Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Increlex 10 mg/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mecasermin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
- INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
- It is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF-1. This condition is called primary IGF-1 deficiency.
2.
What you need to know before you take it
e INCRELEX
Do not use INCRELEX
- If you currently have any tumour or growth, either cancerous or non-cancerous
- if you have had cancer in the past
- if you have any conditions which may increase the risk of cancer
- if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6)
- in premature babies or neonates because it contains benzyl alcohol Warnings and precautions There is an increased risk of tumours and growths (both cancerous and non-cancerous) in children and adolescents treated with INCRELEX. If any new growth, skin lesion or any unexpected symptom occurs during treatment or after treatment, see your doctor immediately since mecasermin may play a role in cancer development. Talk to your doctor or pharmacist before using INCRELEX if you have a curved spine (scoliosis). You should be monitored for progression of scoliosis. if you develop a limp or hip or knee pain. if you have enlarged tonsils (tonsillar hypertrophy). You should have examinations periodically. if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
- if you have a localised reaction at the injection site or generalised allergic reaction with INCRELEX. Call the doctor as soon as possible if you get a localised rash. Get medical help immediately if you have page 1 of 12
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a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell). if you have finished growing (the bone growth plates are closed). In this case INCRELEX cannot help you grow and should not be used.
Children under 2 years old 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 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially tell the doctor if you take insulin or other anti-diabetes medicines. A dose adjustment may be needed for these medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin. It is also recommended that all women of childbearing potential use adequate contraception during treatment. Mecasermin therapy should be discontinued if pregnancy occurs. Mecasermin should not be administered to a breast-feeding mother. Driving and using machines Mecasermin may cause hypoglycaemia (very common side effect, see section 4) that may impair your ability to drive and use machines because your ability to concentrate or react may be reduced. You should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the start of INCRELEX treatment, until a dose of INCRELEX has been found which does not cause side effects that make these activities risky. INCRELEX contains benzyl alcohol and sodium INCRELEX contains benzyl alcohol as a preservative which may cause toxic reactions and allergic reactions in infants and children up to 3 years old. This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'. 3.
How to take it
INCRELEX
Always use this medicine exactly as your doctor has told you. Check with your 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 skin shortly before or after a meal or snack because it may have insulinlike hypoglycaemic effects and so it may decrease blood sugar levels (see hypoglycaemia in section 4). Do page 2 of 12
not inject your dose of INCRELEX if you cannot eat for any reason. Do not make up the missed dose by giving two doses the next time. The next dose should be taken as usual, with a meal or snack. Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Change the injection site for each injection. Never inject it into a vein or muscle. Only use INCRELEX that is clear and colourless. Treatment with mecasermin is a long-term therapy. For further information ask the doctor. If you use more INCRELEX than you should Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4). If more INCRELEX than recommended was injected, contact your doctor immediately. Acute overdose could lead to hypoglycaemia (low blood sugar). Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia. Sugarcontaining fluids or food should be consumed. If the patient is not awake or alert enough to drink sugarcontaining 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. 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. If you suspect long-term overdose, contact your doctor immediately. If you forget to use INCRELEX Do not use a double dose to make up for a forgotten dose. If a dose is skipped, the next dose should not be made larger to compensate. The next dose should be taken as usual, with a meal or snack. If you stop using INCRELEX A disruption or early ending of treatment with mecasermin 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 medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any
Possible side effects
, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections. Serious allergic reactions have also been reported with INCRELEX. If you develop any of these events, please follow the advice given for each event in the sections below. Frequency not known (frequency cannot be estimated from the available data) Cancerous and non-cancerous tumours An increase in both cancerous and non-cancerous tumours has been reported in patients treated with INCRELEX. The risk of such tumours may be higher if INCRELEX is used for condition other than what is stated in Section 1 or used at higher than recommended dose as per Section 3. Serious allergic reactions (anaphylaxis) page 3 of 12
Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use. Stop INCRELEX immediately and seek urgent medical advice if you develop a serious allergic reaction. Local allergic reactions at the injection site (itching, hives) have also been reported. Hair loss (alopecia) Hair loss has also been reported following mecasermin use. Very common (may affect more than 1 in 10 people) Low blood sugar (hypoglycaemia) Mecasermin 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/fits or death. Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious. If you take INCRELEX, you 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 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 are 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 have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
You should be monitored at fingertip for blood sugar (glucose) before each meal at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycaemia or severe hypoglycaemia occur, blood sugar monitoring should continue regardless of eating condition and if possible, at the time of the event. Injection site hypertrophy (tissue at injection site increases in size) and bruising These can be avoided by changing the injection site at each injection (injection site rotation). Digestive system Vomiting and pain in the upper belly have occurred with mecasermin treatment. Infections Infections of the middle ear have been observed in children with mecasermin treatment. Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment. Nervous system Headache has occurred with mecasermin treatment. Common (may affect up to 1 in 10 people) Seizures Seizures (fits) have been observed with mecasermin treatment. Dizziness and tremor have also been reported with mecasermin treatment. Heart abnormalities A fast heart rate and abnormal heart sounds have been reported with mecasermin treatment.
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Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment. Enlarged tonsils/adenoids Mecasermin may enlarge your tonsils/adenoids. Some signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnoea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear. Sleep apnoea can cause excessive daytime sleepiness. Call the doctor should these symptoms bother you. The doctor should regularly examine your tonsils/adenoids. Enlarged thymus An enlarged thymus (a specialised organ of the immune system) has been observed with mecasermin treatment. Papilloedema A swelling at the back of the eye (due to increased pressure within the brain) may be observed by a doctor or optician during mecasermin treatment. Hypoacusis (hearing loss) Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment. Tell the doctor if you develop hearing problems. Worsened scoliosis (caused by rapid growth) If you have scoliosis, you will need to be checked often for an increase in the curve of the spine. Pain in muscles has also been seen with mecasermin treatment. Reproductive system Breast enlargement has been observed with mecasermin treatment. Digestive system Pain in the belly has occurred with mecasermin treatment. Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment. Reactions at the injection site Reactions including pain, irritation, bleeding, bruising, redness and hardening have been reported with INCRELEX treatment. Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation). 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 within the brain. The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting. Tell the doctor immediately if you have any of these symptoms. Your doctor can check to see if intracranial hypertension is present. If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy. Mecasermin may be started again after the episode is over. Heart abnormalities In some patients treated with mecasermin, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle and abnormalities of heart valve function. Your doctor may perform an echocardiogram before, during and after mecasermin treatment. Reactions at the injection site Reactions including rash, swelling and fatty lumps have been reported with INCRELEX treatment. Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation). page 5 of 12
Weight increase Weight increase has been observed with mecasermin treatment. Other uncommon side effects seen with mecasermin treatment include depression, nervousness. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. United Kingdom (Great Britain) Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 5.
How to store it
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 expiry date refers to the last day of the month. Store in a refrigerator (2C – 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 2C to 8oC. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other 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 (see section 2 "INCRELEX contains benzyl alcohol and sodium"). What INCRELEX looks like and contents of the pack INCRELEX is a colourless to slightly yellow and clear to slightly opalescent solution for injection (injection) supplied in a glass vial closed with a stopper and a seal. 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 Planta 4 08038 Barcelona Spain Manufacturer: Tjoapack Netherlands B.V. page 6 of 12
Nieuwe Donk 9 4879 AC Etten-Leur The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom (Great Britain) Esteve Pharmaceuticals Ltd. The Courtyard Barns Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT United Kingdom Tel: +44 (0) 1628 77 1800 e-mail: [email protected] This leaflet was last revised in June 2025 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 will review any new information on this medicine every year and this leaflet will be updated as necessary. Other sources of information Is this leaflet hard to see or read? Please phone +44 (0) 1628 77 1800 and ask for help. <—————————————————————————————————————————–>
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INSTRUCTIONS FOR USE INCRELEX should be administered using sterile disposable syringes and injection needles which could be provided by your doctor, pharmacist or nurse. 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 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 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). Never share needles and syringes.
3.
Check the liquid to make sure it is clear and colourless. Do not use after the expiry date (which is stated on the label after EXP and it refers to the last day of the month) or if it is cloudy or if you see bits. If a vial freezes, dispose appropriately. Ask your pharmacist how to throw away medicines you no longer use.
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
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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
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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
9.
Figure 5: Extract correct dose
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
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10.
Remove the needle from the vial and replace the protective cap. 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 are 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) to avoid formation of a lump of fatty tissue under your skin (lipohypertrophy) caused by repeated injections in the same place.
Upper arm 2.
Thigh
Buttock
Abdomen
Use alcohol or soap and water to clean the skin where you are going to inject you. The injection site should be dry before you inject.
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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 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 in the way your doctor described.
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Frequently asked questions about Increlex 10 mg/ml solution for injection
How do I take Increlex 10 mg/ml solution for injection?
Increlex 10 mg/ml solution for injection comes as injection containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Increlex 10 mg/ml solution for injection?
The active substance in Increlex 10 mg/ml solution for injection is mecasermin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Increlex 10 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Increlex 10 mg/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mecasermin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor‑1 deficiency (Primary IGFD).
Severe Primary IGFD is defined by:
• height standard deviation score ≤ –3.0 and
• basal IGF‑1 levels below the 2.5th percentile for age and gender and
• GH sufficiency.
• Exclusion of secondary forms of IGF‑1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF‑1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
4.2. Posology and method of administration
Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Posology
The dose should be individualised for each patient. The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection. If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily. Doses greater than 0.12 mg/kg twice daily should not be exceeded as this may increase the risk of neoplasia (see section 4.3, 4.4 and 4.8).
If the recommended dose is not tolerated by the patient, treatment with a lower dose can be considered. Treatment success should be evaluated based on height velocities. The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Paediatric population
The safety and efficacy of mecasermin in children below age of 2 have not been established (see section 5.1). No data are available.
Therefore, this medicinal product is not recommended in children below age of 2.
Special Populations
Hepatic impairment
There are limited data concerning the pharmacokinetics of mecasermin in children with hepatic impairment, in this specific population of severe primary IGFD patients. It is recommended that the dose be individualised for each patient as described under posology
Renal impairment
There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients. It is recommended that the dose be individualised for each patient as described under posology
Method of administration
INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack. If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. If the patient is unable to eat, for any reason, this medicinal product should be withheld.
Pre-prandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycaemia and/or severe hypoglycaemia occur, blood glucose monitoring should continue regardless of pre-prandial condition and if possible, at the time of the event.
The dose of mecasermin should never be increased to make up for one or more omitted doses.
Injection sites should be rotated to a different site with each injection to help prevent lipohypertrophy.
INCRELEX should not be administered intravenously.
Precaution to be taken before manipulating or administering the medicinal product
The solution should be clear immediately after removal from the refrigerator. If the solution is cloudy, or contains particulate matter, it must not be injected.
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.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
INCRELEX is contraindicated in children and adolescents with active or suspected neoplasia, or any condition or medical history which increases the risk of benign or malignant neoplasia.
Therapy should be discontinued if evidence of neoplasia develops.
As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
4.4. Special warnings and precautions for use
Benign and malignant neoplasms
There is an increased risk of benign and malignant neoplasia in children and adolescents treated with INCRELEX, since IGF-1 plays a role in the initiation and progression of benign and malignant tumours.
There have been post-marketing reports of both benign and malignant neoplasms in children and adolescents who have received treatment with INCRELEX. These cases represented a variety of different malignancies and included rare malignancies usually not seen in children (see section 4.8). The increased risk of neoplasia may be higher in patients who receive INCRELEX for unapproved uses or at higher than recommended doses. Current knowledge of IGF-1 biology suggests that IGF-1 plays a role in malignancies in all organs and tissues. Physicians should therefore be vigilant of any symptoms of potential malignancy.
If benign or malignant neoplasia develops, INCRELEX treatment should be discontinued definitely and appropriate expert medical care sought.
Mecasermin is not a substitute for GH treatment.
Mecasermin should not be used for growth promotion in patients with closed epiphyses.
Mecasermin should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects. Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake. Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of mecasermin treatment, until a well-tolerated dose of INCRELEX has been established. If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required. Persons with a history of severe hypoglycemia should have glucagon available. At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Echocardiogram is recommended before initiation of mecasermin treatment in all patients. Patients who terminate treatment should also have an echocardiogram. Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.
Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product. Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration. IH-associated signs and symptoms resolved after interruption of dosing. Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth. These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during mecasermin treatment. Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported. These have been observed both as being systemic and/or local to the injection site. A small number of cases indicative of anaphylaxis requiring hospitalisation have been reported. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted, and prompt medical attention should be sought.
Treatment should be reconsidered if after a year patients remain non-responsive.
Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1. This may be through the production of anti-IGF-1 IgEs, sustaining antibodies or neutralizing antibodies respectively. In such instances, instructions for antibody testing should be considered.
Excipients
INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females
A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin. It is also recommended that all women of childbearing potential use adequate contraception during treatment.
Pregnancy
There are no or limited amount of data for the use of mecasermin in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
This medicinal product should not be used during pregnancy.
Breast-feeding
Breast-feeding while taking INCRELEX is not recommended, because there is insufficient information on the excretion of mecasermin in human milk.
Fertility
Mecasermin has been tested in a rat teratology study with no effects on fœtus up to 16 mg/kg (20 fold the maximum recommended human dose (MRHD) based on body surface area) and in a rabbit teratology with no effects on foetus at dose of 0.5 mg/kg (2 fold the MRHD based on body surface area). Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC).The effects of mecasermin on the unborn child have not been studied. Therefore, there is insufficient medical information to determine whether there are significant risks to a foetus. Studies have not been conducted with mecasermin in breast-feeding mothers. INCRELEX should not be given to pregnant or nursing women. A negative pregnancy test and adequate contraception is required in all pre-menopausal women receiving INCRELEX.
4.7. Effects on ability to drive and use machines
INCRELEX may have a major influence on the ability to drive or use machines in case of a hypoglycaemic episode. Hypoglycaemia is a very common adverse reaction.
4.8. Undesirable effects
Summary of the safety profile
Adverse reaction data was taken from a total of 413 clinical trial patients with IGFD, including 92 patients with severe primary IGFD. Data was also collected from post-marketing sources.
The most frequently reported adverse reactions from the clinical trials were headache (44%), hypoglycaemia (28%), vomiting (26%), injection site hypertrophy (17%), and otitis media (17%).
Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 – 9 year old treatment naïve subjects.
During clinical trials in other indications totaling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients. There were also reports of systemic hypersensitivity from post-marketing use, of which some cases were indicative of anaphylaxis. Post-marketing reports of local allergic reactions were also received.
Some patients may develop antibodies to mecasermin. No attenuation of growth was observed as a consequence of the development of antibodies.
Tabulated list of adverse reactions
Table 1 contains very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000, < 1/100) adverse reactions which occurred in clinical trials. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Other adverse reactions have been identified during post approval use of INCRELEX. As these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (not known).
Table 1: Adverse reactions
System Organ Class
Reactions observed in the clinical trials
Reactions observed from the post-marketing environment
Blood and lymphatic system disorders
Common: Thymus hypertrophy
Immune system disorders
Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Metabolism and nutrition disorders
Very common: Hypoglycaemia
Common: Hypoglycaemic seizure, hyperglycaemia
Psychiatric disorders
Uncommon: Depression, nervousness
Nervous system disorders
Very common: Headache
Common: Convulsions, dizziness, tremor
Uncommon: Benign intracranial hypertension
Eye disorders
Common: Papilloedema
Ear and labyrinth disorders
Very common: Otitis media
Common: Hypoacusis, ear pain, middle ear effusion
Cardiac disorders
Common: Cardiac murmur, tachycardia
Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Respiratory, thoracic and mediastinal disorders
Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Gastrointestinal disorders
Very common: Vomiting, upper abdominal pain
Common: Abdominal pain
Skin and subcutaneous tissue disorders
Common: Skin hypertrophy, abnormal hair texture
Not known: alopecia
Musculoskeletal and connective tissue disorders
Very common: Arthralgia, pain in extremity
Common: Scoliosis, myalgia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Common: Melanocytic naevus
Not known: Benign and malignant neoplasms
Reproductive system and breast disorders
Common: Gynaecomastia
General disorders and administration site conditions
Very common: Injection site hypertrophy, injection site bruising
Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Uncommon: Injection site rash, injection site swelling, lipohypertrophy
Investigations
Uncommon: Increased weight
Surgical and medical procedures
Common: Ear tube insertion
Description of selected adverse reactions
Neoplasms
There have been post-marketing reports of benign and malignant neoplasms in children and adolescents who have received treatment with INCRELEX. These cases represented a variety of different malignancies and included rare malignancies usually not seen in children (see section 4.4 and 4.3).
Systemic/local hypersensitivity
Clinical Trial
During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions. All cases were mild or moderate in severity and none was serious.
Post-marketing reports
Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea. The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea. Some patients required hospitalization. Upon re-administration, symptoms did not re-occur in all patients. There were also reports of local allergic reactions at the injection site. Typically these were pruritus and urticaria.
Hypoglycaemia
Of the 115 (28%) subjects who experienced one or more episode of hypoglycaemia, 6 subjects experienced a hypoglycaemic seizure on one or more occasion. Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX.
Injection site hypertrophy
This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections. When injections were properly dispersed, the condition resolved.
Tonsillar hypertrophy
This was noted in 38 (9%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.
Snoring
This occurred generally in the first year of treatment and was reported in 30 subjects (7%).
Intracranial hypertension/increased intracranial pressure
This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose. All 4 subjects recovered from the event without sequelae.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed below:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Acute overdose could lead to hypoglycaemia. Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects. Oral glucose or food should be consumed. If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Long-term overdose may result in signs and symptoms of acromegaly or gigantism. Overdosing may lead to supraphysiological IGF-1 levels and may increase the risk of benign and malignant neoplasm.
In case of an acute or a chronic overdose, Increlex must be discontinued immediately. If Increlex is restarted, the dose should not exceed the recommended daily dosage (see section 4.2)
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- INCRELEX 10mg/ml prescriptionMECASERMINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- IncrelexMecaserminum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Increlex 10 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.