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Humatrope

Generic Name: somatropin
Brands: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Nutropin Depot, Saizen, Serostim, Zorbtive


What is the most important information I should know about Humatrope?

· Notify your doctor immediately if you experience nausea, vomiting, headache, or visual changes, especially during the first 8 weeks of treatment. These symptoms could indicate that you need a dosage adjustment or that you need to stop using Humatrope.

· Contact your doctor immediately if you have Prader-Willi syndrome and develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have been reported in patients with Prader-Willi syndrome taking Humatrope.

 

What is Humatrope?

· Humatrope is a form of the naturally occurring human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

· Humatrope is used to treat children and adults with growth failure because of a deficiency of growth hormone, chronic kidney failure, Turner syndrome, and in some cases when the cause of short stature is not known. The Serostim brand of Humatrope is used to prevent severe weight loss that can occur with the acquired immunodeficiency syndrome (AIDS). The Zorbtive brand of Humatrope is used in the treatment of short bowel syndrome.

· Humatrope may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before using Humatrope?

· Humatrope should not be used if     ·the growth areas of the bones has closed and cannot grow longer;     ·there is evidence of cancer or a tumor;     ·the patient has an illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; or     ·the patient has Prader-Willi syndrome and is severely obese or has severe respiratory (lung) problems.

· Humatrope will not be effective in, or may worsen, the conditions listed above.

· Before using this medication, tell your doctor if you have     ·diabetes;     ·hypothyroidism;     ·a history of intracranial lesion;     ·scoliosis; or     ·Prader-Willi syndrome and sleep apnea or snoring.

· You may not be able to use Humatrope, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Some forms of Humatrope require mixing with a diluent: some of these diluents contain preservatives (such as benzyl alcohol, metacresol and glycerin). Notify your doctor if you are allergic to benzyl alcohol, metacresol,or glycerin because you may not be able to use certain diluents. Mixing the powder with Sterile Water for Injection, instead of the diluents above, may be possible. Solutions mixed with Sterile Water for Injection must be used immediately after mixing, or within 24 hours if stored under refrigeration as directed, and not saved for later use.

· Serostim, Saizen, Genotropin, and Zorbtive are in the FDA pregnancy category B. This means that they are not expected to be harmful to an unborn baby. Humatrope, Norditropin, and Nutropin are in the FDA pregnancy category C. This means that it is not known whether they will be harmful to an unborn baby. Do not use Humatrope without first talking to your doctor if you are pregnant or could become pregnant during treatment.

· It is not known whether Humatrope passes into breast milk. Do not use Humatrope without first talking to your doctor if you are breast-feeding a baby.

 

 

How should I use Humatrope?

· Use Humatrope exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

· Humatrope can be injected subcutaneously (under the skin). Humatrope and Saizen can also be injected intramuscularly (into the muscle). If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give an injection. Rotate injection sites as directed by your doctor. Do not inject this medication if you are unsure how.

· Vials of Humatrope may require mixing before injection. Gently swirl the bottle after adding the diluent. Do not shake. Because Humatrope is a protein, shaking the vial of solution may result in a cloudy solution that should not be used. Do not inject any Humatrope product that is not completely dissolved, or that is discolored or cloudy immediately after mixing or after removal from the refrigerator. Occasionally, mixed solution that has been refrigerated may contain small, colorless particles. This is not harmful. Allow the solution to come to room temperature and gently swirl the vial. If the solution is cloudy, the medication must not be injected.

· Consult your doctor, pharmacist, or the package insert regarding storage conditions and how long the medication may be stored after mixing.

· The Nutropin Depot form of Humatrope is only injected once or twice monthly. Follow your doctor's instructions.

· Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture resistant disposal container.

· Your doctor may want you to have blood tests or other medical evaluations during treatment with Humatrope to monitor progress and side effects.

· Notify your doctor immediately if you experience nausea, vomiting, headache, or visual changes, especially during the first 8 weeks of treatment. These symptoms could indicate that you need a dosage adjustment or that you need to stop using Humatrope.

· Use the Norditropin cartridges only with the corresponding color-coded NordiPen. The color-coding system is designed to deliver the appropriate dose of medication.

· Many Humatrope products are available as cartridges for pen delivery systems. The pen delivery systems may not be interchangeable. Use only the pen delivery system provided with your particular product. Ask your doctor or pharmacist if you are unsure if the system is compatible.

· Do not allow any medication kept in the refrigerator to freeze. If the medicine does freeze, do not use it.

· Read the information that comes with the product for specific storage instructions, before and after mixing. Or ask your pharmacist about proper storage.

 

What happens if I miss a dose?

· Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose. Do not use a double dose of this medication.

 

What happens if I overdose?

· Seek emergency medical attention if an overdose is suspected.

· Symptoms of a Humatrope overdose include shaking (tremor), cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea.

 

What should I avoid while using Humatrope?

· There are no restrictions on food, beverages, or activity during treatment with Humatrope unless otherwise directed by your doctor.

 

What are the possible side effects of Humatrope?

· Contact your doctor immediately if you have Prader-Willi syndrome and develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have been reported in patients with Prader-Willi syndrome taking Humatrope.

· If you experience any of the following uncommon but serious side effects, stop using Humatrope and seek emergency medical attention or notify your doctor immediately:     ·an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or     ·nausea, vomiting, headache, or visual changes.

· Other side effects may also occur, although they are not common. Notify your doctor if you experience     ·headache;     ·muscle pain or weakness; or     ·mild symptoms of hyperglycemia such as increased thirst, increased urination, or sugar in the urine.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Humatrope?

· Humatrope may affect blood sugar levels. It may be necessary to adjust the dosage of diabetes medications such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), and others.

· Steroids such as cortisone (Cortef, others), methylprednisolone (Medrol, others), prednisone (Deltasone, Orasone), prednisolone (Prelone, Pediapred, others), and dexamethasone (Decadron) may decrease the effects of Humatrope. Steroid doses may need to be adjusted.

· Drugs other than those listed here may also interact with Humatrope. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products

 

Where can I get more information?

· Your pharmacist has additional information about Humatrope written for health professionals that you may read.


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