• Growth failure in children due to Prader-Willi syndrome.
• Growth failure in children due to deficiency of growth hormone.
• Growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2.
• Short stature associated with Turner syndrome.
• Idiopathic short stature in children.
• Growth hormone deficiency in adults as a result of pituitary disease, hypothalamic disease, surgery, radiation or trauma.

Contraindicated in:

• Hypersensitivity to growth hormone or m-cresol preservative
• Closure of epiphyses
• Active neoplasia
• Acute critical illness secondary to complications of open heart surgery, abdominal surgery or trauma or those with acute respiratory failure
• Diabetic retinopathy
• Prader-Willi syndrome with obesity and respiratory impairment (risk of fatal complications; can be used only if growth hormone deficiency is documented).

Use Cautiously in:

• Growth hormone deficiency due to intracranial lesion
• Pituitary hormone deficiency or hypoadrenalism
• Diabetes (may cause insulin resistance)
• Thyroid dysfunction
• OB: Lactation: Safety not established
• Geri: ↑sensitivity, ↑ risk of adverse reactions
• Pedi: Girls with Turner syndrome (↑ risk for pancreatitis); childhood cancer survivors (↑ risk of intracranial tumors).

CV: edema of the hands and feet.

Endo: hyperglycemia, hypothyroidism, insulin resistance.

GI: PANCREATITIS.

Local: pain at injection site, local lipoatrophy or lipodystrophy with subcutaneous use.

MS: arthralgia.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Excessive corticosteroid use (equivalent to 10–15 mg/m²/day) may ↓ response to growth hormone.

• Powder for subcutaneous injection (intramix cartridges with preservative): 5 mg/cartridge (green); 12 mg/cartridge (purple);
• Powder for subcutaneous injection (Miniquick system without preservative): 0.2 mg/cartridge; 0.4 mg/cartridge; 0.6 mg/cartridge; 0.8 mg/cartridge; 1 mg/cartridge; 1.2 mg/cartridge; 1.4 mg/cartridge; 1.6 mg/cartridge; 1.8 mg/cartridge; 2 mg/cartridge;
• Powder for subcutaneous injection (GoQuick prefilled pen with preservative): 5 mg/pen; 5.3 mg/pen; 12 mg/pen;

• SC (Children): Growth hormone inadequacy–0.16–0.24 mg/kg/wk divided in 6–7 daily doses. Prader-Willi syndrome — 0.24 mg/kg/wk divided into 6–7 daily doses.Children SGA at birth — 0.48 mg/kg/wk divided into 6–7 daily doses.Turner syndrome — 0.33 mg/kg/wk divided into 6–7 daily doses. Idiopathic short stature — 0.47 mg/kg/wk divided into 6–7 daily doses.
• SC (Adults): 0.04mg/kg/wk initially divided in 6–7 daily doses or 0.2 mg/day starting dose (without consideration of body weight) then gradually ↑ by 0.1–0.2 mg/day q 1–2 mo until clinical response achieved (max dose 0.08 mg/kg/wk).

Genotropin, Genotropin MiniQuick

• Produce growth (skeletal and cellular).
• Metabolic actions include:
  • Increased protein synthesis,
  • Increased carbohydrate metabolism,
  • Lipid mobilization,
  • Retention of sodium, phosphorus, and potassium.
• Somatropin has the same amino acid sequence as naturally occurring growth hormone and is produced by recombinant DNA techniques.
• Growth hormone enhances GI tract mucosal transport of water, electrolytes and nutrients.

• Increased skeletal growth in children with growth hormone deficiency.
• Replacement of somatropin in deficient adults.
• Increased bone density in adult growth hormone–deficient patients.

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

Absorption: Well absorbed (80%).

Distribution: Localize to highly perfused organs (liver, kidneys).

Metabolism/Excretion: Broken down in renal cells to amino acids that are recirculated; some liver metabolism.

Half-life: Subcut — 3.8 hr.

Genotropin GoQuick

(growth)

• Instruct patient and parents on correct procedure for reconstituting medication, site selection, technique for subcut injection, and disposal of needles and syringes. Review dose schedule. Parents should report persistent pain or edema at injection site.
• Explain rationale for prohibition of use for increasing athletic performance. Administration to persons without growth hormone deficiency or after epiphyseal closure may result in acromegaly (coarsening of facial features; enlarged hands, feet, and internal organs; increased blood glucose; hypertension).
• Assure parents and child that these dose forms are synthetic and therefore not capable of transmitting Creutzfeldt-Jakob disease, as was the original somatropin, which was extracted from human cadavers.
• Advise parents to monitor blood glucose closely in children with diabetes mellitus. Parents should also be advised to report persistent severe abdominal pain; may be a symptom of pancreatitis, and signs and symptoms of hypersensitivity reactions (rash, facial swelling, difficulty breathing) immediately to health care professional.
• Emphasize need for regular follow-up with endocrinologist to ensure appropriate growth rate, to evaluate lab work, and to determine bone age by x-ray exam.

soe-ma-TROE-pin

NDC Code^*

• 0002- Eli Lilly and Company
  • 0002-7335- HUMATROPE
    • 0002-7335-11- 1 KIT in 1 CARTON (0002-7335-11) * 5 mL in 1 VIAL (0002-7349-01) * 5 mL in 1 VIAL (0002-7336-01)

• 0002- Eli Lilly and Company
  • 0002-8147- HUMATROPE
    • 0002-8147-01- 1 TRAY in 1 CARTON (0002-8147-01) > 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7554-01) * 2.88 mL in 1 SYRINGE (0002-7618-01)

• 0002- Eli Lilly and Company
  • 0002-8148- HUMATROPE
    • 0002-8148-01- 1 TRAY in 1 CARTON (0002-8148-01) > 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7555-01) * 2.88 mL in 1 SYRINGE (0002-7619-01)

• 0002- Eli Lilly and Company
  • 0002-8149- HUMATROPE
    • 0002-8149-01- 1 TRAY in 1 CARTON (0002-8149-01) > 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7556-01) * 2.88 mL in 1 SYRINGE (0002-7619-01)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2626- GENOTROPIN
    • 0013-2626-81- 1 CARTRIDGE in 1 CARTON (0013-2626-81) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2646- GENOTROPIN
    • 0013-2646-81- 1 CARTRIDGE in 1 CARTON (0013-2646-81) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2649- GENOTROPIN
    • 0013-2649-02- 7 CARTRIDGE in 1 CARTON (0013-2649-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2650- GENOTROPIN
    • 0013-2650-02- 7 CARTRIDGE in 1 CARTON (0013-2650-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2651- GENOTROPIN
    • 0013-2651-02- 7 CARTRIDGE in 1 CARTON (0013-2651-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2652- GENOTROPIN
    • 0013-2652-02- 7 CARTRIDGE in 1 CARTON (0013-2652-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2653- GENOTROPIN
    • 0013-2653-02- 7 CARTRIDGE in 1 CARTON (0013-2653-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2654- GENOTROPIN
    • 0013-2654-02- 7 CARTRIDGE in 1 CARTON (0013-2654-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2655- GENOTROPIN
    • 0013-2655-02- 7 CARTRIDGE in 1 CARTON (0013-2655-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2656- GENOTROPIN
    • 0013-2656-02- 7 CARTRIDGE in 1 CARTON (0013-2656-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2657- GENOTROPIN
    • 0013-2657-02- 7 CARTRIDGE in 1 CARTON (0013-2657-02) > 1 KIT in 1 CARTRIDGE

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-2658- GENOTROPIN
    • 0013-2658-02- 7 CARTRIDGE in 1 CARTON (0013-2658-02) > 1 KIT in 1 CARTRIDGE

• 0169- Novo Nordisk
  • 0169-7703- Norditropin
    • 0169-7703-21- 1 SYRINGE in 1 CARTON (0169-7703-21) > 3 mL in 1 SYRINGE

• 0169- Novo Nordisk
  • 0169-7704- Norditropin
    • 0169-7704-21- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7704-21) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0169- Novo Nordisk
  • 0169-7704- Norditropin
    • 0169-7704-92- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7704-92) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0169- Novo Nordisk
  • 0169-7705- Norditropin
    • 0169-7705-21- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-21) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0169- Novo Nordisk
  • 0169-7705- Norditropin
    • 0169-7705-92- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-92) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0169- Novo Nordisk
  • 0169-7708- Norditropin
    • 0169-7708-21- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7708-21) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0169- Novo Nordisk
  • 0169-7708- Norditropin
    • 0169-7708-92- 1 SYRINGE, PLASTIC in 1 CARTON (0169-7708-92) > 1.5 mL in 1 SYRINGE, PLASTIC

• 0781- Sandoz Inc
  • 0781-3001- Omnitrope
    • 0781-3001-07- 1 CARTRIDGE in 1 CARTON (0781-3001-07) > 1.5 mL in 1 CARTRIDGE

• 0781- Sandoz Inc
  • 0781-3001- Omnitrope
    • 0781-3001-26- 5 CARTRIDGE in 1 CARTON (0781-3001-26) > 1.5 mL in 1 CARTRIDGE

• 0781- Sandoz Inc
  • 0781-3004- Omnitrope
    • 0781-3004-07- 1 CARTRIDGE in 1 CARTON (0781-3004-07) > 1.5 mL in 1 CARTRIDGE

• 0781- Sandoz Inc
  • 0781-3004- Omnitrope
    • 0781-3004-26- 5 CARTRIDGE in 1 CARTON (0781-3004-26) > 1.5 mL in 1 CARTRIDGE

• 0781- Sandoz Inc
  • 0781-4004- Omnitrope
    • 0781-4004-36- 1 KIT in 1 CARTON (0781-4004-36) * 1 mL in 1 VIAL (0781-4014-71) * 1.14 mL in 1 VIAL (0781-4024-72)

• 44087- EMD Serono, Inc.
  • 44087-0004- Serostim
    • 44087-0004-7- 1 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASS

• 44087- EMD Serono, Inc.
  • 44087-0005- Serostim
    • 44087-0005-7- 1 KIT in 1 CARTON (44087-0005-7) * 1 mL in 1 VIAL * 1 mL in 1 VIAL

• 44087- EMD Serono, Inc.
  • 44087-0006- Serostim
    • 44087-0006-7- 1 KIT in 1 CARTON (44087-0006-7) * 1 mL in 1 VIAL * 1 mL in 1 VIAL

• 44087- EMD Serono, Inc.
  • 44087-0016- saizenprep
    • 44087-0016-1- 1 KIT in 1 CARTON (44087-0016-1) * 1.51 mL in 1 CARTRIDGE * 1.51 mL in 1 VIAL, GLASS

• 44087- EMD Serono, Inc.
  • 44087-1005- Saizen
    • 44087-1005-2- 1 KIT in 1 CARTON (44087-1005-2) * 3 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS

• 44087- EMD Serono, Inc.
  • 44087-1080- SAIZEN CLICKEASY
    • 44087-1080-1- 1 KIT in 1 CARTON (44087-1080-1) * 1.51 mL in 1 VIAL, GLASS * 1.51 mL in 1 CARTRIDGE

• 44087- EMD Serono, Inc.
  • 44087-1088- Saizen
    • 44087-1088-1- 1 KIT in 1 CARTON (44087-1088-1) * 3 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS

• 44087- EMD Serono, Inc.
  • 44087-3388- Zorbtive
    • 44087-3388-7- 1 KIT in 1 CARTON (44087-3388-7) * 3.5 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

• 50242- Genentech, Inc.
  • 50242-074- Nutropin AQ NuSpin 10
    • 50242-074-01- 1 CARTRIDGE in 1 CARTON (50242-074-01) > 2 mL in 1 CARTRIDGE

• 50242- Genentech, Inc.
  • 50242-075- Nutropin AQ NuSpin 5
    • 50242-075-01- 1 CARTRIDGE in 1 CARTON (50242-075-01) > 2 mL in 1 CARTRIDGE

• 50242- Genentech, Inc.
  • 50242-076- Nutropin AQ NuSpin 20
    • 50242-076-01- 1 CARTRIDGE in 1 CARTON (50242-076-01) > 2 mL in 1 CARTRIDGE

• 55566- Ferring Pharmaceuticals Inc.
  • 55566-1801- ZOMACTON
    • 55566-1801-1- 1 KIT in 1 CARTON (55566-1801-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 5 mL in 1 VIAL

• 55566- Ferring Pharmaceuticals Inc.
  • 55566-1901- ZOMACTON
    • 55566-1901-1- 1 KIT in 1 CARTON (55566-1901-1) * 1 mL in 1 VIAL * 5 mL in 1 VIAL

• 55566- Ferring Pharmaceuticals Inc.
  • 55566-1902- ZOMACTON
    • 55566-1902-1- 1 KIT in 1 CARTON (55566-1902-1) * 1 POWDER, FOR SOLUTION in 1 VIAL * 5 mL in 1 VIAL