Tesamorelin (Injection)

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually injected under the skin of your abdomen or stomach. Do not inject the medicine into a bruise, scar tissue, or the navel.
• A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

Introduction

Tesamorelin Acetate (tes-a-moe-REL-in AS-e-tate)

Used to reduce excess fat (lipodystrophy) in the abdomen or stomach in patients infected with human immunodeficiency virus (HIV).

Brand Name(s)

Egrifta

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, liver disease, diabetes, edema (fluid retention), carpal tunnel syndrome, or vision problems. Tell your doctor if you have breathing problems (acute respiratory failure), trauma, or have had a surgery of the heart or stomach.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine may cause swelling (fluid retention) in some parts of your body. Check with your doctor right away if you have an increase in joint pain, numbness or tingling sensation in your hands or wrist.
• This medicine may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
• Stop using this medicine and check with your doctor right away if you have a rash, hives or welts, itching skin, redness of the skin, shortness of breath, or swelling of the face, lips, hands, or feet.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood and urine tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain.
• Fast, slow, pounding, or uneven heartbeat.
• Joint pain.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain in the arms and legs.
• Pain or numbness in your hands or wrist.
• Redness, pain, swelling, itching, or bruising where the shot was given.
• Swelling in your legs.

If you notice these less serious side effects, talk with your doctor:

• Depression.
• Muscle or bone pain.
• Nausea, vomiting, heartburn, indigestion, or stomach pain.
• Rash or itching skin.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medication box of Egrifta? vials in the refrigerator. Protect the medicine from direct light. Do not freeze. You must store the box of sterile water for injection, syringes, and needles at room temperature. Use the mixed solution right away and throw any unused solution or mixture.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), medicine for seizures, or a steroid medicine (such as cortisone, dexamethasone, prednisolone, prednisone, or Medrol®).