Genotropin 12

Patient Information Leaflet

GENOTROPIN 5.3, 5.3 mg (16 IU), powder and solvent for solution for injection
GENOTROPIN 12, 12 mg (36 IU), powder and solvent for solution for injection
Somatropinum
Please read this leaflet carefully before using this medicine, as it contains important information for you, including the instructions for use of the injection device (GoQuick).

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Genotropin is and what it is used for
2. Important information before using Genotropin
3. How to use Genotropin
4. Possible side effects
5. How to store Genotropin
6. Contents of the pack and other information

1. What Genotropin is and what it is used for

Genotropin contains somatropin – human growth hormone produced in Escherichia coli bacterial cells using recombinant DNA technology. Somatropin is essential for normal growth in children. In adults with growth hormone deficiency, somatropin reduces body fat mass and increases muscle mass.

Genotropin is used in children:

• for growth disorders caused by insufficient production of growth hormone;
• for growth disorders associated with Turner syndrome (abnormal chromosome structure in girls);
• for growth disorders related to chronic renal insufficiency;
• for growth disorders in short children who were born small for gestational age (i.e., were too small for the duration of pregnancy);
• for Prader-Willi syndrome, to improve growth and body composition.

Genotropin is used in adults as replacement therapy for those with severe growth hormone deficiency. Treatment may be initiated in adulthood or continued from childhood.
If you were treated with Genotropin during childhood, your growth hormone levels should be evaluated after completion of growth. If severe growth hormone deficiency is confirmed, your doctor may recommend continuing treatment.

2. Important information before using Genotropin

Before starting treatment with Genotropin, the diagnosis of the disease must be confirmed. Treatment may only be carried out under the supervision of a physician with the necessary knowledge and experience.

When not to use Genotropin

• if the patient is allergic to somatropin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has active cancer. Inform the doctor about any cancer condition. Tumours must be inactive and anticancer therapy must be completed before starting treatment with Genotropin;
• in children who have completed growth;
• if the patient has acute, life-threatening illnesses, complications following open-heart surgery, abdominal surgery, or multi-organ trauma, or acute respiratory failure and similar conditions. Before any planned surgery or during hospitalization, inform the doctor about the use of growth hormone.

Warnings and precautions
Before starting treatment with Genotropin, discuss the following with your doctor or pharmacist:

• in patients with diabetes; after starting Genotropin, the dose of medication used to treat diabetes may need to be adjusted;
• if there are risk factors for diabetes (e.g. if the patient is overweight or if diabetes runs in the family);
• in some patients, thyroid hormone replacement therapy may become necessary after starting treatment with Genotropin;
• in patients receiving thyroid hormone therapy, dose adjustments of these medications may be required;
• if the patient is receiving glucocorticoid replacement therapy, regular consultations with the doctor are necessary, as dose adjustments may be needed;
• if the child begins to limp (applies only to children);
• in case of severe or sudden headaches, visual disturbances, nausea and/or vomiting;
• if symptoms of spinal curvature occur;
• if the patient develops severe abdominal pain, inform the doctor immediately;
• in patients over 80 years of age, due to limited experience in treating this age group and increased susceptibility to adverse effects.

If treatment is related to chronic kidney dysfunction, kidney function should be assessed before starting therapy. Genotropin should be discontinued after kidney transplantation.
In Prader-Willi syndrome, the doctor should pay attention to the presence of the following risk factors before and during treatment: severe obesity, respiratory dysfunction or history of sleep apnoea, and unidentified respiratory infections. The doctor will recommend an appropriate low-calorie diet and/or treat any infections.
In patients with intrauterine growth retardation, other causes of growth disorders should be ruled out before starting treatment. Before initiating therapy, and annually thereafter, the doctor should order tests to measure fasting insulin and glucose levels. Before starting treatment and twice yearly thereafter, the doctor should recommend measuring IGF-I (insulin-like growth factor) levels. Starting therapy is not recommended in children with intrauterine growth retardation approaching puberty.

Genotropin and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is currently or has recently taken:

• oral estrogens or other sex hormones. The doctor may recommend adjusting the dose of Genotropin or other medications.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Genotropin is not recommended in pregnant women or in women planning to become pregnant in the near future.

Driving and operating machinery
Genotropin has no influence on the ability to drive or operate machinery.

Genotropin contains m-cresol
Genotropin contains m-cresol as an excipient, which may be associated with muscle inflammation. Inform the doctor about muscle pain or unusually severe pain at the injection site. If muscle inflammation occurs, the doctor will decide whether to switch to a formulation not containing m-cresol.

Genotropin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, meaning the medicine is considered "sodium-free".

3. How to use Genotropin
This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
The doctor determines the dose individually for each patient.
Genotropin is administered subcutaneously. The injection site should be rotated to avoid skin changes. Follow the instructions provided by the doctor or nurse.

Growth disorders in children due to growth hormone deficiency
Recommended dose: 0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m² body surface area per day.

Growth disorders in children with Prader-Willi syndrome to increase growth rate and improve body composition
Recommended dose: 0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day.
The daily dose should not exceed 2.7 mg/m² body surface area per day. Do not treat children who grow less than 1 cm per year and who are approaching the end of growth.

Growth disorders in children with Turner syndrome
Recommended dose: 0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day.

Growth disorders associated with chronic renal insufficiency in children
Recommended dose: 0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day. If growth velocity is too low, the dose may need to be increased. Dose adjustment may be necessary after 6 months of treatment.

Growth disorders in short children born small for gestational age
Recommended dose: 0.035 mg/kg body weight per day (1 mg/m² body surface area per day). Treatment continues until final adult height is reached. Treatment should be discontinued if growth velocity becomes too slow.

Adults with growth hormone deficiency
In patients continuing growth hormone therapy from childhood GH deficiency, the recommended starting dose for resuming treatment is 0.2–0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements, based on serum IGF-I (insulin-like growth factor) levels.

In adult-onset GH deficiency, treatment should begin with a low dose: 0.15–0.3 mg per day. The dose should be gradually increased depending on serum IGF-I levels, as well as treatment efficacy and adverse effects. The maximum daily dose rarely exceeds 1.0 mg per day. Use the lowest effective dose.

Women may require higher doses than men.
Natural hormone production decreases with age, so over time, dose reduction may be necessary.
Dose adjustments should be monitored every 6 months.

In patients over 60 years of age, treatment should start at a dose of 0.1–0.2 mg per day and be gradually increased according to individual patient needs. Use the lowest effective dose. Maintenance doses in these patients rarely exceed 0.5 mg per day.

Instructions for use
Genotropin solution for injection in GoQuick cartridge. The prefilled dual-chamber cartridge in the GoQuick pen contains growth hormone and solvent.
Remember to screw the needle onto the GoQuick pen before mixing. Use a new needle for each injection. Needles must not be reused.
Mixing of growth hormone and solvent occurs by screwing the cartridge into the pen (see GoQuick User Instructions). Then dissolve the powder by gently tilting the pen until the powder is completely dissolved.

DO NOT SHAKE!
Shaking may cause denaturation of the active substance, leading to loss of biological activity.

Read the instructions for use of the GoQuick pen provided in the patient leaflet.

Use of a higher than recommended dose of Genotropin
If an excessive dose of Genotropin is injected, contact the doctor immediately. A single overdose may affect blood glucose levels, which may become too low or too high. Symptoms may include tremor, sweating, drowsiness, fainting, and a feeling of being "not oneself."

Missed dose of Genotropin
Do not administer a double dose to make up for a missed dose.

For any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Very common (may affect more than 1 in 10 people):
Adults:

• Joint pain.
• Fluid retention (manifesting as swollen fingers or swollen wrists).

Common (may affect up to 1 in 10 people):
Children:

• Joint pain.
• Transient redness, itching, and pain at the injection site.

Adults:

• Numbness/tingling.
• Pain or burning sensation in the hands or arms (known as carpal tunnel syndrome).
• Stiffness of arms and legs, muscle pain.

Uncommon (may affect up to 1 in 100 people):
Children:

• Leukaemia (observed in a small number of patients with growth hormone deficiency, some of whom were treated with Genotropin. However, there is no evidence confirming an increased incidence of leukaemia in patients with growth hormone deficiency without predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Numbness/tingling.
• Rash.
• Itching.
• Raised, itchy skin nodules.
• Muscle pain.
• Breast enlargement (gynecomastia).
• Fluid retention (manifesting as swollen fingers or swollen wrists).

Adults:

• Breast enlargement (gynecomastia).

Frequency not known (cannot be estimated from available data):
Adults and children:

• Type II diabetes.
• Facial swelling.
• Headache.
• Decreased blood cortisol levels.

Children:

• Stiffness of arms and legs.

Adults:

• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Rash.
• Itching.
• Raised, itchy skin nodules.
• Redness, itching, and pain at the injection site.

The development of antibodies directed against the injected growth hormone has been observed;
however, this does not appear to be associated with loss of treatment effect.
Very rarely, inflammatory reactions in muscles around the injection site caused by m-cresol (an excipient) have also been observed. If such a reaction is confirmed by a physician, use of a preparation not containing m-cresol is recommended.
The injection site should be rotated to avoid skin changes such as irregularities or nodules.
Since the medicine has been marketed, rare cases of sudden death in patients with Prader-Willi syndrome treated with Genotropin have been reported. However, a causal relationship with Genotropin has not been established.
In children treated with growth hormone, cases of slipped capital femoral epiphysis and Legg-Calve-Perthes disease have been reported. A causal relationship with Genotropin has not been established.
Other adverse effects associated with growth hormone use may include increased blood glucose levels or decreased thyroid hormone levels in adults and children. This can be confirmed by a physician, who may initiate appropriate treatment if necessary. Pancreatitis has been rarely reported in patients treated with growth hormone.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder or its representative.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Genotropin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store this medicine at 2°C - 8°C (in the refrigerator); do not freeze. The medicine may be stored below 25°C for up to one month. Store in the outer packaging to protect from light.

After reconstitution
The solution can be stored for 28 days at 2°C - 8°C (in the refrigerator); do not freeze. Store in the outer packaging to protect from light.

If a needle protection cap is used, store the injection pen with the needle protection cap and the black cap attached.
If a needle protection cap is not used, store the injection pen with the white cap attached (see Instructions for Use).

These steps will help protect Genotropin from light.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What Genotropin 5.3 contains

• The active substance is somatropin*. Each cartridge contains 5.3 mg of somatropin*.
• The other ingredients are: glycine, mannitol, monosodium dihydrogen phosphate monohydrate (anhydrous basis), disodium hydrogen phosphate dodecahydrate (anhydrous basis) (see section 2 “Genotropin contains sodium”). The solvent contains m-cresol (see section 2 “Genotropin contains m-cresol”), mannitol, water for injections. After reconstitution, the concentration of somatropin is 5.3 mg/ml.

* produced in Escherichia coli bacterial cells by recombinant DNA technology.
What Genotropin 12 contains

• The active substance is somatropin*. Each cartridge contains 12 mg of somatropin*.
• The other ingredients are: glycine, mannitol, monosodium dihydrogen phosphate monohydrate (anhydrous basis), disodium hydrogen phosphate dodecahydrate (anhydrous basis) (see section 2 “Genotropin contains sodium”). The solvent contains m-cresol (see section 2 “Genotropin contains m-cresol”), mannitol, water for injections. After reconstitution, the concentration of somatropin is 12 mg/ml.

* produced in Escherichia coli bacterial cells by recombinant DNA technology.
What the medicine looks like and contents of the pack
Genotropin is available in pre-filled, multi-dose, single-use GoQuick pens containing dual-chamber cartridges, in which one chamber contains the active substance as a white powder and the other chamber contains a clear solution serving as the solvent.
Genotropin is available in packs containing one or five GoQuick pens.
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information on this medicine, please contact the representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel.: 22 335 61 00
Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl
GENOTROPIN 5.3 GOQUICK INSTRUCTIONS FOR USE
Please read the entire instruction before using the GoQuick pen. If you have any questions about the recommended dose or treatment with Genotropin 5.3, please contact your doctor or nurse.
Information about the GoQuick pen
The GoQuick pen is a factory-filled, multi-dose, single-use pen containing 5.3 mg of somatropin. It allows administration of Genotropin 5.3 in doses ranging from 0.1 mg to 1.5 mg. Each click of the black ring changes the dose by 0.05 mg. Genotropin 5.3 in the pen is mixed only once, at the first use of the pen. Cartridges are not replaced in the pen. After emptying the pen, a new one must be used.
The pen is equipped with dose memory. The dose is set once in the pen. Subsequently, each injection is delivered at the same preset dose. This prevents exceeding the set dose.
Important information

• Do not mix the powder and liquid in the pen if there is no needle attached.
• Do not store the pen with a needle attached. Genotropin 5.3 may leak from it, and air bubbles may form in the cartridge. Before storing, always remove the needle and replace the pen cap or the protective needle cap.
• Be careful not to drop the pen. If it is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain a new pen. If the pen is dropped but not broken or damaged, perform reloading of the drug dose according to the instructions in step 6 (Setting up and using a new GoQuick pen).
• Clean the pen with a damp cloth. Do not immerse it in water.
• Always use a new needle for each injection. Do not share needles between pens.
• The volume scale located on the side of the cartridge holder indicates the volume of remaining Genotropin 5.3 in the pen.

Storage and disposal

• Store the pen in the refrigerator (at 2°C to 8°C), inside the outer packaging, to protect it from light. Do not freeze or expose to frost.
• Do not use the pen after the expiry date.
• After 28 days from mixing, the pen must be discarded, even if some medicine remains.
• Information on storage of the GoQuick pen is provided on the second page of this leaflet.
• Dispose of used pens according to local regulations. If in doubt, consult your doctor or nurse.

Components of the GoQuick pen

Needles are not included with the GoQuick pen. Needles up to 8 mm in length should be purchased at a pharmacy.

• Needles suitable for use with the GoQuick pen: 31 G or 32 G (Becton Dickinson and Company), 31 G or 32 G (Novo Nordisk), 32.5 G or 34 G (Terumo)
  Setting up and using a new GoQuick pen
  Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface: a new GoQuick pen, a new needle (not included in the set), a suitable sharps container (not included in the set).
• Check the expiry date on the pen label. Do not use the pen if it has expired.

Step 2 Selecting the injection site

• Select and clean the injection site as advised by your doctor or nurse. Choose a different site for each injection. Each subsequent injection should be given at least 2 cm away from the previous one.
• Avoid bony areas, bruised, red, sore or hardened areas, as well as areas of skin covered with scars or affected by disease.

Step 3 Attaching a new needle

• Remove the white cap from the pen.
• Take a new needle and remove the paper seal.
• Gently press and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage.
• Leave both needle shields in place.

Step 4 Mixing Genotropin 5.3

• Hold the pen with the needle pointing upwards and the letter “A” facing you.
• Firmly twist the cartridge into the pen until you feel a click, when the letter “B” aligns with the notch.
• Gently tilt the pen from side to side to help completely dissolve the powder. Do not shake. Shaking may damage the growth hormone.
• Check whether the liquid in the cartridge is clear and whether all the powder has dissolved. o If the liquid is cloudy or powder is visible, gently tilt the pen from side to side several more times. o If the liquid remains cloudy or powder is visible, do not use this pen and try again with a new one.

Step 5 Removing air from the pen

• Remove the outer needle shield. Keep it to secure the used needle after injection.
• Leave the inner needle shield in place. Note: After removing the outer shield, the inner needle shield should be visible. If not, try reattaching the needle.
• Hold the pen with the needle pointing upwards.
• Gently tap the cartridge to move trapped air to the top.
• Firmly twist the cartridge into the pen until you feel a click when the letter “C” aligns with the notch. A small amount of liquid may appear around the inner needle shield. This is normal.

Step 6 Loading the drug dose

Loading the drug dose removes residual air by expelling a small amount of liquid from the pen. The loaded dose is 0.1 mg and differs from the dose prescribed by your doctor or nurse. Perform this step only at the first use of the pen.

• Remove and discard the inner needle shield. Note: Do not touch the needle to avoid injury.
• Ensure that the dose window displays 0.1 mg.
• Turn the grey knob in the direction indicated by the arrows until it stops clicking.
• Hold the pen with the needle pointing straight upwards.
• Press the blue injection button fully.
• Check whether liquid appears at the needle tip. If it does, the pen is ready for use. o If no liquid appears, repeat the steps described in the dose loading step once or twice. o If no liquid still appears, do not use this pen. Contact your doctor or nurse for advice.

Step 7 Setting and preparing the dose

At the first use of the pen, the dose prescribed by your doctor or nurse will be set. There is no need to reset the dose until a new pen is used or your doctor or nurse advises otherwise.

• Turn the black ring counterclockwise until the recommended dose aligns with the white indicator in the dose window. Be careful not to turn the grey knob. o If the selected dose does not align with the white indicator, turn the black ring in the opposite direction to set the correct dose value. Note: If the black ring cannot be turned, press the blue dose delivery button until it stops clicking, then try setting the dose again. Remember that liquid will flow from the needle. Turn the grey knob in the direction indicated by the arrows until it stops clicking.

Step 8 Checking the drug dose

The dose value visible on the black plunger should align with the white indicator.

• Ensure that the dose value visible on the black plunger matches the value set in the dose window. o If both values are the same, the pen is ready for injection. o If the dose values do not match, ensure that the grey knob has been turned in the correct direction indicated by the arrows until it stops clicking.

Step 9 Injecting Genotropin 5.3

• Hold the pen over the injection site.
• Insert the needle straight into the skin.
• Press the blue injection button until it stops clicking.
• Wait a full 5 seconds to ensure the full dose is delivered. Maintain light pressure on the blue injection button during this time.
• After 5 seconds, remove the needle from the skin without tilting it sideways. Note: If a drop of liquid is visible at the injection site or on the needle tip, during the next injection, hold the blue injection button pressed longer before removing the needle from the skin.

Step 10 Removing the needle

• Carefully place the outer needle shield over the needle. Note: Do not touch the needle to avoid injury.
• Unscrew the needle using the outer shield.
• Dispose of the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Regular (daily) use of the GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface: a GoQuick pen with mixed medicine, a new needle (not included in the set), a suitable sharps container (not included in the set).
• Check the expiry date on the pen label. Do not use the pen if it has expired. Do not use the pen after 28 days from first use.

Step 2 Selecting the injection site

• Select and clean the injection site as advised by your doctor or nurse. Choose a different site for each injection. Each subsequent injection should be given at least 2 cm away from the previous one.
• Avoid bony areas, bruised, red, sore or hardened areas, as well as areas of skin covered with scars or affected by disease.

Step 3 Attaching a new needle

• Remove the white cap from the pen.
• Take a new needle and remove the paper seal.
• Gently press and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage.
• Remove both needle shields. Keep the outer shield to cover the needle after injection.

Step 4 Loading the drug dose

• Turn the grey knob in the direction indicated by the arrows until it stops clicking.
• The dose value visible on the black plunger should align with the white indicator.
• Ensure that the dose value visible on the black plunger matches the value set in the dose window. o If both values are the same, the pen is ready for injection. Note: If the prepared dose is smaller, this means that the full dose of Genotropin 5.3 is not available in the pen. If the full dose is not available, follow your doctor’s or nurse’s advice or contact them for guidance.

Step 5 Injecting Genotropin 5.3

• Hold the pen over the injection site.
• Insert the needle straight into the skin.
• Press the blue injection button until it stops clicking.
• Wait a full 5 seconds to ensure the full dose is delivered. Maintain light pressure on the blue injection button during this time.
• After 5 seconds, remove the needle from the skin without tilting it sideways. Note: If a drop of liquid is visible at the injection site or on the needle tip, during the next injection, hold the blue injection button pressed longer before removing the needle from the skin.

Step 6 Removing the needle

• Carefully place the outer needle shield over the needle. Note: Do not touch the needle to avoid injury.
• Unscrew the needle using the shield.
• Dispose of the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Using the protective needle cap (optional)
The protective needle cap is an optional accessory supplied separately, which allows hiding the needle during injection.
Attaching the protective needle cap:
The protective needle cap should be attached after completing step 5 (Setting up and using a new GoQuick pen) to prevent needle injury.

• Remove the black cap from the protective needle cap. o If the needle safety mechanism protrudes, push it back into the protective cap until it clicks into place.
• Align the black logo on the protective cap with the blue logo on the pen. Gently press the protective cap onto the pen until it clicks.
• After completing step 6 (Setting up and using a new GoQuick pen), press the black button to release the safety mechanism in the protective cap.
• Follow the instructions described in step 7 (Setting up and using a new GoQuick pen).

To remove the needle with the protective cap attached:

• Place the outer needle shield over the end of the needle safety mechanism.
• Using the outer shield, push the safety mechanism forward until it locks in place.
• Unscrew the needle using the shield and dispose of it in a suitable sharps container.
• Leave the protective cap on the pen.
• Replace the black cap on the protective needle cap. Store the pen in the refrigerator.

To remove the protective needle cap:

• First remove the needle, then gently pull the protective cap off the pen.
• Do not discard the protective cap. It can be reused with the next pen.

GENOTROPIN 12 GOQUICK INSTRUCTIONS FOR USE
Please read the entire instruction before using the GoQuick pen. If you have any questions about the recommended dose or treatment with Genotropin 12, please contact your doctor or nurse.
Information about the GoQuick pen
The GoQuick pen is a factory-filled, multi-dose, single-use pen containing 12 mg of somatropin. It allows administration of Genotropin 12 in doses ranging from 0.3 mg to 4.5 mg. Each click of the black ring changes the dose by 0.15 mg. Genotropin 12 in the pen is mixed only once, at the first use of the pen. Cartridges are not replaced in the pen. After emptying the pen, a new one must be used.
The pen is equipped with dose memory. The dose is set once in the pen. Subsequently, each injection is delivered at the same preset dose. This prevents exceeding the set dose.
Important information

• Do not mix the powder and liquid in the pen if there is no needle attached.
• Do not store the pen with a needle attached. Genotropin 12 may leak from it, and air bubbles may form in the cartridge. Before storing, always remove the needle and replace the pen cap or the protective needle cap.
• Be careful not to drop the pen. If it is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain a new pen. If the pen is dropped but not broken or damaged, perform reloading of the drug dose according to the instructions in step 6 (Setting up and using a new GoQuick pen).
• Clean the pen with a damp cloth. Do not immerse it in water.
• Always use a new needle for each injection. Do not share needles between pens.
• The volume scale located on the side of the cartridge holder indicates the volume of remaining Genotropin 12 in the pen.

Storage and disposal

• Store the pen in the refrigerator (at 2°C to 8°C), inside the outer packaging, to protect it from light. Do not freeze or expose to frost.
• Do not use the pen after the expiry date.
• After 28 days from mixing, the pen must be discarded, even if some medicine remains.
• Information on storage of the GoQuick pen is provided on the second page of this leaflet.
• Dispose of used pens according to local regulations. If in doubt, consult your doctor or nurse.

Components of the GoQuick pen

Needles are not included with the GoQuick pen. Needles up to 8 mm in length should be purchased at a pharmacy.

• Needles suitable for use with the GoQuick pen: 31 G or 32 G (Becton Dickinson and Company), 31 G or 32 G (Novo Nordisk), 32.5 G or 34 G (Terumo)
  Setting up and using a new GoQuick pen
  Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface: a new GoQuick pen, a new needle (not included in the set), a suitable sharps container (not included in the set). Check the expiry date on the pen label. Do not use the pen if it has expired.

Step 2 Selecting the injection site

• Select and clean the injection site as advised by your doctor or nurse. Choose a different site for each injection. Each subsequent injection should be given at least 2 cm away from the previous one.
• Avoid bony areas, bruised, red, sore or hardened areas, as well as areas of skin covered with scars or affected by disease.

Step 3 Attaching a new needle

• Remove the white cap from the pen.
• Take a new needle and remove the paper seal.
• Gently press and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage.
• Leave both needle shields in place.

Step 4 Mixing Genotropin 12

• Hold the pen with the needle pointing upwards and the letter “A” facing you.
• Firmly twist the cartridge handle until you feel a click, when the letter “B” aligns with the notch.
• Gently tilt the pen from side to side to help completely dissolve the powder. Do not shake. Shaking may damage the growth hormone.
• Check whether the liquid in the cartridge is clear and whether all the powder has dissolved. o If the liquid is cloudy or powder is visible, gently tilt the pen from side to side several more times. o If the liquid remains cloudy or powder is visible, do not use this pen and try again with a new one.

Step 5 Removing air from the pen

• Remove the outer needle shield. Keep it to secure the used needle after injection.
• Leave the inner needle shield in place. Note: After removing the outer shield, the inner needle shield should be visible. If not, try reattaching the needle.
• Hold the pen with the needle pointing upwards.
• Gently tap the cartridge to move trapped air to the top.
• Firmly twist the cartridge handle until you feel a click when the letter “C” aligns with the notch. A small amount of liquid may appear around the inner needle shield. This is normal.

Step 6 Loading the drug dose

Loading the drug dose removes residual air by expelling a small amount of liquid from the pen. The loaded dose is 0.3 mg and differs from the dose prescribed by your doctor or nurse. Perform this step only at the first use of the pen.

• Remove and discard the inner needle shield. Note: Do not touch the needle to avoid injury.
• Ensure that the dose window displays 0.3 mg.
• Turn the grey knob in the direction indicated by the arrows until it stops clicking.
• Hold the pen with the needle pointing straight upwards.
• Press the purple injection button fully.
• Check whether liquid appears at the needle tip. If it does, the pen is ready for use. o If no liquid appears, repeat the steps described in the dose loading step once or twice. o If no liquid still appears, do not use this pen. Contact your doctor or nurse for advice.

Step 7 Setting and preparing the dose

At the first use of the pen, the dose prescribed by your doctor or nurse will be set. There is no need to reset the dose until a new pen is used or your doctor or nurse advises otherwise.

• Turn the black ring counterclockwise until the recommended dose aligns with the white indicator in the dose window. Be careful not to turn the grey knob. o If the selected dose does not align with the white indicator, turn the black ring in the opposite direction to set the correct dose value. Note: If the black ring cannot be turned, press the purple dose delivery button until it stops clicking, then try setting the dose again. Remember that liquid will flow from the needle. Turn the grey knob in the direction indicated by the arrows until it stops clicking.

Step 8 Checking the drug dose

The dose value visible on the black plunger should align with the white indicator.

• Ensure that the dose value visible on the black plunger matches the value set in the dose window. o If both values are the same, the pen is ready for injection. o If the dose values do not match, ensure that the grey knob has been turned in the correct direction indicated by the arrows until it stops clicking.

Step 9 Injecting Genotropin 12

• Hold the pen over the injection site.
• Insert the needle straight into the skin.
• Press the purple injection button until it stops clicking.
• Wait a full 5 seconds to ensure the full dose is delivered. Maintain light pressure on the purple injection button during this time.
• After 5 seconds, remove the needle from the skin without tilting it sideways. Note: If a drop of liquid is visible at the injection site or on the needle tip, during the next injection, hold the purple injection button pressed longer before removing the needle from the skin.

Step 10 Removing the needle

• Carefully place the outer needle shield over the needle. Note: Do not touch the needle to avoid injury.
• Unscrew the needle using the outer shield.
• Dispose of the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Regular (daily) use of the GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface: a GoQuick pen with mixed medicine, a new needle (not included in the set), a suitable sharps container (not included in the set).
• Check the expiry date on the pen label. Do not use the pen if it has expired. Do not use the pen after 28 days from first use.

Step 2 Selecting the injection site

• Select and clean the injection site as advised by your doctor or nurse. Choose a different site for each injection. Each subsequent injection should be given at least 2 cm away from the previous one.
• Avoid bony areas, bruised, red, sore or hardened areas, as well as areas of skin covered with scars or affected by disease.

Step 3 Attaching a new needle

• Remove the white cap from the pen.
• Take a new needle and remove the paper seal.
• Gently press and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage.
• Remove both needle shields. Keep the outer shield to cover the needle after injection.

Step 4 Loading the drug dose

• Turn the grey knob in the direction indicated by the arrows until it stops clicking.
• The dose value visible on the black plunger should align with the white indicator.
• Ensure that the dose value visible on the black plunger matches the value set in the dose window. o If both values are the same, the pen is ready for injection. Note: If the prepared dose is smaller, this means that the full dose of Genotropin 12 is not available in the pen. If the full dose is not available, follow your doctor’s or nurse’s advice or contact them for guidance.

Step 5 Injecting Genotropin 12

• Hold the pen over the injection site.
• Insert the needle straight into the skin.
• Press the purple injection button until it stops clicking.
• Wait a full 5 seconds to ensure the full dose is delivered. Maintain light pressure on the purple injection button during this time.
• After 5 seconds, remove the needle from the skin without tilting it sideways. Note: If a drop of liquid is visible at the injection site or on the needle tip, during the next injection, hold the purple injection button pressed longer before removing the needle from the skin.

Step 6 Removing the needle

• Carefully place the outer needle shield over the needle. Note: Do not touch the needle to avoid injury.
• Unscrew the needle using the shield.
• Dispose of the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Using the protective needle cap (optional)
The protective needle cap is an optional accessory supplied separately, which allows hiding the needle during injection.

Attaching the protective needle cap:
The protective needle cap should be attached after completing step 5 (Setting up and using a new GoQuick pen) to prevent needle injury.

• Remove the black cap from the protective needle cap. o If the safety mechanism protrudes, push it back into the protective cap until it clicks into place.
• Align the black logo on the protective cap with the purple logo on the pen. Gently press the protective cap onto the pen until it clicks.
• After completing step 6 (Setting up and using a new GoQuick pen), press the black button to release the safety mechanism in the protective cap.
• Follow the instructions described in step 7 (Setting up and using a new GoQuick pen).

To remove the needle with the protective cap attached:

• Place the outer needle shield over the end of the needle safety mechanism.
• Using the outer shield, push the safety mechanism forward until it locks in place.
• Unscrew the needle using the shield and dispose of it in a suitable sharps container.
• Leave the protective cap on the pen.
• Replace the black cap on the protective needle cap. Store the pen in the refrigerator.

To remove the protective needle cap:

• First remove the needle, then gently pull the protective cap off the pen.
• Do not discard the protective cap. It can be reused with the next pen.

Package leaflet: information for the patient

GENOTROPIN 5.3, 5.3 mg (16 IU), powder and solvent for solution for injection
GENOTROPIN 12, 12 mg (36 IU), powder and solvent for solution for injection
Somatropinum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Genotropin is and what it is used for
2. What you need to know before using Genotropin
3. How to use Genotropin
4. Possible side effects
5. How to store Genotropin
6. Contents of the pack and other information

1. What Genotropin is and what it is used for

Genotropin contains somatropin – human growth hormone produced in Escherichia coli bacterial cells by recombinant DNA technology. Somatropin is essential for normal growth in children. In adults with growth hormone deficiency, somatropin reduces fat tissue mass and increases muscle mass.
Genotropin is used in children:

• for growth disorders due to insufficient growth hormone secretion;
• for growth disorders associated with Turner syndrome (abnormal chromosome structure in girls);
• for growth disorders related to chronic renal insufficiency;
• for growth disorders in short children who were born small for gestational age (i.e. too small for the duration of pregnancy);
• in Prader-Willi syndrome, to improve growth and body composition.

Genotropin is used in adults as replacement therapy in patients with significant growth hormone deficiency. Treatment may be initiated in adulthood or continued from childhood.
If you were treated with Genotropin during childhood, your growth hormone levels should be tested after growth has stopped. If severe growth hormone deficiency is confirmed, your doctor may recommend continuing treatment.

2. What you need to know before using Genotropin

Before starting treatment with Genotropin, the diagnosis must be confirmed. Treatment must be supervised by a doctor with appropriate knowledge and experience.
When not to use Genotropin:

• if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6);
• if you have active cancer. Inform your doctor about any cancer. Tumours must be inactive and anticancer therapy must be completed before starting Genotropin treatment;
• in children who have completed growth;
• if you have acute life-threatening illnesses, complications after open-heart surgery, abdominal surgery or multiple trauma, or acute respiratory failure, etc. Before planned surgery or during hospitalization, inform your doctor that you are taking growth hormone.

Warnings and precautions
Before starting Genotropin, discuss the following with your doctor or pharmacist:

• if you have diabetes; after starting Genotropin, the dose of your diabetes medication may need adjustment;
• if you have risk factors for diabetes (e.g. if you are overweight or have a family history of diabetes);
• in some patients, thyroid hormone replacement therapy may become necessary after starting Genotropin;
• if you are taking thyroid hormones, dose adjustments may be needed;
• if you are receiving glucocorticoid replacement therapy, you should have regular check-ups, as dose adjustments may be necessary;
• if a child starts gaining weight (applies only to children);
• in case of severe or sudden headaches, visual disturbances, nausea and/or vomiting;
• if you have symptoms of scoliosis;
• if you experience worsening abdominal pain, inform your doctor;
• in patients over 80 years of age, due to limited experience in this age group and increased susceptibility to side effects.

If treatment is related to chronic kidney dysfunction, kidney function should be assessed before starting treatment; Genotropin should be discontinued after kidney transplantation.
In Prader-Willi syndrome, your doctor should assess the following risk factors before and during treatment: severe obesity, respiratory dysfunction or history of sleep apnoea, and unidentified respiratory infections. Your doctor will recommend an appropriate low-calorie diet and/or treat infections.
In children with intrauterine growth retardation, other causes of growth disorders should be excluded before starting treatment. Your doctor will order fasting insulin and glucose tests before treatment and annually thereafter; also before treatment and twice yearly, your doctor will recommend measuring IGF-I (insulin-like growth factor) levels. Starting therapy is not recommended in children with intrauterine growth retardation approaching puberty.

Genotropin with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are currently or recently taking:

• oral estrogens or other sex hormones. Your doctor may recommend adjusting the dose of Genotropin or other medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Genotropin is not recommended for use in pregnant women or women planning pregnancy in the near future.
Driving and using machines
Genotropin has no effect on the ability to drive or operate machinery.
Genotropin contains m-cresol
Genotropin contains m-cresol as an excipient, which may be associated with muscle inflammation. Report any muscle pain or excessive injection site pain to your doctor. If muscle inflammation occurs, your doctor will decide to switch to a formulation without m-cresol.
Genotropin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, meaning it is considered “sodium-free”.

3. How to use Genotropin

Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the dose individually for you.
Genotropin is administered subcutaneously. The injection site should be rotated to avoid skin changes. Follow the instructions provided by your doctor or nurse.
Growth disorders in children due to insufficient growth hormone secretion
Recommended dose: 0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m² body surface area per day.
In children with Prader-Willi syndrome to accelerate growth and improve body composition
Recommended dose: 0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day.
Do not use a daily dose exceeding 2.7 mg/m² body surface area per day. Do not treat children growing less than 1 cm per year or nearing completion of growth.
Growth disorders in children associated with Turner syndrome
Recommended dose: 0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day.
Growth disorders associated with chronic renal insufficiency
Recommended dose: 0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day. If growth velocity is too low, dose increase may be necessary. Dose adjustment may be needed after 6 months of treatment.
Growth disorders in short children born small for gestational age
Recommended dose: 0.035 mg/kg body weight per day (1 mg/m² body surface area per day). Treatment continues until final height is reached. Discontinue treatment if growth rate is too slow.
Adults with growth hormone deficiency
For patients continuing growth hormone therapy after childhood GH deficiency, the recommended starting dose is 0.2–0.5 mg per day. The dose should be gradually increased or decreased according to individual requirements based on IGF-I (insulin-like growth factor) levels.
For adults with acquired GH deficiency, treatment should start with a low dose: 0.15–0.3 mg per day. The dose is gradually increased depending on serum IGF-I levels, treatment efficacy and side effects. The maximum daily dose rarely exceeds 1.0 mg per day. Use the lowest effective dose.
Women may require higher doses than men.
Natural hormone production decreases with age, so dose reduction may be necessary over time.
Dose adjustment should be monitored every 6 months.
For patients over 60 years of age, treatment should start with a dose of 0.1–0.2 mg per day and gradually increased according to individual requirements. Use the lowest effective dose. The maintenance dose in these patients rarely exceeds 0.5 mg per day.

Method of administration
Genotropin 5.3 in the dual-chamber cartridge is administered using the Genotropin Pen 5.3. The dual-chamber cartridge contains growth hormone and solvent.
Genotropin 12 in the dual-chamber cartridge is administered using the Genotropin Pen 12. The dual-chamber cartridge contains growth hormone and solvent.
Genotropin Pen: After inserting the dual-chamber cartridge, twist the Genotropin Pen. The growth hormone and solvent are automatically mixed. Do not shake the solution during preparation.
DO NOT SHAKE!
Shaking may denature the active substance, leading to loss of biological activity.
Refer to the Genotropin Pen user instructions.

If you use more Genotropin than prescribed
If you inject too much Genotropin, contact your doctor. A single overdose may affect blood glucose levels, which may become too low or too high. Symptoms may include trembling, sweating, drowsiness, fainting, or feeling “not yourself.”
If you forget to use Genotropin
Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people)
Adults:

• Joint pain.
• Fluid retention (manifested as swollen fingers or wrists).

Common (may affect up to 1 in 10 people)
Children:

• Joint pain.
• Transient redness, itching and pain at the injection site.

Adults:

• Numbness/tingling.
• Pain or burning sensation in hands or wrists (known as carpal tunnel syndrome).
• Stiffness of arms and legs, muscle pain.

Uncommon (may affect up to 1 in 100 people)
Children:

• Leukaemia (reported in a small number of patients with growth hormone deficiency, some treated with Genotropin. However, there is no evidence that leukaemia incidence is increased in growth hormone-deficient patients without predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances or vomiting).
• Numbness/tingling.
• Rash.
• Itching.
• Raised, itchy skin nodules.
• Muscle pain.
• Water retention (manifested as swollen fingers or wrists).
• Breast enlargement (gynaecomastia).

Adults:

• Breast enlargement (gynaecomastia).

Frequency not known (cannot be estimated from available data)
Adults and children:

• Type 2 diabetes.
• Facial swelling.
• Headache.
• Decreased blood cortisol levels.

Children:

• Stiffness of arms and legs.

Adults:

• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances or vomiting).
• Rash.
• Itching.
• Raised, itchy skin nodules.
• Redness, itching and pain at the injection site.

Antibodies against the injected growth hormone have been observed, but this does not appear to affect treatment efficacy.
Very rarely, inflammatory muscle reactions around the injection site caused by m-cresol (excipient) have been observed. If confirmed by a doctor, a formulation without m-cresol should be used.
Rotate injection sites to avoid skin changes such as lumps or nodules.
Since marketing, rare cases of sudden death in Prader-Willi syndrome patients treated with Genotropin have been reported. A causal relationship with Genotropin has not been established.
In children treated with growth hormone, cases of slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported. A causal relationship with Genotropin has not been established.
Other side effects associated with growth hormone use may include increased blood glucose or decreased thyroid hormone levels in adults and children. This may be confirmed by your doctor, who may initiate appropriate treatment if necessary. Pancreatitis has been rarely reported in patients treated with growth hormone.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder or its representative.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Genotropin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Store the medicine at 2°C–8°C (in the refrigerator), do not freeze. The medicine may be stored below 25°C for one month. Store in the outer packaging to protect from light.
After reconstitution
The solution may be stored for 4 weeks at 2°C–8°C (in the refrigerator), do not freeze. Store in the outer packaging to protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures help protect the environment.

6. Contents of the pack and other information

What Genotropin 5.3 contains

• The active substance is somatropin*. Each cartridge contains 5.3 mg of somatropin*.
• The other ingredients are: glycine, mannitol, monosodium dihydrogen phosphate monohydrate (anhydrous basis), disodium hydrogen phosphate dodecahydrate (anhydrous basis) (see section 2 “Genotropin contains sodium”). The solvent contains m-cresol (see section 2 “Genotropin contains m-cresol”), mannitol, water for injections. After reconstitution, the concentration of somatropin is 5.3 mg/ml.

* produced in Escherichia coli bacterial cells by recombinant DNA technology.
What Genotropin 12 contains

• The active substance is somatropin*. Each cartridge contains 12 mg of somatropin*.
• The other ingredients are: glycine, mannitol, monosodium dihydrogen phosphate monohydrate (anhydrous basis), disodium hydrogen phosphate dodecahydrate (anhydrous basis) (see section 2 “Genotropin contains sodium”). The solvent contains m-cresol (see section 2 “Genotropin contains m-cresol”), mannitol, water for injections. After reconstitution, the concentration of somatropin is 12 mg/ml.

* produced in Escherichia coli bacterial cells by recombinant DNA technology.
What the medicine looks like and contents of the pack
Genotropin is available in dual-chamber cartridges, in which one chamber contains the active substance as a white powder and the other chamber contains a clear solution serving as the solvent.
Genotropin is available in packs containing 1 or 5 dual-chamber cartridges.
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information on this medicine, please contact the representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel.: 22 335 61 00
Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl