Prospect: Information for the User

Humatrope 6 mg/ 12 mg/ 24 mg Powder and Diluent for Injectable Solution

somatropin

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Your medication or the medication of the person in your care is called Humatrope. It contains human growth hormone, also known as somatropin. Humatrope is obtained through a special process known as recombinant DNA technology. It has the same structure as the growth hormone produced by your body.

Growth hormone regulates the growth and development of cells in your body. When it stimulates cell growth in the spine and long bones of the legs, it causes an increase in height.

In cases of growth hormone deficiency, growth hormone also increases bone mineral content, the number and size of muscle cells, and reduces body fat deposits.

Humatrope is used for

• Treatment of children and adolescents with any of the following growth disorders:

• Insufficient production of growth hormone (growth hormone deficiency),
• Absence of all or some sex chromosomes-X in short women (Turner Syndrome),
• A disease in which the kidneys are damaged(chronic problems with how the kidneys function) in children with growth retardation before puberty,
• Low birth height (PEG = small for gestational age) that have not recovered the corresponding height by 4 years of age or later,
• A genetic alteration called SHOX (SHOX deficiency).

No use Humatrope

• if you areallergic(hypersensitive) to somatropin or any of the other components of Humatrope (e.g. metacresol, glycerol of the solvent) see section 6.
• inform your doctor if you have an active tumor (cancer). Tumors must be inactive and you must have completed antitumor treatment before starting Humatrope treatment.
• if you have stopped growingand want to increase growth in height (growth plates at the end of long bones closed). Your doctor will examine you and decide if you still need Humatrope after your bones have stopped growing.
• if you arevery illand require intensive care due to a severe heart or abdominal intervention, having been treated for multiple injuries after an accident, or requiring treatment to help you breathe after suffering acute respiratory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Humatrope.

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

If you were treated for growth hormone deficiency during your childhood, your doctor will re-examine your growth hormone deficiency to decide if you need Humatrope treatment during your adult age.

If you have completed previous antitumor treatment, it may be necessary to have a brain scan before starting Humatrope treatment. You must be examined regularly to ensure that the tumor does not recur or start growing.

A higher risk of developing a second tumor (benign or malignant) has been reported in patients who survived cancer and were treated with somatropin. Of these second tumors, in particular, brain tumors were the most common.

If you experience symptoms such as frequent or severe headaches, nausea, and/or visual problems, inform your doctor immediately. Your doctor must perform an eye examination to observe if there is evidence of increased intracranial pressure. Depending on the results of this examination, Humatrope treatment may need to be interrupted.

If you experience gait disturbance or hip pain, please consult your doctor. During growth periods, alterations in the bone of your hip may occur.

If you start treatment, Humatrope may affect the amount of thyroid hormones in your blood. If the level of thyroid hormone is low, it may reduce your response to Humatrope. Therefore, you must have regular thyroid function tests regardless of whether you receive thyroid hormone treatment or not.

If you are a child, ensure that you maintain treatment until you reach your final height.

If you take a higher dose than prescribed for Humatrope, you may experience overgrowth of some parts of your body such as ears, nose, jaw, hands, and feet. Overdose may also trigger increased blood sugar levels and sugar in the urine. Use Humatrope only as directed by your doctor.

If you have had growth alterations due to renal damage, you must suspend Humatrope treatment before renal transplantation.

If you have critical acute diseases, you must notify the doctor treating you. Cases of death have been reported in patients receiving somatropin during critical diseases.

If you have growth hormone deficiency and also have Prader-Willi syndrome (a genetic disorder), your doctor must examine your respiratory problems and airway infections before starting Humatrope treatment, especially if you are overweight, have had previous severe respiratory problems (especially during sleep) or have had pulmonary or airway infections. If during treatment you experience signs of respiratory problems (snoring), treatment must be interrupted and the cause evaluated by your doctor.

Humatrope may affect the way your body acts on the sugar from food and drink, interfering with the way your body uses insulin. Therefore, if you take Humatrope, your doctor must confirm if your body is handling sugar correctly.

If you have diabetes mellitus, you may need to adjust your insulin dose after starting Humatrope treatment. Your doctor will check your blood sugar levels and may adjust your treatment for diabetes.

If you have growth alterations associated with being born small for your gestational age, your blood sugar levels and insulin levels must be measured before starting treatment and regularly during treatment.

If you are an elderly patient (over 65 years old), you may be more sensitive to Humatrope and may be prone to adverse effects.

Humatrope may cause pancreatitis, which causes intense pain in the abdomen and back. Contact your doctor if you or your child develop stomach pain after taking Humatrope.

Scoliosis (increased lateral curvature of the spine) may progress in any child during rapid growth. Signs of scoliosis must be monitored during treatment.

Other medicines and Humatrope

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

In particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Humatrope or the other medicines:

• medicines for the treatment ofdiabetes mellitusthat may need to be adjusted.
• adrenal cortical steroid hormone(glucocorticoid), such as cortisone or prednisolone; your doctor may need to adjust the dose because the combination of these medicines with Humatrope may reduce the effect of both treatments.
• estradiol administered orally or other sex hormones, as they may affect the response to growth hormone treatment. If there is a change in the way sex hormones are taken (e.g. from oral to transdermal: through the skin); the dose of Humatrope may need to be adjusted.
• medicines to prevent seizures (anticonvulsants) or cyclosporine.

Pregnancy and breastfeeding

Humatrope should not be used during pregnancy, unless your doctor tells you to. Inform your doctor immediately if you are pregnant.

The passage of somatropin to breast milk is unknown. If you are breastfeeding or intend to do so, consult your doctor before using Humatrope.

Driving and operating machinery

Humatrope has no known effects on the ability to drive or operate machinery.

Humatrope contains sodium

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

Use in athletes

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Always make sure to use the cartridge with the concentration prescribed by your doctor (concentration of 6 mg, 12 mg or 24 mg) and the correct Humatrope pen injection system with CE marking. Never use cartridges of other medications in your Humatrope pen.
• Each Humatrope cartridge comes with a syringe containing a diluent (solvent for injectable solution) for reconstitution (mixing and preparing the injectable solution).
• Do not mix or inject Humatrope until you have received sufficient training from your doctor or other qualified healthcare professionals.
• For detailed instructions on how to prepare and inject Humatrope, see the section“How to inject Humatrope”at the end of this prospectus. Only mix Humatrope with the diluent provided. Never mix it with anything else unless your doctor tells you to.
• After reconstitution, Humatrope must be injected into the fatty tissue just below the skin using a short needle and a pen injection system.
• The injection sites should be varied to avoid local reduction and hardening of the subcutaneous tissue (lipatrophy).
• After mixing Humatrope, do not leave it out of the refrigerator for more than 30 minutes each day.
• Keep your pen with the remaining Humatrope in the refrigerator. Do not use the remaining Humatrope after 28 days of mixing.

Dosage

Your doctor will indicate your dosage and administration schedule. Do not change your dosage without consulting your doctor.

Normally, Humatrope treatment is a long-term treatment; your doctor may need to adjust your dosage over time depending on your body weight and response to treatment. Generally, the dosage is calculated according to the following recommendations and is administered once a day:

Children and adolescents with:

• Growth hormone deficiency:

0.025 - 0.035 mg/kg of body weight per day,

• Turner syndrome:

0.045 - 0.050 mg/kg of body weight per day,

• Chronic problems due to kidney function:

0.045 - 0.050 mg/kg of body weight per day,

• Small for gestational age at birth:

0.035 mg/kg of body weight per day. Treatment should be discontinued after the first year of treatment if growth rate is insufficient,

• SHOX gene deficiency:

0.045 - 0.050 mg/kg of body weight per day.

Growth hormone deficiency in adults:

Start treatment with a low dose of 0.15-0.30 mg per day. It may be necessary to start with lower doses in overweight or elderly patients. The initial dose can be gradually increased according to individual needs. The total daily dose usually does not exceed 1 mg.

Dosage requirements may decrease with age. Women, especially those on oral estrogen replacement therapy, may require higher doses than men.

If you use more Humatrope than you should

If you have injected more Humatrope than you should, consult your doctor.

• If you have injected too much Humatrope, your blood sugar may initially decrease and become very low (hypoglycemia) and then increase and become very high (hyperglycemia).
• If you inject too much Humatrope over a long period of time (years), you may experience overgrowth of some parts of your body such as ears, nose, jaw, hands, and feet (acromegaly).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Humatrope

Do not inject a double dose to compensate for the missed doses. Continue with the prescribed dose. If you have forgotten to inject Humatrope and are unsure what to do, consult your doctor.

If you interrupt Humatrope treatment

Ask your doctor before stopping treatment. Premature interruption or suspension of Humatrope treatment may affect the success of Humatrope treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

You may experience any of the following side effects after being injected with Humatrope:

The following criteria have been used to classify side effects:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Other possible side effects (frequency cannot be estimated from available data)

The effect of insulin may be reduced.

Leukemia has been reported in a small number of children treated with growth hormone. However, there is no evidence that the incidence of leukemia is increased in patients receiving growth hormone.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging. The expiration date (EXP) is the last day of the month indicated.

Do not use this medication if you observe that the solution is not transparent or if it contains particles.

Humatrope must be stored in the refrigerator (between 2°C and 8°C) at all times. Do not freeze.

Once reconstituted, do not leave Humatrope out of the refrigerator for more than 30 minutes a day.

Once reconstituted, Humatrope can be used for a maximum of 28 days if stored in the refrigerator and is out of the refrigerator for no more than 30 minutes a day at room temperature.

Medications should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Humatrope Composition

Pen Cartridge Contents

The active principle is somatropin. Each cartridge contains 6 mg, 12 mg or 24 mg depending on the concentration. Once reconstituted:

• Humatrope 6 mgcorresponds to 2.08 mg of somatropin per ml of solution
• Humatrope 12 mgcorresponds to 4.17 mg of somatropin per ml of solution
• Humatrope 24 mgcorresponds to 8.33 mg of somatropin per ml of solution

The other components are: mannitol, glycine, sodium dihydrogen phosphate.

[During the manufacturing process, phosphoric acid or sodium hydroxide (or both) may have been used to adjust the pH].

Pre-filled Syringe Diluent

The pre-filled syringe diluent contains: glycerol, metacresol, water for injection. [During the manufacturing process, hydrochloric acid or sodium hydroxide (or both) may have been used to adjust the pH].

Product Appearance and Packaging Contents

Not all package sizes may be marketed

Marketing Authorisation Holder

LILLY, S.A. Avda. de la Industria, 30. 28108 Alcobendas (Madrid).

Manufacturer

Lilly France, S.A.S. Rue du Colonel Lilly, 67640 Fegersheim (France).

For any information about this medicinal product, please contact the Marketing Authorisation Holder (or the local representative):

Lilly, S.A. Avda. de la Industria, 30. 28108 Alcobendas (Madrid).

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

In the Member States of the European Economic Area where this product is authorised, it is authorised under the name of “Humatrope”, except in France where it is authorised as “Umatrope”.

How to Inject Humatrope 6 mg / 12 mg / 24 mg

The following instructions explain how to inject Humatrope. Read the instructions carefully and follow them step by step.

Humatrope is a registered trademark of Eli Lilly and Company Limited

Last revision date of this leaflet: July 2021

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