Somatropin (Recombinant rhGH) Solution for injection

What is this medicine?

SOMATROPIN (soe ma TROE pin) is a man-made growth hormone. Growth hormone helps children grow taller and helps adults and children grow muscle. It is used to treat many conditions of low growth hormone levels, growth failure, and short stature. This medicine is also used to help adults and children with AIDS, short bowel syndrome, or other medical conditions gain weight.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• diabetes

• Prader-Willi syndrome

• recent surgery or trauma

• sleep apnea, loud snoring

• vision problems

• an unusual or allergic reaction to somatropin, glycerin, benzyl alcohol, m-Cresol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• cyclosporine

• female hormones, like estrogens or progestins and birth control pills

• medicines for diabetes

• some medicines for seizures

• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. You will need to have important lab work done while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• back curves to the side

• breathing problems

• changes in vision

• dark urine

• ear pain or infection

• headache

• lumpy, thinning skin at site where injected

• nausea, vomiting

• pain in hip or knee

• swelling of the feet or hands

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone or muscle pain

• hair loss

• pain and swelling at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Depending on the brand of this medicine, store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F) or at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Ask your health care professional how to store your medicine. Do not freeze. Throw away any unused medicine after the expiration date.