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Increlex Generic Name & Formulations
Legal Class
Rx
General Description
Mecasermin 10mg/mL; soln for SC inj; contains benzyl alcohol.
Pharmacological Class
Recombinant human insulin-like growth factor-1 (rhIGF-1).
How Supplied
Multidose vial (40mg/vial)—1
Manufacturer
Generic Availability
NO
Increlex Indications
Indications
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.
Limitations of Use
Not a substitute to GH for approved GH indications.
Increlex Dosage and Administration
Adult
Closed epiphyses: not recommended.
Children
Administer before or after (+/–20 minutes) a meal/snack; rotate inj sites (upper arm, thigh, buttock or abdomen). <2yrs: not established. Individualized. ≥2yrs: initially 0.04 to 0.08mg/kg SC twice daily; may increase after 1 week by 0.04mg/kg per dose; max 0.12mg/kg twice daily.
Increlex Contraindications
Contraindications
Growth promotion in patients with closed epiphyses. Malignant neoplasia or history of malignancy. IV administration.
Increlex Boxed Warnings
Not Applicable
Increlex Warnings/Precautions
Warnings/Precautions
Not for secondary forms of IGF-1 deficiency. 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. Monitor for malignant neoplasms; discontinue if develops. Do funduscopic exam for intracranial hypertension at the start of therapy, then periodically. Evaluate any child with onset of limp or hip/knee pain for possible slipped capital femoral epiphysis. Monitor for progression of scoliosis. Infants: avoid. Pregnancy. Nursing mothers.
Increlex Pharmacokinetics
See Literature
Increlex Interactions
Increlex Adverse Reactions
Adverse Reactions
Hypoglycemia, local/systemic hypersensitivity (including anaphylaxis), lymphoid tissue hypertrophy (eg, tonsillar and adenoidal hypertrophy); intracranial hypertension.
Increlex Clinical Trials
See Literature
Increlex Note
Not Applicable
Increlex Patient Counseling
See Literature
