1.2 (0.8) +1.4 (1.1) +1.3 (1.2) +1.4 (1.3) +1.4 (1.2) +1.4 (1.1) +1.5 (1.1)
Forty-nine subjects were included in an analysis of the effects of INCRELEX® on bone age advancement. The mean ± SD change in chronological age was 4.9 ± 3.4 years and the mean ± SD change in bone age was 5.3 ± 3.4 years.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC-15054-1040-5 INCRELEX® is supplied as a 10 mg per mL sterile solution in multiple dose glass vials (40 mg per vial).
Before Opening – Vials of INCRELEX® are stable when refrigerated [2º to 8ºC (35º to 46ºF)]. Avoid freezing the vials of INCRELEX®. Protect from direct light. Expiration dates are stated on the labels.
After Opening – Vials of INCRELEX® are stable for 30 days after initial vial entry when stored at 2º to 8ºC (35º to 46ºF). Avoid freezing the vials of INCRELEX®. Protect from direct light.
Vial contents should be clear without particulate matter. If the solution is cloudy or contains particulate matter, the contents must not be injected. INCRELEX® should not be used after its expiration date. Keep refrigerated and use within 30 days of initial vial entry. Remaining unused material should be discarded.
17 PATIENT COUNSELING INFORMATION
Patients and/or their parents should be instructed in the proper administration of INCRELEX®. INCRELEX® should be given shortly before or after (20 minutes on either side of) a meal or snack. INCRELEX® should not be administered when the meal or snack is omitted. The dose of INCRELEX® should never be increased to make up for one or more omitted doses. INCRELEX® therapy should be initiated at a low dose and the dose should be increased only if no hypoglycemia episodes have occurred after at least 7 days of dosing. If severe hypoglycemia or persistent hypoglycemia occurs on treatment despite adequate food intake, INCRELEX® dose reduction should be considered. Providers should educate patients and caregivers on how to recognize the signs and symptoms of hypoglycemia.
Providers should educate patients and caregivers on the identification of signs and symptoms of serious allergic reactions to INCRELEX® and the need to seek prompt medical contact should such a reaction occur. They should be informed that if an allergic reaction occurs, INCRELEX treatment should be discontinued.
Patients and/or parents should be thoroughly instructed in the importance of proper needle disposal. A puncture-resistant container should be used for the disposal of used needles and/or syringes (consistent with applicable state requirements). Needles and syringes must not be reused.
SPL UNCLASSIFIED SECTION
Manufactured for: Ipsen Biopharmaceuticals, Inc.
Basking Ridge, NJ 07920 USA
by: Hospira, Incorporated
McPherson, KS 67460 USA
PATIENT PACKAGE INSERT
Patient Information
INCRELEX® (EENK-RUH-LEX)
(MECASERMIN [RDNA ORIGIN] INJECTION)
Read the Patient Information that comes with INCRELEX® before your child starts taking INCRELEX® and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your child's doctor about your child's condition or treatment.
What is INCRELEX®?
INCRELEX® is a liquid that contains man-made insulin-like growth factor-1 (IGF-1), which is the same as the IGF-1 made by your body. INCRELEX® is used to treat ch |
