increlex
10 mg/ml solution for injection
mecasermin
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask the doctor or pharmacist.
- This medicine has been prescribed for you/your child. Do not pass it on to others. It may harm them, even if their symptoms are the same.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor or pharmacist.
In this leaflet:
- 1. What INCRELEX is and what it is used for
- 2. Before you use INCRELEX
- 3. How to use INCRELEX
- 4. Possible side effects
- 5. How to store INCRELEX
- 6. Further information
What Increlex Is And What It Is Used For
- INCRELEX is a liquid that contains man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
- INCRELEX is used to treat children or adolescents who are very short for their age because their bodies do not make enough IGF-1. This condition is called primary IGF-1 deficiency.
Before You Use Increlex
Do not use INCRELEX
- if you/your child is allergic (hypersensitive) to mecasermin or any of the other ingredients of INCRELEX.
- if you/your child has cancer.
- by injecting directly into a vein.
Benzyl alcohol must not be given to premature babies or neonates.
Take special care with INCRELEX
- if you/your child has a curved spine (scoliosis). They should be monitored for progression of their
scoliosis. - if you/your child has enlarged tonsils (tonsillar hypertrophy). They should have examinations periodically.
- if you/your child has symptoms of increased pressure in the brain (intracranial hypertension), such as headache with vomiting, contact the doctor for advice.
- if you/your child has a mild or serious allergic reaction with INCRELEX. Call the doctor as soon as possible if you/your child get a rash or hives. Get medical help immediately if you/your child have trouble breathing or goes into shock.
- if you/your child has finished growing (the bone growth plates are closed).
The use of INCRELEX has not been studied in children under 2 years of age and is therefore not recommended.
Using other medicines
Especially tell the doctor if you/your child takes insulin or other anti-diabetes medicines. A dose adjustment may be needed for these medicines.
Please tell the doctor or pharmacist if you/your child is taking or has recently taken any other medicines, including medicines obtained without a prescription, herbal medicines and vitamin supplements.
Taking INCRELEX with food and drink
INCRELEX should be administered shortly before or after eating, because it may have insulin-like hypoglycaemic effects and so it may decrease blood sugar levels.
The doses should be withheld when a meal or snack is omitted. The dose should never be increased to make up for one or more omitted doses.
Pregnancy and breast-feeding
INCRELEX therapy should be discontinued if pregnancy occurs.
INCRELEX should not be administered to a breast-feeding mother.
Driving and using machines
No studies of the effects of INCRELEX on the ability to drive and use machines have been performed. However, hypoglycaemia may impair the ability to drive and use machines.
Patients should avoid engaging in any high-risk activities (e.g. driving, etc.) within 2-3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a dose of INCRELEX has been established without occurrence of significant treatment-related adverse events.
Important information about some of the ingredients of INCRELEX
INCRELEX contains 9 mg per ml benzyl alcohol as a preservative.
Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
How To Use Increlex
Always use INCRELEX exactly as your/your child’s doctor has told you. You should check with your/your child’s doctor or pharmacist if you are not sure. The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day. See the ‘Instructions for Use’ at the end of this leaflet.
Inject INCRELEX just under your/your child’s skin shortly before or after a meal or snack. Do not give you/your child’s dose of INCRELEX if you/your child cannot eat for any reason. Do not make up the missed dose by giving two doses the next time.
Inject INCRELEX just below the skin in your/your child’s upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Never inject it into a vein or muscle. Change the injection site for each injection.
Only use INCRELEX that is clear and colourless.
Treatment with INCRELEX is a long-term therapy. For further information ask the doctor.
If you use more INCRELEX than you should
If more INCRELEX than recommended was injected, please tell the doctor.
Acute overdosage could lead to hypoglycaemia (low blood sugar). Long-term overdose may result in enlargement of certain body parts (e.g. hands, feet, parts of the face) or excessive growth of the whole body.
Treatment of acute overdose of INCRELEX should be directed at reversing hypoglycaemia. Sugar-containing fluids or food should be consumed. If the patient is not awake or alert enough to drink sugar-containing fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar. Your doctor or nurse will instruct you how to give the injection of glucagon.
If you forget to use INCRELEX
Do not use a double dose to make up for a forgotten dose.
If you stop using INCRELEX
A disruption or early ending of treatment with INCRELEX may impair the success of the growth therapy. Please ask the doctor for advice before stopping the treatment.
If you have any further questions on the use of this product, ask the doctor or pharmacist.
Possible Side Effects
Like all medicines, INCRELEX can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the
doctor or pharmacist.
The very common side effects (likely to occur in more than 1 out of 10 patients) which occurred in clinical
trials are listed below.
Hypoglycaemia (Low Blood Sugar):
INCRELEX, like insulin, may lower blood sugar levels.
Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating,
sweating, nausea and fast or irregular heartbeats.
Severe hypoglycaemia may cause unconsciousness, seizures or death. If you/your child take INCRELEX, you/your child should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia. You/your child should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of
hypoglycaemia occur. For severe hypoglycaemia, if you/your child is not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon. The doctor or nurse will instruct you how to give the injection. Glucagon raises the blood sugar when it is injected. It is important that you/your child have a well-balanced diet including protein and fat such as meat and cheese in addition to sugar-containing foods.
Increased blood sugar has also been observed with INCRELEX treatment.
Reactions at the Injection Site:
Injecting INCRELEX can cause local lipoatrophy (loss of fat), lipohypertrophy (increase of fat), or pain, redness or bruising at the injection site. Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Enlarged tonsils:
INCRELEX may enlarge you/your child’s tonsils. Some signs of enlarged tonsils include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear. Sleep apnea can cause excessive daytime sleepiness. Call the doctor should these symptoms bother you/your child. An infection of the tonsils has also been observed. The doctor should regularly examine your/your child’s tonsils. Swelling inside the nose, enlarged thymus and lymph nodes have been seen with INCRELEX treatment.
Hypoacusis (hearing loss):
Tell the doctor if you/your child develop hearing problems.
The common side effects (likely to occur in fewer than 1 out of 10 patients) which occurred in clinical trials are listed below.
Heart abnormalities:
In some patients treated with INCRELEX, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle. Your doctor may perform an echocardiogram before, during and after INCRELEX treatment.
Also, a racing pulse and heart valve abnormalities have been reported with INCRELEX treatment.
Intracranial hypertension (increased pressure in the brain):
INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain. The symptoms of intracranial hypertension can include headache and nausea with vomiting. Tell the doctor if you/your child has headache with vomiting. Your doctor can check to see if intracranial hypertension is present. If it is present, your doctor may decide to temporarily reduce or discontinue INCRELEX therapy. INCRELEX may be started again after the episode is over.
Vision disturbances have also been reported.
Slipped capital femoral epiphysis:
This is a situation where the top of the upper leg (femur) slips apart. Get medical attention for you/your child immediately if you/your child develops a limp or has hip or knee pain.
Worsened scoliosis (caused by rapid growth):
If you/your child has scoliosis, you/your child will need to be checked often for an increase in the curve of the spine. Pain and stiffness in muscles or joints, as well as jaw malformations, have also been seen with INCRELEX treatment.
Infections:
Infections of the mouth, throat and the upper airways have been observed in children with INCRELEX treatment. Such infections may be associated with fever.
Kidney disorders:
Kidney stones have been reported, as well as associated pain and kidney swelling.
Reproductive system:
Breast enlargement, as well as cysts in the ovaries, have been observed.
Digestive system:
Stomach pain, difficulties swallowing, retching and vomiting have occurred with INCRELEX treatment. Weight gain has also been reported, as have increases in blood fat and in liver enzyme values.
Skin and hair changes:
Skin thickening, moles, skin tags, and abnormal hair texture have been seen with INCRELEX treatment.
Other reported adverse events include lack of energy, depression, nervousness, disorientation, chest discomfort, dizziness, trembling and restless legs.
How To Store Increlex
Keep out of the reach and sight of children.
Do not use INCRELEX after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
After first use, the vial may be stored for up to 30 days at 2 to 8ºC.
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.
Further Information
What INCRELEX contains
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.
What INCRELEX looks like and contents of the pack
INCRELEX is a clear and colourless solution for injection supplied in a glass vial closed with a stopper and a seal. The vial contains 4 ml of liquid.
INCRELEX is supplied as a pack containing one glass vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last approved in July 2009.
This medicine has been authorised under “Exceptional Circumstances”.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ There are also links to other websites about rare diseases and treatments.
Instructions For Use
INCRELEX should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Preparing the Dose:
- 1. Wash your hands before getting INCRELEX ready for your/your child’s injection.
- 2. Use a new disposable needle and syringe every time you give a dose. Use syringes and needles only once. Throw them away properly. Never share needles and syringes.
- 3. Check the liquid to make sure it is clear and colourless. Do not use after the expiry date or if it is cloudy or if you see particles. If a vial freezes, dispose appropriately.
- 4. If you are 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 swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Figure 1: Wipe top with alcohol
- 6. Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose. Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Figure 2: Inject air into vial
- 7. Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly (see Figure 3).
Figure 3: Prepare for extraction
- 8. Make sure the tip of the needle is in the liquid (see Figure 4). Pull the plunger to withdraw the correct
dose into the syringe (see Figure 5).
Figure 4: Tip in liquid
Figure 5: Extract correct dose
- 9. Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 6).
Figure 6: Remove air bubbles and refill syringe
- 10. Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject (see Figure 7).
Figure 7: Ready to inject
Injecting the Dose:
Inject INCRELEX as instructed by the doctor.
Do not give the injection if you/your child is unable to eat shortly before or after the injection.
- 1. Decide on an injection area – upper arm, thigh, buttock, or abdomen (see below). The injection site should be changed for each injection (rotate the injection site).
- 2. Use alcohol or soap and water to clean the skin where you are going to inject you/your child. The injection site should be dry before you inject.
- 3. Lightly pinch the skin. Insert the needle in the way the doctor showed you. Release the skin (see Figure A).
Figure A: Lightly pinch the skin and inject as instructed
- 4. Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid.
Pull the needle straight out and gently press on the spot where you injected you/your child with gauze or a cotton ball for a few seconds. Do not rub the area (see Figure B).
Figure B: Press (don’t rub) with gauze or cotton
- 5. Follow the doctor’s instructions for throwing away the needle and syringe. Do not recap the syringe. Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can). Such containers should be sealed and disposed of
properly.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
C9 242.01 RV
01.09.2009
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