Tesamorelin

What is Tesamorelin

Tesamorelin is a synthetic growth hormone releasing factor (GRF) analog that is given subcutaneously.

It is the first treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.

Treatment was well-tolerated during clinical trials with hypersensitivity and injection site reactions being the most commonly reported adverse events.

Treatment is contraindicated in patients with disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity to the drug or mannitol, and in pregnant women.

The drug was approved based on the results of 2 clinical trials. During these trials, HIV-infected adult patients treated with tesamorelin over 52 weeks experienced a 17.5% and 18.1% reduction in visceral adipose tissue (VAT) when compared with baseline (p less than 0.001).

These results were achieved without affecting glucose homeostasis nor subcutaneous or extremity fat reserves.

Treatment is contraindicated in patients with disruption of hypothalamic-pituitary axis, active malignancy, known hypersensitivity to the drug or mannitol, and in pregnant women.

Brand Name

Egrifta

Indications

  • HIV-associated lipodystrophy

For the treatment of excess abdominal fat in patients with HIV-associated lipodystrophy

Side Effects

  1. abdominal pain
  2. antibody formation
  3. arthralgia
  4. carpal tunnel syndrome
  5. chest pain (unspecified)
  6. depression
  7. diabetes mellitus
  8. diarrhea
  9. dyspepsia
  10. edema
  11. erythema
  12. flushing
  13. headache
  14. hematoma
  15. hyperglycemia
  16. hypertension
  17. hypoesthesia
  18. injection site reaction
  19. insomnia
  20. musculoskeletal pain
  21. myalgia
  22. nausea
  23. new primary malignancy
  24. night sweats
  25. palpitations
  26. paresthesias
  27. peripheral edema
  28. pruritus
  29. rash
  30. retinopathy
  31. skin irritation
  32. urticaria
  33. vomiting

Monitoring Parameters

  • blood glucose
  • serum IGF-1 concentrations

Contraindications

  • breast-feeding
  • children
  • coronary artery bypass graft surgery (CABG)
  • diabetes mellitus
  • diabetic retinopathy
  • edema
  • geriatric
  • head trauma
  • hypopituitarism
  • hypothalamic-pituitary-adrenal (HPA) suppression
  • infants
  • intramuscular administration
  • intravenous administration
  • mannitol hypersensitivity
  • neonates
  • neoplastic disease
  • pregnancy
  • radiation therapy
  • respiratory insufficiency
  • surgery
  • trauma

Interactions

  • Cortisone
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Ezetimibe; Simvastatin
  • Lopinavir; Ritonavir
  • Niacin; Simvastatin
  • Ombitasvir; Paritaprevir; Ritonavir
  • Prednisone
  • Ritonavir
  • Simvastatin
  • Simvastatin; Sitagliptin
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