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Increlex

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Increlex

Increlex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Increlex (mecasermin [rDNA origin]) Injection is a man-made form of insulin-like growth factor-1 (IGF-1) used to treat growth failure in children whose bodies do not make enough IGF-1. Common side effects include dizziness, joint pain, thickening of facial skin, easy bruising, or pain, redness, bruising, or skin changes where the injection was given.

The recommended starting dose of Increlex is 0.04 to 0.08 mg/kg (40 to 80 micrograms/kg) twice daily by subcutaneous injection. If well tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily. Increlex may interact with insulin or oral diabetes medications. Tell your doctor all medications and supplements you use. During pregnancy, Increlex should be used only if prescribed. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Increlex (mecasermin [rDNA origin]) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Increlex in Detail - Patient Information: Side Effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your child's face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • blurred vision, severe headache or pain behind the eyes, sometimes with vomiting;
  • pain in the hip or knee, walking with a limp;
  • seizure (convulsions); or
  • swollen tonsils -- snoring, breathing problems during sleep, pain or fullness in your ear, hearing problems.

Less serious side effects may include:

  • dizziness;
  • joint pain;
  • thickening of facial skin;
  • easy bruising; or
  • pain, redness, bruising, or skin changes where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Increlex (Mecasermin [rDNA origin] Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Increlex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies of 71 subjects with Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse reactions. Adverse reactions to INCRELEX® treatment that occurred in 5% or more of these study participants are listed below by organ class.

Metabolism and Nutrition Disorders: hypoglycemia

General Disorders and Administrative Site Conditions: lipohypertrophy, bruising

Infections and Infestations: otitis media, serous otitis media

Respiratory, Thoracic and Mediastinal Disorders: snoring, tonsillar hypertrophy

Nervous System Disorders: headache, dizziness, convulsions

Gastrointestinal Disorders: vomiting

Ear and Labyrinth Disorders: hypoacusis, fluid in middle ear, ear pain, abnormal tympanometry

Cardiac Disorders: cardiac murmur

Musculoskeletal and Connective Tissue Disorders: arthralgia, pain in extremity

Blood and Lymphatic System Disorders: thymus hypertrophy

Surgical and Medical Procedures: ear tube insertion

Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX® .

Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Tonsillectomy or tonsillectomy/adenoidectomy was performed in 7 subjects; 3 of these had obstructive sleep apnea, which resolved after the procedure in all three cases.

Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX® treatment. INCRELEX® treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

Mild elevations in the serum AST and LDH were found in a significant proportion of patients before and during treatment. Rise in levels of these serum enzymes did not lead to treatment discontinuation. ALT elevations were occasionally noted during treatment.

Renal and splenic lengths (measured by ultrasound) increased rapidly on INCRELEX® treatment during the first years of therapy. This lengthening slowed down subsequently; though in some patients, renal and/or splenic length reached or surpassed the 95th percentile. Renal function (as defined by serum creatinine and calculated creatinine clearance) was normal in all patients, irrespective of renal growth.

Elevations in cholesterol and triglycerides to above the upper limit of normal were observed before and during treatment.

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.

Thickening of the soft tissues of the face was observed in several patients and should be monitored during INCRELEX® treatment.

As with all therapeutic proteins, there is potential for immunogenicity. Anti-IGF-1 antibodies were present at one or more of the periodic assessments in 14 of 23 children with Primary IGFD treated for 2 years. However, no clinical consequences of these antibodies were observed (e.g., attenuation of growth). The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to INCRELEX® with the incidence of antibodies to other products may be misleading.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of INCRELEX® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Systemic hypersensitivity: anaphylaxis, generalized urticaria, angioedema, dyspnea

In the post-marketing setting, the frequency of cases indicative of anaphylaxis was estimated to be 0.3%. Symptoms included hives, angioedema, and dyspnea, and some patients required hospitalization. Upon re-administration, symptoms did not re-occur in all patients.

Local allergic reactions at the injection site: pruritus, urticaria.

Skin and Subcutaneous Tissue Disorders: alopecia, hair texture abnormal.

General Disorders and Administrative Site Conditions: injection site reactions (e.g. erythema, pain, haematoma, haemorrhage, induration, rash, swelling).

Musculoskeletal and Connective Tissue Disorders: osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis)

Read the entire FDA prescribing information for Increlex (Mecasermin [rDNA origin] Injection) »

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