Details for: 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 if: i) 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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Overdosage

Call your doctor immediately if you or your child take more than the amount of Omnitrope prescribed by your doctor.

Over-dosing growth hormone for several months or years may cause a disease called acromegaly, which causes bones to over-grow and can be fatal. Never share your medication

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.

Note: Do not reconstitute Omnitrope or inject it, until you have been taught the proper technique by your healthcare provider and you understand the instructions. Ask your healthcare provider or pharmacist if you have any questions about injecting OMNITROPE.

INSTRUCTIONS FOR OMNITROPE 5.8 MG/VIAL

The dosage of Omnitrope must be adjusted for the individual patient. The weekly dose should be divided into daily subcutaneous (just under the skin) injections (administered preferably in the evening). Omnitrope may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.

The following instructions explain how to inject Omnitrope 5.8 mg/vial:

Do not inject Omnitrope yourself until you have been taught the proper technique by your healthcare provider and you understand the instructions.

• Omnitrope 5.8 mg/vial is for multiple use.
• The concentration of Omnitrope after reconstitution is 5.0 mg/mL.
• After reconstitution, Omnitrope solution contains a preservative and should not be used in newborns.
• Omnitrope solution is for subcutaneous (just under the skin) injection.
• The injection sites should be rotated daily to help prevent lipoatrophy (local reduction of fatty tissue under the skin).

Preparation

Collect necessary items before you begin:

• a vial with 5.8 mg Omnitrope powder for solution for injection.
• a cartridge with diluent (Bacteriostatic Water for Injection containing benzyl alcohol as preservative).
• a transfer set for mixing and transferring the reconstituted solution back into the cartridge.
• the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5.0 mg/mL reconstituted solution for injection (not supplied in the pack; see Instructions for Use of the transfer set and of the injection device).
• 2 alcohol swabs (not supplied in the pack).

Wash your hands before you start with the next steps.

Reconstituting Omnitrope 5.8 mg/vial

• Remove the protective cap from the vial. With one alcohol swab, disinfect both the rubber membrane of the vial with powder and the cartridge containing diluent.
  
• Use the transfer set to transfer all of the diluent from the cartridge into the vial. Follow the directions that come with the transfer set.
• Gently swirl the reconstituted vial until the content is completely dissolved. Do not shake.
• If the solution is cloudy or contains particles, it should not be used. The solution must be clear and colourless after mixing.
• Transfer all of the dissolved solution back into the cartridge using the transfer set.

Injecting Omnitrope 5.8 mg/vial

• Put the cartridge with the Omnitrope solution into the Pen L for injection. Follow the Instructions for Use of the Pen Injector.
• Eliminate any air bubbles.
• Select the site of injection. The best sites of injection are tissues with a layer of fat between skin and muscle, such as the thigh, buttocks, or abdomen as in the pictures shown below. Do not inject near your belly button (navel) or waistline.
  
• Make sure you rotate the injection sites on your body. Inject at least 1 cm from your last injection site and change the places on your body 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 air dry.


• Insert the needle into the skin the way your doctor has taught you.
  
• With one hand, pinch a fold of loose skin at the injection site. With your other hand, hold the Pen L as you would a pencil. Insert the needle into the pinched skin straight in or at a slight angle (an angle of 45° to 90°).
  
• Pull the needle straight out of the skin. After injection, press the injection site with a small bandage or sterile gauze if needed for bleeding, for several seconds. Do not massage or rub the injection site.

After Injecting Omnitrope 5.8 mg/vial

• After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
• Remove the needle from the pen using the outer needle cap and discard the needle. This will keep Omnitrope sterile and prevent leaking. It will also stop air from 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, replace the pen cap and store in a refrigerator (at 2-8°C) and discard any unused solution 28 days after reconstitution.
• The solution should be clear after removal from the refrigerator. Do not use if the solution is cloudy or contains particles.

Do not inject Omnitrope yourself until you have been taught the proper technique by your healthcare provider and you understand the instructions.