10 mg / ml injection solution
mecasermin
1. What INCRELEX is and what it is used for
INCRELEX is a liquid containing mecasermin, which is an artificial insulin-like growth factor-1 ( IGF -1 ), similar to the IGF -1 produced in the body.
It is used to treat children and adolescents from 2 to 18 years of age who are very short for their age, as their bodies do not 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 a tumor or tumor growth, whether it is cancer or not cancer
- if you have had cancer before
- if you have a condition that may increase your risk of cancer
- if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6)
- to premature or newborn babies, as it contains benzyl alcohol
Warnings and cautions
There is an increased risk of tumors and growth of tumors (both cancer and non-cancer) in children and adolescents treated with INCRELEX. Tell your doctor immediately if new growth, skin damage, or unexpected symptoms occur during or after treatment, as mecasermin may play a role in the development of cancer.
Talk to your doctor or pharmacist before using INCRELEX
- if you have a curved spine (scoliosis). You should be monitored for worsening scoliosis.
- if you develop lameness or hip or knee pain.
- if you have enlarged tonsils ( tonsill hypertrophy ). You should be examined regularly.
- If you have symptoms of increased pressure in the brain ( intracranial hypertension ) such as vision changes, headache, nausea and / or vomiting, consult your doctor.
- if you have a local reaction at the injection site or a generalized allergic reaction to INCRELEX. Call your doctor as soon as possible if you get a local rash. Seek medical attention immediately if you get a generalized allergic reaction ( hives , difficulty breathing, fainting or collapse and a general feeling of illness).
- if you have fully grown (the growth zones in the legs are closed). In this case, INCRELEX can not help you grow and should not be used.
Children under 2 years of age
The use of this drug has not been studied in children under 2 years of age and is therefore not recommended.
Other medicines and INCRELEX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor especially if you are taking insulin or any other diabetes medicine. A dose adjustment of these medications may be necessary.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Negative pregnancy testing is recommended for all fertile women before starting treatment with mecasermin.
Treatment with mecasermin should be discontinued during pregnancy.
Mecasermin should not be given to breastfeeding women.
Driving and using machines
Mecasermin may cause hypoglycaemia (low blood sugar, very common side effect, see section 4). Hypoglycaemia is a very common side effect, which may impair the ability to drive and use machines, as your ability to concentrate and react may decrease.
You should avoid participating in any high-risk activities (eg driving) within 2-3 hours after dosing, especially at the beginning of INCRELEX treatment, until a dose of INCRELEX has been established that does not cause side effects that could make these activities risky.
INCRELEX contains benzyl alcohol and sodium
INCRELEX contains benzyl alcohol as a preservative.
INCRELEX contains benzyl alcohol as a preservative, which can cause poisoning and allergic reactions in infants and children up to 3 years.
This medicine contains less than 1 mmol sodium (23 mg) per bottle, ie essentially ‘sodium-free.
3. How to use INCRELEX
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The most common dose is 0.04 to 0.12 mg/kg patient weight, given twice daily. See the “Instructions for Use” at the end of this leaflet.
Inject INCRELEX directly under your skin just before or after a meal or snack. It may have insulin-like hypoglycaemic effects and may therefore lower blood sugar levels (see section 4 Hypoglycaemia ). Do not inject your INCRELEX dose if you are unable to eat for any reason. Do not compensate for the missed injection one by giving two injections next time. The next dose should be taken as usual, with a meal or snack.
Inject INCRELEX directly under the skin of your upper arm, thigh, abdomen, or buttocks. Never inject into a friend or muscle. Change injection site with each injection.
Only use INCRELEX if it is clear and colorless.
Treatment with mecasermin is a long-term treatment. Ask your doctor if you need further information.
If you use more INCRELEX than you should
Mecasermin, like insulin, may lower blood sugar (see Hypoglycaemia in section 4).
If more INCRELEX than recommended is used, contact your doctor immediately.
Acute overdose may lead to hypoglycaemia (low blood sugar).
Treatment of an acute overdose of mecasermin should be aimed at reversing the reduction in blood glucose. Liquids or foods that contain sugar should be ingested. If the person is not awake or alert enough to drink a fluid that contains sugar, a glucagon injection into the muscle may be necessary to relieve the low blood sugar. Your doctor or nurse will instruct you on how to give a glucagon injection.
Prolonged overdose can lead to enlargement of certain body parts (eg hands, feet, parts of the face) or excessive growth of the whole body. If you suspect that you have overdosed for a long time, contact your doctor immediately.
If you forget to take INCRELEX
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, do not increase the next dose to make up for it. Take the next dose as usual, with a meal or snack.
If you stop using INCRELEX
Discontinuation or premature discontinuation of mecasermin may reduce the success of growth therapy. Consult your doctor before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, INCRELEX can cause side effects, although not everybody gets them.
The most common side effect is with mecasermin are low blood sugar ( hypoglycemia ), vomiting, injection site reaction, headache, and infection of the middle ear. A severe allergic reaction has also been reported for INCRELEX. If you get any of these side effects, follow the advice for the various side effects listed in the following sections.
Has been reported (occurs in an unknown number of users)
The malignant and benign tumor you
An increase in both malignant and benign tumors has been observed in patients treated with INCRELEX. The risk of such tumors may be higher if INCRELEX is used to treat conditions other than those listed in section 1, or when using higher doses than recommended (see section 3).
Severe allergic reaction ( anaphylaxis )
General hives, shortness of breath, dizziness, swelling of the face and/or throat have been reported with the use of mecasermin. Stop taking INCRELEX immediately and seek emergency medical attention if you have a severe allergic reaction.
Local allergic reaction at the injection site ( itching, hives) has also been reported.
Hair loss ( alopecia )
Hair loss has also been reported with the use of mecasermin.
Very common (may affect more than 1 user in 10)
Low blood sugar ( hypoglycaemia )
Mecasermin may lower blood sugar levels. Signs of low blood sugar are dizziness, fatigue, restlessness, hunger, irritability, difficulty concentrating, sweating, nausea, and rapid or irregular heartbeat.
Severe hypoglycaemia can cause unconsciousness, convulsions, or death. Stop taking INCRELEX immediately and seek emergency care if you have seizures or become unconscious.
If you are taking INCRELEX, you should avoid participating in high-risk activities (such as strenuous physical activity) within 2 to 3 hours after an INCRELEX injection, especially at the beginning of INCRELEX treatment.
Before starting treatment with INCRELEX, your doctor or nurse will explain to you how to treat hypoglycaemia. You should always have access to sugar such as orange juice, glucose gel, sweets, or milk if symptoms of hypoglycaemia occur. In case of severe hypoglycaemia, if you are not contactable and can not drink liquids containing sugar, a glucagon injection should be given. Your doctor or nurse will instruct you on how to inject one. Glucagon raises blood sugar when injected. It is important that you eat a well-balanced diet including protein and fat, such as meat and cheese, in addition to foods that contain sugar.
Injection site reactions (tissue enlargement at the injection site) and bruising
This can be avoided by changing the injection site at each injection (switching injection site).
The digestive system
Vomiting and pain in the upper abdomen have occurred during mecasermin treatment.
Infection is
Infection in the middle ear has been observed in children receiving mecasermin treatment.
Musculoskeletal system
Pain in the joints and in the arms and legs has occurred with mecasermin treatment.
The nervous system
Headaches have occurred with mecasermin treatment.
Common (may affect up to 1 in 10 people)
Cramps
Seizures have been observed with mecasermin therapy. Dizziness and tremors have also been reported with mecasermin therapy.
Heart abnormalities
Rapid heartbeat and abnormal heartbeat have been reported with mecasermin therapy.
Elevated blood sugar ( hyperglycaemia )
Elevated blood sugar has also been observed with mecasermin therapy.
Enlarged tonsils / adenoids (tonsils)
Mecasermin can enlarge your tonsils/adenoids. Some signs of enlarged tonsils/adenoids are snoring, difficulty breathing or swallowing, sleep apnea (a condition in which breathing ceases briefly during sleep) or fluid in the middle ear, as well as ear infections. Sleep apnea can cause extreme sleepiness during the day. Contact a doctor if these symptoms bother you. Your doctor should regularly examine your tonsils/adenoids.
Enlargement of the thymus
Enlargement of the thymus (a special organ in the immune system) has been observed with mecasermin therapy.
Papilloedema
Swelling at the back of the eye (due to increased pressure in the brain) can be observed by a doctor or optician during mecasermin treatment.
Hypoacusis (hearing loss)
Hearing loss, pain in the ear, and fluid in the middle ear have been observed with mecasermin treatment. Tell your doctor if you experience hearing problems.
Deterioration of scoliosis (caused by rapid growth):
If you have scoliosis, you need to be examined frequently to check if the curvature of the spine has increased. Muscle pain has also been seen with mecasermin therapy.
Reproductive system:
Breast augmentation has been observed with mecasermin therapy.
The digestive system
Abdominal pain has occurred during mecasermin treatment.
Skin and hair change:
Skin thickening, birthmarks, and abnormal hair structure have been seen with mecasermin treatment.
Injection site reactions:
Reactions such as pain, irritation, bleeding, bruising, redness and hardness at the injection site have been reported during INCRELEX treatment. Injection site reactions can be avoided by changing the injection site at each injection (switching injection site).
Uncommon (may affect up to 1 in 100 people)
Increased pressure in the brain ( intracranial hypertension )
INCRELEX can sometimes cause a temporary increase in pressure in the brain. Symptoms of intracranial hypertension may include changes in vision, headache, nausea, and/or vomiting. Tell your doctor immediately if you get any of these side effects. Your doctor may check if you have intracranial hypertension. If this is the case, the doctor may decide to temporarily reduce the dose or discontinue treatment with mecasermin. Treatment with mecasermin can be started again when the episode is over.
Impact on the heart
In some patients treated with mecasermin, an ultrasound examination of the heart (echocardiogram) showed an enlargement of the heart muscle and an effect on the function of the heart valves. Your doctor may perform an echocardiogram before, during, and after mecasermin treatment.
Injection site reactions
Reactions such as rash, swelling, and lumps of fat at the injection site have been reported during INCRELEX treatment. Injection site reactions can be avoided by changing the injection site at each injection (switching injection site).
Weight gain
Weight gain has been observed with mecasermin therapy.
Other less common side effects of mecasermin are depression and nervousness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store INCRELEX
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
After the first use, the vial can be stored for up to 30 days at 2 ° C to 8 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is mecasermin. One ml contains 10 mg of mecasermin. Each vial contains 40 mg of mecasermin.
- The other ingredients 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”).
What the medicine looks like and contents of the pack
INCRELEX is a clear and colorless solution for injection , which is supplied in a glass vial , sealed with a stopper and a seal. The vial contains 4 ml of liquid.
Pack of 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Pharma
65, quai Georges Gorse
92100 Boulogne-Billancourt
France
Manufacturer:
Beaufour Ipsen Industry
Rue d’Ethe Virton
28100 Dreux
France
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
Denmark, Norway, Finland / Finland, Sweden, Iceland
Institut Synthesis Institute (IPSEN) AB
Kista Science Tower
Färögatan 33
SE-164 51 Kista
Sverige / Ruotsi / Sverige
Phone / Phone / Phone / Phone: +46 (0) 8 451 60 00
This medicine has been authorized under the “Exceptional Authorization” Rules. This means that it has not been possible to obtain complete information about this medicine as the disease is rare.
Every year, the European Medicines Agency (EMEA) reviews any new information on the medicine that may have been obtained about this medicine and updates this leaflet when necessary.