Consumer Drug Information

Humatrope


Generic Name: Somatropin (rDNA origin - Refrigerated) (Humatrope) (SOE-ma-TROE-pin)
Brand Name: Humatrope

Humatrope is used for:

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Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or certain other conditions (eg, idiopathic short stature). It may also be used for other conditions as determined by your doctor.

Humatrope is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Humatrope if:

  • you are allergic to any ingredient in Humatrope
  • you have or are being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing
  • you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)
  • you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Humatrope :

Some medical conditions may interact with Humatrope . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have endocrine problems, including pituitary or adrenal gland problems; diabetes or a family history of diabetes; or an underactive thyroid
  • if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer
  • if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infections), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma

Some MEDICINES MAY INTERACT with Humatrope . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Humatrope
  • Corticosteroids (eg, prednisone) because they may decrease Humatrope 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Humatrope may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.



How to use Humatrope :

Use Humatrope as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Humatrope is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Humatrope at home, a health care provider will teach you how to use it. Be sure you understand how to use Humatrope . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Humatrope if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Always change the location where you inject Humatrope .
  • Do not shake Humatrope . Swirl the vial gently to mix it.
  • If you miss a dose of Humatrope , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Humatrope .

Important safety information:

  • Humatrope may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Humatrope with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Never reuse needles and syringes. Follow your health care provider's instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.
  • Humatrope may contain benzyl alcohol, metacresol, or glycerin. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.
  • Diabetes patients - Humatrope may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood sugar levels and thyroid function, may be performed while you use Humatrope . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Humatrope with caution in the ELDERLY; they may be more sensitive to its effects.
  • Rare, sometimes fatal, lung and breathing problems may be caused by Humatrope in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Humatrope , contact your doctor immediately. Tell your doctor right away if your child becomes very sick or is hospitalized while using Humatrope . Humatrope may need to be stopped.
  • Humatrope may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Humatrope while you are pregnant. It is not known if Humatrope is found in breast milk. If you are or will be breast-feeding while you use Humatrope , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Humatrope :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; nerve tingling; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; stomach pain; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Humatrope :

Before mixing, store Humatrope in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Humatrope past the expiration date on the product label. After mixing, store Humatrope according to the product label. Contact your pharmacist if you have any questions about the proper storage of Humatrope . Keep Humatrope , as well as needles and syringes, out of the reach of children and away from pets.

General information:

  • If you have any questions about Humatrope , please talk with your doctor, pharmacist, or other health care provider.
  • Humatrope is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Humatrope . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: August 5, 2009
Database Edition 09.3.1.002
Copyright © 2009 Wolters Kluwer Health, Inc.

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