Omnitrope 5 mg/1.5 ml (SC Injection)

Indications

• Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone
• Treatment of pediatric patients with short stature associated with Noonan syndrome
• Treatment of pediatric patients with short stature associated with Turner syndrome
• Treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
• Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
• Growth hormone provocative test for diagnosis
• GH deficiency treatment in childhood and adulthood
• Reevaluation before continuation of Omnitrope therapy in adults with closed epiphyses
• Confirmation of the diagnosis of adult GHD
• Glucocorticoid replacement therapy for 11ß-Hydroxysteroid Dehydrogenase Type 1 inhibition
• Careful adjustment of glucocorticoid replacement therapy
• Monitoring for drug interactions with cytochrome P450-metabolized drugs
• Larger doses of Omnitrope may be required in women using oral estrogen
• Adjustment of insulin and/or oral/injectable hypoglycemic agents
• Contraindication for acute critical illness
• Caution in children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment
• Contraindication for active malignancy
• Contraindication for hypersensitivity to somatropin or excipients
• Contraindication for active proliferative or severe non-proliferative diabetic retinopathy
• Contraindication for children with closed epiphyses
• Monitoring for signs of upper airway obstruction and sleep apnea in children with Prader-Willi syndrome
• Monitoring for progression or recurrence in patients with preexisting tumors
• Monitoring for second neoplasm in childhood cancer survivors treated with Omnitrope
• Monitoring for impaired glucose tolerance and diabetes mellitus
• Periodic monitoring of glucose levels in all patients
• Adjustment of antihyperglycemic drugs doses in diabetics
• Exclusion of preexisting papilledema for intracranial hypertension
• Monitoring for development of slipped capital femoral epiphysis in children
• Evaluation of children with the onset of a limp or hip/knee pain for progression of preexisting scoliosis
• Consideration of pancreatitis in patients with persistent severe abdominal pain

Pharmacology

• Binding of somatropin to a dimeric GH receptor in the cell membrane
• Intracellular signal transduction
• Pharmacodynamic effects mediated by IGF-I produced in the liver and locally
• Direct effects of somatropin such as lipolysis

Dosage & Administration

• Subcutaneous administration of somatropin
• Rotation of injection sites to avoid lipoatrophy
• Different dosage recommendations for pediatric growth hormone deficiency, Noonan Syndrome, Turner Syndrome, Short stature born small for gestational age (SGA), and adult growth hormone deficiency

Interaction

• Potential need for glucocorticoid replacement therapy due to 11ß-Hydroxysteroid Dehydrogenase Type 1 inhibition
• Careful adjustment of glucocorticoid replacement therapy
• Monitoring for drug interactions with cytochrome P450-metabolized drugs
• Possible larger doses of Omnitrope required in women using oral estrogen
• Adjustment of insulin and/or oral/injectable hypoglycemic agents

Contraindications

• Acute critical illness
• Prader-Willi syndrome in severely obese or severe respiratory impairment children
• Active malignancy
• Hypersensitivity to somatropin or excipients
• Active proliferative or severe non-proliferative diabetic retinopathy
• Children with closed epiphyses

Side Effects

• Headaches
• Muscle pain
• Joint stiffness
• High blood sugar (hyperglycemia)
• Sugar in urine (glucosuria)

Pregnancy & Lactation

• Pregnancy Category C
• Caution in administration to pregnant and nursing women

Precautions & Warnings

• Assessment of potential benefit vs. risk in acute critical illness
• Evaluation for signs of upper airway obstruction and sleep apnea in children with Prader-Willi syndrome
• Monitoring for progression or recurrence in patients with preexisting tumors
• Increased risk of second neoplasm in childhood cancer survivors treated with Omnitrope
• Monitoring for impaired glucose tolerance and diabetes mellitus
• Periodic monitoring of glucose levels in all patients
• Adjustment of antihyperglycemic drugs doses in diabetics
• Exclusion of preexisting papilledema for intracranial hypertension
• Monitoring for development of slipped capital femoral epiphysis in children
• Evaluation of children with the onset of a limp or hip/knee pain for progression of preexisting scoliosis
• Consideration of pancreatitis in patients with persistent severe abdominal pain

Therapeutic Class

• Drugs for Growth failure

Storage Conditions

• Store at 2-8°C
• Avoid freezing
• Avoid direct light
• Keep out of reach of children

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