EGRIFTA SV® is an injectable prescription medicine used to reduce excess visceral abdominal fat in adult patients living with HIV and lipodystrophy.
Taken as a daily subcutaneous injection (under the skin) in your abdominal (belly) area, your healthcare provider may recommend that you use EGRIFTA SV® continually to maintain a reduction in excess visceral abdominal fat.
Though it reduces excess visceral abdominal fat, EGRIFTA SV® is not indicated for weight loss management. Its impact and safety on cardiovascular health have not been studied, and it’s not known whether taking EGRIFTA SV® helps improve compliance with antiretroviral medications.
It lies deeper in the abdomen area, is harder and firmer than the regular soft, squishy fat that is just under the skin. And it can be difficult to control with diet and exercise alone.
TAKE THE HARD BELLY TEST
(for excess visceral abdominal fat)
Watch as a patient prepares and injects EGRIFTA SV®.
In some people living with HIV and lipodystrophy, excess visceral abdominal fat occurs partly due to a reduced amount of growth hormone (which regulates how fat is stored in the body).
By stimulating the production of growth hormone, EGRIFTA SV® helps reduce the amount of excess visceral abdominal fat.
Studied in two clinical trials in adult patients living with HIV and lipodystrophy who developed excess visceral abdominal fat.
Each trial lasted 6 months, with an additional 6-month extension phase.
EGRIFTA SV® has demonstrated results in 6 months, and people who used EGRIFTA SV® continually for one year continued to experience significant reductions in excess visceral abdominal fat.
In a post-hoc analysis done with two clinical studies, those who responded to EGRIFTA SV® had a significant reduction in excess visceral abdominal fat.
The results of the post-hoc analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA SV®.
*Responders defined as patients who experienced ≥8% reduction in excess visceral abdominal fat.
Keep in mind, excess visceral abdominal fat is a chronic condition for patients living with HIV and lipodystrophy. Even with taking EGRIFTA SV® every day, it can take time to see results and maintain the reduction in excess visceral abdominal fat.
What is EGRIFTA SV® (tesamorelin for injection)?
EGRIFTA SV® is an injectable prescription medicine used to reduce excess abdominal fat in adult patients living with HIV and lipodystrophy. EGRIFTA SV® is a growth hormone-releasing factor (GHRF) analog.
EGRIFTA SV® is not for weight loss management.
The long-term safety of EGRIFTA SV® on the heart and blood vessels (cardiovascular) is not known.
It is not known whether taking EGRIFTA SV® helps improve how well you take your antiretroviral medications.
It is not known if EGRIFTA SV® is safe and effective in children, do not use in children.
You should not take EGRIFTA SV® if you:
Have a pituitary gland tumor, surgery, or other problems related to your pituitary gland, or have had radiation treatment to your head or head injury.
Have active cancer.
Are allergic to tesamorelin or any of the ingredients in EGRIFTA SV®.
Are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA SV® and talk with your healthcare provider.
Are less than 18 years of age.
Before using EGRIFTA SV®, tell your healthcare provider if you:
Have or have had cancer.
Have problems with blood sugar or diabetes.
Have scheduled heart or stomach surgery.
Have breathing problems.
Are breastfeeding or plan to breastfeed.
Are taking any other prescription and non-prescription medicines, vitamins, and herbal supplements.
EGRIFTA SV® may cause serious side effects including:
Increased risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA SV® if any cancer symptoms come back.
Increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking EGRIFTA SV®.
Serious allergic reaction such as rash or hives anywhere over the body or on the skin, swelling of the face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting, itching and reddening or flushing of the skin. If you have any of these symptoms, stop using EGRIFTA SV® and get emergency medical help right away.
Swelling or fluid retention. Call your healthcare provider if you have swelling, an increase in joint pain, or pain or numbness in your hands or wrist.
Increase in blood sugar (glucose) or diabetes.
Injection site reactions. Injection site reactions are a common side effect of EGRIFTA SV®, but may sometimes be serious.
Increased risk of death in people who have critical illness because of heart or stomach surgery, trauma or serious breathing (respiratory) problems has happened when taking certain growth hormones.
The most common side effects of EGRIFTA SV® include:
Pain in legs and arms
These are not all of the possible side effects of EGRIFTA SV®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to THERA patient support® toll-free at 1-833-23THERA (1-833-238-4372).
This information is not intended to replace discussions with your doctor. For additional information about EGRIFTA SV®, see the full Prescribing Information, Patient Information, Patient Instructions for Use, and talk to your doctor. For more information about EGRIFTA SV® contact THERA patient support® toll-free at 1-833-23THERA (1-833-238-4372).