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Basic Drug Info
Drug Name:Increlex
Manufacturer:Tercica, Inc.
Other Info:

Before Opening - Vials of INCRELEX™ are stable when refrigerated [2º to 8ºC (35º to 46ºF)].

Avoid freezing the vials of INCRELEX™.

Protect from direct light.

Expiration dates are stated on the labels.After Opening – Vials of INCRELEX™ are stable for 30 days after initial vial entry when stored at 2º to 8ºC (35º to 46ºF).

Avoid freezing the vials of INCRELEX™.

Protect from direct light.Vial contents should be clear without particulate matter.

If the solution is cloudy or contains particulate matter, the contents must not be injected.

INCRELEX™ should not be used after its expiration date.

Keep refrigerated and use within 30 days of initial vial entry.

Remaining unused material should be discarded.



Clinical Trials:


Indications and Usage

INCRELEX™ (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Severe Primary IGFD is defined by:height standard deviation score ?–3.0 andbasal IGF-1 standard deviation score ?–3.0 andnormal or elevated growth hormone (GH).Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.INCRELEX™ is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.  Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX™ treatment.INCRELEX™ is not a substitute for GH treatment.
Malnutrition -- disorder of nutrition due to unbalanced or insufficient diet or to defective assimilation or utilization of nutrients.

Hypothyroidism -- A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA.

Contraindications
INCRELEX™ should not be used for growth promotion in patients with closed epiphyses.INCRELEX™ is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.Intravenous administration of INCRELEX™ is contraindicated.INCRELEX™ should not be used by patients who are allergic to mecasermin (IGF-1) or any of the inactive ingredients in INCRELEX™.
Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Warnings

INCRELEX contains benzyl alcohol as a preservative.

Benzyl alcohol as a preservative has been associated with neurologic toxicity in neonates.If sensitivity to INCRELEX™ occurs, treatment should be discontinued.

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