Adult Dosing

Growth hormone deficiency (childhood or adult-onset GHD)

• Weight-based dosing
• Start 0.004 mg/kg/day SC; may titrate gradually upward, as needed, after 6 weeks to a max of 0.016 mg/kg/day
• Max: 0.016 mg/kg/day

• Non-weight-based dosing for obese individuals
• Start 0.2 mg/day (range: 0.15-0.30 mg/day) SC; may gradually increase dose q1-2 months by increments of approximately 0.1-0.2 mg/day

• 1 mg of somatropin is equivalent to approximately 3 IU
• Rotate the site of injections daily to help prevent lipoatrophy
• Consider a lower starting dose and smaller dose titration in elderly patients

Pediatric Dosing

Growth hormone deficiency (GHD)

• 0.024-0.034 mg/kg/day SC, 6-7 injections/wk; discontinue when epiphyses close or when patient reaches satisfactory height

Short stature associated with Turner Syndrome

• Dosage up to 0.067 mg/kg/day SC; discontinue when epiphyses close or when patient reaches satisfactory height

Short stature associated with Noonan Syndrome

• Up to 0.066 mg/kg/day SC; discontinue when epiphyses close or when patient reaches satisfactory height

SGA-associated growth failure (for children who fail to manifest catch-up growth by 2-4 yrs)

• 0.033-0.067 mg/kg/day SC; discontinue when epiphyses close or when patient reaches satisfactory height

• 1 mg of somatropin is equivalent to approximately 3 IU
• Rotate the site of injections daily to help prevent lipoatrophy
• Establish that the patient does have short stature prior to initiating therapy in a child with Noonan syndrome

• Treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome or Turner syndrome; also indicated for treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by 2-4 yrs of age
• Replacement of endogenous GH in adult patients with either adult-onset or childhood-onset growth hormone deficiency (GHD)

• Hypersensitivity to any of the ingredients of the product
• IV administration
• Active malignancy
• Intracranial lesion
• Pediatric patients with closed epiphyses
• Active proliferative or severe non-proliferative diabetic retinopathy
• Acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma
• Acute respiratory failure
• Children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment
• Pediatric patients with growth failure due to genetically confirmed Prader-Willi syndrome
• Respiratory infections

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Therapy should be directed by physicians who are well trained in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, TS, SGA and adults with childhood-onset or adult-onset GHD
• Somatropin therapy increases mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, acute respiratory failure, or multiple accidental trauma. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk
• Fatalities have been reported following therapy initiation in pediatric patients with PWS who had one or more of the following risk factors: severe obesity, unidentified respiratory infection, or history of upper airway obstruction or sleep apnea; male patients are more prone to such fatalities
• Evaluate patients with PWS for signs of upper airway obstruction and sleep apnea before treatment initiation with somatropin; interrupt therapy if such signs develop during treatment
• Effective weight control measures should be considered in patients with PWS treated with somatropin. Monitor for signs of respiratory infection, which should be diagnosed at the earliest and treated aggressively
• Routinely examine patients with preexisting tumors or GHD secondary to an intracranial lesion for progression or recurrence of the underlying disease process. Increased risk of a second neoplasm has been reported in childhood cancer survivors treated with somatropin following their first neoplasm. Intracranial tumors, particularly meningiomas, have occurred in patients treated with radiation to the head for their first neoplasm. Carefully monitor patients for any malignant transformation of skin lesions
• Therapy may decrease insulin sensitivity, particularly at higher doses in susceptible patients. Monitor glucose levels periodically in all patients receiving therapy, especially in those with risk factors for diabetes mellitus, including obesity, Turner syndrome, or a family history of diabetes mellitus. Closely monitor patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance; if required, adjust doses of antihyperglycemic drugs when somatropin therapy is initiated in these patients
• Intracranial hypertension (IH) with papilledema, visual changes, headache, and other signs have been reported with somatropin therapy; perform funduscopic examination before initiating treatment to exclude preexisting papilledema and periodically during the course of somatropin therapy
• Discontinue treatment if papilledema is observed by funduscopy and restart at a lower dose after IH-associated signs and symptoms have resolved
• Patients with Turner syndrome and PWS are more susceptible for the development of IH
• Fluid retention may occur in adult patients during somatropin replacement therapy
• Closely monitor patients with hypopituitarism (multiple pituitary hormone deficiencies) during somatropin treatment
• Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, particularly, the growth response in children. Patients with Turner syndrome posses an increased risk of developing autoimmune thyroid disease and primary hypothyroidism
• Periodically perform thyroid function tests during therapy; initiate thyroid hormone replacement therapy or appropriately adjust the dose when indicated
• Pediatric patients with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated, as slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth
• Patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis as somatropin increases growth rate. Scoliosis is commonly seen in untreated patients with PWS; hence, physicians should be alert to these abnormalities, which may manifest during therapy
• Therapy may be associated with an increased risk of ear and hearing disorders. Therefore, patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders
• Closely monitor patients with Turner syndrome for cardiovascular disorders such as stroke, hypertension, and aortic aneurysm as they are at an increased risk for these conditions
• Patients treated with somatropin replacement therapy in childhood should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults
• Rotate the injection site of somatropin as it can cause tissue atrophy if administered subcutaneously at the same site over a long period of time
• Local or systemic allergic reactions may occur during therapy. Inform parents/patients that such reactions are possible and prompt medical attention should be sought on occurrence of these allergic reactions
• Rare cases of pancreatitis have been reported in children and adults receiving therapy; girls with Turner syndrome are more susceptible to this risk
• Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase during somatropin therapy

Cautions: Use cautiously in

• Elderly patients
• Neonates

Supplemental Patient Information

• Inform patients and caregivers about the potential benefits and risks associated with somatropin therapy
• Instruct patients and caregivers regarding the importance of proper disposal of used needles and syringes; strongly recommend a puncture-resistant container for the disposal of such materials

Pregnancy Category:C

Breastfeeding: Safety unknown. Limited data indicate that exogenous somatropin is not expected to cause any adverse effects in breastfed infants of mothers who receive somatropin. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 February 2011). Manufacturer advises caution.

• CNS: Intracranial hypertension, intracranial tumors, headache
• NEURO: Paresthesias
• CV: Hypertension, edema of the hands and feet
• EENT: Diabetic retinopathy, otitis media (Turner syndrome use)
• RESP: URTI
• GI: Pancreatitis, gastroenteritis
• ENDO: Hypothyroidism, insulin resistance, glucose intolerance, diabetes mellitus, gynecomastia
• METABOLIC: Hyperglycemia, hypertriglyceridemia
• HEMA: Leukemia (pediatric patients)
• LOCAL: Pain at injection site, injection site reactions/rashes, local lipoatrophy or lipodystrophy with subcutaneous use, edema
• GU: Glucosuria
• MUSC: Slipped capital femoral epiphysis, progression of preexisting scoliosis, arthralgia, myalgia, skeletal pain
• MISC: Hypersensitivity reactions, influenza-like symptoms, increased sweating, sudden death, weakness

• Growth hormone (GH); mimics action of naturally occurring GH 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, increases plasma fatty acids, and reduces body fat stores and lipid mobilization
• Metabolism: Primarily renal; some hepatic metabolism also occurs
• Excreted in bile
• Half-life: 7-10 hrs

US Trade Name(s)

• Norditropin
• Norditropin FlexPro
• Norditropin NordiFlex

US Availability

Norditropin

• INJ (cartridges): 5 mg/1.5 mL
• INJ (cartridges): 15 mg/1.5 mL

Norditropin FlexPro

• INJ (prefilled pens): 5 mg/1.5 mL
• INJ (prefilled pens): 10 mg/1.5 mL
• INJ (prefilled pens): 15 mg/1.5 mL

Norditropin NordiFlex

• INJ (prefilled pens): 5 mg/1.5 mL
• INJ (prefilled pens): 10 mg/1.5 mL
• INJ (prefilled pens): 15 mg/1.5 mL
• INJ (prefilled pens): 30 mg/3 mL

Canadian Trade Name(s)

• Norditropin SimpleXx
• Norditropin NordiFlex

Canadian Availability

Norditropin SimpleXx

• SOLN for INJ (cartridges): 5 mg/1.5 mL
• SOLN for INJ (cartridges): 10 mg/1.5 mL
• SOLN for INJ (cartridges): 15 mg/1.5 mL

Norditropin NordiFlex

• INJ (prefilled pens): 5 mg/1.5 mL
• INJ (prefilled pens): 10 mg/1.5 mL
• INJ (prefilled pens): 15 mg/1.5 mL

UK Trade Name(s)

• Norditropin SimpleXx
• Norditropin NordiFlex

UK Availability

Norditropin SimpleXx

• SOLN for INJ: 5 mg/1.5 mL
• SOLN for INJ: 10 mg/1.5 mL
• SOLN for INJ: 15 mg/1.5 mL

Norditropin NordiFlex

• INJ (prefilled pens): 15 mg/1.5 mL

Australian Trade Name(s)

• Norditropin SimpleXx
• Norditropin NordiFlex

Australian Availability

Norditropin SimpleXx

• SOLN for INJ (cartridges): 5 mg/1.5 mL
• SOLN for INJ (cartridges): 10 mg/1.5 mL
• SOLN for INJ (cartridges): 15 mg/1.5 mL

Norditropin NordiFlex

• INJ (prefilled pens): 5 mg/1.5 mL
• INJ (prefilled pens): 10 mg/1.5 mL
• INJ (prefilled pens): 15 mg/1.5 mL

Endocrine/Metabolic

Growth Hormones

Pricing data from www.DrugStore.com in U.S.A.

• Norditropin 5 MG/1.5ML SOLN [Cartridge] (NOVO NORDISK)
  1.5 1.5ml = $351.06
  4.5 1.5ml = $1015.2
• Norditropin FlexPro 5 MG/1.5ML SOLN [Pen] (NOVO NORDISK)
  1.5 1.5ml = $399
  4.5 1.5ml = $1130.98
• Norditropin 15 MG/1.5ML SOLN [Cartridge] (NOVO NORDISK)
  1.5 1.5ml = $1055.3
  4.5 1.5ml = $3128.16
• Norditropin NordiFlex Pen 5 MG/1.5ML SOLN [Pen] (NOVO NORDISK)
  1.5 1.5ml = $376
  4.5 1.5ml = $1055.96
• Norditropin FlexPro 10 MG/1.5ML SOLN [Pen] (NOVO NORDISK)
  1.5 1.5ml = $788
  4.5 1.5ml = $2300
• Norditropin FlexPro 15 MG/1.5ML SOLN [Pen] (NOVO NORDISK)
  1.5 1.5ml = $1178.98
  4.5 1.5ml = $3431.86

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.