SOMATROPO® (Somatropin, rhGH)

PLEASE READ THE PACKAGE INSERT CAREFULLY BEFORE USE.

Keep the package insert for reference. If you have any questions that are not addressed here, please consult your physician. This drug has been individually prescribed by your physician for personal use. Under no circumstances do not administer it to others, even if they appear with the same symptoms, it may harm them. If you notice any of the side effects stated in this package please notify your doctor or pharmacist immediately.

WHAT IS SOMATROPIN

Somatropin is a form of human growth hormone important for the growth of bones and muscles.

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with short stature due to Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used in adults to treat short bowel syndrome, or to prevent severe weight loss related to AIDS. Somatropin may also be used for purposes not listed in this medication guide.

IMPORTANT INFORMATION

You should not use somatropin 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 somatropin if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

HOW TO USE SOMATROPIN

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. Somatropin is injected into a muscle or under the skin. A healthcare provider can teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Do not use somatropin 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 medication bottle or you may ruin 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. Your care provider will show you the best places on your body to inject somatropin. Use a different place each time you give an injection. Do not inject into the same place two times in a row. You may need frequent medical tests. Follow any diet plan created for you by your doctor or nutrition counselor to help control your condition.

SOMATROPIN DOSING INFORMATION

Weight Based Regimen:
Initial dose: Not more than 0.004 mg/kg subcutaneously once a day (or a total of 0.04 mg/kg per week in divided doses).

Maximum dose: 0.016 mg/kg once a day (0.08 mg/kg per week in divided doses)

SOMATROPIN 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 somatropin. 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;
• pain or swelling in your joints;
• pancreatitis–severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision;
• 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 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.