Pregnancy Category: C
Pharmacologic: growth hormones
Pharmacologic: growth hormones
Long-term treatment of growth failure in children due to primary insulin-like growth factor-1 (IGF) deficiency or growth hormone gene deletion with antibodies to growth hormone.
Under normal conditions, growth hormone attaches to receptors resulting in increased production of IGF-1. IGF-1 stimulates uptake of glucose, fatty acids and amino acids which support tissue growth. These processes signal and support statural growth.
Replacement of IGF-1 in deficiency states resulting in achievement of optimal potential statural growth.
Absorption: Well absorbed following subcutaneous administration.
Distribution: Bound to various binding proteins.
Metabolism and Excretion: Some metabolism in liver and kidney.
Half-life: 5.8 hr.
Time/action profile (blood levels)
|subcut||rapid||3 hr||12 hr|
Contraindicated in: Hypersensitivity; Pediatric: Contains benzyl alcohol, avoid in neonates; Closed epiphyses; Active/suspected neoplasia.
Use Cautiously in: Adults (safety not established); Pediatric: Children <2 yr (safety not established); Obstetric / Lactation: Safety not established.
Adverse Reactions/Side Effects
Central nervous system
- seizures (life-threatening)
- intracranial hypertension
- tonsillar hypertrophy (most frequent)
- hypoglycemia (life-threatening)
- extremity pain
- anaphylaxis (life-threatening)
- hypersensitivity reactions (life-threatening)
- thymus hypertrophy
Drug-Drug interactionNone noted.
Subcutaneous (Children) 0.04–0.08 mg/kg twice daily; may be ↑ weekly by 0.04 mg/kg/dose up to 0.12 mg/kg twice daily.
Solution for injection: 10 mg/mL
- Monitor bone age annually and growth rate determinations, height, and weight every 3–6 mo during therapy.
- Assess tonsils for hypertrophy periodically during therapy. Signs may include (snoring, difficulty breathing or swallowing, sleep apnea, fluid in the middle ear).
- To assess for intracranial hypertension, fundoscopic examinations are recommended prior to and periodically during therapy. May cause headache with nausea and vomiting.
- Monitor patient for allergic reactions (rash, hives, angioedema, pruritus, urticaria, difficulty breathing). May require interruption of therapy.
- Monitor patients for thickening of soft tissues of the face periodically during therapy.
- Lab Test Considerations: Monitor preprandial glucose levels during therapy.
- May cause mild ↑ in serum AST, ALT, and LDH.
Potential Nursing DiagnosesDisturbed body image (Indications)
- Administer within 20 min of a meal or snack; may have insulin-like hypoglycemic effects. Do not administer if meal or snack is omitted. If a dose is omitted, do not increase dose to make up for missed doses.
- Therapy should be initiated at a low dose and not increased until no hypoglycemic episodes have occurred for at least 7 day. If sever hypoglycemia occurs despite adequate food intake, consider dose reduction.
- If using syringes measuring dose in units, convert doses in mg/kg to units using formula: Weight (kg) x Dose (mg/kg) x 1 mL/10 mg x 100 units/1 mL = units/injection.
- Subcutaneous: Administer twice daily in upper arm, thigh, abdomen, or buttocks. Rotate sites with each injection. Solution is clear; do not administer solution that is cloudy or contains a precipitate. Solution is stable for 30 days after opening vial if refrigerated. Keep vial away from direct heat and bright light. Discard unused solution.
- Instruct patients and/or their parents how to administer mecasermin, injection technique, and equipment disposal. Advise patient and/or parents to read Patient Information package insert before starting therapy and with each prescription refill in case of changes.
- Advise patient and parents not to give mecasermin to any other person; may be harmful.
- Discuss the importance of a well-balanced diet including protein and fat such as meat and cheese. Advise parents to monitor for signs of hypoglycemia (dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, fast or irregular heartbeat). Severe hypoglycemia may result in unconsciousness, seizures, and death. A source of sugar such as orange juice, glucose gel, candy, or milk should be available at all times.
- Caution patients to avoid driving and other activities requiring alertness until response to medication is known.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
- Advise parent to notify health care professional if signs of tonsillar hypertrophy, increased intracranial pressure, or allergic reaction occur.
- Increase in statural growth.
a biological response modifier and insulin-like growth factor.
indications This drug is used to treat growth failure in children with severe primary insulin-like growth factor-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
contraindications Known hypersensitivity to this drug or benzyl alcohol, closed epiphyses, active or suspected neoplasia, and IV use prohibit its use.
adverse effects Adverse effects of this drug include headache, dizziness, cardiac valvulopathy, cardiac murmur, ear pain, otitis media, abnormal tympanometry, papilledema, visual impairment, vomiting, thymus hypertrophy, hypoglycemia, bruising, lipohypertrophy, hypersensitivity reactions, arthralgia, joint pain, snoring, and tonsillar hypertrophy. Life-threatening side effects include seizures, hypoglycemia, ketosis, hypothyroidism, apnea, and antibodies to growth hormone.