TESAMORELIN

Other

Brand names: EGRIFTA SV

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects. Some, but not all these effects, are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

Indications

See full prescribing information

Contraindications

• hypopituitarism
• pituitary tumor/surgery

FDA Warnings

5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV
1 Increased Risk of Neoplasms New Malignancy Carefully consider the decision to start treatment with EGRIFTA SV based on the increased background risk of malignancies in HIV-positive patients
For patients with a history of treated and stable malignancies, initiate EGRIFTA SV therapy only after careful evaluation of the potential benefit of treatment relative to the risk of re-activation of the underlying malignancy
An increased risk of developing diabetes with EGRIFTA (HbA 1c level ≥ 6

Known Side Effects

6 documented side effects by frequency

Injection Site Pain

1-10%

Drug Not Working

1-10%

Weight Gain

1-10%

Joint Pain

1-10%

Limb Pain

0.1-1%

Fatigue

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous