Adult Dosing

Growth hormone deficiency (GHD)

• Weight-based dosing
• Start 0.005 mg/kg/day SC/IM; if indicated, gradually increase dose after 4 wks to a max of 0.01 mg/kg/day
• Max: 0.01 mg/kg/day]

• Non-weight-based dosing for obese individuals
• Start 0.2 mg/day (range: 0.15-0.30 mg/day) SC/IM; 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)

• 0.18 mg/kg/wk SC/IM divided equally 3 days/wk or 6-7 days/wk; 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

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prolonged treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone
• Treatment of adult patients with either adult onset or childhood onset growth hormone deficiency (GHD)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to benzyl alcohol
• Acute critical illness following open heart surgery, abdominal surgery, or multiple accidental trauma
• Acute respiratory failure
• In children with closed epiphyses
• Active malignancy
• Intracranial lesion
• Active proliferative or severe non-proliferative diabetic retinopathy
• Patients with Prader-Willi syndrome (PWS) who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment or respiratory infection
• Prolonged treatment of pediatric patients having growth failure due to genetically confirmed PWS
• IV administration

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Fatalities have been reported following therapy initiation in pediatric patients with Prader-Willi Syndrome who had one or more of the following risk factors including severe obesity, unidentified respiratory infection, history of upper airway obstruction or sleep apnea; male patients with one or more of these factors 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
• Contraindicated for prolonged treatment of pediatric patients who have growth failure due to genetically confirmed PWS
• Somatropin therapy increases mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, and those with acute respiratory failure. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk
• Therapy should be directed by physicians who are well trained in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with childhood-onset or adult-onset GHD
• 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
• 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
• Carefully monitor patients for any malignant transformation of skin lesions
• 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, chronic renal insufficiency, and PWS are more susceptible for the development of IH
• 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
• 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
• 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
• 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
• Fluid retention may occur in adult patients during somatropin replacement therapy
• Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase during somatropin therapy

Cautions: Use cautiously in

• Neonates
• Elderly patients

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:B

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 7 February 2011). Manufacturer advises caution.

• CNS: Dizziness, headache, insomnia, intracranial hypertension, seizures (pediatric patients)
• PSYCHIATRY: Depression
• CV: Chest pain, hypertension, edema of the hands and feet
• ENDO: Hypoglycemia, hypothyroidism, insulin resistance, diabetes mellitus, glucose intolerance
• NEURO: Paresthesia, hypoesthesia
• HEMA: Leukemia (pediatric patients)
• DERM: Exacerbation of preexisting psoriasis (pediatric patients)
• EENT: Rhinitis
• RESP: URTI
• GI: Nausea, pancreatitis
• MUSC: Arthralgia, back pain, myalgia, skeletal pain, carpal tunnel syndrome, stiffness, swelling, scoliosis progression, slipped capital femoral epiphysis
• Local: Injection site reactions such as pain, redness, numbness, and swelling
• MISC: Influenza-like symptoms, sudden death, hypersensitivity reactions, fluid imbalance

• 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
• Absolute bioavailability: 70-90%
• Metabolism: Undergoes classical protein catabolism in both liver and kidneys
• Excretion: Bile
• Half life:
• SC: 1.75 hrs
• IM: 3.4 hrs

US Trade Name(s)

• Saizen

US Availability

Saizen

• PWDR for INJ: 5 mg/vial (10 mL vial)
• PWDR for INJ: 8.8 mg/vial (10 mL vial)
• Saizen click.easy: 1.5 mg/mL (4 mg)
• Saizen click.easy: 5.83 mg/mL (8.8 mg)
• Saizen click.easy: 8 mg/mL (8.8 mg)

Canadian Trade Name(s)

• Saizen

Canadian Availability

Saizen

• PWDR for INJ: 1.33 mg (1 mL vial)
• PWDR for INJ: 3.33 mg (5 mL vial)
• PWDR for INJ: 5 mg (10 mL vial)
• PWDR for INJ: 8.8 mg (10 mL vial)
• Saizen click.easy: 1.5 mg/mL (4 mg)
• Saizen click.easy: 5.83 mg/mL (8.8 mg)
• Saizen click.easy: 8 mg/mL (8.8 mg)
• SOLN for INJ: 5.83 mg/mL (6 mg/cartridge)
• SOLN for INJ: 8 mg/mL (12 mg/cartridge)
• SOLN for INJ: 8 mg/mL (20 mg/cartridge)

UK Trade Name(s)

• Saizen

UK Availability

Saizen

• PWDR for INJ: 1.33 mg (5 mL vial)
• PWDR for INJ: 3.33 mg (10 mL vial)
• Saizen click.easy: 5.83 mg/mL (8 mg)
• SOLN for INJ: 5.83 mg/mL (6 mg/cartridge)
• SOLN for INJ: 8 mg/mL (12 mg/cartridge)
• SOLN for INJ: 8 mg/mL (20 mg/cartridge)

Australian Trade Name(s)

• Saizen

Australian Availability

Saizen

• PWDR for INJ: 3 mg (5 mL vial)
• Saizen 8 mg click.easy: 5.83 mg/mL (8 mg)
• SOLN for INJ: 5.83 mg/mL (6 mg/cartridge)
• SOLN for INJ: 8 mg/mL (12 mg/cartridge)
• SOLN for INJ: 8 mg/mL (20 mg cartridge)

[Outline]

Endocrine/Metabolic

Growth Hormones

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

• Saizen 8.8 MG SOLR [Vial] (SERONO)
  1 mg = $662.97
  3 mg = $1870.94
• Saizen 5 MG SOLR [Vial] (SERONO)
  1 mg = $419.99
  3 mg = $1242.94
• Saizen Click.Easy 8.8 MG SOLR [Vial] (SERONO)
  1 mg = $627.99
  3 mg = $1799.96

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.