"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
Severe Primary IGF-1 Deficiency (Primary IGFD)
INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the treatment of:
- growth failure in children with severe primary IGF-1 deficiency.
- growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
Severe Primary IGF-1 deficiency (IGFD) is defined by:
- height standard deviation score ≤ –3.0 and
- basal IGF-1 standard deviation score ≤ –3.0 and
- normal or elevated growth hormone (GH).
Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
INCRELEX® is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX® treatment.
Limitations of use
INCRELEX® is not a substitute to GH for approved GH indications.
DOSAGE AND ADMINISTRATION
Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. The dosage of INCRELEX® should be individualized for each patient. 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. Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with Primary IGFD and, due to potential hypoglycemic effects, should not be used. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced. INCRELEX® should be administered shortly before or after (± 20 minutes) a meal or snack. If the patient is unable to eat shortly before or after a dose for any reason, that dose of INCRELEX® should be withheld. Subsequent doses of INCRELEX® should never be increased to make up for one or more omitted dose.
INCRELEX® is administered by subcutaneous injection.
INCRELEX® injection sites should be rotated to a different site (upper arm, thigh, buttock or abdomen) with each injection to help prevent lipohypertrophy.
INCRELEX® should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume so that the prescribed dose can be withdrawn from the vial with accuracy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
If using syringes that measure dose in units, doses in mg/kg must be converted to units using the following formula: Weight (kg) x Dose (mg/kg) x 1 mL/10 mg x 100 units/1 mL = units/injection.
Dosage Forms And Strengths
INCRELEX® is a sterile solution available at a concentration of 10 mg per mL (40 mg per vial).
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 [2° to 8°C (35° to 46°F)]. 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 2° to 8°C (35° to 46°F). 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.
Manufactured for: Ipsen Biopharmaceuticals, Inc. Basking Ridge, NJ 07920 USA by: Hospira, Incorporated McPherson, KS 67460 USA
Manufactured for: Tercica, Inc. Brisbane, CA 94005 USA. Revised: February 2010
Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Increlex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.