NORDITROPIN

Administration and Use Instructions buy norditropin pen online

Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which Norditropin is indicated [see Indications and Usage (1)].

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Fundoscopic examination should be performed routinely before initiating treatment with Norditropin to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5)].

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Administer Norditropin by subcutaneous injection to the back of the upper arm, abdomen, buttocks, or thigh with regular rotation of injection sites to avoid lipoatrophy.

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Inspect visually for particulate matter and discoloration. Norditropin should be clear and colorless. If the solution is cloudy or contains particulate matter do not use.

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Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the Norditropin FlexPro prefilled pen.

Pediatric Dosage

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Individualize dosage for each patient based on the growth response.

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Divide the calculated weekly Norditropin dosage into equal doses given either 6, or 7 days per week.

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The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:

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Pediatric GH Deficiency: 0.17 mg/kg/week to 0.24 mg/kg/week (0.024 to 0.034 mg/kg/day)

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Noonan Syndrome: Up to 0.46 mg/kg/week (up to 0.066 mg/kg/day)

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Turner Syndrome: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)

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Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)

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In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of Norditropin (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.

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Idiopathic Short Stature: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)

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Prader-Willi Syndrome: 0.24 mg/kg/week (0.034 mg/kg/day)

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Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.

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Discontinue Norditropin for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4)].

Adult Dosage

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Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.

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Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with Norditropin than younger individuals [see Use in Specific Populations (8.5)].

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Estrogen-replete women and patients receiving oral estrogen may require higher doses [see Drug Interactions (7)].

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Administer the prescribed dose daily.

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Either of two Norditropin dosing regimens may be used:

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Non-weight based

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Initiate Norditropin with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.

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Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range.

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Maintenance dosages will vary considerably from person to person, and between male and female patients.

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Weight-based

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Initiate Norditropin at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily.

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Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.

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Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen

Dosage Forms and Strengths

Norditropininjection is a clear and colorless solution available as follows:

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5 mg in 1.5 mL (orange): NorditropinFlexPro single-patient-use pen

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10 mg in 1.5 mL (blue): Norditropin FlexPro single-patient-use pen

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15 mg in 1.5 mL (green): Norditropin FlexPro single-patient-use pen

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30 mg in 3 mL (purple): Norditropin FlexPro single-patient-use pen