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INCRELEX is a brand name for Mecasermin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Increlex® (mecasermin) is indicated for the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD). SPIGFD is defined by: • height standard deviation score ≤ –3.0 and; • basal IGF-1 levels below the 2.5th percentile for…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 04/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................... 2 TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 3 1 INDICATIONS ...................................................................................................................
1 Pediatrics ................................................................................................................. 3 2 CONTRAINDICATIONS ...................................................................................................
3 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................ 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration .......................................................................................................... 5 Missed Dose ............................................................................................................
4 5 OVERDOSAGE ................................................................................................................ 5
1 Adverse Reaction Overview Data from 4 predecessor studies and the pivotal study 1419 were pooled for safety analyses and formed the integrated safety database, which included a total of 92 children with SPIGFD who received at least one dose of Increlex.
The most common treatment emergent adverse events (TEAEs) were hypoglycemia (43 subjects (47%)), hypersensitivity (33 subjects (35%)), injection site hypertrophy (32 subjects (35%)), headache (25 subjects (27%)) and snoring (20 subjects (22%)).
Seventy-six subjects (83%) had at least one reported TEAE during treatment. Eighteen subjects (20%) experienced at least one serious adverse event. 5%) subjects. There were no deaths reported. No patient discontinued the treatment due to AEs.
Hypoglycemia was the most frequently reported AE. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 2 summarises adverse reactions that occurred in ≥1% of patients in pivotal study 1419. Table 2 – Adverse Reactions* Occurring in ≥ 1% of Increlex Treated Patients in Pivotal Study 1419 Increlex n = 92 n (%) Blood and Lymphatic Disorders Thymus hypertrophy 9 (10) Cardiac Disorders Cardiac murmur Tachycardia 7 (8) 6 (7) Ear and Labyrinth Disorders Hypoacusisa Middle ear effusion Ear pain Ear discomfort 19 (21) 10 (11) 6 (7) 5 (5) Eye Disorders Papilloedema 5 (5) Gastrointestinal Disorders Vomiting Abdominal pain Upper abdominal pain 16 (17) 8 (9) 5 (5) General Disorders and Administration Site Conditions Injection site hypertrophy Injection site reactionsb Hypertrophy 32 (35) 18 (19) 8 (9) Immune system disorders Hypersensitivityc 33 (35) Infection and Infestations Otitis media 19 (21) Investigations Increased weight 3 (3) Metabolism and Nutrition Disorders Hypoglycemiad Hypoglycemic seizure Hyperglycemia 43 (47) 7 (7) 4 (4) INCRELEX (mecasermin) Page 10 of 27 Unclassified / Non classifié Increlex n = 92 n (%) Musculoskeletal and Connective Tissue Arthralgia Pain in extremity Myalgia Scoliosis 8 (9) 8 (9) 2 (2) 1 (1) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic nevus Acrochordon Skin papilloma 4 (4) 3 (3) 2 (2) Nervous System Disorders Headache Intracranial hypertensione Dizziness Convulsions Tremor 25 (27) 6 (7) 6 (7) 4 (4) 1 (1) Respiratory, Thoracic, and Mediastinal Snoring Tonsillar hypertrophy Adenoidal hypertrophy Sleep apnea syndrome 20 (22) 19 (21) 9 (10) 3 (3) Reproductive system and breast disorders Gynecomastia 6 (7) Skin and Subcutaneous Tissue Disorders Skin hypertrophy Abnormal hair texture 10 (11) 4 (4) *Derived from treatment-emergent adverse events aincludes hypoacusis, conductive deafness and deafness.
General Increlex is not a substitute for GH treatment. Carcinogenesis and Mutagenesis 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 tumors (see CONTRAINDICATIONS).
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 ADVERSE REACTIONS, Neoplasms and Post-Market Adverse Reactions).
The increased risk Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Injection Sterile solution 10 mg/mL (40 mg per vial) Benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate trihydrate, water for injection.
INCRELEX (mecasermin) Page 6 of 27 Unclassified / Non classifié of neoplasia may be higher in patients who receive Increlex for unapproved uses, at higher than recommended doses or at doses that produced serum IGF-1 levels above the normal reference ranges for age and sex.
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. Advise patients/caregivers to report development of new neoplasms.
If benign or malignant neoplasia develops, Increlex treatment should be discontinued definitely and appropriate expert medical care sought. Driving and Operating Machinery Increlex may cause hypoglycemia (very common side effect), dizziness and convulsions (see ADVERSE REACTIONS, Hypoglycemia) that may impair your ability to drive and use machines.
) within 2-3 hours after dosing, particularly during the initiation of Increlex treatment until tolerability and a stable dose have been established. , tonsillar) hypertrophy associated with complications, such as snoring, sleep apnea, and chronic middle-ear effusions have been reported with the use of Increlex.
Increlex (mecasermin) is contraindicated in • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Children and adolescents with active or suspected neoplasia, or any condition or medical history which increases the risk of benign or malignant neoplasia. • Increlex contains benzyl alcohol and must not be given to premature babies or neonates.
• Increlex should not be used for growth promotion in patients with closed epiphyses. INCRELEX (mecasermin) Page 4 of 27 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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bincludes injection site bruising, injection site pain, injection site reaction, injection site hematoma, injection site induration and injection site hemorrhage. cincludes cough, rash, dyspnea, pruritic rash, drug hypersensitivity, hypersensitivity, pruritus, asthma, urticaria and injection site urticaria.
dformerly hypoglycemia NOS eincludes papilloedema Description of Selected Adverse Reactions Neoplasms In Study 1419, 7 subjects (8%) reported benign neoplasms. Hypoglycemia In Study 1419, 43 subjects (47%) experienced one or more episodes of hypoglycemia during treatment of Increlex.
Seven (8%) subjects had severe hypoglycemia (requiring assistance and treatment) and 7 (7%) experienced hypoglycemic seizures/loss of consciousness on one or more occasions. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children (see WARNINGS AND PRECAUTIONS, Hypoglycemia).
INCRELEX (mecasermin) Page 11 of 27 Unclassified / Non classifié Hypersensitivity In Study 1419, 33 subjects (35%) reported a local and/or systemic hypersensitivity reaction, including cough, rash, dyspnea, pruritic rash, drug hypersensitivity, hypersensitivity, pruritus, asthma, urticaria and injection site urticaria (see WARNINGS AND PRECAUTIONS, Systemic/local hypersensitivity and Post-Market Adverse Reactions, Systemic hypersensitivity).
e, papilloedema and benign IH) and headache occurred in 6 subjects (7%) and 25 subjects (27%), respectively. One subject had severe benign IH classed as a related SAE. In post-marketing experience, 2 intracranial hypertension events were life threatening and involved hospitalisation (see WARNINGS AND PRECAUTIONS, Intracranial hypertension).
Injection site hypertrophy In Study 1419, injection site hypertrophy occurred in 32 (35%) subjects and was generally associated with lack of proper rotation of injections. When injections were properly dispersed, the condition resolved.
Tonsillar hypertrophy and snoring In Study 1419, tonsillar hypertrophy was noted in 19 (21%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Snoring occurred generally in the first year of treatment and was reported in 20 subjects (22%).
Organomegaly Echocardiographic evidence of cardiomegaly/valvulopathy was observed in a few individuals without associated clinical symptoms. The relation of these cardiac changes to drug treatment cannot be assessed due to underlying disease and the lack of a control group (See WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Thickening of the soft tissues of the face was observed in several patients and should be monitored during Increlex treatment. Renal and […]
Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment (see ADVERSE REACTIONS, Tonsillar hypertrophy and snoring). Endocrine and Metabolism Hypoglycemia Increlex should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycemic effects.
Glucose monitoring and Increlex dose titration are recommended until a well-tolerated dose is established (see DOSAGE AND ADMINISTRATION). Increlex should not be administered when a meal or snack is omitted. The dose of Increlex should never be increased to make up for one or more omitted doses.
Special attention should be paid to young children, children with a history of hypoglycemia 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 Increlex 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 hypoglycemia, including injection of glucagon.
Doses of insulin and/or other hypoglycemic medicinal products may need to be reduced for diabetic subjects using this medicinal product. Bone Metabolism 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 Increlex treatment. Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Patients with a history of scoliosis who are treated with Increlex should be monitored for progression of scoliosis. INCRELEX (mecasermin) Page 7 of 27 Unclassified / Non classifié Immune Systemic/local hypersensitivity Allergic reactions to Increlex have been reported in clinical trials and post-marketing experience.
, urticaria, pruritus, erythema) to systemic reactions, including anaphylaxis, generalized urticaria, angioedema and dyspnea. Some patients required hospitalization. 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 (see CONTRAINDICATIONS, ADVERSE REACTIONS, Hypersensitivity and Post-Market Adverse Reactions, Systemic hypersensitivity).
Monitoring and Laboratory Tests Echocardiogram is recommended before initiation of Increlex treatment in all patients and in patients who terminate treatment. Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures (see ADVERSE REACTIONS, Organomegaly).
Neurologic Intracranial hypertension Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with Increlex, 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 Increlex therapy and at the occurrence of clinical symptoms (see ADVERSE RECTIONS, Intracranial hypertension).
Others Benzyl alcohol toxicity Benzyl alcohol may […]