Norditropin (Somatropin) Nordiflex

What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Coming Soon – Save up to 85%

Sign up to get exclusive coupon discounts and be the first to be notified when we have this product available.

Prescription Required

  • Related Products & Conditions

  • Product Details

    Description

    Norditropin® is a recombinant human growth hormone (somatropin) produced by recombinant DNA technology. It is indicated for the treatment of growth failure in children due to growth hormone deficiency (GHD), Turner syndrome, Noonan syndrome, idiopathic short stature, and short stature associated with small for gestational age (SGA) with no catch-up growth. In adults, it is indicated for adult-onset or childhood-onset GHD. The NordiFlex® prefilled pen delivers Norditropin via subcutaneous injection, providing precise, easy-to-use, and convenient dosing for home administration.

    Fact Table

    Formula

    C990H1528N262O300S7

    License

    US FDA, EMA

    Bioavailability

    ~81% (subcutaneous)

    Legal status

    Rx-only

    Chemical Name

    Somatropin (recombinant human growth hormone)

    Elimination half-life

    ~2–3 hours (SC); biological activity lasts longer

    Dosage (Strength)

    5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL prefilled NordiFlex pens (SC)

    Pregnancy

    Category C – consult physician

    Brands

    Norditropin NordiFlex, Norditropin FlexPro

    Protein binding

    Low; binds to GH receptors and plasma proteins

    PubChem CID

    16129663

    MedlinePlus

    a605050

    ChEBI

    74573

    ATC code

    H01AC01

    DrugBank

    DB00052

    KEGG

    D04466

    Routes of administration

    Subcutaneous injection

    Directions

    The dose of Norditropin varies based on indication, patient age, weight, and clinical response:

    • Pediatric GHD: 0.024–0.034 mg/kg/day
    • Turner syndrome: up to 0.067 mg/kg/day
    • Noonan syndrome: up to 0.066 mg/kg/day
    • SGA: up to 0.067 mg/kg/day
    • Adult GHD: Initiate at 0.2 mg/day (titrate based on IGF-1 levels and tolerability)

    Norditropin should be injected subcutaneously into the thigh, buttock, abdomen, or upper arm, rotating injection sites to reduce lipodystrophy.

    • Pens should be stored refrigerated before use and can be kept at room temperature (=77°F or 25°C) for up to 21 days after first use.
    • Do not shake or freeze.

    Ingredients

    Each Norditropin NordiFlex pen contains:

    • Somatropin (5, 10, 15, or 30 mg/1.5 mL prefilled pen options)
    • Mannitol
    • Histidine
    • Poloxamer 188
    • Phenol (preservative)
    • Water for injection

    pH is adjusted with hydrochloric acid or sodium hydroxide.

    Contraindications

    Norditropin is contraindicated in patients with:

    • Active malignancy
    • Closed epiphyses in children
    • Acute critical illness (e.g., post-surgery, trauma, or respiratory failure)
    • Hypersensitivity to somatropin or any excipients
    • Proliferative or severe non-proliferative diabetic retinopathy (in adults)

    Cautions

    • Monitor patients for glucose intolerance, especially those with preexisting diabetes or obesity.
    • Increased risk of intracranial hypertension; assess for headaches, visual changes, and vomiting.
    • Use with caution in patients with active scoliosis, hypothyroidism, or pancreatitis history.
    • Slipped capital femoral epiphysis has been reported in pediatric patients.
    • Monitor IGF-1 levels, growth velocity, glucose levels, and thyroid function regularly.
    • Long-term safety in patients with a history of cancer or CNS tumors should be carefully considered.

    Side Effects

    Common side effects include:

    • Injection site reactions
    • Headache
    • Arthralgia and myalgia
    • Edema
    • Nausea
    • Fatigue
    • Elevated blood glucose

    Serious adverse effects may include:

    • Intracranial hypertension
    • Pancreatitis
    • New or recurrent malignancy
    • Hypothyroidism
    • Slipped capital femoral epiphysis
    • Worsening of preexisting scoliosis

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 12425

  • Product Reviews