Uses

This medication is used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Some HIV drugs may cause this side effect (increased fat in the upper back and stomach areas, decreased fat in the arms and legs). Tesamorelin works by causing your body to make more growth hormone.

This medication should not be used for weight loss.

How To Use

Read the Patient Information Leaflet and Patient Instructions for Use provided by your pharmacist before starting this medication and each time you get a refill. A health care professional will teach you how to properly use this medication. Learn all preparation and usage instructions in the product package or from your health care professional. If any of the information is unclear, consult your doctor or pharmacist.

Wash your hands with soap and water before using this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin on your stomach (abdomen) as directed by your doctor, usually once daily. To help you remember, use it at the same time each day.

Pick an injection site that is below your belly button to the left or right. Avoid any area with scar tissue, bruises, reddening, or irritation. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

Side Effects

Redness, itching, pain, irritation, or bruising at the injection site may occur. Muscle aches may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur:

• muscle/joint pain or stiffness
• numbness/tingling/swelling in your arms or legs

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may rarely increase the risk of getting a new cancer or of a previous cancer coming back. Talk with your doctor for details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• cancer
• diabetes
• tumors
• hypothalamus or pituitary gland problems (such as due to head injury, pituitary tumor/surgery)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood sugar, IGF-1 levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.