In the U.S.—

• Growth hormone–releasing hormone

Sermorelin (ser-moe-REL-in) is a synthetic (man-made) version of a naturally occurring substance that causes release of growth hormone from the pituitary gland. Growth hormone is naturally produced by the pituitary gland and is necessary for growth in children. In children who fail to grow normally because their bodies are not producing enough growth hormone, this medicine may be used to increase the amount of growth hormone produced by the pituitary gland.

This medicine is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sermorelin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sermorelin has not been studied in pregnant women. However, studies in animals have shown that sermorelin causes minor birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

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. When you are taking sermorelin, it is especially important that your health care professional know if you are taking any of the following:

• Corticosteroids (cortisone-like medicines)—These medicines can interfere with the effects of sermorelin

• Underactive thyroid—This condition can interfere with the effects of sermorelin

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine needed has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve the condition.

Each package of sermorelin contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes and needles, including safe handling and disposal.
• How to give the injection.
• How long the injection is safe to use.

It is best to use a different place on the body for each injection (for example, abdomen, hip, thigh, or upper arm). To help you remember to do this, you may want to keep a record of the date and location for each injection.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits.

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 as soon as possible if any of the following side effects occur:

• More common
  • Pain, redness, or swelling at the place of injection 
  
  

• Rare
  • Itching;  trouble in swallowing 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• Rare
  • Dizziness;  flushing;  headache;  sleepiness;  trouble sitting still 
  
  

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