Norditropin

Indications
Dosage
How Supplied

INDICATIONS

Pediatric Patients

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.

Norditropin [somatropin (rDNA origin) 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 [somatropin (rDNA origin) 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 somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin 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.

DOSAGE AND ADMINISTRATION

For subcutaneous injection. Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.

Dosing Of Pediatric Patients

General Pediatric Dosing Information

The Norditropin dosage and administration schedule should be individualized based on the growth response of each patient. Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with Norditropin for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

A dosage of 0.024 to 0.034 mg/kg/day, 6 to 7 times a week, is recommended.

Pediatric Patients with Short Stature Associated with Noonan Syndrome

Not all patients with Noonan syndrome have short stature; some will achieve a normal adult height without treatment. Therefore, prior to initiating Norditropin for a patient with Noonan syndrome, establish that the patient does have short stature. A dosage of up to 0.066 mg/kg/day is recommended.

Pediatric Patients with Short Stature Associated with Turner Syndrome

A dosage of up to 0.067 mg/kg/day is recommended.

Pediatric Patients with Short Stature Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 to 4 Years

A dosage of up to 0.067 mg/kg/day is recommended.

Recent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.067 mg/kg/day), especially in very short children (i.e., HSDS < -3), and/or older/pubertal children, and that a reduction in dosage (e.g., gradually towards 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately < 4 years) (who respond the best in general) with less severe short stature (i.e., baseline HSDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the rhGH dose as necessary.

Dosing Of Adult Patients

Adult Growth Hormone Deficiency (GHD)

Either of two approaches to Norditropin dosing may be followed: a non-weight-based regimen or a weight-based regimen.

Non-weight basedbased on published consensus guidelines, 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 to 2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age-and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.

Weight-based based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.004 mg/kg/day. The dose 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 concentrations should be used as guidance in dose titration.

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.

Preparation And Administration

Norditropin® FlexPro® 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 leaflets enclosed with the Norditropin FlexPro prefilled pen.

Norditropin NordiFlex® 30 mg/3 mL:

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

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Norditropin MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Injection sites should always be rotated to avoid lipoatrophy.

HOW SUPPLIED

Dosage Forms And Strengths

Norditropin is available preloaded in the Norditropin FlexPro or Norditropin NordiFlex pens:

  • 5 mg/1.5 mL (orange): Norditropin FlexPro pen
  • 10 mg/1.5 mL (blue): Norditropin FlexPro pen
  • 15 mg/1.5 mL (green): Norditropin FlexPro pen
  • 30 mg/3 mL (purple): Norditropin NordiFlex prefilled pen

Storage And Handling

Norditropin FlexPro prefilled pens [somatropin (rDNA origin) injection] 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL:

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

Norditropin FlexPro 5 mg/1.5 mL (orange) NDC 0169-7704-21
Norditropin FlexPro 10 mg/1.5 mL (blue) NDC 0169-7705-21
Norditropin FlexPro 15 mg/1.5 mL (green) NDC 0169-7708-21

Norditropin NordiFlex prefilled pen [somatropin (rDNA origin) injection] 30 mg/3 mL:

Norditropin NordiFlex is individually cartoned as a 30 mg/3 mL prefilled pen.

Norditropin NordiFlex 30 mg/3 mL (purple) NDC 0169-7703-11

Norditropin Flexpro 5 mg/1.5 mL (orange),10 mg/1.5 mL (blue), 15mg/1.5 mL (green) and NordiFlex 30 mg/3 mL (purple) prefilled pens:

Unused Norditropin FlexPro and NordiFlex prefilled pens must be stored at 2°C-8°C/36°F-46°F (refrigerator). Do not freeze.

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

Table 10 : Storage Options

Norditropin Product Formulation Before Use In-use (After 1st injection)
Storage requirement Storage Option 1 (Refrigeration) Storage Option 2 (Room temperature)
5 mg 2-8°C/ 36-46°F
Until exp date
2-8°C/36-46°F
4 weeks
Up to 25°C/77°F
3 weeks
10 mg
15 mg
30 mg

For information contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536, USA 1-888-668-6444. Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Revised: September 2014

Last reviewed on RxList: 10/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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