Somatropin, E-Coli Derived (soe-ma-TROE-pin, E-KOH-lye dee-rived)

Treats conditions in which a person's body does not grow properly or does not produce enough natural growth hormone.

Brand Name(s):

Genotropin, Genotropin Miniquick, Humatrope, Norditropin Flexpro, Nutropin AQ NuSpin 10, Nutropin AQ NuSpin 20, Nutropin AQ NuSpin 5, Omnitrope, Zomacton

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given as a shot under your skin in the stomach, buttock, upper arm, or thigh.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• There are many different types of injection devices available for this medicine. Check if you have received the proper device each time you get your medicine. Talk to your pharmacist if you have questions about the device that you were given.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.
• Missed dose: Call your doctor or pharmacist for instructions.
• The storage instructions differ from brand to brand. Ask your pharmacist how to store your brand of medicine. Make sure you know how long you can store this medicine after mixing.
• Store mixed Humatrope® in the refrigerator for up to 28 days. Do not leave at room temperature for more than 30 minutes per day. Throw away any mixed medicine that has not been used after 28 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how somatropin works. Tell your doctor if you are using any of the following:
  • Cyclosporine
  • Birth control pills or hormone replacement treatment (including estrogen)
  • Insulin or oral diabetes medicine
  • Medicine for seizures
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, diabetes, thyroid problems, pituitary problems, scoliosis (curved spine), Turner syndrome, or a history of cancer.
• This medicine may cause the following problems:
  • Hip bone dislocation
  • Increased risk for cancer
  • Changes in blood sugar levels
  • Increased pressure in the head
  • Fluid retention (extra water in the body)
  • Pancreatitis (swelling of the pancreas)
  • Increased risk for cancer
  • Adrenal gland problems
  • Thyroid problems
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles, weakness, tiredness, weight loss
• Decrease or loss of body fat, especially in the face, arms, legs, or buttocks
• Headache, pain behind your eyes, vision problems
• Hip or knee pain, limping
• Increased thirst or hunger, increase in how much or how often you urinate
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid growth or weight gain, swelling in your hands, legs, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Trouble breathing, new or worsening snoring
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Ear pain, fluid draining from your ear
• Increased sweating
• Joint or muscle pain, stiffness or pain in your arms or legs
• Pain, redness, burning, swelling, a hard lump, or skin changes where your shot is given
• Swelling of the breasts or breast soreness (in both females and males)

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088