided for educational purposes and does not replace individualized medical advice. Sermorelin provided through telehealth is compounded pursuant to a valid prescription. It is not FDA-approved for anti aging or performance enhancement uses.