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Omnitrope

(somatropin (Omnitrope))

How does this medication work? What will it do for me?

Somatropin belongs to a class of medications known as growth stimulants. Somatropin is a synthetic growth hormone. Growth hormone is made naturally in our bodies by the pituitary gland and is necessary for the stimulation of growth in children.

Somatropin is used to treat growth hormone deficiency in children. It replaces the growth hormone that the child is not able to produce naturally. It may also be used to encourage growth in children who were born small for their gestational age and are significantly smaller than their peers by age 2 to 4 years. Somatropin is used to encourage growth in children who have Turner syndrome and in children who are short in stature for no apparent reason (idiopathic short stature or non-growth hormone deficient short stature).

Somatropin may also be used by adults who have growth hormone deficiency, that either developed during adulthood or continued from childhood. Adult onset growth hormone deficiency may result from pituitary disease, surgery, radiation therapy, hypothalamic disease, or trauma.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose depends on the circumstances and body weight of the person being treated.

Your doctor will determine the appropriate dose of somatropin to be injected.

Somatropin is administered by injection only. It is usually injected subcutaneously (under the skin) in the thigh, buttocks, or abdomen. It is important to rotate the site of injection in order to minimize the risk of fat wasting at the site of injection.

If you are using this medication at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please refer to the appropriate package insert for details on how to mix the medicine and for proper injection procedures. It is important to visit your doctor regularly during therapy to ensure that the medication is working safely and effectively.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of the medicine, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Somatropin vials and pen cartridges should be refrigerated, protected from light, and kept from freezing. After the first injection, the cartridge is stable for up to 28 days provided that it is stored in a refrigerator. Leave the cartridge in the pen injector. Do not use the solution if it is discoloured or contains particles.

Keep this medication out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Vial
Each vial of sterile lyophilized powder for reconstitution contains 5.8 mg of somatropin. Nonmedicinal ingredients: glycine, disodium hydrogen phosphate heptahydrate and sodium dihydrogen phosphate dehydrate. Diluent contains bacteriostatic water for injection, benzyl alcohol (as preservative).

Pen cartridge
5 mg/1.5 mL
Each 1.5 mL pen cartridge contains 5 mg of somatropin (15 IU/1.5 mL). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, poloxamer 188, benzyl alcohol, mannitol, and water for injection. Phosphoric acid and/or sodium hydroxide may have been used to adjust pH.

10 mg/1.5 mL
Each 1.5 mL pen cartridge contains 10 mg of somatropin (30 IU/1.5 mL). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, poloxamer 188, phenol, glycine, and water for injection. Phosphoric acid and/or sodium hydroxide may have been used to adjust pH.

Who should NOT take this medication?

Do not use somatropin if you:

  • are allergic to somatropin or any ingredients of this medication
  • have active cancer
  • have an active brain tumour
  • have an acute illness due to complications of surgery, have respiratory (breathing) failure, or have just had a serious accident
  • have Prader-Willi syndrome and are severely obese or have severe breathing problems
  • have had a kidney transplant
  • have vision problems due to long-term effects of diabetes
Do not give this medication to children with closed epiphyses (bone growth plates).

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • carpal tunnel syndrome
  • headache
  • joint pain
  • muscle pain
  • pain and swelling at site of injection
  • swelling of hands, feet, or lower legs
  • unusual tiredness or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • a limp
  • numbness, tingling or pain in the arms, legs or face
  • pain in hip or knee
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of hypothyroidism (e.g., constipation, dry skin, cold intolerance, weight gain)
  • skin rash or itching
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe or frequent headaches with nausea and vomiting or vision problems
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Cancer: There is an increased risk of tumour growth, both cancerous and non-cancerous, when growth hormone is used by survivors of childhood cancer. Discuss any concerns you may have with your doctor.

Diabetes: Somatropin may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypothyroidism (low level of thyroid hormone): If you have uncontrolled hypothyroidism, treatment with somatropin may not work as well as it could. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Treatment with somatropin may trigger hypothyroidism. If you experience unexplained weight gain, muscle aches or stiffness, constipation, dry skin or fatigue, this may be a result of too little thyroid hormone and you should contact your doctor as soon as possible.

Pancreatitis: Somatotropin can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Scoliosis: People with scoliosis are at risk of their condition worsening while taking somatropin. If you have scoliosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Turner Syndrome: When somatropin is used to encourage growth in children with Turner Syndrome, there may be an increased risk of certain side effects. These children may be at increased risk of developing increased blood pressure in the brain. Because they are at an increased risk of ear and hearing disorders, the doctor should thoroughly review the child's medical history. If you or your child has ear or hearing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if somatropin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 3 years of age.

Seniors: The safety and effectiveness of using this medication have not been established for adults over 65 years of age.

What other drugs could interact with this medication?

There may be an interaction between somatropin and any of the following:

  • corticosteroids (e.g., cortisone, prednisone)
  • diabetes medications (e.g., glyburide, insulin, metformin, sitagliptin)
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Omnitrope

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