Norditropin Flexpro Dosage, forms & strengths
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Get started todayNorditropin FlexPro (somatropin) is an injectable growth hormone (GH) replacement therapy that Novo Nordisk A/S manufactures. It is FDA-approved to treat children with growth failure due to growth hormone deficiency, Turner syndrome, Noonan syndrome, idiopathic short stature, Prader-Willi Syndrome, or those born small for their gestational age with no catch-up growth by 2 to 4 years of age. In adults, Norditropin FlexPro is used as a replacement for endogenous GH in those with a GH deficiency.
What is Norditropin FlexPro’s mechanism of action?
Norditropin FlexPro is a recombinant human growth hormone used in patients whose pituitary gland does not make a sufficient amount of growth hormone. Growth hormone stimulates skeletal, connective tissue, muscle, and organ growth in children and adolescents. In adults, it helps to regulate many bodily functions, especially those that involve metabolism (how the food you eat is turned into energy). Recombinant products such as Norditropin FlexPro mimic all of these actions.
Norditropin FlexPro dosage forms and strengths
Norditropin FlexPro prefilled pens are available in single-patient-use pens in the following strengths and associated colors:
- 5mg/1.5ml (orange)
- 10mg/1.5ml (blue)
- 15mg/1.5ml (green)
- 30mg/3ml (purple)
Norditropin FlexPro dosage
Pediatric patients
Their dose should be patient-specific based on their growth response. Once the weekly dose of Norditropin FlexPro is calculated, it should be divided into equal doses and given 6 or 7 days a week. It is calculated using their body weight and the condition being treated:
- Pediatric Growth Hormone Deficiency (GHD): The dose of Norditropin FlexPro is 0.024 to 0.034 mg/kg/day (0.17mg/kg/week to 0.24mg/kg/week).
- Noonan Syndrome: The dose of Norditropin FlexPro is up to 0.066mg/kg/day (0.46mg/kg/week).
- Turner Syndrome: The dose of Norditropin FlexPro is up to 0.067mg/kg/day (0.47mg/kg/week).
- Small for Gestational Age (SGA): The dose of Norditropin FlexPro is up to 0.067mg/kg/day (0.47mg/kg/week).
- Idiopathic Short Stature: The dose of Norditropin FlexPro is up to 0.067mg/kg/day (0.47mg/kg/week).
- Prader-Willi Syndrome (PWS): The dose of Norditropin FlexPro is 0.034 mg/ kg/day (0.24 mg/kg/week).
Adult patients
Their dose is administered daily and can be weight-based or non-weight based.
- Weight-based: Norditropin FlexPro should be started at 0.004mg/kg daily and can be increased to a maximum of 0.016 mg/kg daily based on their individual response, adverse reactions, and adjusted serum insulin-like growth factor 1 (IGF-1) concentrations. This regimen should not be used in obese patients as they are more likely to develop serious adverse reactions.
- Non-weight based: Norditropin FlexPro should be started at a dose of 0.15mg/day to 0.3mg/day. The daily dose can be increased every 1 to 2 months by 0.1mg/day to 0.2mg/day based on the patient’s clinical response and serum IGF-1 levels. The dose can be decreased if needed based on adverse reactions and IGF-1 levels that are above the age-specific or gender-specific normal range.
Norditropin FlexPro dosage restrictions
No guidelines or dose reduction recommendations are available for patients with hepatic (liver) or renal (kidney) impairment, and it appears no adjustments are needed.
How to take Norditropin FlexPro
- Read the Patient Information, Instructions for Use, and Medication Guide that comes with this medication.
- Use Norditropin FlexPro exactly as your healthcare provider tells you to. Do not change your dose or stop taking Norditropin FlexPro without discussing it with them first.
- Your healthcare provider should demonstrate how to prepare and inject Norditropin FlexPro before you give your first dose.
- Norditropin FlexPro should be given subcutaneously (under the skin) to the back of your upper arm, abdomen, buttocks, or thigh. You should rotate the injection site to avoid lipoatrophy (loss of fat tissue).
- Do not share your Norditropin FlexPro prefilled pen or NovoFine needles with other people, even if you have changed the needle. This can lead to possible contamination and infection.
Norditropin FlexPro dosage FAQs
What are some side effects of Norditropin FlexPro?
The most common side effects of Norditropin FlexPro include:
- Fluid retention (edema)
- Injection site reactions
- Rash
- Headache
- Arthralgias (joint pain) in adults
- Hip and knee pain or a limp in children (slipped capital femoral epiphysis), especially if they have endocrine disorders or are undergoing rapid growth
- Abdominal pain
- Upper respiratory infections
- Myalgia (muscle pain)
- Tingling sensation
- Otitis media (ear infections)
- Impaired glucose tolerance, especially at higher doses
- Carpal tunnel syndrome in adults
Norditropin FlexPro can sometimes cause more serious side effects, including:
- Severe, life-threatening hypersensitivity reactions (hives, swelling of your face or throat, and shortness of breath)
- Increased risk of intracranial hypertension (increased pressure in your skull) with papilledema
- Pancreatitis (inflammation of the pancreas)
- Increased risk of neoplasms (cancer)
- Worsening scoliosis
- Hypothyroidism (impaired thyroid function)
- Hypoadrenalism (decreased cortisol levels)
Contact your healthcare professional for medical advice about any adverse reactions you experience while taking Norditropin FlexPro. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are some drug interactions with Norditropin FlexPro?
The concomitant use of Norditropin FlexPro with other drugs can change how they work or increase the frequency and severity of side effects. You should ask your healthcare professional if any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, such as glucocorticoids, oral estrogen, insulin, oral diabetic drugs, or drugs metabolized by the CYP450 system.
Are there any contraindications for Norditropin FlexPro?
You should avoid the use of Norditropin FlexPro if you have:
- An allergy to somatropin or any of the inactive ingredients in this product
- An acute critical illness
- Prader-Willi syndrome with severe obesity, a history of upper airway obstruction, or severe respiratory problems
- Closed epiphysis (growth plates) in children
- Active malignancy
- Diabetic retinopathy
What precautions are there with Norditropin FlexPro?
Before beginning Norditropin FlexPro treatment, make sure your doctor is aware of your medical conditions, including:
- Heart, stomach surgery, trauma, or respiratory problems
- Sleep apnea
- Current or history of cancer
- Diabetes mellitus
- Are pregnant, plan on becoming pregnant, or are breastfeeding
Is it safe to use Norditropin FlexPro while pregnant or breastfeeding?
There is no information on the effects of Norditropin FlexPro on the fetus. Animal reproduction studies did not demonstrate any harm to the fetus when given to female rats during pregnancy. While there is no information available on whether Norditropin FlexPro is found in breast milk during lactation, no adverse effects on the breastfed infant have been reported with its use. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
How many milligrams of Norditropin FlexPro should I take daily?
Norditropin FlexPro is given as a daily subcutaneous injection. The dose of Norditropin FlexPro will depend on your condition being treated, age, and/or body weight. The dose for pediatric patients is based on weight and can range from 0.024 to 0.067 mg/kg/day. Adult patients have a weight-based and non-weight based regimen. The weight-based regimen ranges from 0.004 mg/kg daily to a maximum of 0.016 mg/kg daily. The non-weight based regimen starts at 0.15 mg/day to 0.3 mg/day and can be increased every 1-2 months by increments of 0.1 mg/day to 0.2 mg/day based on the response.
How many IU are there in a Norditropin FlexPro 5mg pen?
Every 1mg of somatropin corresponds to 3 IU (International Unit) of somatropin so a 5mg pen will contain 15 IU of somatropin.
What is the average price of Norditropin FlexPro?
Currently, there is no generic Norditropin FlexPro available and the brand name is extremely expensive. The average cost of 4 prefilled pens of Norditropin FlexPro 10mg/1.5ml is almost $11,000.
Related resources for Norditropin FlexPro dosage
- https://reference.medscape.com/drug/genotropin-somatropin-342860
- https://www.novo-pi.com/norditropin.pdf
- https://www.rxlist.com/norditropin-drug.htm
- https://www.drugs.com/mtm/norditropin-flexpro-pen.html
- https://www.nicerx.com/blog/norditropin-side-effects/
- https://www.mayoclinic.org/drugs-supplements/growth-hormone-parenteral-route/proper-use/drg-20069416
- https://www.ncbi.nlm.nih.gov/books/NBK482141/
- https://pdr.net/drug-summary/Norditropin-somatropin–rDNA-origin–2478