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Tesamorelin
Specialty Drug

Egrifta

TESAMORELIN is used to reduce excess abdominal fat in HIV-infected patients. Compare growth hormone releasing factors.
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What is Tesamorelin?

Commonly Used Brand Name(s)Egrifta

Therapeutic ClassificationsEndocrine-Metabolic Agent

Pharmacologic ClassificationsTesamorelin

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OverviewTOP

Tesamorelin injection is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used to reduce excess fat (lipodystrophy) in the abdomen or stomach in patients infected with human immunodeficiency virus (HIV).

This medicine is available only with your doctor's prescription.

Proper UseTOP

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin, usually in the abdomen or stomach. Do not inject the medicine into a bruise, scar tissue, or the navel.

Tesamorelin injection comes with a patient instructions. Read the instructions and make sure you understand:

  • How to prepare the injection.
  • Proper use of disposable syringes.
  • How to give the injection.
  • How long the injection is stable.

If you have any questions about any of this, check with your doctor.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use a new needle and syringe each time you inject your medicine.

You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For HIV-infected lipodystrophy:
      • Adults—2 milligrams (mg) injected under your skin once a day.
      • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use & StorageTOP

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medication box of Egrifta™ vials in the refrigerator. Protect the medicine from direct light. Do not freeze. You must store the box of sterile water for injection, syringes, and needles at room temperature.

Use the mixed solution right away and throw any unused solution or mixture.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of tesamorelin injection in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

No information is available on the relationship of age to the effects of tesamorelin injection in geriatric patients.

PregnancyTOP

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast FeedingTOP

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to mannitol, history of or
  • Cancer, active or history of or
  • Pituitary gland tumor or surgery or
  • Pressure in the head—Should not be used in patients with these conditions.
  • Breathing problems or lung disease (e.g., acute respiratory failure) or
  • Carpal tunnel syndrome or
  • Diabetes or
  • Edema (fluid retention or swelling) or
  • Retinopathy (damage to the retina) or
  • Surgery (e.g., heart, stomach) or
  • Trauma—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—It is not known if this medicine will work properly in patients with these conditions.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause swelling (fluid retention) in some parts of your body. Check with your doctor right away if you have an increase in joint pain, numbness or tingling sensation in your hands or wrist.

Tesamorelin injection may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

Stop using this medicine and check with your doctor right away if you have a rash, hives or welts, itching skin, redness of the skin, shortness of breath, or swelling of the face, lips, hands, or feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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