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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
Mechanism of Action
Activates insulin-like growth factor-1 (IGF-1) receptor, leading to intracellular signaling which stimulates multiple processes resulting in statural growth.
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.
Administration
Administer by SC injection shortly before or after meal/snack; do not give if meal/snack is omitted. Rotate inj sites (upper arm, thigh, buttock or abdomen). Use sterile disposable syringes and needles. Syringes should be of small enough volume so the dose can be withdrawn from the vial with accuracy. If using syringes that measure dose in units, doses (mg/kg) must be converted to units with the following formula: weight (kg) x dose (mg/kg) x 1mL/10mg x 100units/1mL = units/inj.
Nursing Considerations
Administer by SC injection shortly before or after meal/snack; do not give if meal/snack is omitted. Rotate inj sites (upper arm, thigh, buttock or abdomen). Use sterile disposable syringes and needles. Syringes should be of small enough volume so the dose can be withdrawn from the vial with accuracy. If using syringes that measure dose in units, doses (mg/kg) must be converted to units with the following formula: weight (kg) x dose (mg/kg) x 1mL/10mg x 100units/1mL = units/inj.
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
Absorption
Absolute bioavailability: estimated to be close to 100% after SC administration.
Distribution
Volume of distribution: 0.257 (± 0.073) L/kg. In blood, IGF-1 is bound to six IGF binding proteins, with > 80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Elimination
Renal. Half-life: 5.8 hours.
Increlex Interactions
Not Applicable
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
