Tesamorelin

Tesamorelin is a prescription medication used to reduce excess abdominal (stomach area) fat in HIV-infected patients with lipodystrophy (increased body fat in certain areas of the body). This medication belongs to a group of drugs called human growth hormone-releasing factor (GRF) analogs. It works by stimulating the synthesis and release of growth hormone which helps break down fatty tissue.

Tesamorelin comes in an injectable form to be injected just under the skin (subcutaneously) of the stomach area. It is usually injected once daily.

Common side effects include joint pain, pain in arms and legs, and swelling in the legs.

Tesamorelin is a prescription medication used to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tesamorelin may be found in some form under the following brand names:

• Egrifta

Common side effects include:

• joint pain
• pain in legs and arms
• swelling in your legs
• muscle soreness
• tingling, numbness and pricking
• nausea
• vomiting
• rash
• itching

This is not a complete list of tesamorelin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid. Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Cortril, Hydrocortone)
• ritonavir (Norvir)

This is not a complete list of tesamorelin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with tesamorelin including the following:

• serious allergic reactions. Some people taking tesamorelin may have an allergic reaction. Stop using tesamorelin and get emergency help right away if you have any of the following symptoms: a rash over your body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, or feeling of faintness or fainting.
• swelling (fluid retention). Tesamorelin can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome).
• an increase in glucose (blood sugar). Your healthcare provider will measure your blood sugar periodically.
• injection site reactions. Change (rotate) your injection site to help lower your risk for injection site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site: redness, itching, pain, irritation, bleeding, rash, or swelling.

Do not take tesamorelin if you:

• are allergic to tesamorelin or to any of its ingredients
• have a pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland
• have active cancer (either newly diagnosed or recurrent) or are receiving treatment for cancer
• are pregnant or become pregnant. If you become pregnant, stop using tesamorelin and talk to your healthcare provider

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tesamorelin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking tesamorelin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to tesamorelin or to any of its ingredients
• have or have had cancer
• have diabetes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have kidney or liver problems
• have any other medical condition

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tesamorelin falls into category X. It has been shown that women taking tesamorelin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

If you become pregnant, stop using tesamorelin and talk to your healthcare provider immediately.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if tesamorelin passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk to your healthcare provider about the best way to feed your baby if you are taking tesamorelin.

Take tesamorelin exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) of your stomach area.

After mixing tesamorelin with sterile water for Injection, it should look clear and colorless, with no particles in it. Do not use tesamorelin if it looks cloudy, discolored, or if you see particles in it.

Do not use tesamorelin after the date on the Medication Box and tesamorelin vial. Do not use a syringe or needle more than one time.

Do not share your tesamorelin needles with another person. Sharing needles can result in the transmission of infectious diseases, such as HIV. Do not share your tesamorelin syringe with another person, even if the needle is changed.

You should inject tesamorelin into the skin on your stomach. Pick an injection site that is around your belly button to the left or right. Stay away from any area with scar tissue, bruises, reddening, infection, or irritation.

Change your injection site from one day to the next to prevent bruising or irritation.

Do not recap the needle or remove the needle from the syringe after you inject tesamorelin. Put your used tesamorelin needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of tesamorelin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of tesamorelin is 2 mg injected directly under the skin (subcutaneously) once a day.

If you take too much tesamorelin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store the medication box of tesamorelin vials in the refrigerator.
• Store the injection box of sterile water for Injection, syringes, and needles at room temperature.
• Keep tesamorelin vials away from light.
• After mixing, use tesamorelin right away and throw away any unused tesamorelin. Do not store mixed tesamorelin. Throw away the used bottle of sterile water for Injection.
• Do not use tesamorelin after the expiration date printed on the medication box and vial labels.
• Keep this and all medicines out of the reach of children.