Somatropin

Trade Names:
Genotropin
- Powder for injection, lyophilized 5.8 mg (approx. 17.4 units)/vial
- Powder for injection, lyophilized 13.8 mg (approx. 41.4 units)/vial

Trade Names:
Genotropin Miniquick
- Powder for injection, lyophilized 0.2 mg/vial
- Powder for injection, lyophilized 0.4 mg/vial
- Powder for injection, lyophilized 0.6 mg/vial
- Powder for injection, lyophilized 0.8 mg/vial
- Powder for injection, lyophilized 1 mg/vial
- Powder for injection, lyophilized 1.2 mg/vial
- Powder for injection, lyophilized 1.4 mg/vial
- Powder for injection, lyophilized 1.6 mg/vial
- Powder for injection, lyophilized 1.8 mg/vial
- Powder for injection, lyophilized 2 mg/vial

Trade Names:
Humatrope
- Powder for injection, lyophilized 5 mg (approx. 15 units)/vial
- Powder for injection, lyophilized 6 mg (18 units)/cartridge
- Powder for injection, lyophilized 12 mg (36 units)/cartridge
- Powder for injection, lyophilized 24 mg (72 units)/cartridge

Trade Names:
Norditropin
- Powder for injection, lyophilized 4 mg (approx. 12 units)/vial
- Powder for injection, lyophilized 8 mg (approx. 24 units)/vial
- Injection 5 mg per 1.5 mL
- Injection 10 mg per 1.5 mL
- Injection 15 mg per 1.5 mL

Trade Names:
Nutropin
- Powder for injection, lyophilized 5 mg (approx. 15 units)/vial
- Powder for injection, lyophilized 10 mg (approx. 26 units)/vial

Trade Names:
Nutropin AQ
- Injection 10 mg (approx. 30 units)/vial

Trade Names:
Saizen
- Powder for injection, lyophilized 5 mg (approx. 15 units)/vial

Trade Names:
Serostim
- Powder for injection, lyophilized 4 mg (approx. 12 units)/vial
- Powder for injection, lyophilized 5 mg (approx. 15 units)/vial
- Powder for injection, lyophilized 6 mg (approx. 18 units)/vial

Pharmacology

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Mimics actions of naturally occurring growth hormone to stimulate linear and skeletal growth; increases number and size of skeletal muscle cells; increases RBC mass and internal organ size; increases cellular protein synthesis; reduces body fat stores and lipid mobilization, and increases plasma fatty acids.

Pharmacokinetics

Absorption

Somatropin C _max with concentrations of 5.3 mg/mL is approximately 23 ng/mL. C _max with concentrations of 1.3 mg/mL is approximately 17.4 ng/mL. Following a 0.03 mg/kg subcutaneous injection of 1.3 mg/mL, about 80% was systemically available as compared with that available following IV dosing.

Distribution

Vd is approximately 1.3 L/kg.

Metabolism

Somatropin undergoes classical protein catabolism in both liver and kidneys.

Elimination

Somatropin's t _½ is approximately 0.4 h (IV) and approximately 3 h (subcutaneously). Mean Cl of subcutaneous administration is about 0.3 L/h/kg.

Indications and Usage

Long-term treatment of children with growth failure caused by lack of adequate endogenous growth hormone secretion (except Serostim ); ( Genotropin only) long-term treatment of children with growth failure caused by Prader-Willi syndrome (PWS); ( Genotropin , Nutropin , Nutropin AQ , and Humatrope only) long-term replacement therapy in adults with growth hormone deficiency of either childhood- or adult-onset etiology; ( Nutropin and Nutropin AQ only) treatment of growth failure associated with chronic renal insufficiency up to time of renal transplantation; ( Nutropin , Nutropin AQ , and Humatrope only) long-term treatment of short stature associated with Turner syndrome; ( Serostim only) treatment of AIDS wasting or cachexia.

Contraindications

Closed epiphyses; evidence of tumor activity or active neoplasm; intracranial lesion must be inactive and antitumor therapy complete prior to instituting therapy; sensitivity to benzyl alcohol ( Nutropin diluent) glycerin or M-cresol ( Humatrope diluent).

Dosage and Administration

( Genotropin ) Subcutaneous 0.16 to 0.24 mg/kg/wk (divided into 6 or 7 injections) ( Humatrope ). IM/Subcutaneous 0.18 mg/kg/wk (divided into equal doses given on 3 alternate days, 6 times/wk, or daily) to a max of 0.3 mg/kg of body weight; ( Norditropin ) Subcutaneous 0.024 to 0.034 mg/kg 6 to 7 times/wk, ( Nutropin / Nutropin AQ ) Subcutaneous 0.3 mg/kg/wk (divided into daily injections); ( Saizen ) IM/Subcutaneous 0.06 mg/kg 3 times/wk.

( Genotropin ) Subcutaneous 0.24 mg/kg/wk.

( Genotropin ) Subcutaneous Start with up to 0.04 mg/kg/wk (divided into 6 or 7 injections), increasing the dose at 4- to 8-wk intervals according to patient requirements (max, 0.08 mg/kg/wk); ( Humatrope ) Subcutaneous start with up to 0.006 mg/kg/day, increasing the dose according to patient requirements (maximum 0.0125 mg/kg/day); ( Nutropin / Nutropin AQ ) Subcutaneous start with up to 0.006 mg/kg/day, increasing the dose according to patient requirements to a maximum of 0.025 mg/kg/day in patients younger than 35 yr and max of 0.0125 mg/kg daily in patients older than 35 yr.

( Nutropin / Nutropin AQ ) Subcutaneous Up to 0.35 mg/kg weekly (divided into daily injections) continued up to time of renal transplantation.

( Humatrope ) Subcutaneous Up to 0.375 mg/kg/wk (divided into equal doses given either daily or on 3 alternate days); ( Nutropin / Nutropin AQ ) Subcutaneous up to 0.375 mg/kg/wk (divided into equal doses 3 to 7 times/wk).

( Serostim ) Subcutaneous (at bedtime) greater than 55 kg body weight 6 mg daily; 45 to 55 kg body weight 5 mg daily; 35 to 45 kg body weight 4 mg daily; less than 35 kg body weight 0.1 mg/kg.

Storage/Stability

Store before and after administration in refrigerator. Use reconstituted drug within 14 days; refrigerate until used; avoid freezing.

Drug Interactions

May inhibit growth-promoting effects of somatropin.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; weakness; recurrent growth of intracranial tumor.

Dermatologic

Rash; urticaria; pain; inflammation at injection site.

Genitourinary

Glucosuria; hypercalciuria.

Metabolic

Hypothyroidism; hyperglycemia.

Miscellaneous

Localized muscle pain; mild, transient edema; antibodies to growth hormone.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Concomitant glucocorticoid therapy

May inhibit growth-promoting effects.

Hypothyroidism

May develop during therapy; monitor thyroid function.

Insulin resistance

May be induced with therapy; monitor for glucose intolerance.

Intracranial hypertension

Intracranial hypertension, with papilledema, visual changes, headache, nausea, or vomiting has been reported in few patients.

Intracranial lesion

Frequently examine patients with history of lesion.

Slipped capital epiphysis

May be seen in children with advanced renal osteodystrophy; may be affected by growth hormone. Be alert to development of limp or complaints of hip or knee pain.

Overdosage

Symptoms

Hypoglycemia followed by hyperglycemia; acromegaly (chronic overdosage).

Patient Information

• Instruct diabetic patients to monitor blood sugar closely and to report variations to health care provider.
• Tell children and parents to report limp or complaints of hip or knee pain to health care provider as soon as possible.
• Instruct patient to report these symptoms to health care provider: headache, weakness, localized muscle pain, or mild, transient edema.

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