Mecasermin Dosage

Usual Pediatric Dose for Primary IGF-1 Deficiency

Initial dose: 0.4 to 0.8 mg/kg subcutaneously 2 times a day for at least 7 days

Maximum dose: 0.12 mg/kg subcutaneously 2 times a day

Comments:
-Not a substitute to growth hormone (GH) for approved GH indications.

Uses: 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

-The dosage should be individualized for each patient.
-May increase by 0.04 mg/kg per dose if initial dose is well-tolerated for at least one week.
-Doses over 0.12 mg/kg have not been evaluated, and should not be used due to hypoglycemic effects.
-Reduce dose if hypoglycemia occurs with recommended doses despite adequate food intake.

Precautions

Safety and efficacy have not been established in patients younger than 2 years or older than 64 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Rotate injection sites with each injection (upper arm, thigh buttock, or abdomen).
-Administer shortly before or after (within 20 minutes) a meal or snack.
-Hold dose if the patient is unable to eat shortly before or after a dose for any reason.
-Do not increase dose to make up for one or more omitted dose.
-Administer using a disposable syringe of small enough volume to accurately withdraw the dose.
-If using syringes that measure dose in units, convert dose using the following formula: Weight (kg) x Dose (mg/kg) x 1 mL/10 mg x 100 units/1 mL = units/injection.

Storage requirements:
-Keep refrigerated; protect from light.
-Avoid freezing.
-Use within 30 days of first vial entry.
-Discard any unused product after 30 days.

Reconstitution/preparation techniques:
-Solution should be clear.
-Do not use if solution is cloudy or has particulate matter.

Monitoring:
-Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established.
-Continue preprandial glucose monitoring for frequent hypoglycemia symptoms or severe hypoglycemia.

Patient advice:
-Educate patients/caregivers on how to recognize the signs of hypoglycemia.
-Educate patients/caregivers on the symptoms of serious allergic reactions and the need to seek prompt medical attention should such a reaction occur.
-If an allergic reaction occurs, treatment should be discontinued.