tesamorelin for injection
Standard Dose1.4 mg, injected subcutaneously (under the skin) daily in stomach (abdominal) area, rotating the site for each injection and avoiding scar tissue, bruises, and the navel. A step-by-step administration guide and video are available at egriftasv.com.
A potential complication of HIV, antiretroviral therapy, or growth hormone (GH) deficiency may cause a fat redistribution of adipose tissue known as lipohypertrophy (a form of lipodystrophy). Abdominal lipohypertrophy is defined by an accumulation of excess visceral abdominal tissue (also called “hard belly”) surrounding all abdominal organs (liver, stomach, pancreas, etc.). Hard belly is a different type of fat compared to subcutaneous fat (regular, or soft, fat). Excess visceral abdominal fat may be linked with serious health issues like cardiovascular disease, cognitive decline, diabetes, dyslipidemia, non-alcoholic steatohepatitis (fatty liver disease), or increased mortality risk, and may make it hard to perform certain daily activities.
Hard belly may be a complicated term to accurately describe and can be mistaken for general weight gain or obesity. To understand if you are at risk, talk with your health care provider, who can assess the risk in two easy steps. Step one: feel your belly to see if it is hard. Step two: measure your waist and hip circumference to calculate a waist-to-hip ratio.
Unlike growth hormone (GH) products, Egrifta SV is an analogue of human growth hormone-releasing hormone (GHRH), which stimulates the pituitary gland to produce and secrete the body’s own GH. Egrifta SV reduces visceral abdominal fat while preserving subcutaneous fat. The effect appears after three months, increases at six months and is sustained for 12 months.
The effect on visceral abdominal tissue was seen in two Phase 3 clinical trials. A post-hoc responder analysis has shown, on average, a reduction in waist circumference of 1.85 inches and 31% of decrease in visceral abdominal fat. It is important to note that visceral abdominal fat returns in a few months once tesamorelin is discontinued.
Egrifta SV should not be administered to people who have a pituitary gland tumor, surgery, or other pituitary gland problems; active cancer; hypersensitivity to either tesamorelin or ingredients in tesamorelin; who are pregnant or become pregnant; or are less than 18 years old. Egrifta SV should be used with caution in people who have a history of cancer or problems with blood sugar or diabetes, and should be discontinued in critically ill people.
Thera Patient Support:
(833) 23-THERA; (833-238-4372)
AWP$7,789.20 for 30 2 mg vials
Potential Side Effects and Toxicity
The most common side effects include pain in legs and arms, and muscle pain. Despite initial concerns that tesamorelin may have significant drug-drug interactions with medications that use CYP450 (a liver enzyme) for metabolism, a study in healthy volunteers proved otherwise. People need to be monitored for potential interaction. Long-term safety of the heart and the blood vessels is unknown. Each dose necessitates mixing 2 mg vials stored at room temperature with 0.5 mL of sterile water for injection. Do not use Egrifta SV if the solution is discolored, cloudy, or contains visible particles. Once reconstituted, the vial should be rolled gently, not shaken, between the hands for 30 seconds to ensure mixture is a clear, colorless solution, and is administered right away. If not used immediately, the reconstituted Egrifta SV should be discarded.
CAP & PAP INFO
Co-pay covers up to $7,000 a year. If someone is having difficulty paying for Egrifta SV, there are several programs available through Thera’s patient support at (833) 23-THERA (833-238-4372), Monday–Friday, 8:30 a.m.–8 p.m., EST or at therapatientsupport.com or egriftasv.com.