When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tesamorelin or mannitol, or if you are pregnant. Do not use this medicine if you have an active cancer or pituitary gland problems, including a tumor, or if you had pituitary gland surgery.

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.
• A nurse or other health provider 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. Do not inject the medicine into a bruise, scar tissue, or your navel.
• Use the mixed solution right away. Throw away any mixed medicine that is leftover after your injection.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Vials: Store in the refrigerator. Protect from direct light. Do not freeze.
• Sterile water for injection, syringes, and needles: Store at room temperature.

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

• Some medicines can affect how tesamorelin works. Tell your doctor if you are using any of the following:
  
  • Cyclosporine
  • Medicine for seizures
  • Steroid medicine (including cortisone, dexamethasone, prednisolone, prednisone)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, liver disease, lung disease, diabetes, edema (fluid retention), or a history of cancer, recent surgery, or trauma.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  
  • Fluid retention (swelling)
  • Increased blood sugar levels
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Increased hunger or thirst
• Joint or muscle pain, numbness or pain in your hands or wrists
• Rapid weight gain, swelling in your hands, legs, or feet

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

• Redness, pain, swelling, itching, or bruising where the shot was given

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