HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INCRELEX ® safely and effectively. See full prescribing information for INCRELEX ®.
INCRELEX ® (mecasermin [rDNA origin] injection), for subcutaneous use
Initial U.S. Approval: 2005
INDICATIONS AND USAGE
INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. (1.1)
Limitations of use: INCRELEX® is not a substitute to GH for approved GH indications.
DOSAGE AND ADMINISTRATION
INCRELEX® should be administered subcutaneously. (2.2)
Injection sites should be rotated to avoid lipohypertrophy. (2.2)
Recommended starting dose: 0.04 to 0.08 mg/kg (40 to 80 micrograms/kg) twice daily. 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. (2.1)
DOSAGE FORMS AND STRENGTHS
INCRELEX® is a sterile solution supplied in a multiple dose glass vial at a concentration of 10 mg per mL (40 mg per vial). (3)
CONTRAINDICATIONS
Active or Suspected Neoplasia (4)
Known Hypersensitivity to mecasermin (4)
Intravenous Administration (4)
Closed Epiphyses (4)
WARNINGS AND PRECAUTIONS
Hypoglycemia: INCRELEX® should be administered shortly before or after a meal or snack, because it has insulin-like hypoglycemic effects. (5.1)
Hypersensitivity and Allergic Reactions, including Anaphylaxis: A low number of cases indicative of anaphylaxis requiring hospitalization 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. (5.2)
Intracranial Hypertension: Funduscopic examination is recommended at the initiation and periodically during the course of INCRELEX® therapy. (5.3)
Lymphoid Tissue Hypertrophy (tonsillar/adenoidal hypertrophy): Patients should have periodic examinations to rule out potential complications and receive appropriate treatment if necessary. (5.4)
Slipped Capital Femoral Epiphysis (SCFE): eva luate any child with onset of a limp or hip/knee pain for possible SCFE. (5.5)
Progression of Scoliosis: Monitor any child with scoliosis for progression of the spine curve. (5.6)
ADVERSE REACTIONS
Common INCRELEX®-related adverse reactions in clinical trials include: hypoglycemia (5.1, 6.1), local and systemic hypersensitivity (5.2, 6.1, 6.3), tonsillar hypertrophy (5.4, 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-866-837-2422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, INCRELEX® may cause fetal harm. (8.1)
Pediatric Use: Safety and effectiveness has not been established in children less than 2 years of age. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Severe Primary IGF-1 Deficiency (Primary IGFD) 2 DOSAGE AND ADMINISTRATION
2.1 Dosage 2.2 Administration 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND