No

Growth Hormone

Long-term treatment of growth failure from lack of adequate endogenous growth hormone secretion

Nutropin®: Treatment of children who have growth failure associated with chronic renal insufficiency up until the time of renal transplantation

C

Closed epiphyses, known hypersensitivity to drug, benzyl alcohol (somatrem), or m-Cresol or glycerin (somatropin); progression of any underlying intracranial lesion or actively growing intracranial tumor

Use with caution in patients with diabetes; when administering to newborns, reconstitute with sterile water for injection

S.C. administration can cause local lipoatrophy or lipodystrophy and may enhance the development of neutralizing antibodies

<1%: Rash, itching, hypoglycemia, pain at injection site, small risk for developing leukemia, pain in hip/knee

Symptoms include hypoglycemia, hyperglycemia, acromegaly

Decreased effect: Glucocorticoid therapy may inhibit growth-promoting effects.

Somatrem (Protropin®): Store vials at 2°C to 8°C/36°F to 46°F; reconstitute each 5 mg vial with 1-5 mL of bacteriostatic water for injection; use reconstituted vials within 7 days; avoid freezing

Somatropin (Humatrope®/Nutropin®): Store vials at 2°C to 8°C/36°C to 46°F; avoid freezing; reconstitute each 5 mg vial with 1-5 mL of bacteriostatic water for injection; use reconstituted vials within 14 days; avoid freezing

Somatropin and somatrem are purified polypeptide hormones of recombinant DNA origin; somatropin contains the identical sequence of amino acids found in human growth hormone while somatrem's amino acid sequence is identical plus an additional amino acid, methionine; human growth hormone stimulates growth of linear bone, skeletal muscle, and organs; stimulates erythropoietin which increases red blood cell mass; exerts both insulin-like and diabetogenic effects

Somatrem and somatropin have equivalent pharmacokinetic properties

Absorption: I.M.: Well absorbed

Metabolism: ~90% in the liver

Half-life: 15-50 minutes

Elimination: 0.1% excreted in urine unchanged

Children (individualize dose):

Somatropin (Genotropin®): S.C.: Weekly dosage of 0.16-0.24 mg/kg divided into 6-7 doses

Somatropin (Humatrope®): I.M., S.C.: Up to 0.06 mg (0.16 units)/kg/dose 3 times/week

Somatropin (Nutropin®): S.C.:

Growth hormone inadequacy: Weekly dosage of 0.3 mg/kg (0.78 units/kg) administered daily

Chronic renal insufficiency: Weekly dosage of 0.35 mg/kg (0.91 units/kg) administered daily

Therapy should be discontinued when patient has reached satisfactory adult height, when epiphyses have fused, or when the patient ceases to respond

Growth of 5 cm/year or more is expected, if growth rate does not exceed 2.5 cm in a 6-month period, double the dose for the next 6 months, if there is still no satisfactory response, discontinue therapy

Do not shake; administer S.C. or I.M.; refer to product labeling; when administering to newborns, reconstitute with sterile water for injection

Growth curve, periodic thyroid function tests, bone age (annually), periodical urine testing for glucose, somatomedin C levels

None reported

None reported

No information available to require special precautions

No effects or complications reported

Reconstitute each 5 mg vial with 1-5 mL bacteriostatic water for injection (benzyl alcohol preserved) only; do not shake; do not inject if solution is cloudy; use a small enough syringe so that the prescribed dose can be drawn from the vial with reasonable accuracy; use a needle of sufficient length ( greater than or equal to 1") to ensure that the injection reaches the muscle layer

Watch for glucose intolerance

Powder for injection (lyophilized):

Genotropin®: 1.5 mg ~4.5 units (5 mL); 5.8 mg ~17.4 units (5 mL)

Humatrope®: 5 mg ~15 units

Norditropin®: 4 mg ~12 units; 8 mg ~24 units

Nutropin®: 5 mg ~15 units (10 mL); 10 mg ~30 units (10 mL)

Nutropin® AQ: 10 mg ~30 units (2 mL)

Nutropin® Depot™: 13.5 mg (3 mL); 18 mg (3 mL); 22.5 mg (3 mL)

Saizen® (rDNA origin): 5 mg ~15 units

Serostim®: 5 mg ~15 units (5 mL); 6 mg ~18 units (5 mL)

Somatrem, Protropin®: 5 mg ~15 units (10 mL); 10 mg ~30 units (10 mL)

Howrie DL, "Growth Hormone for the Treatment of Growth Failure in Children," Clin Pharm, 1987, 6(4):283-91.