Increlex 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

INCRELEX 10 mg/ml injection solution

Mecasermin

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.

Read 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What INCRELEX is and what it is used for

• INCRELEX is a liquid solution containing mecasermin, which is a synthetic insulin-like growth factor-1 (IGF-1), similar to the IGF-1 produced naturally by your body.
• It is used to treat children and adolescents aged 2 to 18 years who are too short for their age because their bodies cannot produce enough IGF-1. This condition is called primary IGF-1 deficiency.

2. What you need to know before using INCRELEX

Do not use INCRELEX

• If you currently have any tumor or abnormal growth, whether cancerous or non-cancerous
• If you have had cancer in the past
• If you have any condition that may increase the risk of developing cancer
• If you are allergic (hypersensitive) to mecasermin or to any of the other ingredients of this medicine (listed in section 6)
• In neonates or premature newborns because it contains benzyl alcohol

Warnings and precautions

There is an increased risk of developing tumors (both cancerous and non-cancerous) in children and adolescents treated with INCRELEX. Since mecasermin may play a role in cancer development, inform your doctor immediately if, during or after treatment, any new tumor, skin lesion, or unexpected symptom appears.

Consult your doctor or pharmacist before starting to use INCRELEX

• If you have lateral curvature of the spine (scoliosis). Monitoring of scoliosis progression is recommended.
• If you develop limping or pain in the knee or hip
• If you have enlarged tonsils (tonsillar hypertrophy). Periodic examinations are recommended.
• If you experience symptoms indicating increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting; consult your doctor.
• If you develop a localized reaction at the injection site or a generalized allergic reaction to INCRELEX. Seek medical advice as soon as possible if you develop a localized skin rash. Seek immediate medical attention if you experience a generalized allergic reaction (hives, difficulty breathing, fainting or collapse, and general feeling of discomfort).
• If you have stopped growing (closure of the bone growth plates has occurred). In this case, INCRELEX will not help you grow and should not be used.

Children under 2 years of age

The use of this medicine has not been studied in children under 2 years of age and is therefore not recommended.

Other medicines and INCRELEX

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially inform your doctor if you are being treated with insulin or other antidiabetic medicines.

Dosage adjustments of these medicines may be necessary.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

A negative pregnancy test is recommended in all women of childbearing potential before starting treatment with mecasermin. It is also recommended that all women of childbearing potential use adequate contraceptive measures during treatment.

Treatment with mecasermin should be discontinued if pregnancy occurs.

Mecasermin must not be administered to a breastfeeding mother.

Driving and use of machines

Mecasermin may cause hypoglycemia (a very common adverse effect, see section 4), which may impair your ability to drive and operate machinery, as your concentration and reaction ability may be reduced.

You should avoid any high-risk activities (e.g., driving, etc.) within 2–3 hours after dose administration, especially at the beginning of treatment with INCRELEX and until a dose of INCRELEX has been established that does not cause adverse effects that could make such activities risky.

INCRELEX contains benzyl alcohol and sodium

INCRELEX contains benzyl alcohol as a preservative, which may cause toxic and allergic reactions in infants and children up to 3 years of age.

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

3. How to use INCRELEX

Follow exactly the administration instructions given by your doctor for this medicine.

Consult your doctor or pharmacist if you have any doubts.

The usual dose is 0.04 to 0.12 mg per kg of patient body weight administered twice daily.

Refer to the "Instructions for use" at the end of this leaflet.

Inject INCRELEX just under your skin shortly before or after a meal or snack, as it may have insulin-like hypoglycemic effects and therefore may lower blood sugar levels (see hypoglycemia in section 4). Do not inject your dose of INCRELEX if you are unable to eat for any reason. Do not attempt to compensate for a missed dose by administering a double dose next time. The next dose should be administered as usual, with a meal or snack.

Inject INCRELEX just under your skin at any site on the arm, thigh, stomach area (abdomen), or buttocks. Change the injection site each time. Never inject into a vein or muscle.

Do not use INCRELEX if it is not clear and colorless.

Treatment with mecasermin is a long-term treatment. Consult your doctor for further information.

If you use more INCRELEX than you should

Mecasermin, like insulin, can lower blood sugar levels (see hypoglycemia in section 4).

If you have injected more INCRELEX than recommended, contact your doctor immediately.

An acute overdose may cause hypoglycemia (low blood glucose concentration).

Treatment of acute mecasermin overdose should focus on reversing hypoglycemia. Sugary food or drinks should be consumed. If the patient is not sufficiently conscious to take sugary drinks, an intramuscular injection of glucagon may be necessary to reverse hypoglycemia. Your doctor or nurse will teach you how to inject glucagon.

Prolonged overdose may cause an increase in the size of certain body parts (e.g., hands, feet, facial parts) or excessive growth of the entire body. If you suspect prolonged overdose, contact your doctor immediately.

If you forget to use INCRELEX

Do not take a double dose to make up for forgotten doses.

If you have missed a dose, do not increase the next dose to compensate. The next dose should be administered as usual, with a meal or snack.

If you stop using INCRELEX

Interrupting or prematurely stopping treatment with mecasermin may reduce the success of growth therapy. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

The most frequently reported adverse effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache, and middle ear infections. Severe allergic reactions have also been reported with INCRELEX. If you experience any of these effects, follow the advice provided for each effect in the sections below.

Frequency not known (frequency cannot be estimated from the available data)

Tumors, cancerous and non-cancerous

An increased occurrence of cancerous and non-cancerous tumors has been reported in patients treated with INCRELEX. The risk of developing such tumors may be higher if INCRELEX is used for a condition other than that specified in section 1 or at doses higher than those recommended in section 3.

Severe allergic reactions (anaphylaxis)

Generalized hives, difficulty breathing, somnolence, and swelling of the face and/or throat have been reported after the use of mecasermin. If you develop a severe allergic reaction, you must stop INCRELEX immediately and seek urgent medical assistance.

Local allergic reactions at the injection site (itching, hives) have also been reported.

Hair loss (alopecia)

Hair loss has also been reported with the use of mecasermin.

Very common (may affect more than 1 in 10 people)

Low blood sugar (hypoglycemia)

Mecasermin may decrease blood sugar levels. Signs of low blood sugar include: drowsiness, tiredness, restlessness, hunger, irritability, difficulty concentrating, sweating, nausea, and rapid or irregular heartbeat.

Severe hypoglycemia may lead to unconsciousness, seizures/epileptic fits, or death. If you experience seizures/epileptic fits or unconsciousness, stop INCRELEX immediately and seek urgent medical assistance.

If you are taking INCRELEX, you should avoid engaging in high-risk activities (such as intense physical exercise) during the 2 to 3 hours following an INCRELEX injection, especially at the beginning of treatment with INCRELEX.

Before starting treatment with INCRELEX, your doctor or nurse will explain how to manage hypoglycemia. You should always have a source of sugar readily available, such as orange juice, glucose gel, sweets, or milk, in case symptoms of hypoglycemia occur. In cases of severe hypoglycemia, if you are unresponsive and unable to drink a sugary beverage, a glucagon injection should be administered. Your doctor or nurse will teach you how to administer the injection. A glucagon injection increases blood glucose concentration. It is important that you follow a balanced diet that includes, in addition to sugary foods, proteins and fats such as meat and cheese.

At the beginning of treatment and until a well-tolerated dose is established, blood sugar (glucose) should be monitored by finger-prick testing before each meal. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, glucose monitoring should continue regardless of feeding status and, if possible, during episodes of hypoglycemic symptoms.

Injection site hypertrophy (tissue at the injection site increases in size) and bruising

This can be avoided by changing the injection site each time (rotation of injection sites).

Gastrointestinal system

Cases of vomiting and upper abdominal pain have occurred with mecasermin treatment.

Infections

Middle ear infections have been observed in children receiving mecasermin treatment.

Musculoskeletal system

Cases of joint pain and limb pain have occurred with mecasermin treatment.

Nervous system

Cases of headache have occurred with mecasermin treatment.

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

Seizures

Cases of seizures (episodes) have been observed with mecasermin treatment.

Cases of dizziness and tremors have also been reported with mecasermin treatment.

Cardiac abnormalities

Cases of rapid pulse and abnormal heart sounds have been reported with mecasermin treatment.

Increased blood sugar (hyperglycemia)

Increased blood sugar has also been observed with mecasermin treatment.

Enlargement of tonsils/adenoids

Mecasermin may increase the size of the tonsils/adenoids. Signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnea (a disorder in which brief episodes of breathing cessation occur during sleep), or fluid in the middle ear, in addition to ear infections. Sleep ap游戏副本

5. Storage of INCRELEX

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

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

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the vial tightly closed to protect it from light.

After first use, the vial may be stored for up to 30 days at between 2 °C and 8 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of INCRELEX

• The active substance is mecasermin. One millilitre contains 10 mg of mecasermin. Each vial contains 40 mg of mecasermin.
• The other components are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 “INCRELEX contains benzyl alcohol and sodium”).

Appearance of the product and contents of the pack

INCRELEX is an injectable solution (injection), colourless to slightly yellow and clear to slightly opalescent, supplied in a glass vial closed with a stopper and a cap. The vial contains 4 ml of solution.

Pack size of 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Esteve Pharmaceuticals S.A.

Passeig de la Zona Franca 109, 4th Floor

08038 Barcelona

Spain

Manufacturer:

Tjoapack Netherlands B.V.

Nieuwe Donk 9

4879 AC Etten-Leur

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

This medicine has been authorised under "exceptional circumstances".

This type of approval means that, due to the rarity of the disease, it has not been possible to obtain complete information about this medicine.

The European Medicines Agency will review any new information about the medicine annually, and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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INSTRUCTIONS FOR USE

INCRELEX must be administered using sterile, disposable needles and syringes, which your doctor/pharmacist or nurse can provide. Small-volume syringes should be used to allow accurate withdrawal of the prescribed dose from the vial.

Preparation of the dose

1. Wash your hands before preparing INCRELEX for injection.

2. Always use a new disposable needle and syringe each time a dose is administered. Do not reuse syringes or needles. Dispose of them properly in a sharps container (e.g., a container for biological hazardous waste), a rigid plastic container (e.g., a detergent bottle), or a metal container (such as an empty coffee can). Never share needles or syringes.

3. Check that the solution is clear and colourless. Do not use after the expiry date (shown on the label after EXP and referring to the last day of the month), or if the solution is cloudy or contains particles. If a vial has been frozen, dispose of it properly. Ask your pharmacist how to dispose of medicines no longer in use.

4. If using a new vial, remove the protective cap. Do not remove the rubber stopper.

5. Wipe the rubber stopper of the vial with an alcohol-soaked cotton pad to prevent contamination from germs that could be introduced by repeated needle insertions (see Figure 1).

6. Before inserting the needle into the vial, pull the plunger back to draw into the syringe an amount of air equal to the prescribed dose. Insert the needle through the rubber stopper of the vial and push the plunger to inject air into the vial (see Figure 2).

7. Leave the needle in the vial and turn both the vial and syringe upside down. Hold the syringe and vial firmly (see Figure 3).

8. Ensure the tip of the needle is immersed in the liquid (see Figure 4). Pull back the plunger to draw up the correct dose into the syringe (see Figure 5).

9. Before removing the needle from the vial, check for air bubbles in the syringe. If air bubbles are present, hold the vial and syringe with the needle pointing straight upwards and gently tap the side of the syringe until the bubbles rise to the top. Expel the air bubbles by pushing the plunger, then withdraw liquid again to obtain the correct dose (see Figure 6).

10. Remove the needle from the vial and replace the protective cap. Do not let the needle touch anything. The syringe is now ready for injection (see Figure 7).

Administration of the dose:

Inject INCRELEX as instructed by your doctor.

Do not administer the injection if you are unable to eat something shortly before or after the injection.

1. Choose an injection site, either the arm, thigh, buttock, or abdomen (see below). It is advisable to change the injection site each time (rotate injection sites) to avoid the formation of a fatty lump under the skin (lipo-hypertrophy) caused by repeated injections in the same location.

2. Use alcohol or soap and water to clean the skin area where the injection will be given. The injection site must be dry before injecting.

3. Gently pinch the skin. Insert the needle as instructed by your doctor. Release the skin (see Figure A).

4. Slowly push the syringe plunger fully to ensure all the liquid is injected. Remove the needle straight out and gently press the injection site with a gauze or cotton pad for a few seconds. Do not rub the area (see Figure B).

5. Follow your doctor's instructions for disposal of the used needle and syringe. Do not recap the syringe. Used needles and syringes must be placed in a sharps container (e.g., a container for biological hazardous waste), a rigid plastic container (e.g., a detergent bottle), or a metal container (such as an empty coffee can). These containers should be sealed and disposed of properly, as explained by your doctor.