Genotropin 5.3 mg powder and solvent for solution for injection – patient leaflet, side effects, dosage

1. What Genotropin is and what it is used for

• If you are receiving treatment with thyroid hormones it may be necessary

2. What you need to know before you use Genotropin

to adjust your thyroid hormone dose.

3. How to use Genotropin

Do not use a double dose to make up for a forgotten dose.

• If you are taking growth hormone to stimulate growth and walk with a limp

  Children with Turner syndrome:

4. Possible side effects

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.

or if you start to limp during your growth hormone treatment due to pain in your hip, you should inform your doctor.

0.045-0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day. Children with chronic renal (kidney) insufficiency:

5. How to store Genotropin

Reporting of side effects

6. Contents of the pack and other information

• If you develop raised intracranial pressure (with symptoms such as strong

  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

  0.045-0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day). Higher doses may be necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of treatment.

  headache, visual disturbances or vomiting) you should inform your doctor about it.

• What Genotropin is and what it is used for

  If you stop using Genotropin

  Ask for advice from your doctor before you stop using Genotropin. If you have any further questions on the use of this product, ask your doctor or pharmacist.

  effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Genotropin 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 helps your fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from human or animal tissue.

• If your doctor confirms that you have developed inflammation of the

  muscles near the injection site because of the preservative metacresol, you should use a Genotropin product without metacresol.

  Children with Prader-Willi syndrome:

  0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day. The daily dosage should not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after puberty.

  1. 4. Possible side effects

• If you are receiving Genotropin for growth hormone deficiency following a

  1. 5. How to store Genotropin

previous tumour (cancer), you should be examined regularly for recurrence of the tumour or any other cancer.

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

In children, Genotropin is used to treat the following growth disturbances:

Children born smaller or lighter than expected and with growth disturbance: 0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day). It is important to continue treatment until final height is reached. Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing.

Keep out of the sight and reach of children.

• If you experience worsening abdominal pain you should inform your doctor.

• If you are not growing properly and you do not have enough of your own

  The very common and common side effects in adults may start within the first months of treatment and may either stop spontaneously or if your dose is reduced. Very common side effects (may affect more than 1 in 10 people) include: In adults

• Experience in patients above 80 years of age is limited. Elderly persons

  Do not use this medicine after the expiry date which is stated on the carton as MM/YYYY. The expiry date refers to the last day of that month. Before reconstitution:

growth hormone.

may be more sensitive to the action of Genotropin, and therefore may be more prone to develop side effects.

• 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 have chronic renal (kidney) insufficiency. As kidneys lose their ability

  Children with chronic renal (kidney) insufficiency:

  Store in a refrigerator (2°C – 8°C). Keep the two-chamber cartridge in the outer carton in order to protect from light.

  Adults with growth hormone deficiency:

  • Joint pain.

to function normally, this can affect growth.

• Your doctor should examine your kidney function and your growth rate

  If you continue Genotropin after treatment during childhood you should start with 0.2-0.5 mg per day. This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects. If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day. This dosage should be gradually increased according to blood test results as well as clinical response and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 mg per day. Follow the instructions given to you by your doctor. Injecting Genotropin

  • Water retention (which shows as puffy fingers or swollen ankles). Common side effects (may affect up to 1 in 10 people) include: In children:

• If you have Prader-Willi syndrome (a chromosomal disorder). Growth

  before starting Genotropin. Medical treatment for your kidney condition should be continued. Genotropin treatment should be stopped at kidney transplantation.

  Before opening, the product may be taken out of the refrigerator, without being replaced, for a maximum period of 1 month at a temperature not above 25°C but after this it must be discarded.

  hormone will help you grow taller if you are still growing, and will also improve your body composition. Your excessive fat will decrease and your reduced muscle mass will improve.

  • Temporary reddening, itchiness or pain at the injection site.

Children with Prader-Willi syndrome:

After reconstitution:

• Joint pain.
• If you were small or too light at birth. Growth hormone can help you grow

• Your doctor will give you diet restrictions to follow to control your weight.

  Store in a refrigerator (2°C – 8°C) for up to 4 weeks. Do not freeze. Keep the GoQuick pre-filled pen in the GoQuick outer carton, or the two-chamber cartridge in the Pen box in order to protect from light.

• Rash.

taller if you have not been able to catch up or maintain normal growth by four years of age or later.

• Your doctor will assess you for signs of upper airway obstruction, sleep

  • Raised itchy bumps on the skin.

apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with Genotropin.

In adults:

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

Do not use this medicine if you notice particles or if the solution is not clear. Do not freeze or expose Genotropin to frost. If it freezes, do not use it. Never throw away needles or partly used or empty cartridges with your ordinary rubbish. When you have finished with a needle, you must discard it carefully so that no-one will be able to use it or prick themselves on it. You can get a special “sharps” bin from your hospital or growth clinic.

• Numbness / tingling.
• During treatment, if you show signs of upper airway obstruction (including
• Stiffness in the arms and legs, muscle pain.

starting to snore or worsening of snoring), your doctor will need to examine you and may interrupt your treatment with Genotropin.

• Pain or burning sensation in the hands or underarms (known as Carpal

If you have been treated with Genotropin 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 Genotropin treatment.

Tunnel Syndrome).

• During treatment, your doctor will check you for signs of scoliosis, a type

  of spinal deformity.

  Uncommon side effects (may affect up to 1 in 100 people) include: In children:

  Genotropin 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 Genotropin. Always inject Genotropin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• During treatment, if you develop a lung infection, tell your doctor so that he

  can treat the infection.

  • Water retention (which shows as puffy fingers or swollen ankles, for a

You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

short time at the start of treatment).

Children born small or too light at birth:

• Itching.
• If you were small or too light at birth and are aged between 9 and 12 years,

2 What you need to know before you use Genotropin

• Breast enlargement (gynaecomastia)

ask your doctor for specific advice relating to puberty and treatment with this product.

The instructions for using the pre-filled pen GoQuick^® are provided in the carton with the pre-filled pen.

1. 6. Contents of the pack and other information What Genotropin contains

In adults:

• Your doctor will check your blood sugar and insulin levels before the start

  • Breast enlargement (gynaecomastia)

The instructions for using the Genotropin two-chamber cartridge with the Genotropin Pen or Genotropin Mixer are provided with your devices. Refer to the instuctions for use before using your medicine.

Do not use Genotropin and tell your doctor if

of treatment and every year during treatment.

Rare side effects (may affect up to 1 in 1,000 people) include: In children:

• You are allergic (hypersensitive) to somatropin or any of the other

  • The active substance is somatropin*.
  • Treatment should be continued until you have stopped growing. Using other medicines

ingredients of Genotropin.

• One cartridge contains 5.3 mg or 12 mg of somatropin*.
• Numbness / tingling.
• You have an active tumour (cancer). Tumours must be inactive and you
• After reconstitution the concentration of somatropin* is 5.3 mg or

When using a pre-filled pen, a pen injection device or reconstitution device, the needle must be screwed on before mixing. A new needle must be used for each injection. Needles must not be re-used.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription. Warnings and precautions

• Leukaemia (This has been reported in a small number of growth hormone

must have finished your anti-tumour treatment before you start your treatment with Genotropin.

12 mg per ml.

deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors).

• The other ingredients in the powder are: glycine (E640), mannitol (E421),

• You are seriously ill (for example, complications following open heart

  sodium dihydrogen phosphate anhydrous (E339), and disodium phosphate anhydrous (E339) (see section 2 “Genotropin contains sodium”).

• Preparing the injection:

Talk to your doctor or pharmacist before using Genotropin.

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.

You can take your Genotropin out of the refrigerator half an hour before your injection. This lets it warm up slightly and can make your injections more comfortable.

• Increased intracranial pressure (which causes symptoms such as strong

If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose. You should tell your doctor if you are using:

• The ingredients in the solvent are: water for injections, mannitol (E421)

headache, visual disturbances or vomiting).

and metacresol.

• Muscle pain.

  * Produced in Escherichia coli cells by recombinant DNA technology

The GoQuick pre-filled pen contains the two-chamber cartridge that has both the growth hormone and the dissolving liquid in it. The growth hormone and the dissolving liquid are mixed together by twisting the cartridge holder (see the detailed steps in the Instructions for Use). A separate device is not needed.

Not known: frequency cannot be estimated from the available data

• Genotropin has been prescribed to stimulate growth but you have already

  • medicines to treat diabetes,

    What Genotropin looks like and contents of the pack

    • Type 2 diabetes.

stopped growing (closed epiphyses).

• thyroid hormones,

  • A decrease in the levels of the hormone Cortisol in your blood.

• synthetic adrenal hormones (corticosteroids),

  • Facial swelling.

Date: 06 Oct 2021 Time:

10:05

Smallest

Mat

P

(5.3 mg/ml or 12 mg/ml). The cartridge may be contained in a pre-filled pen. Pack size of 1 or 5 pre-filled pen(s), or 1 or 5 or 20 cartridge(s). Not all strengths and pack sizes may be marketed.

The powder is white and the solvent is clear.

You can use the cartridges in a specific pen injection device for Genotropin. Genotropin cartridges are colour coded and must be used with the matching colour coded Genotropin Pen to give the correct dose: The Genotropin 5.3 mg cartridge (blue) must be used with the Genotropin Pen 5.3 (blue). The Genotropin 12 mg cartridge (purple) must be used with the Genotropin Pen 12 (purple). The instructions for use of the device are enclosed in the device package. You should ask your doctor for an injection or reconstitution device if you do not already have one.

Marketing Authorisation Holder

UK:

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ ,

United Kingdom

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom

Genotonorm: Belgium, France, Luxembourg

Genotonorm Kabipen: Spain

This leaflet was last approved in: 02/2021

Ref: 36_0

GoQuick^®

INSTRUCTIONS FOR USE Important Information

Please read these instructions completely before using GoQuick. If you have any questions about your dose or your treatment with Genotropin, call your doctor or nurse.

About GoQuick

GoQuick is a prefilled, multidose, disposable injection pen that holds 12 mg of somatropin. The Genotropin in the pen is mixed only once, when you start a new pen. A single pen can be used up to 28 days after mixing. You never have to change cartridges. When the pen is empty, you just start a new pen.

The pen has dose memory. The dose is set once on a new pen. The pen then gives the same dose for each injection. You can use the pen with or without the optional needle guard.

Before You Use GoQuick

• Get training from your doctor or nurse.
• Know your dose. Know the pen parts.
• Make sure you have the pen with the purple injection button.
• Wash your hands.

Setting Up and Using a New GoQuick

Step 1. Attach the Needle

a. Pull the white pen cap straight off the

pen.

b. Peel the seal from a new needle.

c. Firmly grasp the cartridge holder.

(Figure 1)

d. Push the needle onto the cartridge

holder tip.

e. Gently screw the needle onto the pen.

Do not overtighten.

f. Leave both needle covers on the

needle.

Step 2. Mix the Genotropin

a. Hold the pen with the needle-end

pointing up and the A facing you.

(Figure 2)

b. Firmly twist the cartridge holder into

the pen until B clicks into the notch.

• Gently tilt the pen from side to side.

  Do not shake the pen. Shaking may

  damage the growth hormone.

c. Check that the liquid in the cartridge

is clear. All the powder should be

dissolved.

• If not, gently tilt the pen from side

  to side a few more times.

d. Check the liquid again. Make sure it is

clear.

• If the liquid is clear, go to Step 3.

• If the liquid is still cloudy or you see

  any powder, use a new pen.

Step 3. Remove the Air

a. Pull the outer needle cover off. Save it

to remove the needle. (Figure 3a)

b. Leave the inner needle cover on.

c. Hold the pen with the needle-end

pointing up. (Figure 3b)

d. Tap the cartridge holder gently to help

any trapped air move to the top.

e. Firmly, twist the cartridge holder into

the pen until C clicks into the notch.

• Some liquid may appear around the

  inner needle cover.

  c. Check that the dose you drew up on the black rod is the same as the dose you set in the memory window. Figure 7b shows an example.

  to 4.5 mg of Genotropin. Each click of the black ring changes the dose by 0.15 mg. Step 4. Attach the Needle Guard (Optional)

  QUESTIONS AND ANSWERS a. Pull the black cap off the needle guard. (Figure 4a)

  Question Answer

  1. 4.

     If you use the needle guard, press the

     What should I do if I see more than a small

     For your next injection wait the full time of 5 seconds before taking the needle from the skin. If you still see some liquid after you take out the needle, hold in for a little longer next time.

     black release button to extend the

  • If the needle shield slides out, push it back into the needle guard until it clicks into place.

    d. If the doses do not match, make sure you have turned the grey dial in the direction of the arrow until it does not click anymore.

    drop of liquid on the needle after giving my

    needle shield.

    injection?

b. Hold the pen in one hand below the purple logo. With the other hand, hold the needle guard below the needle shield. (Figure 4b)

Is it a problem if I see air bubbles in the

No, small amounts of air may be present in the cartridge during normal use.

cartridge?

Step 8. Give the Injection

What should I do if I see Genotropin leaking

Make sure that the needle has been attached correctly.

a. Prepare an injection site as your doctor or nurse has told you.

from the pen?

c. Line up the black logo on the needle guard with the purple logo on the pen. Carefully push the needle guard onto the pen until it snaps into place.

What should I do if the pen that I am using

Discard the pen and use a new GoQuick.

1. 5. To draw up the dose, turn the grey dial

b. Hold the pen over the injection site. c. Push the pen down to insert the needle into the skin.

was not put in the refrigerator overnight?

until it stops clicking.

What should I do if I can’t turn the black

You have probably accidentally turned the grey dial. If you have turned the grey dial the pen will prevent you from turning the black ring so that your dose does not change during your injection.

ring?

d. Using your thumb, push the purple injection button down until it stops clicking. (Figure 8)

Step 5. Prime the Pen

• Count for 5 seconds before you pull the needle out of the skin. Keep light pressure on the button with your thumb while you count.

  1. 6.

     Check that the dose you drew up is

     To release the black ring, press in the purple injection button until it stops. Note that liquid will come out of the needle. Then continue to set your dose using the black ring. What if my doctor changes my dose when

a. Pull the inner needle cover off. Throw it away. (Figure 5a)

the same as the dose you set in the

memory window.

• If the dose you drew up is smaller,

e. Pull the pen straight out from the skin. Step 9. Remove the Needle; Cap and Store Your Pen

the pen does not have a full dose of

Set the new dose by turning the black ring.

Genotropin.

I’ve already started a pen?

• Follow what your doctor or nurse told

  What if I inject the wrong dose? Call your doctor or nurse immediately and

Step 9a: With needle guard

you to do when the pen does not have

b. Check that 0.3 mg is set in the memory window.

follow his/her instructions.

a. Place the outer needle cover into the end of the needle shield. (Figure 9a) b. Use the needle cover to push in the needle shield until it locks into place. c. Use the needle cover to unscrew the needle and put it in a proper container for used needles.

a full dose left.

What if my pen will not prime (i.e. if liquid

Call your doctor or nurse and follow his/her instructions.

c. Turn the grey dial in the direction of the arrows until it stops clicking. (Figure 5b)

did not appear in step 5g)?

What doses can my pen deliver? The pen can deliver doses from 0.30 mg

1. 7.

   Prepare an injection site as your doctor

   or nurse has told you.

2. 8. Give the injection.
3. •

   Push the pen down to insert the needle

   into the skin.

d. Leave the needle guard on the pen. e. Place the black cap on the needle guard. Store your pen in the

• Push the purple injection button down

  until it stops clicking.

• Count for 5 seconds before you pull

refrigerator.

d. Hold the pen with the needle pointing up. (Figure 5c with and without needle guard)

the needle out of the skin. Keep light

Step 9b: Without needle guard

pressure on the button with your thumb

a. Do not touch the needle.

while you count.

b. Carefully cover the needle with the outer needle cover. (Figure 9b) c. Use the needle cover to unscrew the needle and put it in a proper container for used needles.

e. Push the purple injection button until liquid appears.

• Pull the pen straight out from the skin.
• Remove the needle.

f. If liquid does not appear at Step “e”, repeat Steps b-e in this section up to two more times.

• With the needle guard:

  • Use the outer needle cover to push

    in the needle shield until it locks

d. Place the white cap on the pen. Store your pen in the refrigerator.

g. If liquid still does not appear, do not use the pen.

into place.

• Without the needle guard:

• See the Questions and Answers section below for more information.

  • Carefully cover the needle with the

    outer needle cover.

Routine Use of GoQuick

• Use the outer needle cover to unscrew

  the needle. Throw the needle away in

h. If you use the needle guard, press the black button to release the needle shield. (Figure 5d)

a proper container for used needles.

1. 10.

   Cap your needle guard or pen and

   store it in the refrigerator.

2. 1.

   Pull the black cap from the needle guard or the white cap from the pen.

   ADDITIONAL INFORMATION

Step 6. Set the Dose

• Use the black ring to set the dose. Be careful not to turn the grey dial while setting the dose.

a. Hold the black ring as shown in Figure 6.

b. Turn the black ring until your dose lines up with the white pointer. Your doctor or nurse has told you your dose.

c. If you turn your dose past the white pointer, just turn the black ring back to set the correct dose.

d. Once you have set your dose, do not change it unless your doctor or nurse tells you.

Note: If you cannot turn the black ring, press in the purple injection button until it stops clicking. Then continue to set your dose using the black ring (for more information, see also the Questions and Answers section below).

Step 7. Draw Up a Dose

a. Turn the grey dial in the direction of the arrow until the clicking stops. (Figure 7a)

b. Your dose on the black rod should line up with the white pointer.

1. 2. Attach a new needle.
2. •

   With the needle guard:

   • If the needle shield releases, push it back into place.
   • Attach a new needle to the cartridge holder tip.
3. •

   Without the needle guard:

   • Attach a new needle to the cartridge holder tip.
4. 3.

   Remove both needle covers. Save the outer needle cover to remove the needle.

   Storage

   • See the other side of this leaflet for how to store your GoQuick.
   • After 4 weeks, dispose of the pen (or discard) even if there is some medicine left.
   • Do not freeze or expose GoQuick to frost.
   • Do not use your GoQuick after its expiry date.

   • Follow your local health and safety laws to dispose of (or discard) your pen. Ask your

     doctor or nurse, if you are not sure what to do.

Handling

• Do not mix the powder and liquid of GoQuick unless a needle is on the pen.

• Do not store your GoQuick with the needle attached. The Genotropin may leak from

  the pen and air bubbles may form in the cartridge. Always remove the needle and attach the pen cap or needle guard cap before storing.

• Take care not to drop your GoQuick.

• If you do drop the pen you must perform another prime as described in Step 5 (Setting

  Up and Using a New GoQuick). But if any part of your GoQuick appears broken or damaged, do not use the pen. Contact your doctor or nurse for another pen.

• Clean the pen and needle guard with a damp cloth. Do not put the pen in water.

Needles

• Always use a new needle for each injection.

• Put all used needles in an appropriate “sharps” container. Follow your local health

  and safety laws to dispose of your needles. Ask your doctor or nurse, if you are not sure what to do.

• Do not share your pen or needles.

General

• The numbers and lines on the cartridge holder can help you estimate how much

  Genotropin is left in the pen.

• If in routine use Step 6 the pen does not have a full dose of Genotropin, the scale on

  the black rod indicates the amount of drug remaining in the pen.

• Patients who are blind or who do not see well should only use GoQuick with the help

  of someone trained to use the pen.

• Follow your doctor or nurse’s instructions for cleaning your hands and skin when you

  prepare and give the injection.

• Do not discard your needle guard, to remove it from the pen just twist it off. Save it to

  use with each new pen.

• If you have questions about how to use GoQuick, ask your doctor or nurse.

Date: 06 Oct 2021 Time:

10:05

PAA168279

Barcode Nº ITF 2 of 5 Supplier Nº

Market

N/A

Perigord Nº

Proof Nº

Puurs

Supplier

N/A

United Kingdom

02

Leaflet

1458

7 pt

Drawing Nº

I136/B_03

520 x 300 mm

Source Code

Material Name

I-GENOTROPIN GQ 12MG PTCC GB

PAR Number

PAR-2021-0001076

PAA168279