somatropin (recombinant)

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

REMS

Growth failure in children due to deficiency of growth hormone.
Children with short stature associated with Noonan syndrome or Turner syndrome.
Children with short stature born small for gestational age with no catch-up growth by age 2–4 yr.
Growth hormone deficiency in adults as a result of pituitary disease, hypothalamic disease, surgery, radiation, trauma, or childhood onset.

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.

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.

(growth)

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

Contraindicated in:

Hypersensitivity to growth hormone or phenol 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: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Childhood cancer survivors (↑ risk of intracranial tumors);
Geri: ↑sensitivity and risk of adverse reactions in older adults.

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.

Adult Growth Hormone Deficiency

SC (Adults ): 0.004 mg/kg/day, may be ↑ to 0.016 mg/kg/day after 6 wk 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.

Pediatric Growth Hormone Deficiency

SC (Children ): 0.024–0.034 mg/kg/day given 6–7 times weekly.

Short Stature Associated with Noonan or Turner Syndrome

SC (Children ): Noonan syndrome–Up to 0.066 mg/kg/day may be used; Turner syndrome–Up to 0.067 mg/kg/day may be used.

Short Stature Born Small for Gestational Age

SC (Children ): Up to 0.067 mg/kg/day may be used.

Solution for subcutaneous injection (FlexPro prefilled pens): 5 mg/1.5 mL (orange); 10 mg/1.5 mL (blue); 15 mg/1.5 mL (green); 30 mg/3 mL (purple)

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.

SC: Inject in back of upper arm, abdomen, buttock, or thigh. Rotate injection sites with each injection.
- Norditropin FlexPro prefilled pens contain multiple doses. After initial injection, use within 4 wk if stored in refrigerator or within 3 wk if stored at room temperature.

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. Advise parents to report signs and symptoms of pancreatitis (persistent severe abdominal pain) and hypersensitivity reactions (rash, facial swelling, difficulty breathing) immediately to health care professional.
Advise patients of reproductive potential to notify healthcare professional if pregnancy is planned or suspected or if breastfeeding.
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.

Norditropin Nordiflex

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)

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) * 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 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)

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