Label: information for the user

GENOTONORM KABIPEN 5.3 mg and 12 mg powder and solvent for injection solution

somatropin

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Contents of the package and additional information

Genotonorm Kabipen is a recombinant human growth hormone (also known as somatropin). It has the same structure as human growth hormone, which is necessary for the growth of bones and muscles. It also helps to develop body fat and muscle tissue in adequate amounts. The fact that it is recombinant means that it does not come from human or animal tissue.

In children, Genotonorm Kabipen is used to treat growth disorders:

• If you do not grow at an adequate rate or if you do not have enough growth hormone of your own.
• In the case of Turner syndrome. Turner syndrome is a chromosomal alteration that occurs in girls and can affect growth – your doctor will indicate if you have it.
• In the case of chronic kidney insufficiency. If the kidney loses its ability to function properly, growth can be affected.
• In the case of Prader-Willi syndrome (a chromosomal alteration). Growth hormone will help you grow if you are still in the growth period and will also improve body composition. Excess fat will decrease and muscle mass loss will improve.
• If you were born small or with low weight. Growth hormone may help you grow if you have not been able to reach or maintain normal growth by the age of 4 or later.

In adults, Genotonorm Kabipen is used to treat people with a marked deficiency of growth hormone. This can start in adulthood, or it may have started in childhood and continued into adulthood.

If you have been treated with Genotonorm Kabipen for growth hormone deficiency during childhood, your growth hormone levels should be reevaluated after completing the growth phase. If severe growth hormone deficiency is confirmed, your doctor will recommend continuing treatment with Genotonorm Kabipen.

This medication can only be prescribed by a doctor with experience in treating growth hormone and who has confirmed your diagnosis.

Do not use Genotonorm Kabipen and contact your doctor if

• You are allergic (hypersensitive) to somatropin or to any of the other components of Genotonorm Kabipen.
• You have an active tumor (cancer). Tumors must be inactive and you must have completed antitumor treatment before starting treatment with Genotonorm.

• You are severely ill (for example, complications after open-heart surgery, abdominal surgery, acute respiratory failure, accidental trauma, or a similar situation). If you are about to undergo or have undergone major surgery or are about to be admitted to the hospital for any reason, tell your doctor and remind the other doctors who examine you that you use growth hormone.
• You have already completed your growth period (closed epiphyses) and were prescribed Genotonorm Kabipen to stimulate growth.

Be especially careful with Genotonorm Kabipen and contact your doctor

• If you have a risk of developing diabetes, your doctor will monitor your blood sugar levels during treatment with Genotonorm Kabipen.
• If you have diabetes, you must carefully monitor your blood sugar levels during treatment with Genotonorm Kabipen and see the results with your doctor to determine if you need to change the dose of your diabetes medications.
• After starting treatment with Genotonorm Kabipen, some patients may need to begin treatment with thyroid hormone.
• If you are receiving treatment with thyroid hormones, it may be necessary to adjust the dose of thyroid hormone.
• If you are receiving growth hormone to stimulate growth and limp, or if you start limping due to hip pain during growth hormone treatment, you must inform your doctor.
• If increased intracranial pressure (with symptoms such as severe headaches, vision problems, or vomiting) occurs, you must inform your doctor about it.
• If your doctor confirms that you have developed inflammation of the muscles near the injection area due to the preservative metacresol, you must use another presentation of Genotonorm that does not contain metacresol.
• If you are receiving Genotonorm Kabipen for a deficiency of growth hormone after a previous tumor (cancer), you must undergo regular follow-up for possible recurrences of the tumor or any other cancer.
• If you experience abdominal pain that worsens, you must inform your doctor.
• Experience in patients over 80 years of age is limited. Older people may be more sensitive to the action of Genotonorm Kabipen, and therefore may be more prone to developing adverse effects.

Children with chronic renal insufficiency:

• Your doctor will examine your renal function and growth rate before starting treatment with Genotonorm Kabipen. Your renal disease treatment must continue. Treatment with Genotonorm Kabipen should be suspended in the event of a kidney transplant.

Children with Prader-Willi syndrome:

• Your doctor will give you dietary restrictions to control your weight.
• Your doctor will perform an examination before starting treatment with Genotonorm Kabipen to determine if you have upper airway obstruction, sleep apnea (when breathing is interrupted during sleep), or respiratory infections.
• If during treatment you present signs of upper airway obstruction (including the onset or increase of snoring), your doctor will need to examine you and may interrupt treatment with Genotonorm Kabipen.
• During treatment, your doctor will monitor any signs of scoliosis, a type of spinal deformity.
• If during treatment you develop a lung infection, inform your doctor so that they can treat the infection.

Children born small or underweight:

• If you were born small or underweight and are between 9 and 12 years old, consult your doctor specifically about puberty and treatment with this product.
• Your doctor will perform blood sugar and insulin analyses before starting treatment and once a year while it continues.
• Treatment must continue until you complete your growth phase.

Use in athletes

This medication contains somatropin, which may produce a positive result in doping control tests.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Genotonorm.

If you are receiving glucocorticoid replacement therapy, you must consult your doctor regularly as it may be necessary to adjust your glucocorticoid dose.

Inform your doctor if you are using:

• diabetes medications
• thyroid hormones
• synthetic adrenal hormones (corticosteroids)
• estrogens administered orally or other sex hormones
• ciclosporin (a medication that weakens the immune system after a transplant)
• medications for epilepsy control (anticonvulsants)

Your doctor may need to adjust the dose of these medications or the dose of Genotonorm Kabipen.

Pregnancy and lactation

Do not use Genotonorm Kabipen if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Consult your doctor before using this medication while breastfeeding.

Consult your doctor or pharmacist before using any medication.

Genotonorm Kabipen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Recommended Dose

The dose depends on your body surface area, the pathology for which you are being treated, and how your growth hormone works. Each person is different. Your doctor will inform you of your individualized dose of Genotonorm Kabipen in milligrams (mg) wellin accordance with your body weight in kilograms (kg) or your calculated body surface area based on your height and weight in square meters (m2), as well as your treatment schedule. Do not change or discontinue the dose or treatment schedule without consulting your doctor.

Children with growth hormone deficiency:

0.025-0.035mg/kg of body weight per day or 0.7-1.0 mg/m2of body surface area per day. Higher doses may be used. When growth hormone deficiency continues into adolescence, treatment with GenotonormKabipenshould be continued until physical development is complete.

Children with Turner syndrome:

0.045-0.050mg/kg of body weight per day or 1.4 mg/m2of body surface area per day.

Children with chronic renal insufficiency:

0.045-0.050mg/kg of body weight per day or 1.4 mg/m2of body surface area per day. If growth velocity is too low, higher doses may be necessary. Dose adjustment may be required after 6 months of treatment.

Children with Prader-Willi syndrome:

0.035mg/kg of body weight per day or 1.0 mg/m2of body surface area per day. The daily dose should not exceed 2.7 mg. This treatment should not be used in children whose growth phase has practically ended after puberty.

Small for gestational age or growth-retarded children and children with growth disorders:

0.035mg/kg of body weight per day or 1.0 mg/m2of body surface area per day. It is essential to continue treatment until final height is reached. Treatment should be discontinued after the first year if there is no response or if final height is reached and growth has stopped.

Adults with growth hormone deficiency:

If you continue to use Genotonorm after treatment during childhood, start with a dose of 0.2-0.5 mg per day. This dose should be increased or decreased gradually based on analytical results, as well as clinical response and adverse effects.

If growth hormone deficiency begins during adulthood, start with 0.15-0.3mg per day. This dosing should be increased gradually based on analytical results, as well as clinical response and adverse effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months. Patients over 60 years old should start with doses of 0.1-0.2 mg per day and gradually increase as needed. Use the minimum effective dose. The maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions provided by your doctor.

Genotonorm Kabipen Injection

This medication is administered subcutaneously. This means it is injected through a small needle into the fatty tissue, just below the skin. Your doctor will teach you how to use it. Always use the medication as instructed by your doctor. Consult your doctor or pharmacist if you have any doubts.

The instructions for using the pre-filled GoQuick device are also provided in the device packaging.

The instructions for using Genotonorm Kabipen in a dual-chamber vial with Genotonorm Pen are provided in the device packaging.

Consult these instructions before using your medication.

When using a pre-filled device or a Genotonorm Pen device, you must place the needle in the device before mixing.Use a new needle for each injection. Needles should not be reused.

• Preparation of the injection:

You can remove the medication from the refrigerator 30 minutes before injection. This allows it to warm up a bit and makes the injection more comfortable.

The pre-filled GoQuick device contains a dual-chamber vial with growth hormone and liquid solvent. The growth hormone and solvent mix when you turn the vial (see detailed steps in the Instructions for Use). No additional device is required.

Genotonorm is also available in a dual-chamber vial containing growth hormone and liquid solvent for use with the Genotonorm Pen device. The growth hormone and solvent in the dual-chamber vial can be mixed by twisting the Genotonorm Pen device together.

In both cases, the pre-filled GoQuick device and the dual-chamber vial, dissolve the powder by gently tilting it until the powder is completely dissolved.

When mixing Genotonorm Kabipen, DO NOT SHAKE the solution. Mix it gently. If you shake the solution, it may foam and damage the medication. Observe the solution and do not inject it if you notice turbidity or particles in it.

• Genotonorm Kabipen Injection:

Remember to wash your hands first and clean the skin at the injection site.

Administer the growth hormone injection at the same time every day. A good time is before bedtime, as it is easy to remember. It is also normal to have higher levels of growth hormone at night.

Most patients use the thighs or buttocks for injection. Place the injection where your doctor has instructed. The fatty tissue under the skin may decrease in size at the injection site. To avoid this, change the injection site each time. This will give your skin and the tissue under the skin time to recover between injections.

Remember to store the medication in the refrigerator immediately after injection.

If you use more Genotonorm Kabipen than you should

If you inject more than you should, consult your doctor or pharmacist immediately. Blood sugar levels may drop suddenly and then rise to excessively high levels. You may feel agitated, sweaty, drowsy, or feel strange and may experience dizziness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 5620420, indicating the medication and the amount ingested.

If you forget to administer Genotonorm Kabipen

Do not administer a double dose to compensate for the missed dose.

It is better to administer the growth hormone regularly. If you forget to administer a dose, administer the next injection at the corresponding time the next day. Note the missed injections and inform your doctor at the next review.

If you interrupt treatment with Genotonorm Kabipen

Consult your doctor before discontinuing treatment with thismedication.

If you have any other doubts about using this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent and very frequent side effects in adults can start in the first few months of treatment and disappear spontaneously or when the dose is reduced.

Very frequent side effects (can affect more than 1 in 10 patients)) include:

Adults:

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

Frequent side effects (can affect up to 1 in 10 patients)) include:

Children:

• Joint pain.
• Redness, itching, or temporary pain at the injection site.

Adults:

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

Rare side effects (can affect up to 1 in 100 people) include:

Children:

• Leukemia (notified in a small number of patients with growth hormone deficiency, some of whom have received somatropin treatment. However, there is no evidence that leukemia incidence is increased in growth hormone receptor patients without predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
• Numbness/tingling.
• Rash.
• Itching.
• Hives on the skin with itching.
• Muscle pain.
• Enlargement of the breast (gynecomastia).
• Fluid retention (manifesting as swollen fingers or ankle swelling, for a short period at the beginning of treatment).

Adults:

• Enlargement of the breast (gynecomastia).

Unknown frequency: cannot be estimated from available data:

• Type 2 diabetes.
• Swelling of the face.
• Headache.
• Decreased cortisol hormone concentrations in the blood.

Children:

• Stiffness in arms and legs.

Adults:

• Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
• Rash.
• Itching.
• Hives on the skin with itching.
• Redness, itching, or pain at the injection site.

Formation of antibodies against the injected growth hormone, although this does not appear to affect the action of the growth hormone.

The skin around the injection area may become rough and irregular, but this should not occur if the injection is made in a different location each time.

The preservative metacresol can cause a very rare side effect of muscle inflammation near the injection site. If your doctor confirms that you have developed this side effect, you should use Genotonorm without metacresol.

Rare cases of sudden death in patients with Prader-Willi syndrome have been reported. However, no relationship has been established between these cases and treatment with this medicine.

If you experience discomfort or pain in the hip or knee while receiving treatment with Genotonorm, your doctor may consider the possibility of suffering from femoral epiphysiolysis or Legg-Calvé-Perthes disease.

Other possible side effects related to treatment with growth hormone are as follows.

You (or your child) may experience an increase in blood sugar levels or a decrease in thyroid hormone concentrations. Your doctor may perform tests to determine this and, if necessary, prescribe appropriate treatment. Occasionally, pancreatitis has been reported in patients treated with growth hormone.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging as MM/YYYY. The expiration date is the last day of the month indicated.

Before reconstitution

Store in refrigerator (2°C-8°C). Store the dual-chamber vial in the outer packaging to protect it from light.

Before opening, the medication can be stored outside the refrigerator for a maximum period of 1 month at a temperature not exceeding 25°C, but after this period, it must be discarded.

After reconstitution

Store in refrigerator (2°C-8°C) for a maximum period of 28 days. Do not freeze. Store the pre-loaded GoQuick device in the outer packaging, or the dual-chamber vial in the injection device case, to protect it from light.

Do not use this medication if you observe particles or if the solution is cloudy.

Do not freeze or expose this medication to ice. If it freezes, do not use it.

Never throw away needles or empty vials in regular trash. When you have finished using the needle, you must dispose of it carefully in a special needle container, so that no one can use it or prick themselves.

Medications should not be thrown away through drains or in regular trash. Deposit the packaging and medications you do not need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

Composition of Genotonorm Kabipen

• The active ingredient is somatropin*.
• A vial contains 5.3 mg or 12 mg of somatropin*.
• After reconstitution, the concentration of somatropin* is 5.3 mg or 12 mg per ml.
• The other components of the powder are: glycine (E640), mannitol (E421), sodium hydrogen phosphate anhydrous (E339) and disodium dihydrogen phosphate anhydrous (E339) (see section 2 “Genotonorm Kabipen contains sodium”).
• The ingredients of the solvent are: water for injectable preparations, mannitol (E421) and metacresol.

*Obtained in Escherichia coli cells by DNA recombinant technology.

Appearance of Genotonorm Kabipen and contents of the pack

Lyophilisate and solvent for solution for injection, in a double-chamber vial containing the lyophilisate in one section and the solvent in the other (5.3 mg/ml or 12 mg/ml). The vial may be included in a preloaded device. Pack sizes: 1 or 5 preloaded devices, or 1, 5 or 20 vials.

Only some pack sizes may be marketed.

The lyophilisate is white and the solvent is transparent.

The vials must be used with a specific Genotonorm Kabipen injection device.

The Genotonorm Kabipen vials have a colour code, and must be used with the Genotonorm Kabipen injection device that matches the colour code, to provide the correct dose: the Genotonorm Kabipen 5.3 mg vial (blue) must be used with the Genotonorm Kabipen 5.3 (blue) injection device. The Genotonorm Kabipen 12 mg vial (purple) must be used with the Genotonorm Kabipen 12 (purple) injection device.

The device instructions are included in the packaging. If you do not have an injection device, ask your doctor.

Marketing authorisation holder

Pfizer, S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid), Spain.

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom (Northern Ireland).

Genotonorm: Belgium, France, Luxembourg.

Genotonorm Kabipen: Spain.

Last update of the summary of product characteristics: May 2024

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/