Omnitrope: Uses, Side Effects and Dosage

What is Omnitrope used for?

In children, Omnitrope is used to treat the following growth problems:

• If you are not growing properly and you do not have enough of your own growth hormone.
• If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect growth - your doctor will have told you if you have this.
• If you were small or too light at birth. Growth hormone may help you grow taller if you have not been able to catch up or maintain normal growth by two years of age or later.
• If you have idiopathic (unknown cause) short stature.

In adults, Omnitrope is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood.

If you have been treated with Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment.

How does Omnitrope work?

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also

Serious Warnings and Precautions

helps your fat and muscle tissues to develop in the right amounts. Recombinant means it is made using bacteria instead of being taken out of human or animal tissue.

What are the ingredients in Omnitrope?

Medicinal ingredient: Somatropin (recombinant human growth hormone)

Non-medicinal ingredients:

5.0 mg/1.5 mL cartridge contains: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injection.

10.0 mg/1.5 mL cartridge contains: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injection.

15.0 mg/1.5 mL cartridge contains: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injection.

Omnitrope comes in the following dosage forms:

Omnitrope (somatropin for injection) is supplied as a solution:

5.0 mg/1.5 mL cartridge, 10 mg/1.5 mL cartridge and 15 mg/1.5 mL cartridge.

Do not use Omnitrope if:

• You are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope.
• You have an active tumour. Tumours must be inactive and you must have finished your anti-tumour treatment before you start using Omnitrope.
• You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone.
• Omnitrope has been prescribed to stimulate growth but you have already stopped growing (the growth plates on your long bones are closed).
• In patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).
• If you or your child are allergic to benzyl alcohol. Benzyl alcohol is also associated with toxicity in newborns and therefore the Omnitrope 5.0 mg/1.5 mL cartridge must not be used in newborns.
• You have uncontrolled diabetes or active psychosis.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Omnitrope. Talk about any health conditions or problems you may have.

Omnitrope therapy should be carried out under the regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth hormone deficiency.

BEFORE you use Omnitrope talk to your doctor or pharmacist:

• If the patient is at risk of developing diabetes, the doctor will need to monitor their blood sugar level during treatment with Omnitrope.
• If the patient has diabetes, they should closely monitor their blood sugar level during treatment with Omnitrope and discuss the results with their doctor to determine whether they need to change the dose of their medicines to treat diabetes.
• If the patient is receiving treatment with thyroid hormones it may be necessary to adjust their thyroid hormone dose.
• If the patient is taking growth hormone to stimulate growth and walk with a limp or if they start to limp during their growth hormone treatment due to pain in their hip, they should inform their doctor.
• If the patient develops a strong headache, visual disturbances or vomiting they should inform their doctor about it.
• If the patient is receiving Omnitrope for growth hormone deficiency following a previous tumour, they should be examined regularly for recurrence of the tumour.
• If the patient is a survivor of childhood cancer.
• If the patient, especially a child, develops severe abdominal pain (inflammation of the pancreas).

• If the patient is, or plans to become pregnant or is breastfeeding.

• If the patient develop a limp while being treated with Omnitrope.
• If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.
• If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during omnitrope treatment.

After starting Omnitrope treatment some patients may need to start thyroid hormone replacement.

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth.

The patient should not use Omnitrope if they are pregnant or are trying to become pregnant.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Omnitrope:

You should tell your doctor if you are using:

• medicines to treat diabetes,
• thyroid hormones,
• synthetic adrenal hormones (corticosteroids),
• sex hormones (for example oral estrogens),
• cyclosporine (a medicine that weakens the immune system after transplantation),
• medicines to control epilepsy (anticonvulsants).

Your doctor may need to adjust the dose of these medicines or the dose of Omnitrope.

How to take Omnitrope:

Recommended dosage

The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.

Children with growth hormone deficiency:

0.16-0.24 mg/kg body weight per week. Higher doses can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development.

Children with Turner syndrome:

0.33 mg/kg body weight per week.

Children with idiopathic short stature:

UP TO 0.47 mg/kg body weight per week

Children born smaller or lighter than expected and with growth disturbance:

UP TO 0.48 mg/kg body weight per week. Your doctor will determine the most appropriate dose and length of treatment. Treatment should be discontinued: i) if after the first year if you are not responding or ii) if you have reached your final height and stopped growing.

Adults with growth hormone deficiency:

You should start with 0.15-0.3 mg per day.

This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.

Follow the instructions given to you by your doctor

Injecting Omnitrope

Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you use more Omnitrope than you should

If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.

If you forget to use Omnitrope

Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next check-up.

If you stop using Omnitrope

Ask for advice from your doctor before you stop using Omnitrope.

Overdose:

Missed Dose:

Missing injections can interfere with the effectiveness of the medication. Talk to your doctor if this should happen. Do not try to make up for missed injections by “doubling up” on injections.

INSTRUCTIONS FOR USE OMNITROPE 5.0 mg/1.5mL

(somatropin for injection)

How to inject Omnitrope 5.0 mg/1.5 mL

The following instructions explain how to inject Omnitrope 5.0 mg/1.5 mL yourself. Please read the instructions carefully and follow them step by step. Your doctor or other suitably qualified healthcare professionals will show you how to inject Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and requirements for injection.

• Omnitrope is given as a subcutaneous (just under the skin) injection.
• Carefully inspect the solution before injecting it and use only if clear and colourless.
• Change the injection sites to minimize the risk of local lipoatrophy (local reduction of fatty tissue under the skin).

Preparation

Collect necessary items before you begin:

• a cartridge with Omnitrope 5.0 mg/1.5 mL solution for injection.
• the Omnitrope® Surepal 5, an injection device specifically developed for use with Omnitrope 5.0 mg/1.5 mL solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope® Surepal 5).
• a pen needle for subcutaneous (just under the skin) injection.
• 2 alcohol swabs (not supplied in the pack).

Wash your hands before you continue with the next steps.

Injecting Omnitrope

• With an alcohol swab, disinfect the rubber membrane of the cartridge.
• The contents must be clear and colourless.

• Insert the cartridge into the pen for injection. Follow the Instructions for Use of the pen injector. To set up the pen dial the dose.
• Select the site of injection. The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh, buttocks, or abdomen (except the navel or waistline).
• Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.
• Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to dry.

• Insert the needle into the skin in the way your doctor has taught you.

After Injecting

• After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
• Take the needle off the pen using the outer needle cap, and discard the needle. This will keep the Omnitrope solution sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.
• Leave the cartridge in the pen, put the cap on the pen, and store it in the refrigerator.
• The solution should be clear after removal from the refrigerator. Do not use if the solution is cloudy or contains particles.

• After the first injection, the cartridge should remain in the pen injector in a refrigerator between 2°C to 8°C for a maximum of 28 days.

  INSTRUCTIONS FOR USE OMNITROPE 10.0 mg/1.5 mL

  (somatropin for injection)

How to inject Omnitrope 10.0 mg/1.5 mL

The following instructions explain how to inject Omnitrope 10.0 mg/1.5 mL yourself. Please read the instructions carefully and follow them step by step. Your doctor or other suitably qualified healthcare professionals will show you how to inject Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and requirements for injection.

• Omnitrope is given as a subcutaneous (just under the skin) injection.
• Carefully inspect the solution before injecting it and use only if clear and colourless.
• Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).

Preparation

Collect necessary items before you begin:

• a cartridge with Omnitrope 10.0 mg/1.5 mL solution for injection.
• the Omnitrope® Surepal 10, an injection device specifically developed for use with Omnitrope 10.0 mg/1.5 mL solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope® Surepal 10).
• a pen needle for subcutaneous (just under the skin) injection.
• 2 alcohol swabs (not supplied in the pack).

Wash your hands before you continue with the next steps.

Injecting Omnitrope

• With an alcohol swab, disinfect the rubber membrane of the cartridge.
• The contents must be clear and colourless.

• Insert the cartridge into the pen for injection. Follow the Instructions for Use of the pen injector. To set up the pen, dial the dose.
• Select the site of injection. The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh, buttocks, or abdomen (except the navel or waistline).
• Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.
• Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to dry.

• Insert the needle into the skin in the way your doctor has taught you.

After Injecting

• After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
• Take the needle off the pen using the outer needle cap, and discard the needle. This will keep the Omnitrope solution sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.
• Leave the cartridge in the pen, put the cap on the pen, and store it in the refrigerator.
• The solution should be clear after removal from the refrigerator. Do not use if the solution is cloudy or contains particles.

• After the first injection, the cartridge should remain in the pen injector in a refrigerator between 2°C to 8°C for a maximum of 28 days.

  INSTRUCTIONS FOR USE OMNITROPE 15.0 mg/1.5 mL

  (somatropin for injection)

How to inject Omnitrope 15.0 mg/1.5 mL

The following instructions explain how to inject Omnitrope 15.0 mg/1.5 mL yourself. Please read the instructions carefully and follow them step by step. Your doctor or other suitably qualified healthcare professionals will show you how to inject Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and requirements for injection.

• Omnitrope is given as a subcutaneous (just under the skin) injection.
• Carefully inspect the solution before injecting it and use only if clear and colourless.
• Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).

Preparation

Collect necessary items before you begin:

• a cartridge with Omnitrope 15.0 mg/1.5 mL solution for injection.
• the Omnitrope® Surepal 15, an injection device specifically developed for use with Omnitrope 15.0 mg/1.5 mL solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope® Surepal 15).
• a pen needle for subcutaneous (just under the skin) injection.
• 2 alcohol swabs (not supplied in the pack).

Wash your hands before you continue with the next steps.

Injecting Omnitrope

• With an alcohol swab, disinfect the rubber membrane of the cartridge.
• The contents must be clear and colourless.

• Insert the cartridge into the pen for injection. Follow the Instructions for Use of the pen injector. To set up the pen, dial the dose.
• Select the site of injection. The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh, buttocks, or abdomen (except the navel or waistline).
• Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.
• Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to dry.

• Insert the needle into the skin in the way your doctor has taught you.

After Injecting

• After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
• Take the needle off the pen using the outer needle cap, and discard the needle. This will keep the Omnitrope solution sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.
• Leave the cartridge in the pen, put the cap on the pen, and store it in the refrigerator.
• The solution should be clear after removal from the refrigerator. Do not use if the solution is cloudy or contains particles.
• After the first injection, the cartridge should remain in the pen injector in a refrigerator between 2°C to 8°C for a maximum of 28 days.

What are possible side effects from using Omnitrope?

These are not all the possible side effects you may have when taking Omnitrope. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, Omnitrope can cause side effects, although not everybody gets them.

Serious side effects and what to do about them

Serious side effects and what to do about them

Slipped capital femoral epiphysis and Legg-Calve-Perthes disease may be considered by your doctor if discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope.

Since Somatropin has been on the market, serious strong reactions have occurred in patients including very bad allergic reactions that can cause difficulty breathing and swelling of the face and lips. Patients and caregivers should get medical attention immediately if an allergic reaction occurs.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Omnitrope must be refrigerated between 2 and 8°C.
• Omnitrope solution must be used within 28 days after the first injection.
• Do NOT freeze.
• Omnitrope is light sensitive and should be stored in the original package.
• Do NOT use after the expiry date on the label and carton.
• Do NOT use Omnitrope if the solution is cloudy or contains particles.
• After the first injection, the cartridge should remain in the pen injector and must be kept in a refrigerator between 2 and 8°C (see Instructions for Use of the pen injector).
• Keep out of reach and sight of children.

If you want more information about Omnitrope:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this

  • by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

Last Revised: May 23, 2024