Tesamorelin is made with growth hormone-releasing factor (GRF).

Tesamorelin is used to reduce excess fat around the stomach that is caused by taking certain HIV medications. This condition is also called lipodystrophy (LYE-poe-DIS-troe-fee).

Tesamorelin is not a weight-loss medication and should not be used to treat obesity.

Tesamorelin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use tesamorelin if you are allergic to it, or if you have a history of tumor or surgery of your pituitary gland, a history of head injury or radiation treatment,

Before using tesamorelin, tell your doctor if you have heart disease, high blood pressure, kidney disease, diabetes, epilepsy, asthma, migraines, an adrenal gland disorder, or if you have ever had cancer, any type of tumor, or open heart surgery.

Also tell your doctor about any major illness or recent trauma or medical emergency.

Usual Adult Dose for Lipodystrophy:

2 mg subcutaneously once a day

Comments:
-Long term cardiovascular safety and benefit have not been studied.
-Not indicated for weight loss (weight neutral effect).
-There are no data to support improved compliance with anti-retroviral therapies in HIV positive patients.

Use(s): Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

You should not use tesamorelin if you are allergic to it, or if you have:

• cancer;

• a pituitary gland disorder;

• a history of pituitary gland tumor or surgery;

• a history of head injury or radiation treatment; or

• if you are pregnant.

To make sure you can safely take tesamorelin, tell your doctor if you have any of these other conditions:

• a history of cancer or any tumor (either benign or malignant);

• heart disease, high blood pressure;

• kidney disease;

• diabetes, eye problems caused by diabetes;

• epilepsy

• asthma;

• migraine headaches;

• adrenal gland disorder;

• if you have ever had open heart surgery; or

• if you have any major illness, or a recent trauma or medical emergency.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use tesamorelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give tesamorelin to a child without medical advice.

How tesamorelin given?

Tesamorelin is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tesamorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

After mixing tesamorelin with a diluent, you must use it right away. Do not store the mixture for later use.

Tesamorelin is usually given once per day. Follow your doctor's dosing instructions very carefully.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Never share a tesamorelin syringe with another person, even if you change the needle. Sharing syringes or needles can allow HIV or other diseases to pass from one person to another.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

Store vials of tesamorelin powder in the refrigerator, do not freeze.

Store the diluent at room temperature away from moisture, heat, and light.

Throw away any unused vials after the expiration date on the label has passed.

Call your doctor for instructions if you miss a dose of tesamorelin.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject tesamorelin into scar tissue or on skin that is bruised. Do not inject directly into your navel (belly-button).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:

• swelling in your hands, ankles, or feet;

• pain or stiffness in your muscles or joints;

• pain in your arms or legs;

• wrist pain or numbness;

• numbness or tingling in your hands or fingers;

• pounding heartbeats or fluttering in your chest;

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

Less serious side effects may include:

• depressed mood, sleep problems (insomnia);

• night sweats;

• mild rash or itching;

• muscle spasm;

• nausea, vomiting, upset stomach;

• pain, redness, itching, swelling, bruising, bleeding, or other irritation where the injection was given;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• cyclosporine;

• testosterone or hormone replacement therapy;

• seizure medication;

• steroids;

This list is not complete and there are many other drugs that can interact with tesamorelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.