Omnitrope Sandoz

Omnitrope Sandoz

Strength:5mg/1,5ml
Quantity:5ml
Active substance: somatropin
Manufacturer: Sandoz a Novartis company

Omnitrope® (somatropin) by Sandoz is a recombinant human growth hormone (rhGH) product used to treat growth hormone deficiency in both children and adults. It is a biosimilar to the brand-name product, Genotropin®, and contains the same amino acid sequence as the naturally occurring human growth hormone.

Indications:

• In Children:
  • Growth hormone deficiency (GHD).
  • Turner syndrome.
  • Chronic renal insufficiency (CRI).
  • Prader-Willi syndrome.
  • Small for gestational age (SGA), with no catch-up growth by age 2.
  • Idiopathic short stature (ISS).
• In Adults:
  • Growth hormone deficiency (GHD) due to pituitary disease, hypothalamic disease, or other causes.
  • Short bowel syndrome (as part of a comprehensive treatment plan for intestinal failure).

Mechanism of Action:

Omnitrope contains recombinant human growth hormone (somatropin) that acts on growth plates in bones and tissues to promote growth, increase muscle mass, and stimulate protein synthesis. Growth hormone also affects lipid metabolism, bone density, and the regulation of blood glucose.

Formulation & Administration:

• Form: Powder for solution for injection.
• Strength: Typically available in vials containing 5.8 mg, 12 mg, or 15 mg of somatropin.
• Administration: Omnitrope is administered via subcutaneous injection, typically once a day, but dosing frequency may vary based on the patient’s condition and response.

Dosage:

• Children: Dosing is individualized, typically based on body weight or ideal body weight, with doses ranging from 0.025 to 0.035 mg/kg/day, depending on the specific condition being treated.
• Adults: Dosing is typically between 0.15 and 0.3 mg/day, though it is adjusted based on the patient’s clinical response and tolerance.

Side Effects:

Common side effects include:

• Injection site reactions (pain, redness, swelling).
• Edema (fluid retention).
• Arthralgia (joint pain).
• Headache.
• Muscle pain.
• Carpal tunnel syndrome. Serious side effects (though rare) can include:
• Hypothyroidism.
• Increased risk of diabetes.
• Intracranial hypertension.
• Slipped capital femoral epiphysis (in children).

Storage:

• Unopened vials should be stored in a refrigerator (2°C to 8°C / 36°F to 46°F).
• After reconstitution, the solution should be used within a specific time frame as indicated in the product instructions (typically 28 days).

Contraindications:

Omnitrope should not be used in patients with:

• Active malignancy.
• Critical illness due to complications from open heart surgery, trauma, or respiratory failure.
• Prader-Willi syndrome patients who are severely obese or have severe respiratory impairment.

Note:

Omnitrope is not a weight-loss drug, and it should not be used for increasing athletic performance or anti-aging purposes.

Conclusion:

Omnitrope provides an important treatment option for individuals with growth hormone deficiencies, whether congenital or acquired. The Sandoz biosimilar offers a cost-effective alternative to the reference product while maintaining the same therapeutic efficacy.

For more detailed information, consult the prescribing information or a healthcare professional.