What you should know

about Humatrope

Please read this leaflet carefully before starting your child on Humatrope. It does not contain all the information that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Humatrope.

What is in your Humatrope

Your medicine is called Humatrope. It is a brand of human growth hormone (also called somatropin).

Humatrope is a powder and comes in bottles of 4 International Units (1.48mg human growth hormone) or 16 International Units (5.92mg human growth hormone).

The bottles also contain mannitol, glycine and dibasic sodium phosphate.

Each bottle of Humatrope comes with a bottle of sterile Diluent (liquid) which has m-cresol and glycerol in it. Use the 2ml Diluent with the 4-unit bottle of Humatrope and the 8ml Diluent with the 16-unit size.

 

Human growth hormone is a protein hormone which is made in the laboratory by a 'recombinant DNA technology' process. It has the same structure as the hormone that the body produces. It is important for normal bone growth in children and teenagers.

Humatrope is made by Lilly France SA, Rue du Colonel Lilly, 67640 Fegersheim, France. The product licence is held by Lilly Industries Limited, Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 2SY.

Why Humatrope?

Humatrope is used to treat children and teenagers who do not develop to their normal height because of poor bone growth. Growth hormone deficiency or Turner's syndrome are medical conditions which result in slow bone growth.

Before injecting Humatrope

Make sure it is safe for the patient to be injected with Humatrope.
  • Humatrope should not be used if:
  • The bones can no longer grow.
  • The patient has an active brain tumour or any other tumour (cancer). However, your doctor may prescribe Humatrope if the patient has had a brain tumour and needs no more treatment for it. The patient should be reexamined frequently to make sure that the tumour has not come back or started to grow.
  • Do not use the Diluent if the patient is extremely sensitive to m-cresol - read the section on mixing Humatrope.
  • A doctor trained in hormone disorders must examine the patient to decide if it is safe to use Humatrope.
  • Tell your doctor if the patient is pregnant or breast-feeding .
  • Tell your doctor if the patient is diabetic because he or she may need more or less insulin when taking Humatrope.
  • Tell your doctor if the patient is already taking a glucocorticoid hormone such as cortisone or prednisone. This is because the combination may reduce the response to growth hormone. The patient must be frequently re-examined.

Using Humatrope

Your doctor will tell you which Humatrope strength to use; how much to use; and where to inject it. The patient's total dose each week will depend on his or her body weight or body size (surface area).

Use Humatrope exactly as your doctor tells you to. The usual dose is:

  • Dose for Growth hormone deficiency

Inject up to 0.07 international units per kilogram of body weight (0.026mg per kilogram) once a day.

Or

Inject up to 0.16 international units per kilogram of body weight (0.06mg per kilogram) on 3 days each week.
  • Dose for Tumer's syndrome

Inject 0.8 to 0.9 international units (0.30 to 0.33mg) per kilogram of body weight each week. Divide the total weekly dose into 6 or 7 doses and inject one dose each day. Inject Humatrope under the skin.

Humatrope can be injected under the skin or into a muscle.

 

 

 

Please read the back of this leaflet

What you should know about Humatrope - continued

Mixing, Preparing and Injecting Humatrope

You must not mix Humatrope or Inject it until your doctor has trained you to do it correctly. Make sure that everything you use in the procedure is sterile.

  • Mixing Humatrope

You must only mix Humatrope with Diluent. Never mix it with anything else unless your doctor tells you to. He or she will tell you to use 'Water for Injections' if the patient is extremely sensitive to m-cresol. In this case, mix the powder with 'Water for Injections' instead of Diluent. You must get the 'Water' from your pharmacist or doctor. Do not use tap water. Make up and use one dose out of each bottle and use the dose within 24 hours. Safely dispose of the leftover mixture.

Your doctor will tell you what size of syringe and needle to use and how much Diluent to add. It will usually be 0.5 to 2.0ml with the 4-unit size or 2.0 to 8.0ml with the 16-unit size.
  • Always wash your hands before you start.
  • Take off and throw away the caps from the tops of the Diluent and Humatrope bottles.
  • Wipe the tops of both the bottles with an alcohol swab. Fix the needle onto the syringe. Take off and keep the needle cover. Pull back the syringe plunger to draw up an amount of air into the syringe equal to the amount of Diluent that your doctor has told you to use. Push the needle into the stopper of the Diluent bottle and inject the air into the bottle.
  • Hold the bottle upside down and, making sure that the tip of the needle is in the solution, draw up the amount of Diluent that your doctor has told you to. After making sure that there are no air bubbles in the syringe, turn the bottle upright and, holding the barrel, take out the syringe.
  • Using the same needle, slowly inject the Diluent into the bottle of Humatrope aiming the stream of liquid against the side of the bottle. Do not aim it at the white powder at the bottom of the bottle. Before taking the syringe out of the bottle, draw in the same amount of air as the Diluent you have injected into the bottle. This is to equalise the pressure in the bottle. If the needle is the type that can be taken out of the barrel of the syringe, take it out and dispose of the needle safely. If the needle and syringe are one complete unit, safely dispose of the whole unit.
  • Swirl the bottle gently to completely dissolve the contents. Do not shake the bottle.
  • Label the bottle with the date you mixed it and throw away any leftover Diluent.
  • Preparing the injection
  • Do not inject the mixture if it is cloudy or has any particles in it.
  • If the needle can be changed in the syringe that you are using, always use a new needle for each injection. If the syringe and needle are a complete unit, always use a new unit for every injection.
  • Before and after every injection, wipe the rubber stopper of the bottle with rubbing alcohol or an alcoholic antiseptic solution to keep it clean and safe.
  • When you are ready to inject, take off the needle cover and draw the same amount of air into the syringe as your measured dose of Humatrope.
  • Push the needle into the bottle of mixed Humatrope and inject the air into the bottle. Turn the bottle upside down and, making sure the tip of the needle is in the solution, draw out your correct dose. Make sure that there are no air bubbles in the syringe.
  • Remove the syringe and put back the needle cover.
  • Keep the rest of the Humatrope in the fridge. You must use it within 14 days. Dispose of any leftover after this time.

 

 

  • Injecting Humatrope

Use the method and needles your doctor has told you to use and follow this general advice:
  • Gently tap the skin where you are going to inject several times with your fingers.
  • Wipe the skin thoroughly with an alcohol swab. Use a circular motion and work outward from the inside of the circle.
  • Injections beneath the skin (subcutaneous): With your thumb and forefinger, pinch up a large area of skin. Do not inject into exactly the same place each time.
  • Holding the syringe at a 90-degree angle with the needle aimed at the injection site, quickly put the needle all the way into the pinched area of skin.
  • Slowly inject the mixture.
  • Quickly take the needle out of the skin and firmly press a dry gauze pad or cotton ball onto the injection site. Rub the injection site with the pad for several seconds.
  • Safely dispose of the needle, or the needle and syringe, after every injection.
  • Injection into muscle (intramuscular): With your thumb and first 2 fingers, press the skin down firmly against a large muscle mass, such as the thigh.
  • Holding the syringe at a 90-degree angle with the needle aimed at the injection site, quickly put the needle all the way into the skin.

When the needle is in place, slowly pull back on the plunger. If blood comes into the syringe, take out the needle; safely dispose of the syringe and drug, and start all over again.

If no blood comes into the syringe, slowly inject the mixture into the muscle.
  • Take the needle out quickly, and firmly press a dry gauze pad or cotton ball onto the injection site. Rub the injection site with the pad for several seconds.
  • Safely dispose of the needle, or the needle and syringe, after every injection.

If you have any questions, please ask your doctor.

 

While using Humatrope

  • If the patient becomes pregnant, stop the injections and tell your doctor.
  • Humatrope can affect the amount of thyroid hormone in the blood, so patients must have thyroid function tests from time to time. If the thyroid is not working properly, Humatrope may not work as well as it should.
  • Any child who begins to limp must be examined by a doctor.
  • Humatrope sometimes causes side effects. If there is any pain or redness at the injection site, or if there is any swelling, tell your doctor.
  • Tell your doctor if the patient looks unusually pale or bruises more easily than usual.

 

How to store Humatrope

Do not use Humatrope after the 'Use Before' date.

Both before and after mixing, keep your Humatrope and Diluent in a fridge, between 2° and 8°C. Do not freeze the Diluent or the mixed bottle. Humatrope can be used for up to 14 days after mixing if you keep it in these conditions.

Do not keep the mixed Humatrope in plastic syringes.

REMEMBER: This medicine is for a child. Never give it to anyone else. It may harm them, even if their symptoms are the same.

‘Humatrope' is a registered trademark of Eli Lilly and Company (USA).

Date of Leaflet Preparation: October 1993

© Eli Lilly and Company Limited, 1993.