tesamorelin for injection
Standard Dose1.4 mg, injected subcutaneously (under the skin) daily in the 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.
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, a reconstituted Egrifta SV dose should be discarded.
Body fat redistribution to the abdomen, called central adiposity, can develop as a result of HIV, antiretroviral therapy, and/or growth hormone (GH) deficiency. Central adiposity in HIV has a higher amount of visceral abdominal fat. This visceral abdominal fat is inside the abdomen surrounding internal organs like the stomach, liver, intestines, etc. Excess visceral abdominal fat may be linked with serious health issues like cardiovascular disease, non-alcoholic steatohepatitis (fatty liver disease), diabetes, or increased mortality. People with this condition describe symptoms of a regular bloating feeling, difficulty bending down/reduced flexibility, or anxiety/depression due to reduced physical activity and dissatisfaction with body image.
Central adiposity may be a complicated term to accurately describe, but it is different from obesity. To understand if you have excess visceral abdominal fat, talk with your HIV health care provider. Simple measurements of waist circumference and hip circumference can determine if you are likely to have excess visceral abdominal fat.
Different from all other growth hormone (GH) treatments, Egrifta SV is similar to the natural form of human growth hormone-releasing hormone (GHRH), that stimulates the pituitary gland to produce and secrete more of the body’s own GH, mostly during sleep. Egrifta SV reduces visceral abdominal fat while preserving subcutaneous fat, which is important for some individuals. A response typically appears within three months and continues to improve in time with a sustained effect at 12 months.
The effect on excess visceral abdominal fat was seen in two Phase 3 clinical trials. A post-hoc responder analysis has shown, on average, 31% of decrease in visceral abdominal fat in those who respond. The reduction in visceral fat alone resulted in an average 1.85-inch smaller waist circumference. It is important to note that visceral abdominal fat can return a few months after tesamorelin is discontinued as the underlying causes are still present.
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 Egrifta SV; 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 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
Thera Patient Support can assist with private or government insurance coverage, including AIDS Drug Assistance Program (ADAP), and will also assist in applying any eligible co‑pay assistance. Commercially insured people may be eligible for co-pay assistance and may pay as little as $0. Call (833) 23-THERA (833-238-4372) or go to egriftasv.com.