Norditropin Simplexx Injection

Pediatric Patients: Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH). Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome. … Read morePediatric Patients: Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH). Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome. Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome. Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years. Adult Patients: Norditropin SimpleXx 5 mg/1.5 ml injection is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria: Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood-Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients who were treated with Norditropin SimpleXx 5 mg/1.5 ml for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of Norditropin SimpleXx 5 mg/1.5 ml therapy at the reduced dose level recommended for GHD adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency. Genotropin Injection

Drugs for Growth failure

Norditropin SimpleXx 5 mg/1.5 ml is a synthetic human growth hormone of recombinant DNA origin. It stimulates skeletal and soft tissue growth by promoting cell division, amino acid uptake and protein synthesis. It also possesses both insulin-like and diabetogenic effects.

Children with short stature homeobox-containing (SHOX) deficiency: Child: 50 mcg/kg/day may be used. Growth retardation due to chronic renal insufficiency, Turner’s syndrome: Child: 45-50 mcg/kg or 1.4 mg/m2 daily. Growth retardation in children who were born small for gestational age, Prader-Will syndrome: Child: 35 mcg/kg or 1 mg/m2 daily. Max: 2.7 mg daily. Growth hormone deficiency: Adult: Initially, 6 mcg/kg daily. May increase gradually according to patient response. Max: 12.5 mcg/kg/day. Reassess 9 mth after starting treatment. Child: 25-35 mcg/kg daily. Reassess 9 mth after starting treatment. Elderly: Lower doses may be required. Short bowel syndrome: Adult: 100 mcg/kg/day for 4 wk. Max: 8 mg/day. HIV-associated wasting or cachexia: Adult: 0.1 mg/kg daily at bedtime. May be taken on alternate days for patients at increased risk of adverse effects. Max: 6 mg/day.

Norditropin SimpleXx 5 mg/1.5 ml should be administered subcutaneously. Injection sites should always be rotated to avoid lipoatrophy. Pediatric growth hormone deficiency: 0.024 to 0.034 mg/kg/day, 6 to 7 times a week. Noonan Syndrome: Up to 0.066 mg/kg/day. Turner Syndrome: Up to 0.067 mg/kg/day. Short stature born small for gestational age (SGA): Up to 0.067 mg/kg/day. Adult growth hormone deficiency: 0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.

Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses. Glucocorticoid Replacement: Should be carefully adjusted. Cytochrome P450-Metabolized Drugs: Monitor carefully if used with Norditropin SimpleXx 5 mg/1.5 ml. Oral Estrogen: Larger doses of Norditropin SimpleXx 5 mg/1.5 ml may be required in women. Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment.

Acute Critical Illness Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment-reports of sudden death Active Malignancy Hypersensitivity to Norditropin SimpleXx 5 mg/1.5 ml or excipients Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy Children with closed epiphyses

The most common side effects of Norditropin SimpleXx 5 mg/1.5 ml include headaches, muscle pain, joint stiffness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria).

Pregnancy category B1. Animal reproduction studies have not been conducted with Norditropin. It is not known whether Norditropin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies conducted with Norditropin in nursing mothers and it is not known whether Norditropin is excreted in breast milk.

Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential riskPrader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment for GHD. Discontinue treatment if these signs occur.Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with Norditropin SimpleXx 5 mg/1.5 ml- in particular meningiomas in patients treated with radiation to the head for their first neoplasm.Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction.Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome- especially in adults): May occur frequently. Reduce dose as necessary.Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.Hypothyroidism: May first become evident or worsen.Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain.Progression of Preexisting Scoliosis: May develop.Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain.

Store at 2-8°C. Do not freeze. Avoid direct light. Keep out of reach of children.

Drugs for Growth failure

Norditropin SimpleXx 5 mg/1.5 ml (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-I produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of Norditropin SimpleXx 5 mg/1.5 ml (e.g., lipolysis).

Pregnancy Category C. Animal reproduction studies have not been conducted with Norditropin SimpleXx 5 mg/1.5 ml. It is not known whether Norditropin SimpleXx 5 mg/1.5 ml can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Norditropin SimpleXx 5 mg/1.5 ml should be given to a pregnant woman only if clearly needed. It is not known whether Norditropin SimpleXx 5 mg/1.5 ml is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Norditropin SimpleXx 5 mg/1.5 ml is administered to a nursing woman.