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
- abdominal pain
- antibody formation
- arthralgia
- carpal tunnel syndrome
- chest pain (unspecified)
- depression
- diabetes mellitus
- diarrhea
- dyspepsia
- edema
- erythema
- flushing
- headache
- hematoma
- hyperglycemia
- hypertension
- hypoesthesia
- injection site reaction
- insomnia
- musculoskeletal pain
- myalgia
- nausea
- new primary malignancy
- night sweats
- palpitations
- paresthesias
- peripheral edema
- pruritus
- rash
- retinopathy
- skin irritation
- urticaria
- 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