Sermorelin

Vials of Sermorelin (sermorelin acetate for injection) should be stored refrigerated (2°-8°C/36°-46°F). Expiration dates are stated on the labels.

Sermorelin acetate (sermorelin) is a sterile, nonpyrogenic, lyophilized powder supplied in packages containing:

1 vial 0.5 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection, USP NDC xxxxxxxxxxxx
1 vial 3.0 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection, USP NDC xxxxxxxxxxxx

Manufacturer information: n/a. FDA rev date: 10/2/2001

Patients being treated with Sermorelin and/or their parents should be informed of the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including a review of the contents of the Patient Information Insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.

If home use is prescribed, a puncture resistant container for the disposal of used syringes and needles should be recommended to the patient. Patients and/or parents should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes (see Patient Information Insert).

Sermorelin is part of the drug classes:

• Somatropin and somatropin agonists

• Tests for pituitary function

This is not a complete list of Sermorelindrug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sermorelin falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Sermorelin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Sermorelin should be given to a pregnant woman only if clearly needed.

Take sermorelin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Sermorelin dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Sermorelin is available in the following doses:

• Sermorelin 0.5 Mg Subcutaneous Powder For Injection
• Sermorelin 1 Mg Subcutaneous Powder For Injection
• Sermorelin 50 Mcg Intravenous Powder For Injection