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Tesamorelin

Side Effects

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.

Precautions

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.

Before Using

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.

Pediatric

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.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies 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.

Breastfeeding

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.

Drug Interactions

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.

Description

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.