somatropin (recombinant)

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

REMS

Growth failure in children due to inadequate secretion of growth hormone.
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.

Therapeutic effects:

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.

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;IM—4.9 hr.

(growth)

ROUTE	ONSET	PEAK	DURATION
IM, subcut	within 3 mo	unknown	12–48 hr

Contraindicated in:

Hypersensitivity to growth hormone or benzyl alcohol 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);
OB: Safety not established;
Geri: ↑sensitivity;↑ risk of adverse reactions;
Thyroid dysfunction;
Pedi: Neonates (diluent contains benzyl alcohol and may cause fatal gasping syndrome);
Pedi: Childhood cancer survivors (↑ risk of intracranial tumors).

CV: edema of the hands and feet

Derm: exacerbation of pre-existing psoriasis

Endo: hyperglycemia, hypothyroidism, insulin resistance

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

MS: arthralgia,, musculoskeletal pain,, swelling, stiffness

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 IM (Adults ): initially 0.005 mg/kg/day, may be increased to 0.01 mg/kg/day after 4 wk.
SC IM (Children ): 0.06 mg (0.18 unit/kg) 3 times weekly.

Powder for injection: 5 mg/vial; 8.8 mg/vial; 8.8 mg/vial (for use with Saizen click easy or Saizenprep reconstitution devices)

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

Lab Test Considerations:

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. Diabetic patients 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.
- Saizen: Reconstitute each 5-mg vial with 1–3 mL of bacteriostatic water for injection; use 2–3 mL for 8.8 mg vial. Aim the liquid against glass vial wall. Do not shake; swirl gently to dissolve. Solution is clear; do not use solutions that are cloudy or contain a precipitate. Reconstituted vials are stable for 14 days if refrigerated. To use cool.click needle-free injector, wind the device to energize the spring, and draw medication into the Crystal Check nozzle. Using firm pressure at the injection site, hold the injector at a 90° angle and press the blue actuator button.
SC: Injection volume should not exceed 1 mL.

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 report 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.

Child’s attainment of adult height in growth failure secondary to pituitary growth hormone deficiency. 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.

Saizen, Saizen Click Easy, Saizenprep

Disturbed body image(Indications)

NDC Code

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- Pfizer Laboratories Div Pfizer Inc
- 0013-2626- GENOTROPIN
  - 0013-2626-81- 1 CARTRIDGE in 1 CARTON (0013-2626-81) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2646- GENOTROPIN
  - 0013-2646-81- 1 CARTRIDGE in 1 CARTON (0013-2646-81) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2649- GENOTROPIN
  - 0013-2649-02- 7 CARTRIDGE in 1 CARTON (0013-2649-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2650- GENOTROPIN
  - 0013-2650-02- 7 CARTRIDGE in 1 CARTON (0013-2650-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2651- GENOTROPIN
  - 0013-2651-02- 7 CARTRIDGE in 1 CARTON (0013-2651-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2652- GENOTROPIN
  - 0013-2652-02- 7 CARTRIDGE in 1 CARTON (0013-2652-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2653- GENOTROPIN
  - 0013-2653-02- 7 CARTRIDGE in 1 CARTON (0013-2653-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2654- GENOTROPIN
  - 0013-2654-02- 7 CARTRIDGE in 1 CARTON (0013-2654-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2655- GENOTROPIN
  - 0013-2655-02- 7 CARTRIDGE in 1 CARTON (0013-2655-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2656- GENOTROPIN
  - 0013-2656-02- 7 CARTRIDGE in 1 CARTON (0013-2656-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2657- GENOTROPIN
  - 0013-2657-02- 7 CARTRIDGE in 1 CARTON (0013-2657-02) / 1 KIT in 1 CARTRIDGE

0013- Pfizer Laboratories Div Pfizer Inc
- 0013-2658- GENOTROPIN
  - 0013-2658-02- 7 CARTRIDGE in 1 CARTON (0013-2658-02) / 1 KIT in 1 CARTRIDGE

0078- Novartis Pharmaceuticals Corporation
- 0078-1427-
  - 0078-1427-02- 1 kg in 1 BOTTLE (0078-1427-02)

0078- Novartis Pharmaceuticals Corporation
- 0078-1497-
  - 0078-1497-01- 1.5 mL in 1 CARTRIDGE (0078-1497-01)

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
- 0169-7703- Norditropin
  - 0169-7703-92- 1 SYRINGE in 1 CARTON (0169-7703-92) / 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

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

50242- Genentech, Inc.
- 50242-931-
  - 50242-931-01- 120 L in 1 TANK (50242-931-01)

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

55566- Ferring Pharmaceuticals Inc.
- 55566-1901- ZOMACTON
  - 55566-1901-1- 1 KIT in 1 CARTON (55566-1901-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 1 mL in 1 SYRINGE, PLASTIC

62287- Wasserburger Arzneimittelwerk GmbH
- 62287-190-
  - 62287-190-10- 8 TRAY in 1 BOX (62287-190-10) / 352 VIAL in 1 TRAY / 1 POWDER, FOR SOLUTION in 1 VIAL

68594- Boehringer Ingelheim RCV GmbH & Co KG
- 68594-040-
  68594-040-99- 1 mg in 1 BOTTLE (68594-040-99)

84606- Bio-Technology General (Israel) Ltd.
- 84606-0824-
  84606-0824-1- 10 g in 1 BOTTLE, GLASS (84606-0824-1)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-01- 1 g in 1 BAG (85717-001-01)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-02- 2 g in 1 BAG (85717-001-02)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-05- 5 g in 1 BAG (85717-001-05)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-10- 10 g in 1 BAG (85717-001-10)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-11- 100 g in 1 BAG (85717-001-11)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-30- 30 g in 1 BAG (85717-001-30)

85717- Jilin Qijian Bio-Pharmaceutical Co.,Ltd.
- 85717-001-
  85717-001-50- 50 g in 1 BAG (85717-001-50)

85893- Hefei Xinzhu Biological Technology Co., Ltd.
- 85893-006-
  85893-006-01- 60 g in 1 BAG (85893-006-01)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

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