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.

Orladeyo (Berotralstat)

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Brand

Orladeyo (Berotralstat)

Prescription Required

Strength
Qty
150mg

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  • Product Details

    Description

    Orladeyo (Berotralstat) is a plasma kallikrein inhibitor used to prevent attacks of hereditary angioedema (HAE) in individuals aged 12 and older. It works by blocking the action of kallikrein, a protein in the blood, which helps reduce the production of bradykinin, a substance that causes swelling and pain. Orladeyo is available in capsule form.

    Directions

    Take Orladeyo exactly as prescribed by the healthcare provider. The usual dosage of Orladeyo medication for adults is one 150 mg capsule taken once daily with food. Do not crush, chew, or break the capsule; swallow it whole with water. If a dose is missed, take it as soon as remembered, unless it's almost time for the next dose. Then, skip the missed dose and proceed with the regular schedule.

    Ingredients

    Berotralstat is the active ingredient in Orladeyo.

    Contraindications

    Avoid taking or using this medication if any of the following apply:

    • Pregnancy or breastfeeding: Safety hasn't been fully established.
    • Known allergies to any ingredient of Orladeyo.
    • Children under 12: Not recommended for this age group.

    Cautions

    • Before beginning treatment with Orladeyo, it's important to discuss the following with your healthcare provider:
      • Your current health conditions
      • Any allergies you may have
      • All medications you are currently using
      • Whether you are pregnant or breastfeeding
    • Do not exceed the recommended dose of 150 mg once daily. Higher doses can lead to an increase in QT prolongation, which is a heart rhythm issue that can be serious.
    • Orladeyo is not suitable for treating acute attacks of HAE.

    Side Effects

    While it is generally well-tolerated, Orladeyo can cause some side effects. Common side effects that you might experience include stomach pain, vomiting, diarrhea, back pain, and heartburn. These side effects are typically manageable and often resolve over time.

    It's important to adhere strictly to the prescribed dosage as taking more than one capsule of Orladeyo per day can lead to serious heart rhythm problems, known as QT prolongation, which can cause an abnormal heartbeat. In addition, less common side effects include changes in liver function tests and, rarely, a brief, itchy rash may develop. If you notice any severe reactions or if common side effects persist or worsen, contact your healthcare provider immediately for guidance.

    References

    1. Orladeyo (Berotralstat) Product Monograph. Durham, NC: BioCryst Pharmaceuticals, Inc.; 2023.
    2. Orladeyo (Berotralstat) Drug Label Information. Durham, NC: BioCryst Pharmaceuticals, Inc.; 2023.



    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 : 13766

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