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What Is EGRIFTA SV®?

EGRIFTA SV® (tesamorelin) for injection is an injectable prescription medicine used to reduce excess visceral abdominal (belly) fat in adults with HIV and lipodystrophy.

Taken once daily, EGRIFTA SV® is injected under the skin (also known as a subcutaneous injection) in the abdominal area.*

EGRIFTA SV® has over 10 years of established safety.

* 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.

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How Does EGRIFTA SV® Work?

Many people with HIV have lower levels of growth hormone than normal. Growth hormone helps to maintain the body’s metabolism and healthy muscles. It also plays an important role in how fat is used and stored in the body, and not having enough can lead to the build-up of visceral abdominal fat.

EGRIFTA SV® is a growth hormone-releasing factor (GHRF), which means it causes the body to make more of its own growth hormone. By increasing the levels of growth hormone, EGRIFTA SV® helps to restore the body’s normal metabolic processes and reduce the amount of excess visceral abdominal fat.

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Proven Results Through Rigorous Clinical Trials

  • Tesamorelin, the active ingredient in EGRIFTA SV® was studied in two clinical trials in adults with HIV and lipodystrophy who had excess visceral abdominal fat.
  • Each trial lasted 6 months, with an additional 6-month extension phase, for a total of 1 year of treatment
Tesamorelin significantly reduced excess visceral abdominal fat in both clinical trials.
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Trial 1

average reduction at 6 months

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Trial 2

average reduction at 6 months

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People who used tesamorelin continuously for 1 year maintained their results over this period.

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Excess visceral abdominal fat returned when tesamorelin was stopped after 6 months of therapy.

Losing Too Much Lean Body Mass Can Negatively Affect Your Health

People with HIV may have concerns about losing healthy muscle mass, also known as lean body mass. During clinical trials, people who used tesamorelin did not lose lean body mass.

EGRIFTA SV® may increase lean body mass by up to 5 pounds.

Ask a Healthcare Provider if EGRIFTA SV® Can Help.

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IMPORTANT PATIENT INFORMATION ABOUT EGRIFTA SV® (TESAMORELIN) FOR INJECTION

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What is EGRIFTA SV® (tesamorelin) for injection?

  • EGRIFTA SV® is an injectable prescription medicine used to reduce excess abdominal fat in adults 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 adults with HIV or your cancer coming back (reactivation). Stop using EGRIFTA SV® and inform your healthcare provider 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 been reported after treatment with therapeutic doses of growth hormones.

The most common side effects of EGRIFTA SV® include:

  • Pain in legs and arms
  • Muscle pain

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).