Humatrope 6 mg powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Humatrope 6 mg/12 mg/24 mg powder and solvent for injectable solution

somatropin

Read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Humatrope is and what it is used for

Your medicine or the medicine of the person in your care is called Humatrope. It contains human growth hormone, also known as somatropin. Humatrope is produced by 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 your body's cells. 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

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

• Insufficient production of growth hormone (growth hormone deficiency),

• Absence of all or part of the X sex chromosomes in short-statured females (Turner Syndrome),

• A disease in which the kidneys are damaged (chronic kidney dysfunction) in children with growth retardation before puberty,

• Short stature at birth (SGA = small for gestational age) who have not caught up in height by age 4 or later,

• A disorder of a gene called SHOX (SHOX deficiency).

• Treatment of adults with confirmed growth hormone deficiency, whether beginning in childhood or in adulthood.

2. What you need to know before using Humatrope

Do not use Humatrope

• if you are allergic (hypersensitive) to somatropin or to any of the other components of Humatrope (e.g. metacresol, glycerol from the solvent); see section 6.
• and inform your doctor if you have an active tumor (cancer). Tumors must be inactive and you must have completed anti-tumor treatment before starting Humatrope therapy.
• if you have stopped growing and wish to increase height growth (growth plates at the ends of the long bones closed). Your doctor will examine you and decide whether you still need Humatrope after your bones have stopped growing.
• if you are seriously ill and require intensive care due to major heart or abdominal surgery, following treatment for multiple injuries after an accident, or requiring treatment to assist breathing after acute respiratory failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Humatrope.

If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need adjustment.

If you were treated for growth hormone deficiency during childhood, your doctor will re-evaluate your growth hormone deficiency to determine whether you require Humatrope treatment in adulthood.

If you have previously completed anti-tumor treatment, a brain scan may be necessary before starting Humatrope treatment. You should be examined regularly to ensure that the tumor does not reappear or begin to grow.

An increased risk of a second tumor (benign or malignant) has been reported in patients who survived cancer and were treated with somatropin. Among these second tumors, brain tumors were the most common.

If you experience symptoms such as frequent or severe headaches, with nausea and/or visual disturbances, inform your doctor immediately. Your doctor should perform an eye examination to check for signs of increased intracranial pressure. Depending on the results of this examination, Humatrope treatment may need to be discontinued.

If you develop a limp or hip pain, please consult your doctor. During periods of growth, abnormalities in the hip bone may occur.

When starting treatment, Humatrope may affect the amount of thyroid hormones in your blood. If thyroid hormone levels are low, your response to Humatrope may be reduced. Therefore, regular thyroid function tests should be performed regardless of whether you are receiving thyroid hormone treatment.

If you are a child, make sure to continue treatment until final height is reached.

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

If you have growth disturbances due to kidney disease, you should discontinue Humatrope treatment before kidney transplantation.

If you have acute critical illness, you must inform your treating doctor. Cases of death have been reported in patients receiving somatropin during critical illness.

If you have growth hormone deficiency and also have Prader-Willi syndrome (a genetic disorder), your doctor should evaluate your respiratory problems and airway infections before starting Humatrope treatment, especially if you are overweight, have previously had serious breathing problems (particularly during sleep), or have had a lung or airway infection. If you develop signs of breathing problems (such as snoring) during treatment, treatment should be stopped and the cause evaluated by your doctor.

Humatrope may affect how your body processes sugar from food and drink by interfering with how your body uses insulin. Therefore, if you take Humatrope, your doctor must confirm that your body is properly managing sugar.

If you have diabetes mellitus, you may require an adjustment in your insulin dose after starting Humatrope treatment. Your doctor will monitor your blood sugar levels and may adjust your diabetes treatment.

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

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

Humatrope may cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you or your child develops stomach pain after taking Humatrope.

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

Other medicines and Humatrope

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

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 of the other medicines:

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

Pregnancy and breastfeeding

Humatrope should not be used during pregnancy unless specifically instructed by your doctor. Inform your doctor immediately if you become pregnant.

It is unknown whether somatropin passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before using Humatrope.

Driving and using machines

Humatrope has no known effects on the ability to drive or use machines.

Humatrope contains sodium

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

Use in athletes

This medicine contains somatropin, which may result in a positive doping test.

3. How to use Humatrope

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Always make sure to use the cartridge with the concentration prescribed by your doctor (6 mg, 12 mg, or 24 mg concentration) and the correct Humatrope pen injection system bearing the CE mark. Never use cartridges from other medicines in your Humatrope pen.
• Each Humatrope cartridge comes with a syringe containing a diluent (solvent for injectable solution) for its reconstitution (mixing and preparation of the injectable solution).
• Do not mix or inject Humatrope until you have received adequate training from your doctor or other qualified healthcare professionals.
• For detailed instructions on how to prepare and inject Humatrope, see section “How to inject Humatrope” at the end of this leaflet. Humatrope should only be mixed with the provided diluent. Never mix it with anything else unless your doctor instructs you to do so.
• After reconstitution, Humatrope must be injected into the fatty tissue just beneath the skin using a short needle and a pen injection system.
• Injection sites should be rotated to avoid localized reduction and hardening of the subcutaneous fatty tissue (lipoatrophy).
• After mixing Humatrope, do not leave it outside the refrigerator for more than 30 minutes each day.
• Keep your pen with the remaining Humatrope in the refrigerator. Do not use any leftover Humatrope after 28 days from the time of mixing.

Dosage

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

Typically, treatment with Humatrope is long-term; your doctor may need to adjust your dose over time depending on your body weight and response to treatment. In general, the dose is calculated according to the following recommendations and is administered once daily:

Children and adolescents with:

• Growth hormone deficiency:

0.025 - 0.035 mg/kg body weight per day,

• Turner syndrome:

0.045 - 0.050 mg/kg body weight per day,

• Chronic kidney problems due to impaired kidney function:

0.045 - 0.050 mg/kg body weight per day,

• Small for gestational age at birth:

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

• SHOX gene deficiency:

0.045 - 0.050 mg/kg body weight per day.

Growth hormone deficiency in adults:

Treatment should be initiated with a low dose of 0.15–0.30 mg daily. Even lower starting doses may be necessary for overweight patients or elderly patients. The initial dose may be gradually increased according to individual requirements. 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 have, consult your doctor.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Humatrope

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

If you stop treatment with Humatrope

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

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

4. Possible adverse effects

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

You may experience any of the following adverse effects after injecting Humatrope:

The following criteria have been used to classify adverse effects:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

Other possible adverse 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 adverse reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Humatrope

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

Do not use this medicine after the expiry date stated on the label and packaging. The expiry date (EXP) refers to the last day of the month indicated.

Do not use this medicine if you notice that the solution is not clear or if it contains particles.

Humatrope must always be stored in a refrigerator (between 2°C and 8°C). Do not freeze.

After reconstitution, do not leave Humatrope outside the refrigerator for more than 30 minutes per day.

After reconstitution, Humatrope may be used for up to 28 days provided it is stored in the refrigerator and removed from the refrigerator for no more than 30 minutes per day at room temperature.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Humatrope

Cartridge powder

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

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

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

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

Sterile solvent in the syringe

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

Appearance of the medicinal product and contents of the container

Not all pack sizes may be marketed.

Marketing Authorization 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 Authorization Holder (or the local representative):

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

This medicinal product is authorized in the European Economic Area member states under the following names:

In the European Economic Area member states where this product is authorized, it is marketed under the name "Humatrope", except in France where it is authorized as "Umatrope".

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

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

Humatrope is a registered trademark of Eli Lilly and Company Limited

Date of the most recent review of this summary: July 2021

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