Important Safety Information for Sermorelin

Indications and Overview:
Sermorelin is a synthetic peptide that stimulates the release of growth hormone by mimicking the body’s natural growth hormone–releasing hormone (GHRH). It may be prescribed by a licensed clinician to support natural growth hormone production in adults diagnosed with or suspected of having growth hormone deficiency, or to help maintain healthy hormone balance under medical supervision.

It is not approved by the U.S. Food and Drug Administration (FDA) for anti-aging, performance enhancement, or weight-management purposes. Licensed clinicians may prescribe Sermorelin off-label when clinically appropriate.

Contraindications:
 Sermorelin should not be used in patients who:

• Have a known hypersensitivity to Sermorelin or any of its components
• Are pregnant or planning to become pregnant
• Are breastfeeding
• Have active cancer or a history of cancer not in remission
• Have any condition in which stimulation of growth hormone could worsen disease progression

Warnings and Precautions:
Endocrine and Metabolic Effects:
Sermorelin may influence growth hormone and related hormone levels. Regular clinical monitoring—including blood tests for insulin-like growth factor 1 (IGF-1) and other metabolic markers—is recommended throughout therapy. Patients with pre-existing endocrine disorders, thyroid dysfunction, diabetes, or metabolic disease should use Sermorelin with caution.
Injection Site Reactions:

Mild pain, redness, swelling, or itching at the injection site may occur. These effects are usually temporary and resolve without medical treatment.

Allergic Reactions:
Although uncommon, hypersensitivity or allergic reactions can occur. Symptoms may include rash, itching, swelling, dizziness, or difficulty breathing. If any of these occur, discontinue Sermorelin immediately and seek medical attention.

Central Nervous System Effects:
Some individuals may experience mild dizziness, headache, fatigue, flushing, or restlessness. Use caution when performing tasks that require alertness until you know how Sermorelin affects you.

Underlying Health Conditions:
Patients with endocrine, cardiovascular, hepatic, renal, or metabolic disorders should discuss risks and benefits with their healthcare provider before initiating therapy.

Adverse Reactions:
 Common side effects may include:

• Mild fatigue or drowsiness
• Temporary dizziness or headache
• Injection site reactions (pain, redness, swelling, or itching)
• Transient flushing or warmth

Less common side effects may include restlessness, hyperactivity, changes in mood or sleep patterns, mild nausea, or dry mouth (in oral formulations).
Most side effects are mild and resolve without medical intervention. Contact your healthcare provider if symptoms persist or worsen.

Drug Interactions:
 Sermorelin may interact with medications that influence hormone balance, including:

• Glucocorticoids (such as prednisone), which may reduce the effectiveness of Sermorelin
• Thyroid medications, which may alter hormonal balance or interfere with growth hormone monitoring

Always inform your healthcare provider of all prescription drugs, over-the-counter medications, supplements, and herbal products you are taking before starting Sermorelin therapy.

Pregnancy and Lactation:
Sermorelin is not recommended during pregnancy or while breastfeeding. Its safety has not been established in these populations. Effective contraception should be used during treatment unless otherwise directed by your provider.

Storage and Handling:

• Injection form: Store refrigerated at 2–8 °C (36–46 °F). Do not freeze. Protect from light.
• Oral disintegrating tablet (ODT) form: Store at room temperature in a dry place, away from heat, moisture, and direct sunlight.
 Keep out of reach of children. Do not use after the expiration date printed on the packaging.
 Patients should follow all storage and handling instructions provided by their pharmacy or healthcare provider to ensure product stability and safety.

Patient Counseling Information:
Patients should be advised on the potential risks and benefits of Sermorelin therapy, including possible side effects, injection-site reactions, and the need for regular monitoring of hormone levels.

Therapy should be administered only under the direction of a licensed clinician experienced in peptide or hormone-modulating treatments.
Patients should promptly report any new or worsening symptoms, allergic reactions, or adverse effects.

Do not adjust dosing without provider guidance. Regular follow-up visits and laboratory monitoring are recommended to assess response and safety.

Note:
This information is provided for educational purposes only and does not replace professional medical advice. Patients should consult a licensed healthcare provider to determine whether Sermorelin therapy is appropriate for their individual health needs.
 Compounded Sermorelin is not FDA-approved, and the FDA has not evaluated compounded medications for safety, effectiveness, or quality. Sermorelin should be used only as prescribed and dispensed by a state-licensed pharmacy in accordance with applicable laws and regulations.