SEROSTIM

Serostim is a form of human growth hormone important for the growth of bones and muscles. Serostim is used in adults to prevent severe weight loss related to AIDS. Serostim may also be used for purposes not listed in this medication guide.

Warnings

You should not use Serostim if you have cancer, diabetic retinopathy, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use this medicine if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Before taking this medicine

You should not use Serostim if you are allergic to Serostim or benzyl alcohol, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

Tell your doctor if you have ever had:

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

In some cases, Serostim should not be used in a child. Certain brands of somatropin contain an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Serostim?

Your dose and brand of somatropin, and how often you use it will depend on the condition you are treating. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Serostim is injected into a muscle or under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not inject the subcutaneous injection (under the skin) into the same place two times in a row.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Serostim if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

If your medicine comes with a syringe, cartridge, or injection pen, use only that device to give your medicine.

You may need frequent medical tests.

Follow any diet plan created for you by your doctor or nutrition counselor to help control your condition.

How you store this medicine will depend on the Serostim brand and the diluent you are using. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any Serostim left over after the expiration date on the label has passed.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using Serostim?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Serostim side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Serostim. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints;
• pancreatitis–severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem–extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common side effects of Serostim may include:

• pain, itching, or skin changes where the medicine was injected;
• swelling, rapid weight gain;
• muscle or joint pain;
• numbness or tingling;
• stomach pain, gas;
• headache, back pain; or
• cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.