Adult Dosing
Pediatric Dosing
Growth failure in children w/ severe primary IGFD/GH gene deletion (>2 yrs)
- Initial dose: 0.04-0.08 mg/kg SC q12 hrs x 1 wk; if well tolerated, then increase dose by 0.04 mg/kg/dose
- Max: 0.24 mg/kg/day
Notes:- Administer prescribed dose 20 min before or after a meal or snack. Do not administer when a meal or snack is skipped
- Reduce dose if hypoglycemia occurs with recommended doses despite adequate food intake
- To avoid lipohypertrophy, rotate the injection sites to a different site with each injection (upper arm, thigh, buttock or abdomen)
- Safety and effectiveness in pediatric patients <2 years of age have not been established
[Outline]
See Supplemental Patient Information
- Administer mecasermin recombinant shortly before or after (+/-20 minutes) a meal or snack, because it has insulin-like hypoglycemic effects. Monitor glucose and titrate the dose until a well tolerated dose is established and subsequently as indicated
- Do not administer when a meal or snack is omitted; never increase the dose to make up for one or more omitted doses
- Advise patients to avoid performing any high-risk activities such as driving within 2-3 hrs after dosing, particularly during therapy initiation
- Allergic reactions including localized reactions to anaphylaxis requiring hospitalization have been reported post-marketing. Inform parents and patients that such reactions are possible and advise them to interrupt the treatment and seek prompt medical attention if a systemic allergic reaction occurs
- Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting have been reported during therapy. Perform funduscopic examination at the initiation and periodically during the course of therapy
- Therapy may cause lymphoid tissue (such as tonsillar and adenoidal) hypertrophy associated with complications, such as snoring, sleep apnea, and chronic middle-ear effusions. Examine the patients periodically for such complications and provide appropriate treatment if necessary
- Carefully evaluate pediatric patients with the onset of a limp or complaints of hip or knee pain during therapy as slipped capital femoral epiphysis may occur in patients who experience rapid growth
- Patients with a history of scoliosis who are treated with mecasermin recombinant should be monitored for progression of scoliosis, as therapy increases growth rate
- Benzyl alcohol, an ingredient of this product, may cause serious adverse events and death, particularly in pediatric patients. Gasping syndrome has been reported in neonates and low-birth weight neonates receiving benzyl alcohol dosages >99 mg/kg/day. Hence, during therapy administration, consider the combined daily metabolic load of benzyl alcohol from all sources
- Thyroid and nutritional deficiencies should be corrected before therapy initiation
Cautions: Use cautiously in
- Hypoglycemia
- Scoliosis
- Sleep apnea
- Small children
- Diabetes mellitus
Supplemental Patient Information
- Educate patients and caregivers on how to recognize the signs and symptoms of hypoglycemia
Pregnancy Category:C
Breastfeeding: Safety unknown. Because many drugs are excreted in human milk, manufacturer advises caution while administering to a nursing woman.
