Omnitrope

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

Your doctor will determine the appropriate dose of Omnitrope (Somatropin) to be injected.

Omnitrope (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 Omnitrope (Somatropin) 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 Omnitrope (Somatropin) 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.

Omnitrope (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 Omnitrope (Somatropin) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause joint pain; it may cause pain at the injection site; it may cause muscle pain; it may cause nausea or, rarely, vomiting; it may cause leg swelling or water retention; it may cause numbness and a decreased sensitivity to touch. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Vial

Each vial of sterile lyophilized powder for reconstitution contains 5.8 mg of Omnitrope (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 Omnitrope (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 Omnitrope (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.

15 mg/1.5 mL
Each 1.5 mL pen cartridge contains 15 mg of Omnitrope (Somatropin) (45 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.

Do not use Omnitrope (Somatropin) if you:

• are allergic to Omnitrope (Somatropin) or any ingredients of Omnitrope (Somatropin)
• 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
• are a child with closed epiphyses (growth plates)

Do not give Omnitrope (Somatropin) to children with closed epiphyses (bone growth plates).

There may be an interaction between Omnitrope (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 Omnitrope (Somatropin). 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.

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 Omnitrope (Somatropin).

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: Omnitrope (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 Omnitrope (Somatropin).

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

Hypothyroidism (low level of Thyroid hormone): If you have uncontrolled hypothyroidism, treatment with Omnitrope (Somatropin) may not work as well as it could. Discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed. Treatment with Omnitrope (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 Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), 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 Omnitrope (Somatropin). If you have scoliosis, discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Turner Syndrome: When Omnitrope (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 Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Pregnancy: Omnitrope (Somatropin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Omnitrope (Somatropin), contact your doctor immediately.

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

Children: Some formulations of Omnitrope (Somatropin) contain the preservative benzyl alcohol. Be careful about giving these formulations to children under the age of 3 years.

Seniors: The safety and effectiveness of using Omnitrope (Somatropin) have not been established for adults over 65 years of age.

This product must be injected under the skin (subcutaneously): Clean the tip of the pen with an alcohol swab and attach a needle. Select the required dose. Clean the skin at the injection site with an alcohol swab. Pinch the skin and inject the medication into the fold (wait several days before injecting the same site again). Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.