Tesamorelin Injection

WHY is this medicine prescribed?

Tesamorelin injection is used to decrease the amount of extra fat in the stomach area in adults with human immunodeficiency virus (HIV) who have lipodystrophy (increased body fat in certain areas of the body). Tesamorelin injection is not used to help with weight loss. Tesamorelin injection is in a class of medications called human growth hormone-releasing factor (GRF) analogs. It works by increasing the production of a certain natural substance that can decrease the amount of body fat.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Tesamorelin injection comes as a powder to be mixed with the liquid provided with your medication and injected subcutaneously (under the skin). It is injected once a day. Use tesamorelin injection at around the same time every day.

Use tesamorelin injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Before you use tesamorelin injection for the first time, read the manufacturer's information for the patient that comes with the medication. Your medication comes in 2 boxes: one box with tesamorelin injection vials and another with vials containing liquid to mix with the medication, needles, and syringes. Ask your pharmacist or doctor to show you how to mix and inject the medication. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

You should inject tesamorelin into the skin of your stomach area below the navel (belly button). Do not inject tesamorelin into the navel or into any scarred, reddened, irritated, infected, or bruised areas of skin. Do not inject tesamorelin into any areas with hard bumps from previous injections. Choose a different area for each injection to help prevent bruising and irritation. Keep track of the areas where you inject tesamorelin, and do not give an injection into the same spot two times in a row.

You should always look at tesamorelin injection solution (liquid) after mixing and before you inject it. The solution should be clear and colorless with no particles in it. Do not use tesamorelin injection solution if it is colored, cloudy, contains particles, or if the expiration date on the bottle has passed.

Never reuse syringes or needles, and never share needles with another person. Do not share syringes with another person even if the needle was changed. Sharing needles and syringes can cause the spread of certain diseases, such as HIV. If you accidently prick someone with a used needle, tell him to talk to his healthcare provider right away. Dispose of any remaining tesamorelin injection, extra liquid used to mix the injection, and used needles and syringes in a puncture-resistant container made of hard plastic or metal that has a lid. Never throw used needles or syringes into the trash. Ask your doctor or pharmacist how to dispose of the puncture-resistant container and all other used materials.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using tesamorelin injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using tesamorelin injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have ever received radiation therapy in the area of the head or brain; if you recently had a head accident or trauma; or if you have or have ever had pituitary gland surgery, a pituitary gland tumor, or any other problems related to your pituitary gland. Also tell your doctor if you have or have ever had cancer or any kind of growth or tumor. Your doctor may tell you not to use tesamorelin injection.

• tell your doctor if you have recently had heart or stomach surgery, or if you have or have ever had diabetes, breathing problems, or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using tesamorelin injection, call your doctor immediately. Tesamorelin may harm the fetus.

• tell your doctor if you are breast-feeding or plan to breast-feed. You should not breast-feed if you are infected with HIV or are using tesamorelin injection.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using tesamorelin injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Tesamorelin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling of the hands, feet, ankles, or lower legs
• pain or numbness in the hands or wrists
• tingling, numbness, or pricking sensation
• redness, itching, pain, bruising, bleeding, or swelling at the site of the injection
• joint or muscle pain
• pain in the arms or legs
• vomiting
• heartburn
• night sweats

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash, hives, itching, flushing of the skin, swelling of the face or throat, shortness of breath, difficulty breathing, fast heartbeat, dizziness, or fainting

Tesamorelin injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Store the boxes containing tesamorelin injection vials, the provided liquid, needles, and syringes at room temperature away from light, excess heat, and moisture (not in the bathroom). Do not freeze.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to tesamorelin injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.