Geref (Injection)

Sermorelin is a man-made version of a substance that helps release growth hormone from the pituitary gland. Growth hormone is naturally made by the pituitary gland and is important for growth in children. For children who do not grow normally because their bodies are not making enough growth hormone, this medicine may be used to boost the amount of growth hormone produced by the pituitary gland.

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

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or packaging ingredients carefully.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require 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 injection site

Rare

• Itching
• Trouble swallowing

Some side effects may occur that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also provide information on how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Dizziness
• Flushing
• Headache
• Sleepiness
• Trouble sitting still

Other side effects not listed may also happen in some patients. If you notice any other effects, consult 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.

In the U.S.

• Geref
• Geref Diagnostic

Pharmacologic Class: Growth Hormone Releasing Hormone Analog

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.

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.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.