Egrifta

tesamorelin for injection

Injectable for treating HIV-related excess belly fat (lipohypertrophy)
Non-HIV Drug

Standard Dose

2 mg via subcutaneous (under the skin) injection once daily in the abdomen, rotating injection sites and avoiding scar tissue, bruises, and the navel (see step-by-step video at egrifta.com and this page for more information).

A potential complication of HIV, antiretroviral therapy, or both may be changes in the distribution of adipose tissue (fat), otherwise known as lipodystrophy; previous reports of prevalence in the U.S. varied widely, anywhere from 2–60% of all HIV-positive patients. Abdominal lipohypertrophy (a form of lipodystrophy) is the accumulation of excess visceral adipose tissue (VAT)—deep belly fat surrounding the liver, stomach, and other abdominal organs. Egrifta is the first, and only, FDA approved medication to reduce VAT. This is different from subcutaneous fat. Unlike growth hormone products, Egrifta 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 reduces VAT while preserving subcutaneous fat. The effect of this agent appears to be greatest within the first three to six months of initiation.

Two Phase 3 clinical trials found that Egrifta significantly lowered VAT (up to 15–20% on average) at both 26 and 52 weeks. Egrifta may also lower triglycerides (a type of cholesterol). Adverse events were more commonly seen in the groups given Egrifta than in those receiving placebos. It is important to note that excess VAT returns once Egrifta is discontinued. Egrifta should not be administered to patients who have pituitary gland tumor(s), pituitary gland surgery, or other pituitary gland problems; active cancer; hypersensitivity to either tesamorelin and/or mannitol; or who are pregnant. Egrifta should be used with caution in patients who have a history of non-malignant neoplasms (abnormal growth of tissue such as a tumor), a history of treated and stable malignancies, elevated insulin-like growth factor 1 (IGF-1), fluid retention, diabetes, or pre-diabetes.

The most common side effects include joint pain, injection site reactions (including redness, pain, and itching), pain in legs and arms, swelling in legs, muscle soreness, tingling, numbness and prickling, nausea, vomiting, rash, and itchiness. Other warnings include hypersensitivity reactions and acute critical illness. In the Phase 3 clinical studies, patients receiving Egrifta had a higher risk of developing diabetes compared to those on placebo. Despite initial thoughts that Egrifta may have significant drug-drug interactions with medications that use CYP450 (an enzyme in the liver) for metabolism, a study in healthy volunteers proved otherwise. However, it has not been studied with medications that use other enzymes in the liver; therefore, response to medications that are metabolized through the liver should be monitored for response and adverse reactions. Long-term safety data is unknown. There have been previous reports of a theoretical increased risk of cancer with elevated IGF-1 levels. Other long-term concerns include potential development of retinopathy in patients with diabetes. Each dose necessitates mixing 1-mg vials (requiring refrigeration) of Egrifta with 2.2 mL of sterile water for injection (vial stored at room temperature). Do not use an unopened vial if the solution is colored, cloudy, or contains visible particles. Once mixed, the vial should be rolled gently, not shaken, between the hands for 30 seconds to ensure reconstitution into a clear, colorless solution and administered right away. If not used immediately, the reconstituted Egrifta should be discarded.

CAP & PAP INFO

Co-pay covers up to $6,000 per year. If someone is having difficulty paying for Egrifta, there are several programs available through Thera patient support at (833) 23-THERA (833-238-4372), Monday–Friday, 8 a.m.–8 p.m., EST or at egrifta.com.

Manufacturer

Theratechnologies, Inc.
egrifta.com
Thera Patient Support:
(833) 23-THERA
(833-238-4372)
therapatientsupport.com

AWP

$5,850.00/month

Potential Side Effects and Toxicity

More Information