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Increlex

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Increlex

Increlex

INDICATIONS

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

Dosage

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.

Administration

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 avoid 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.

HOW SUPPLIED

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. Revised: 09/2012

Last reviewed on RxList: 9/21/2012
This monograph has been modified to include the generic and brand name in many instances.

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