Saizen (Somatropin)

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.

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  • Product Details

    Description

    Saizen is a form of human growth hormone, crucial for the growth of bones and muscles. It is synthetic, produced through recombinant DNA technology, and mirrors the natural hormone with 191 amino acid residues. Saizen is prescribed to treat growth hormone deficiency in children and adults, aiding those whose bodies don't produce enough growth hormone. It works by stimulating growth and cell reproduction, which is essential for development.

    Directions

    When using Saizen, it is crucial to adhere closely to the instructions provided by the healthcare provider. Typically, the medication is administered via subcutaneous injection, which requires precise and sterile technique to ensure safety and efficacy. The standard dosage is tailored to the individual needs of the patient, but commonly, the advised weekly dosage in children is 0.18 mg/kg of body weight. This dosage should be distributed in equal amounts administered either three times a week on alternate days, six times a week, or daily.

    Ingredients

    Saizen contains the active ingredient Somatropin.

    Contraindications

    Patients should avoid taking or using Saizen if any of the following conditions apply:

    • Allergy to Somatropin or any of the formulation's components
    • Presence of active malignancy or active cancer
    • Acute critical illness
    • Diabetic retinopathy, a complication of diabetes that affects the eyes
    • Prader-Willi syndrome with obesity or severe respiratory impairment
    • Children who have closed growth plates or epiphyses

    Cautions

    • Before beginning treatment with Saizen, be sure to disclose the following to your healthcare provider:
      • Any existing medical conditions
      • Known allergies
      • All medications you are currently taking
      • Whether you are pregnant or breastfeeding
    • For patients recovering from severe illnesses or surgeries, the risks of continuing Saizen should be carefully considered against the benefits.
    • Before starting Saizen, children with Prader-Willi Syndrome should be checked for signs of sleep apnea and upper airway obstruction. If these symptoms appear, treatment should be stopped.
    • Patients with a history of tumors need to be closely monitored for cancer progression or recurrence. There is a noted risk of developing a second cancer, particularly brain cancer in those who have previously had radiation treatment to the head.
    • Saizen can affect blood sugar control. Patients may need more frequent monitoring of their blood sugar levels, and those with diabetes may require adjustments to their diabetes medications.
    • This medication can cause increased pressure in the brain. If symptoms like headaches or vision changes occur, the treatment may need to be adjusted or stopped.
    • Watch for signs of serious allergic reactions. If symptoms like swelling, rash, or difficulty breathing occur, get medical help right away.
    • Saizen can cause fluid retention, leading to symptoms like swelling, joint pain, or carpal tunnel syndrome, especially in adults. The dose may need to be adjusted if these symptoms occur.
    • Patients known to have adrenal gland problems should be monitored for signs that their condition is worsening.
    • Thyroid function might change, so regular thyroid monitoring is necessary, and treatment may need to be adjusted accordingly.
    • Children might experience problems like slipped capital femoral epiphysis (a hip joint issue) or worsening of scoliosis (spine curvature). Look out for symptoms like limping or hip/knee pain.
    • Be alert for severe abdominal pain, as it could indicate pancreatitis, a serious inflammation of the pancreas.
    • Be aware of the preservative benzyl alcohol, which can cause reactions in some people.

    Side Effects

    Saizen side effects include reactions at the injection site, including pain, numbness, redness, and swelling. Users might also experience fluid retention, leading to swelling in the arms and legs (peripheral edema). Other common side effects include joint pain (arthralgia), muscle pain (myalgia), a tingling sensation (paresthesia), and headaches. These effects are generally manageable and can vary in intensity from person to person.

    While most side effects of Saizen are mild, monitoring for the intensity and duration of symptoms is important. If injection site reactions worsen or do not resolve, or if swelling and pain become problematic, consulting a healthcare provider is advised. Regular follow-ups may be necessary to adjust dosages and ensure the treatment is effective without causing significant discomfort.

    References:

    1. Saizen (Somatropin) Product Monograph. Rockland, MA: EMD Serono Inc.; 2017.
    2. Saizen (Somatropin) Drug Label Information. Rockland, MA: EMD Serono Inc.; 2017.



    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 : 9486

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