What is EGRIFTA SV (tesamorelin for injection)?

• EGRIFTA SV  or Tesamorelin 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 or Tesamorelin is not for weight loss management.

• The long-term safety of Tesamorelin 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 Tesamorelin 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

• 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).