DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Norditropin (Somatropin) - Indications and Dosage

 
 



Indications and Usage

Pediatric Patients:

Norditropin is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

Adult Patients:

Norditropin cartridges [somatropin (rDNA origin) injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset: Patients who have growth hormone deficiency, 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: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.

Dosage and Administration

Pediatric Patients

The Norditropin dosage and schedule of administration must be individualized for each patient. For the treatment of growth hormone insufficiency in children, a dosage of 0.024 – 0.034 mg/kg body weight/day, 6-7 times a week, by subcutaneous injection is recommended. The thighs are recommended as the preferred sites of injection and the injection site should be rotated.

Treatment with Norditropin of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused. Patients who fail to respond adequately while on Norditropin therapy should be evaluated to determine the cause of unresponsiveness.

Adult Patients

Based on the weight-based dosing utilized in the original pivotal study described herein, the recommended dosage at the start of therapy is not more than 0.004 mg/kg given as a daily subcutaneous injection. The dosage may be increased to not more than 0.016 mg/kg/day after approximately 6 weeks according to individual patient requirements. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I levels may be used as guidance in dose titration.

Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-I concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-I levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

All Patients

Norditropin cartridges must be administered using the NordiPen injection pen. Each cartridge size has a color-coded corresponding pen which is graduated to deliver the appropriate dose based on the concentration of Norditropin in the cartridge.

Norditropin MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Measuring The Prescribed Dose

Norditropin® cartridges 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

Each cartridge of Norditropin must be inserted into its corresponding NordiPen injection pen. Instructions for delivering the dosage are provided in the NordiPen instruction booklet.

Norditropin NordiFlex® 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

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

STABILITY AND STORAGE

Norditropin® cartridges (somatropin [rDNA origin] injection) 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

Non-injected/unused Norditropin cartridges must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light.

Norditropin cartridges retain their biological potency until the date of expiry indicated on the label.

5 mg/1.5 mL (orange) and 10 mg/1.5 mL (blue) cartridges:

After a Norditropin cartridge (5 mg/1.5 mL or 10 mg/1.5 mL) has been inserted into the NordiPen injector (NordiPen 5 or NordiPen 10 respectively), it may be EITHER stored in the pen in the refrigerator (2-8°C/36-46°F) and used within 4 weeks OR may be stored for up to 3 weeks at not more than 25°C (77°F). Discard unused portion.

15 mg/1.5 mL (green) cartridges:

After a Norditropin 15 mg/1.5 mL cartridge has been inserted into the NordiPen 15 injector, it must be stored in the pen in the refrigerator (2-8°C/36-46°F) and used within 4 weeks. Discard unused portion after 4 weeks.

Norditropin NordiFlex® (somatropin [rDNA origin] injection) 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

Non-injected/unused Norditropin NordiFlex prefilled pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light.

The Norditropin NordiFlex prefilled pens retain their biological potency until the date of expiry indicated on the label.

5 mg/1.5 mL (orange) and 10 mg/1.5 mL (blue) prefilled pens:

After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL or 10 mg/1.5 mL) prefilled pen may be EITHER stored in the refrigerator (2-8°C/36-46°F) and used within 4 weeks OR may be stored for up to 3 weeks at not more than 25°C (77°F). Discard unused portion.

15 mg/1.5 mL (green) prefilled pens:

After the initial injection, a Norditropin NordiFlex 15 mg/1.5 mL prefilled pen must be stored in the refrigerator (2-8°C/36-46°F) and used within 4 weeks. Discard unused portion after 4 weeks.

How Supplied

Norditropin® cartridges (somatropin [rDNA origin] injection) 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

Norditropin is individually cartoned in 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL cartridges which must be administered using the corresponding color-coded NordiPen® injection pen.

Norditropin cartridge 5 mg/1.5 mL (orange) NDC 0169-7768-11

Norditropin cartridge 10 mg/1.5 mL (blue) NDC 0169-7769-11

Norditropin cartridge 15 mg/1.5 mL (green) NDC 0169-7770-11

Norditropin NordiFlex® (somatropin [rDNA origin] injection) 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL prefilled pens.

Norditropin NordiFlex 5 mg/1.5 mL (orange) NDC 0169-7704-11

Norditropin NordiFlex 10 mg/1.5 mL (blue) NDC 0169-7705-11

Norditropin NordiFlex 15 mg/1.5 mL (green) NDC 0169-7708-11

Date of Issue: June 2006

© 2002-2006 Novo Nordisk Inc.

Novo Nordisk®, Norditropin®, NordiPen® and Norditropin NordiFlex® are registered trademarks of Novo Nordisk A/S.

For information contact:

Novo Nordisk Inc.

100 College Road West

Princeton, New Jersey 08540, USA

1-888-NOVO-444

www.norditropin-us.com

Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014