Humatrope 6MG (18IU)

Humatrope 6MG (18IU): Humatrope (somatropin, rDNA origin, for injection) is a polypeptide hormone of recombinant DNA origin. Humatrope is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human GH. The peptide is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence of the peptide is identical to that of human GH of pituitary origin.

Humatrope is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular administration after reconstitution to its liquid form. Humatrope is a highly purified preparation. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive.

Vial

Each vial of Humatrope contains 5 mg somatropin (15 IU or 225 nanomoles); 25 mg mannitol; 5 mg glycine; and 1.13 mg dibasic sodium phosphate. Each vial is supplied in a combination package with an accompanying 5-mL vial of diluting solution (diluent). The diluent contains Water for Injection with 0.3% metacresol as a preservative and 1.7% glycerin.

INDICATIONS

Pediatric Patients

HUMATROPE is indicated for the treatment of pediatric patients with:

• growth failure due to inadequate secretion of endogenous growth hormone (GH),
• short stature associated with Turner syndrome,
• Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
• short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency,
• short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

Adult Patients

HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.

DOSAGE AND ADMINISTRATION

Administration And Use Instructions

• Therapy with HUMATROPE should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which HUMATROPE is indicated
• Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter
• Leave HUMATROPE at room temperature for 10 minutes prior to administration.
• Administer HUMATROPE by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.