Humatrope

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Humatrope


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

Humatrope is used for:

Treating growth hormone deficiency (GHD) in certain children and adults when the body does not produce enough. It is also used to treat certain children who are not growing normally due to Turner syndrome or 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, 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 side effects may be increased or effectiveness may be decreased by Humatrope
  • Corticosteroids (eg, prednisone) because effectiveness of Humatrope may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine 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 sometimes used at home as an injection. Before you use Humatrope , a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Humatrope or giving injections.
  • If you are using Humatrope at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
  • 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 this medicine, 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. If 2 or more treatments with Humatrope are missed, contact your health care provider for instructions.

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

Important safety information:

  • Humatrope may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.
  • 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 levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.
  • Lab tests may be required to monitor therapy. Be sure to keep appointments.
  • ELDERLY patients may be more sensitive to the effects of Humatrope .
  • 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 immediately if your child becomes very sick or is hospitalized while using Humatrope . Humatrope may need to be stopped.
  • Humatrope may contain benzyl alcohol, a preservative. Do not use medicine containing benzyl alcohol in NEWBORNS or INFANTS because serious and sometimes fatal nervous system problems and other side effects may occur.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Humatrope during pregnancy with your doctor. It is unknown if Humatrope is excreted in breast milk. If you plan to breast-feed while you are using Humatrope , talk with your doctor about the 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; bone pain; breast growth; breast milk production; bronchitis; carpal tunnel syndrome; decreased sensitivity of the skin; dizziness; fatigue; flu-like symptoms; gas; headache; increased sweating; muscle pain; reactions at the injection site (redness, pain, numbness, and swelling); runny nose; sleeplessness; swelling of the ankle or leg; tingling, burning, or prickling sensation on the skin; upper respiratory tract infection; weakness.

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

Severe allergic reactions (rash; hives; 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; depression; constant feeling of need to empty the bowel; curvature of the spine; ear infection; excessive thirst or hunger; fast heartbeat; fever; frequent urination; increased pressure in the head or eye; infection; nausea; pain or stiffness in joints; stomach pain; swelling of the ankles, legs, hands, or feet; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), 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: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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