tesamorelin for injection
Standard Dose1.4 mg, injected subcutaneously (under the skin) daily in the abdomen, 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). Previous reports of lipohypertrophy prevalence in the U.S. varied widely, anywhere from 2–60% of all patients with HIV. Abdominal lipohypertrophy is defined by an accumulation of excess abdominal (visceral) adipose tissue (VAT, also called “hard belly”) surrounding all abdominal organs (liver, stomach, and pancreas, etc.). Hard belly is a different type of fat (hard fat) compared to subcutaneous fat (regular, or soft, fat). Untreated hard belly (excess visceral/abdominal fat) is linked with serious health issues like cardiovascular disease and/or diabetes, increased mortality risk, or may make it hard to perform certain daily activities.
Hard belly may be complicated to accurately describe and can be mistaken for general weight gain or obesity. To understand if you are at risk you can talk with your health care provider, who will in two easy steps assess the risk. Step one: feel your belly (feel if it is hard). Step two: measure your waist circumference and calculate a waist-to-hip ratio.
Unlike growth hormone products, Egrifta SV is an analogue of human growth hormone-releasing factor (GRF), which stimulates the pituitary gland to produce and secrete the body’s own growth hormone. Egrifta SV reduces VAT while preserving subcutaneous fat. The effect of this agent appears to be greatest within the first three to six months of initiation.
The effect on visceral adipose 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 fat. It is important to note that hard belly returns in a few months once tesamorelin is discontinued.
Egrifta SV should not be administered to patients who have 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 patients who have a history of cancer, problems with blood sugar or diabetes, have scheduled heart or stomach surgery, have breathing problems, are breastfeeding or plan to breastfeed, or taking any other prescription and non-prescription medicines, vitamins, or herbal supplements. Go to EgriftaSV.com and TheraPatientSupport.com.
Thera Patient Support:
Potential Side Effects and Toxicity
The most common side effects include pain in legs and arms and muscle pain. Other warnings include increased risk of cancer reactivation, insulin-like growth factor-1 (IGF-1), fluid retention, glucose intolerance or diabetes, hypersensitivity reactions, injection site reactions, and mortality in acute critical illness. In the Phase 3 clinical studies, patients receiving tesamorelin had a higher risk of developing diabetes compared to those on placebo. Despite initial thoughts 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. The patients need to be monitored for potential interaction. Long-term safety on 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 the 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 per year. If someone is having difficulty paying for Egrifta SV, there are several programs available through Thera patient support at (833) 23-THERA (833-238-4372), Monday–Friday, 8:30 a.m.–8 p.m., EST or at egriftasv.com.