FACTROPIN GENLI® 4900mcg 700mcg x 7 vials IGF1LR3 (1 kit)

Description

Genentech has received US clearance to market its Nutropin Depot (somatropin [rDNA origin] as an injectable suspension) for pediatric growth hormone deficiency. This long-acting recombinant human growth hormone will permit dosing only once or twice a month, as opposed to the current regimen of multiple doses per week. The firm’s partner Alkermes has “accelerated its manufacturing efforts,” and Genentech says that it now “expects to improve upon the original mid-year 2000 launch target date.” Nutropin Depot is a long-acting formulation of Genentech’s rHGH using Alkermes’ ProLease injectable extended-release drug delivery system.

DESCRIPTION

Nutropin Depot® [somatropin (rDNA origin) for injectable suspension] is a long-acting dosage form of recombinant human growth hormone (rhGH). Somatropin has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary-derived human growth hormone. The protein is synthesized by a specific laboratory strain of E. coli as a precursor consisting of the rhGH molecule preceded by the secretion signal from an E. coli protein. This precursor is directed to the plasma membrane of the cell. The signal sequence is removed and the native protein is secreted into the periplasm so that the protein is folded appropriately as it is synthesized.

Somatropin is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay.

The Nutropin Depot (somatropin rdna origin for inj) formulation consists of micronized particles of rhGH embedded in biocompatible, biodegradable polylactide-coglycolide (PLG) microspheres. Nutropin Depot (somatropin rdna origin for inj) is packaged in vials as a sterile, white to off-white, preservative-free, free-flowing powder. Before administration, the powder is suspended in Diluent for Nutropin Depot (somatropin rdna origin for inj) (a sterile aqueous solution).

Each 13.5 mg 3 cc single-use vial of Nutropin Depot (somatropin rdna origin for inj) contains 13.5 mg somatropin, 1.2 mg zinc acetate, 0.8 mg zinc carbonate, and 68.9 mg PLG.

Each 18 mg 3 cc single-use vial of Nutropin Depot (somatropin rdna origin for inj) contains 18 mg somatropin, 1.6 mg zinc acetate, 1.1 mg zinc carbonate, and 91.8 mg PLG.

Each 22.5 mg 3 cc single-use vial of Nutropin Depot (somatropin rdna origin for inj) contains 22.5 mg somatropin, 2.0 mg zinc acetate, 1.4 mg zinc carbonate, and 114.8 mg PLG.

Each dosage size contains an overage of rhGH microspheres to ensure delivery of labeled contents.

Each 1.5 mL single-use vial of Diluent for Nutropin Depot (somatropin rdna origin for inj) contains 30 mg/mL carboxymethylcellulose sodium salt, 1 mg/mL polysorbate 20, 9 mg/mL sodium chloride, and sterile water for injection; pH 5.8-7.2.

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