Humatrope (somatropin) for injection 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 homeoboxcontaining gene (SHOX) deficiency,
• short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

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

Contraindications

Acute Critical Illness: Humatrope should not be used to treat patients with acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin.

Dosing Chart

Recommended pediatric dosing for Humatrope administration

Indication

Daily (mg/kg/day)

Weekly (mg/kg/week)

Indication

Growth hormone deficiency1

Daily (mg/kg/day)

0.026 to 0.043

Weekly (mg/kg/week)

0.18 to 0.30

Indication

Turner syndrome1

Daily (mg/kg/day)

Up to 0.054

Weekly (mg/kg/week)

Up to 0.375

Indication

Idiopathic short stature (ISS)1

Daily (mg/kg/day)

Up to 0.053

Weekly (mg/kg/week)

Up to 0.37

Indication

SHOX deficiency1

Daily (mg/kg/day)

0.050

Weekly (mg/kg/week)

0.35

Indication

Small for gestational age (SGA)1

Daily (mg/kg/day)

Up to 0.067

Weekly (mg/kg/week)

Up to 0.47

Larger doses of somatropin (e.g., 0.067 mg/kg/day) are recommended especially in children with height SDS < -3, and/or older pubertal children, and a reduction in dosage (e.g., gradually toward 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy.

For SGA children less than 4 years old and with less baseline height DSD values between -2 and -3, consider initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time.

Recommended adult dosing for Humatrope administration2