Monograph Details
|
|
Endocrine System
> Pituitary disorders
|
|
INCRELEX |
| Manufacturer |
|
Tercica, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Recombinant human insulin-like growth factor-1 (rhIGF-1). |
| Generic Name |
|
Mecasermin 10mg/mL; soln for SC inj; contains benzyl alcohol. |
| Indications |
|
Long term therapy of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or in those with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. |
| Children |
|
Administer shortly before or after a meal/snack; rotate inj sites. <2yrs: not recommended. ≥2yrs: initially 0.04 to 0.08mg/kg SC twice daily; may increase after 1-week by 0.04 mg/kg per dose; max 0.12mg/kg per dose twice daily. |
| Adults |
|
Closed epiphyses: not recommended. |
| Contraindications |
|
Not for secondary forms of IGF-1 deficiency and growth promotion in patients with closed epiphyses. Active or suspected neoplasia. |
| Precautions |
|
Correct thyroid and nutritional deficiences before treatment. Measure preprandial glucose level before treatment and monitor until a tolerated dose is established. Reduce dose if hypoglycemia occurs despite adequate food intake with therapy. Monitor for lymphoid tissue hypertrophy complications and for signs and symptoms of rapid growth. Do funduscopic exam at the start of therapy, then periodically. Pregnancy (Cat.C). Nursing mothers. |
| Adverse Reactions |
|
Hypoglycemia, intracranial hypertension, lymphoid tissue hypertrophy complications (eg, tonsillar hypertrophy, snoring, sleep apnea, chronic middle ear effusions), otitis media, headache, dizziness, convulsions, ear pain, hypoacusis, abnormal tympanometry, cardiac murmur, transaminase elevations, arthralgia. |
| How Supplied |
|
Multidose vial (40mg/vial)—1 |
|
|
|
|
