Tesamorelin, Injection

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KEY POINTS

• This medicine is given by injection to reduce excess belly fat in people who have HIV. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: growth hormone releasing factor

Generic and brand names: tesamorelin, injection; Egrifta

What is this medicine used for?

This medicine is given by injection (shots) to reduce excess belly fat (lipodystrophy) in people who have HIV. This medicine is not used for weight loss.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to mannitol
• Breathing or lung problems
• Cancer or tumors
• Carpal tunnel syndrome
• Diabetes
• Diabetic retinopathy (eye problems caused by diabetes)
• Edema (fluid buildup)
• Heart problems or high blood pressure
• Kidney or liver problems
• Pituitary gland problems

Tell your healthcare provider if you have recently had a severe illness, surgery or injury.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

Follow your healthcare provider's instructions exactly. These shots are given just under the skin. You may be able to give yourself the shots, or have someone at home give them to you. Your healthcare provider will teach you how to use this medicine at home. Check the label on the medicine for directions about your specific dose. Make sure that you understand exactly how to give the shots. If you do not understand how to use the disposable syringes, or how to mix the medicine, ask your healthcare provider or pharmacist to demonstrate. Check with your healthcare provider before using this medicine in children under age 18 years.

Carefully follow the instructions included in the medicine package for preparing and using this medicine. This medicine comes in the form of powder and sterile water for injection. Once the powder is mixed with the water, it must be used right away.

Only inject the mixed solution if it is clear, colorless, and does not have particles in it.

Never share needles or syringes with another person. This may increase your risk of transmitting infection to another person.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may develop diabetes when you take this medicine. If you already have diabetes, it may get worse. Check with your healthcare provider.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicine you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Swelling of fingers, arms, feet, or legs; numbness or tingling in hands, arms, or feet; joint or muscle pain or stiffness; depression; fainting; fast, slow, or irregular heartbeat; chest pain.

Other: Pain, redness, swelling, itching, or rash at the injection site; trouble sleeping; mild stomach pain, nausea, vomiting, night sweats.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as alogliptin (Nesina), canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and sitagliptin (Januvia)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the vials of powder in the refrigerator, in the original medicine box until you mix it or until the expiration date. Do not let it freeze. Protect it from direct light.

Store the sterile water, syringes, and needles at room temperature. Once you mix the powder with the water, use the solution right away. Do not freeze or refrigerate the mixed solution. Discard any of the mixed solution that you do not use.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.