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Humatrope ®

Humatrope ® (somatropin [rDNA origin] for injection)

Growth hormone deficiency can be treated with Humatrope, a "man-made" form of growth hormone (somatropin). Humatrope is the same in its chemical structure as the growth hormone that is naturally produced by the pituitary gland. Humatrope is administered by injecting it into the fatty tissue under the skin - subcutaneously.

In 1996, Humatrope was the first growth hormone therapy to receive FDA approval for treatment of adult growth hormone deficiency. Humatrope is approved for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

• Adult-onset growth hormone deficiency - patients who have growth hormone deficiency, either alone or accompanied by multiple hormone deficiencies (hypopituitarism), as a result of hypothalamic disease, pituitary disease, surgery, radiation therapy, or trauma

OR

• Childhood-onset growth hormone deficiency - patients who were growth hormone-deficient during childhood, and who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started

Humatrope is a protein. If it were taken orally, Humatrope would be digested in the stomach, in the way that food proteins are digested, and would not be useful to the body. Humatrope must be injected to be properly absorbed and used by the body.

Treatment
Response to treatment varies from patient to patient. Some studies suggest that several months of treatment may be necessary for an adequate response. You should ask your doctor for his or her opinion.

In the past, patients diagnosed with growth hormone deficiency as children usually were treated only until they had finished growing and did not receive treatment once they reached adulthood. More recently, certain benefits of growth hormone replacement therapy in adults have been recognized. Also, in the past, supplies of growth hormone were limited. However, with the advances in biotechnology, it is now possible for everyone who is lacking growth hormone to receive replacement therapy.

The Best Time of Day for Humatrope
Growth hormone normally is produced at peak levels when you are asleep. Accordingly, it is usually recommended that growth hormone be given in the evening to imitate what happens naturally in your body. However, there may be reasons to give the injection at other times of the day in certain cases. Check with your doctor for the most appropriate time for your injections.

If You Miss a Dose of Humatrope
If you miss a dose of Humatrope, simply take your next dose at the regularly scheduled time. Do not double up on your dose. If you frequently forget your injection, talk to your doctor, as your treatment may be less effective.

How is Humatrope Used and Stored
Vials and cartridges of powdered Humatrope and diluent for Humatrope must be kept in your refrigerator. Do not freeze them.

Once Humatrope is mixed, it must be used within 14 days (vials) or 28 days (cartridges).

Do not use expired Humatrope or diluent.

Do not shake the vial or cartridge of Humatrope when mixing it, instead, roll it gently between your palms.

If your mixed Humatrope is cloudy or contains any particles, it should not be injected. Report the situation to your Humatrope provider, who will advise you what to do with the product.

When Traveling
Keep your Humatrope cold (not frozen!) in a small cooler or thermal lunch bag with cool packs. You can carry these items with you in a car or on board an airplane. However, do not check the cooler as baggage - keep it with you at all times. Ask your doctor or nurse for a Humatrope cooler bag. Alternatively, you may call Lilly at 1-800-LillyRx, or 1-800-545-5979, to receive a cooler.

Humatrope - somatropin (rDNA origin) for injection - made by Eli Lilly and Company. For more information call 800-545-6962 or visit www.humatrope.com.

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