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INCRELEX
Pituitary disorders
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Drug Name:

INCRELEX Rx

Generic Name and Formulations:
Mecasermin 10mg/mL; soln for SC inj; contains benzyl alcohol.

Company:
Ipsen Biopharmaceuticals, Inc.

Therapeutic Use:

Indications for INCRELEX:

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.

Adult:

Closed epiphyses: not recommended.

Children:

Administer before or after (+/–20 minutes) a meal/snack; rotate inj sites. <2yrs: not established. ≥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.

Contraindications:

Growth promotion in patients with closed epiphyses. Active or suspected neoplasia. IV administration.

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. 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. Elderly. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Recombinant human insulin-like growth factor-1 (rhIGF-1).

Adverse Reactions:

Hypoglycemia, local/systemic hypersensitivity (including anaphylaxis), lymphoid tissue hypertrophy (eg, tonsillar and adenoidal hypertrophy); intracranial hypertension.

Metabolism:

Hepatic, renal.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Multidose vial (40mg/vial)—1

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