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Increlex is a brand name for Mecasermin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
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. 04 mg/kg of body weight twice daily by subcutaneous injection.
12 mg/kg given twice daily. 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. 04 mg/kg twice daily (BID). 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 or severe hypoglycaemia occur, blood glucose monitoring should continue regardless of pre-prandial condition and if possible, in case of hypoglycaemic symptoms.
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.
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%).
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 7 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 8 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.
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. 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.
1. 4 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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%).
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 […]
Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures. , 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. 5 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