Norditropinis given by injection under the skin (subcutaneous) and is used to treat:
children who are not growing because of low or no growth hormone.
Norditropinis a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.
children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.
children who have Idiopathic Short Stature (ISS).
children who are not growing who have Prader-Willi syndrome (PWS).
adults who do not make enough growth hormone.
What are the possible side effects of Norditropin?
Norditropin may cause serious side effects, including:
high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.
high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.
increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin.
new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with Norditropin.
increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider.
serious allergic reactions. Get medical help right away if you or your child has the following symptoms:
swelling of your face, lips, mouth, or tongue
trouble breathing
wheezing
severe itching
skin rashes, redness, or swelling
dizziness or fainting
fast heartbeat or pounding in your chest
sweating
your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with Norditropin. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.
decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Norditropin works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.
hip and knee pain or a limp in children (slipped capital femoral epiphysis)
worsening of curvature of the spine (scoliosis)
severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.
loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject Norditropin.
increase in phosphorus, alkaline phosphate and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.
The most common side effects of Norditropin include:
injection site reactions and rashes
headaches
These are not all the possible side effects of Norditropin.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1- 888-668-6444.
DESCRIPTION
NORDITROPIN(somatropin) for injection is a recombinant human growth hormone. It is a polypeptide of recombination DNA origin and is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone.
NORDITROPIN contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.
NORDITROPIN is supplied as a sterile solution for subcutaneous use in ready-to-administer pre filled pens with a volume of 1.5 mL or 3 mL.
INDICATIONS
Pediatric Patients
NORDITROPIN is indicated for the treatment of pediatric patients with:
growth failure due to inadequate secretion of endogenous growth hormone (GH),
short stature associated with Noon an syndrome,
short stature associated with Turner syndrome,
short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age,
Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
growth failure due to Prader-Willi syndrome (PWS).
Adult Patients
NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
DOSAGE AND ADMINISTRATION
Administration And Use Instructions
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].
Endoscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter [see WARNINGS AND PRECAUTIONS].
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.
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.
Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the NORDITROPIN FlexPro pre filled pen.
Pediatric Dosage
Individualize dosage for each patient based on the growth response.
Divide the calculated weekly NORDITROPIN dosage into equal doses given either 6, or 7 days per week.
The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
Pediatric GH Deficiency: 0.17 mg/kg/week to 0.24 mg/kg/week (0.024 to 0.034 mg/kg/day)
Noonan Syndrome: Up to 0.46 mg/kg/week (up to 0.066 mg/kg/day)
Turner Syndrome: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
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.
Idiopathic Short Stature: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
Prader-Willi Syndrome: 0.24 mg/kg/week (0.034 mg/kg/day)
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.
Discontinue NORDITROPIN for stimulation of linear growth once epiphyseal fusion has occurred [see CONTRAINDICATIONS].
Adult Dosage
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.
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].
Estrogen-replete women and patients receiving oral estrogen may require higher doses [see DRUG INTERACTIONS].
Administer the prescribed dose daily.
Either of two NORDITROPIN dosing regimens may be used:
Non-weight based
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.
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.
Maintenance dosages will vary considerably from person to person, and between male and female patients.
Weight-based
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.
Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen
HOW SUPPLIED
Dosage Forms And Strengths
NORDITROPIN injection is a clear and colorless solution available as follows:
5 mg in 1.5 mL (orange): NORDITROPIN Flex-Pro single-patient-use pen
10 mg in 1.5 mL (blue): NORDITROPIN Flex-pro single-patient-use pen
15 mg in 1.5 mL (green): NORDITROPIN Flex-pro single-patient-use pen
30 mg in 3 mL (purple): NORDITROPIN Flex-pro single-patient-use pen
Storage And Handling
NORDITROPIN injection is a clear and colorless solution available as Flex-pro pre filled pens:
NORDITROPIN Flex-Pro 5 mg/1.5 mL (orange) NDC 0169-7704-21
NORDITROPIN Flex-pro 10 mg/1.5 mL (blue) NDC 0169-7705-21
NORDITROPIN Flex-pro 15 mg/1.5 mL (green) NDC 0169-7708-21
NORDITROPIN Flex-pro 30 mg/3 mL (purple) NDC 0169-7703-21
Each NORDITROPIN Flex-pro pen is for use by a single patient. A NORDITROPIN Flex-pro pen must never be shared between patients, even if the needle is changed.
Unused NORDITROPIN FlexPro pre filled pens must be stored at 2°C to 8°C/36°F to 46°F (refrigerator). Do not freeze. Avoid direct light.
Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd Denmark. Revised Mar 2020
SIDE EFFECTS
The following important adverse reactions are also described elsewhere in the labeling:
Increased mortality in patients with acute critical illness [see WARNINGS AND PRECAUTIONS]
Sudden death in children with Prader-Willi syndrome [see WARNINGS AND PRECAUTIONS]
Neoplasms [see WARNINGS AND PRECAUTIONS]
Glucose intolerance and diabetes mellitus [see WARNINGS AND PRECAUTIONS]
Intracranial hypertension [see WARNINGS AND PRECAUTIONS]
Severe hypersensitivity [see WARNINGS AND PRECAUTIONS]
Fluid retention [see WARNINGS AND PRECAUTIONS]
Hypoadrenalism [see WARNINGS AND PRECAUTIONS]
Hypothyroidism [see WARNINGS AND PRECAUTIONS]
Slipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS]
Progression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS]
Pancreatitis [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin product cannot always be directly compared to the rates observed during the clinical trials performed with another somatropin product, and may not reflect the adverse reaction rates observed in practice.
Pediatric Patients
Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone
In one randomized, open label, clinical study the most frequent adverse reactions were headache, pharyngitis, otitis media and fever. There were no clinically significant differences between the three doses assessed in the study (0.025, 0.05 and 0.1 mg/kg/day).
Short Stature Associated with Noonan Syndrome
NORDITROPIN was studied in 21 pediatric patients, 3 years to 14 years of age at doses of 0.033 mg/kg/day and 0.066 mg/kg/day. After the two-year study, patients continued NORDITROPIN treatment until final height was achieved; randomized dose groups were not maintained. Adverse reactions were later collected retrospectively from 18 pediatric patients; total follow-up was 11 years. An additional 6 pediatric patients were not randomized, but followed the protocol and are included in this assessment of adverse reactions.
The most frequent adverse reactions were upper respiratory infection, gastroenteritis, ear infection, and influenza. Cardiac disorders was the system organ class with the second most adverse reactions reported. Scoliosis was reported in 1 and 4 pediatric patients receiving doses of 0.033 mg/kg/day and 0.066 mg/kg/day respectively. The following additional adverse reactions also occurred once: insulin resistance and panic reaction for the 0.033 mg/kg/day dose group; injection site pruritus, bone development abnormal, depression, and self-injurious ideation in the 0.066 mg/kg/day dose group. Headache occurred in 2 cases in the 0.066 mg/kg/day dose group.
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