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 usually injected once a day. Use tesamorelin injection at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.

After mixing tesamorelin injection, use the medication right away. Do not store tesamorelin injection after mixing. Dispose of any used tesamorelin injection and any extra liquid used to mix the injection.

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 and pharmacist if you are allergic to tesamorelin injection, mannitol (Osmitrol), any other medications, or any of the ingredients in tesamorelin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Sandimmune, Neoral); medications for seizures; and corticosteroids or hormonal steroids such as cortisone, dexamethasone (Decadron, Dexone), estrogen (Premarin, Prempro, others), methylprednisolone (Medrol), prednisone (Deltasone), progesterone (Prometrium), and testosterone (Androderm, Androgel, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor 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 or have ever had diabetes or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using tesamorelin injection, call your doctor immediately. Tesamorelin may harm the fetus. You should not breast-feed if you are infected with HIV or 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
• itching
• joint pain
• pain in the arms or legs
• muscle aches, stiffness, or spasms
• vomiting
• night sweats
• difficulty falling asleep or staying asleep

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

• rash
• hives
• swelling of the face or throat
• shortness of breath
• difficulty breathing
• fast heartbeat
• dizziness
• 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 (http://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 medication box containing the tesamorelin injection vials in the refrigerator. Do not freeze. Store the box containing the provided liquid, needles, and syringes at room temperature away from light, excess heat, and moisture (not in the bathroom). Keep each box tightly closed and out of reach of children.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.