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Tesamorelin (Subcutaneous route)

Pronunciation:

tes-a-moe-REL-in AS-e-tate

Brand Names:

  • Egrifta

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Tesamorelin

Uses of This Medicine:

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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

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.

Older adults—

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

Pregnancy—

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-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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 interactions—

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 problems—

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.

Proper Use of This Medicine:

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.

Dosing—

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 dose—

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.

Storage—

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Difficulty with moving
muscle pain or stiffness
pain in the arms or legs
pain in the joints
Less common
Blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning, numbness, pain, or tingling in all fingers except the smallest finger
chest pain
dizziness
fast, irregular, pounding, or racing heartbeat or pulse
headache
nervousness
pounding in the ears
slow or fast heartbeat
swelling of the joints
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site
muscle aching or cramping
Less common
Acid or sour stomach
belching
bone pain
discouragement
feeling of warmth
feeling sad or empty
heartburn
indigestion
irritability
itching skin
lack of appetite
loss of interest or pleasure
muscle spasms
nausea
night sweats
rash
redness of the face, neck, arms, and occasionally, upper chest
sleeplessness
stiffness of the joints
stomach discomfort, upset, or pain
strain in the muscles
sudden sweating
tiredness
trouble concentrating
trouble sleeping
unable to sleep
upper abdominal or stomach pain
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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