Somatrem (SOE-ma-trem)

Used to help children grow when their bodies do not make enough of their own growth hormone.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin, into a muscle, or into a vein.
• You may need to use this medicine for a long time, until you reach your final height and stop growing.
• You may see small specks or particles in the mixed medicine after it has been refrigerated. This is not unusual and the medicine can still be used.
• A nurse or other caregiver trained to give injections will give your treatment.
• Sometimes you or a family member can be taught how to give your medicine at home. Make sure you understand all instructions before giving an injection.
• This medicine is a powder that must be mixed with a special liquid before it is given. You should receive instructions on how to mix the medicine before injecting it. Follow these instructions carefully.
• The liquid usually used to mix with the powder contains benzyl alcohol. If you are allergic to benzyl alcohol, you may need to mix the powder with sterile water instead. Discuss this with your doctor.
• Always wipe the top of the medicine bottle with an alcohol pad before each use.
• To add the liquid to the powder, inject the water into the Protropin® vial, aiming the stream of liquid against the glass wall of the vial.
• After the liquid is added to the powder, gently swirl the medicine inside the bottle. Do not shake the bottle.
• Stick the needle into the rubber stopper at the top of the Protropin® vial. With the needle still stuck in the bottle, turn the bottle upside down and hold it at eye level.
• Pull the plunger until it lines up with the number of your dose on the side of the syringe.
• Gently tap the syringe with your finger to make any air bubbles float to the top of the syringe, just under the needle. Push the plunger in just enough so that the air bubbles go up into the bottle, and pull enough medicine back down into the syringe to make the correct dose.
• Use a new syringe for each shot. Never share syringes, needles, or medicine with anyone else.

If a dose is missed:

• Use your medicine as soon as possible unless it is almost time for your next dose.
• Skip the missed dose if it is almost time for your next regular dose.
• Do not give two doses at the same time or give two shots in one day.

How to Store and Dispose of This Medicine:

• Keep the powder in the refrigerator. After the powder has been mixed with the liquid that comes with it, you can keep it in the refrigerator for up to 14 days. Do not freeze.
• Do not use the medicine if it is cloudy after you mix it. Do not use any medicine that appears cloudy.
• If you have your treatments at home, you should be given a special container to throw away used needles and syringes. Keep this container where children or pets cannot reach it.
• Throw away, unused medicine after the expiration date on the bottle label has passed.
• Keep this and all medicine out of the reach of children.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using any cortisone medicines or steroids (such as prednisone).

Warnings While Using This Medicine:

• If you are pregnant or breastfeeding, talk to your doctor before using this medicine.
• Talk to your doctor before you use somatrem if you have thyroid problems, diabetes, or scoliosis (abnormal curve of the spine)
• Make sure your doctor knows if you have ever had cancer, a tumor, or any other disease in the brain or head.
• Very rarely, a person using somatrem develops a resistance to the medicine, and the medicine stops working. If you think growth has slowed down too much, talk to your doctor.
• If you become ill or are in an accident and are placed in an intensive care unit, be sure the doctor knows you are using this medicine. The doctor may want to stop treating you with somatrem until you get better.
• A few patients treated with growth hormones have developed leukemia. It is not known if growth hormone causes leukemia. If you have any questions about the risks and benefits of treatment, talk with your doctor.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in face or hands, swelling or tingling in the mouth or throat, tightness in chest, trouble breathing
• Blurred vision or other change in vision
• Hip or knee pain, limping
• Increase in how often or how much you urinate
• Increased thirst or increased hunger
• Unexplained headache, nausea, or vomiting

If you notice these less serious side effects, talk with your doctor:

• Pain where the shot is given
• Swelling of fingers, arms, feet, or legs

If you notice other side effects that you think are caused by this medicine, tell your doctor

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