Important Safety Information (Tesamorelin)

Important Safety Information: Tesamorelin

What is Tesamorelin?
Tesamorelin is a synthetic growth hormone-releasing hormone (GHRH) analogue approved for the treatment of HIV-associated lipodystrophy. It is designed to stimulate the production and release of growth hormone, which may help reduce visceral adipose tissue (VAT) in certain conditions.


Warnings and Precautions

  1. Approved Uses
    Tesamorelin is FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Its safety and effectiveness for other uses have not been established.
  2. Contraindications
    Do not use Tesamorelin if:
    • You are pregnant or planning to become pregnant. Tesamorelin may harm the unborn baby.
    • You have a known allergy to Tesamorelin or its components.
    • You have active cancer or a history of cancer due to its growth hormone-stimulating effects.
    • You have an active pituitary gland tumor or any pituitary abnormalities.
  3. Warnings for Specific Conditions
    • Cancer Risk: Tesamorelin stimulates growth hormone production and may increase the risk of tumor growth.
    • Glucose Intolerance: Tesamorelin may affect blood sugar levels, leading to hyperglycemia or worsening of diabetes. Regular monitoring of glucose levels is recommended.
    • Cardiovascular Risks: Use with caution in patients with a history of heart disease, as Tesamorelin may increase lipid levels.
    • Hypothalamic or Pituitary Dysfunction: Avoid use in patients with hypothalamic or pituitary disorders.
  4. Adverse Reactions
    Common side effects may include:
    • Injection site reactions (e.g., redness, swelling, or pain).
    • Nausea or vomiting.
    • Joint pain or stiffness.
    • Swelling of extremities (peripheral edema).
    • Carpal tunnel syndrome symptoms (e.g., tingling or numbness).
    If severe side effects occur, such as difficulty breathing, chest pain, or signs of an allergic reaction, seek immediate medical attention.

Drug Interactions

  • Tesamorelin may interact with insulin or other glucose-lowering medications, requiring adjustments to treatment regimens.
  • Inform your healthcare provider of all medications, supplements, and therapies you are currently using to avoid adverse interactions.

Usage Instructions

  1. Administration
    • Tesamorelin is administered as a subcutaneous injection, typically in the abdomen.
    • Use sterile techniques and follow instructions provided by your healthcare provider.
  2. Dosage
    • The recommended dosage is 2 mg once daily. Do not exceed the prescribed dosage.
  3. Monitoring
    • Periodic monitoring of blood glucose levels, insulin-like growth factor-1 (IGF-1), and lipid profiles is essential during treatment.

Storage and Handling

  • Store Tesamorelin in the refrigerator at 2–8°C (36–46°F).
  • Protect from light and moisture.
  • Keep out of reach of children and unauthorized personnel.

Disclaimers

  • Tesamorelin should only be used under the guidance of a qualified healthcare provider.
  • Off-label use is not recommended and may carry significant health risks.
  • Misuse of Tesamorelin can lead to serious health complications.

For further information, consult with your healthcare provider or contact the product manufacturer. If you experience side effects or have questions about Tesamorelin, seek medical advice immediately.

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