soe-ma-TROE-pin

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

• 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 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.

• 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.

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: 3.8 hr.

(growth)

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)
• OB: Pregnancy.

Use Cautiously in:

• Growth hormone deficiency due to intracranial lesion
• Pituitary hormone deficiency or hypoadrenalism
• Diabetes (may cause insulin resistance)
• Thyroid dysfunction
• Lactation: Safety not established in breastfeeding
• Pedi: Girls with Turner syndrome (↑ risk for pancreatitis); childhood cancer survivors (↑ risk of intracranial tumors)
• Geri: Appears on Beers list. ↑ risk of edema, arthralgia, carpal tunnel syndrome, gynecomastia, and impaired fasting glucose in older adults. Avoid use in older adults, except for confirmed growth hormone deficiency due to an established etiology.

CV: edema of the hands and feet.

Endo: hyperglycemia, hypothyroidism, insulin resistance.

GI: PANCREATITIS.

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

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.

• 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): 0.04 mg/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 every 1–2 mo until clinical response achieved (max dose = 0.08 mg/kg/wk).

• Powder for injection (intramix cartridges with preservative): 5 mg/cartridge (green); 12 mg/cartridge (purple);
• Powder for 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 injection (GoQuick prefilled pen with preservative): 5 mg/pen; 5.3 mg/pen; 12 mg/pen;

• Growth Failure: Monitor bone age annually and growth rate determinations, height, and weight every 3–6 mo during therapy.

• Monitor thyroid function prior to and during therapy. May decrease T⁴, radioactive iodine uptake, and thyroxine-binding capacity. Hypothyroidism necessitates concurrent thyroid replacement for growth hormone to be effective. Serum inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may ↑ with somatropin therapy.
  • Monitor blood glucose periodically during therapy. Patients with diabetes may require ↑ insulin dose.
  • Monitor for development of neutralizing antibodies if growth rate does not exceed 2.5 cm/6 mo.
  • Monitor alkaline phosphatase closely in patients with adult growth hormone deficiency.

• Rotate injection sites with each injection.
  • Genotropin intramix: Dissolve powder with solution provided with 2-chamber cartridge as directed. Gently tip cartridge upside down a few times until contents are completely dissolved. Do not shake; shaking can denature the active ingredient. Solution is clear and colorless; do not administer if solution is discolored, cloudy, or contains particulate matter. Stable for 28 days if refrigerated.
  • Genotropin Pen: Prepare and administer as directed in patient instruction insert. Store in the refrigerator.
  • Genotropin MiniQuick: For single use only. Inject immediately after reconstitution; may be refrigerated for 24 hr after reconstitution. Follow directions on patient package insert for reconstitution and administration.
• SC: Injection volume should not exceed 1 mL.

• Instruct patient and parents on correct procedure for reconstituting medication, site selection, technique for SUBQ 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.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize need for regular follow-up with endocrinologist to ensure appropriate growth rate, evaluate lab work, and determine bone age by x-ray exam.

• Child’s attainment of adult height in growth failure secondary to pituitary growth hormone deficiency or idiopathic causes. Therapy is limited to period before closure of epiphyseal plates (approximately up to 14–15 yr in girls, 15–16 yr in boys).
• Replacement of growth hormone in deficient adults.

Genotropin, Genotropin MiniQuick

Genotropin GoQuick

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