Tesamorelin

Tesamorelin (INN) (trade name Egrifta) is a synthetic form of growth-hormone-releasing hormone (GHRH) which is used in the treatment of HIV-associated lipodystrophy. It is produced and developed by Theratechnologies, Inc. of Canada.

Tesamorelin is a synthetic peptide consisting of all 44 amino acids of human GHRH with the addition of a trans-3-hexenoic acid group

Tesamorelin is used for Reducing excess stomach fat in certain HIV-infected patients.

Tesamorelin is a human growth hormone-releasing factor (GRF) analog. It works by stimulating the pituitary gland to release growth hormone (GH). This causes the breakdown of excess stomach fat.

Do NOT use tesamorelin if:

you are allergic to any ingredient in tesamorelin or to mannitol

you are pregnant

you have cancer, an underactive pituitary gland, or a pituitary gland tumor

you have had your pituitary gland removed, pituitary gland surgery, radiation treatment of the head, or a head injury

Contact your doctor or health care provider right away if any of these apply to you.

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Before using tesamorelin:

Some medical conditions may interact with tesamorelin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of cancer, noncancerous growths, or diabetes

if you have severe breathing problems (eg, respiratory failure); a serious illness caused by complications from surgery, injury, or trauma; or kidney or liver problems

Some MEDICINES MAY INTERACT with tesamorelin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticonvulsants (eg, phenytoin), corticosteroids (eg, prednisone), cyclosporine, or sex hormones (eg, estradiol, Testosterone) because the risk of their side effects may be increased by tesamorelin

This may not be a complete list of all interactions that may occur. Ask your health care provider if tesamorelin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use tesamorelin:

Use tesamorelin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with tesamorelin. Talk to your pharmacist if you have questions about this information.

Tesamorelin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using tesamorelin at home, a health care provider will teach you how to use it. Be sure you understand how to use tesamorelin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not use tesamorelin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.

Be sure to rotate your injection site on the stomach area with each dose as directed. Do not inject tesamorelin into scar tissue, bruises, or the belly button.

Tesamorelin needs to be mixed before use. Follow how to mix as you were told by the doctor.

Do not prepare tesamorelin until you are ready to use it. After mixing, use tesamorelin right away and throw away any unused medicine. Do not store prepared doses for later use.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of tesamorelin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use tesamorelin.

Important safety information:

The safety of long-term use of tesamorelin is not known. Contact your doctor if your condition does not improve while you use tesamorelin.

Tesamorelin is not intended to manage weight loss.

Tesamorelin may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Tesamorelin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

LAB TESTS, including IGF-I and blood sugar levels, may be performed while you use tesamorelin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Tesamorelin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use tesamorelin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you become pregnant, stop taking tesamorelin and contact your doctor right away. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or tesamorelin to the baby.

Possible side effects of tesamorelin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea; night sweats; stomach upset; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; flushing; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); arm, joint, leg, or muscle pain; burning, numbness, or tingling of the skin; decreased sense of touch; fainting or faintness; fast or irregular heartbeat; mental or mood changes (eg, depression); muscle or joint soreness or stiffness; numbness, pain, or weakness in your wrist, hand, or fingers; redness, swelling, itching, pain, irritation, rash, bleeding, or bruising at the injection site; shortness of breath or trouble breathing; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor).

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