Drug Detail:Mecasermin (Mecasermin [ me-ka-ser-min ])
Drug Class: Insulin-like growth factors
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
CONTRAINDICATIONS:
- Hypersensitivity to any of the ingredients
- Closed epiphyses
- Malignant neoplasia or a history of malignancy
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.
