Description

Norditropin is a prescription medicine that contains human growth hormone and is used to treat:

• Children who are not growing because of low or no growth hormone
• Children with Prader-Willi syndrome, Turner syndrome, chronic kidney disease, or who were born small for gestational age
• Adults who have growth hormone deficiency 

The Norditropin FlexPro 10 mg/1.5 ml is a multidose disposable pre-filled pen that contains 10 mg of somatropin (the active ingredient) in 1.5 ml of solution. It delivers a maximum of 3.0 mg of somatropin per dose, in increments of 0.050 mg. The Norditropin NordiFlex 10 mg/1.5 ml is another multidose disposable pre-filled pen that also contains 10 mg of somatropin in 1.5 ml of solution. Norditropin should be stored in the refrigerator before first use. After the first injection, the pen can be stored at room temperature (up to 77°F) for up to 3 weeks or in the refrigerator for up to 4 weeks. The most common side effects of Norditropin in children include common cold, headache, fever, pain in extremity, and reaction to injection. In adults, the most common side effects include back pain, joint pain, indigestion, sleep problems, and dizziness.

Formulation

• Norditropin FlexPro 10 mg/1.5 ml is a multidose disposable pre-filled pen
• Contains 10 mg of somatropin (the active ingredient) in 1.5 ml of solution
• Delivers a maximum of 3.0 mg of somatropin per dose, in increments of 0.050 mg

Storage

• Store in the refrigerator before first use
• After first injection, can be stored at room temperature (up to 77°F) for up to 3 weeks or in the refrigerator for up to 4 weeks

Indications

• Children who are not growing because of low or no growth hormone
• Children with Prader-Willi syndrome, Turner syndrome, chronic kidney disease, or who were born small for gestational age
• Adults who have growth hormone deficiency

Side Effects

• In children: common cold, headache, fever, pain in extremity, and reaction to injection
• In adults: back pain, joint pain, indigestion, sleep problems, and dizziness
  

  Key Benefits of Norditropin 10mg/1.5ml

  Treats Growth Hormone Deficiency

  • Norditropin is used to treat children and adults who lack natural growth hormone, leading to growth failure 
  • It contains a man-made form of growth hormone that is identical to the natural human growth hormone 

  Improves Body Composition

  • In clinical studies, Norditropin significantly increased lean body mass and decreased total body fat compared to placebo in adults with growth hormone deficiency 

  Convenient Delivery

  • Norditropin is available as a multidose disposable pre-filled pen that delivers precise doses 
  • The pen can be stored at room temperature for up to 3 weeks after first use, providing flexibility 

  Key Ingredients

  The active ingredient in Norditropin 10mg/1.5ml is somatropin, which is a recombinant human growth hormone .                                                                                                                                 

  Mechanism of Action of Norditropin

  Norditropin (somatropin) exerts its effects through the following mechanism of action:

  • Somatropin binds to dimeric growth hormone (GH) receptors located on the cell membranes of target tissues
  • This binding activates intracellular signal transduction pathways, leading to the induction of transcription and translation of GH-dependent proteins such as insulin-like growth factor-1 (IGF-1), IGF binding protein-3 (IGF BP-3), and acid-labile subunit
  • Somatropin has both direct tissue effects as well as indirect effects mediated by IGF-1, including:
    • Stimulation of chondrocyte differentiation and proliferation
    • Stimulation of hepatic glucose output, protein synthesis, and lipolysis
  • In children with growth hormone deficiency (GHD), somatropin stimulates skeletal growth by acting on the growth plates (epiphyses) of long bones
  • This stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients with GHD
  • Linear growth is facilitated in part by increased cellular protein synthesis

  Chemical Structure of Norditropin

  Norditropin (somatropin) is a recombinant human growth hormone that contains the identical sequence of 191 amino acids as the naturally occurring pituitary human growth hormone .The chemical structure of Norditropin is:\text{H}_2\text{N}-\text{Met}-\text{Phe}-\text{Pro}-\text{Thr}-\text{Ile}-\text{Pro}-\text{Leu}-\text{Ser}-\text{Arg}-\text{Leu}-\text{Phe}-\text{Asp}-\text{Asn}-\text{Ala}-\text{Met}-\text{Val}-\text{Arg}-\text{Lys}-\text{Val}-\text{Glu}-\text{Gln}-\text{Gln}-\text{His}-\text{Leu}-\text{Ser}-\text{Cys}-\text{Phe}-\text{Ser}-\text{Asn}-\text{Ile}-\text{Asn}-\text{Ser}-\text{Tyr}-\text{Arg}-\text{Arg}-\text{Ala}-\text{Pro}-\text{Arg}-\text{Thr}-\text{Gly}-\text{Ile}-\text{Phe}-\text{Tyr}-\text{Thr}-\text{Phe}-\text{Lys}-\text{Asn}-\text{Ser}-\text{Lys}-\text{Asn}-\text{Leu}-\text{Hie}-\text{Gln}-\text{Leu}-\text{Leu}-\text{Asp Ile Ala Ser text Leu}-Leu}-\text{Arg}-\text{Gly}-\text{Leu}-\text{Glu}-\text{Cys}-\text{Ala}-\text{Glu}-\text{Leu}-\text{Val}-\text{Tyr}-\text{Leu}-\text{Leu}-\text{Cys}-\text{Gly}-\text{Ser}-\text{Leu}-\text{Val}-\text{Phe}-\text{Ala}-\text{Leu}-\text{Lys}-\text{Arg}-\text{Arg}-\text{Leu}-\text{Ile}-\text{Gln}-\text{Asp}-\text{Ser}-\text{Tyr}-\text{Ser}-\text{Leu}-\text{Gln}-\text{Phe}-\text{Leu}-\text{Asn}-\text{Ser}-\text{Asn}-\text{Lys}-\text{Phe}-\text{Leu}-\text{Gly}-\text{Gly}-\text{Ala}-\text{Glu}-\text{Arg}-\text{Gly}-\text{Phe}-\text{Phe}-\text{Tyr}-\text{Thr}-\text{Phe}-\text{OH}This polypeptide chain of 191 amino acids has a molecular weight of approximately 22,000 Daltons .                                 

  Dosage

  • Norditropin dosage varies by indication and patient weight
  • For pediatric growth hormone deficiency, the typical dose is 0.17 to 0.24 mg/kg per week (0.024 to 0.034 mg/kg per day)
  • For adults, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight
  • Dosage should be individualized based on the patient’s growth response

  Storage

  • All unused Norditropin products must be refrigerated (36°F to 46°F) prior to first use
  • Do not freeze and avoid direct light
  • After first injection, Norditropin pens can either be stored outside of the refrigerator (up to 77°F) for use within 3 weeks, or in the refrigerator (between 36°F and 46°F) for use within 4 weeks

  Patient Reviews

  • In a study, 94 people who used the Norditropin FlexPro 30 mg pen rated it 6.7 out of 7 (on a scale of 1 to 7) as “easy to learn to use”
  • The most common side effects reported include injection site reactions, rashes, and headaches
  • Serious side effects may include slipped capital femoral epiphysis, progression of scoliosis, and intracranial hypertension