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Besponsa (Inotuzumab Ozogamicin)

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

    Besponsa (inotuzumab ozogamicin) is a medication given via an intravenous (IV) infusion to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

    Fact Table

    Formula

    C6514H10084N1732O2042S42

    License

    US FDA, EMA

    Bioavailability

    Not applicable (IV administration)

    Legal status

    Prescription only (Rx)

    Chemical Name

    Inotuzumab Ozogamicin

    Elimination half-life

    12.3 days

    Dosage (Strength)

    0.9 mg/vial

    Pregnancy

    Consult a doctor

    Brands

    Besponsa

    Protein binding

    >98%

    PubChem CID

    24978598

    MedlinePlus

    a617023

    ChEBI

    CHEBI:164447

    ATC code

    L01XC26

    DrugBank

    DB13165

    KEGG

    D10823

    Routes of administration

    Intravenous (IV)

    Directions

    Your doctor will determine an appropriate treatment regimen for you, including Besponsa dosing. Besponsa will be administered via an IV infusion by a healthcare professional. Tell your doctor if you have any questions or concerns.

    Ingredients

    The active ingredient in Besponsa is inotuzumab ozogamicin.

    Inactive ingredients include polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). Reconstitution is used with Sterile Water for Injection, USP.

    Contraindications

    There are no contraindications to Besponsa per the most recent Prescribing Information.

    Cautions

    • Besponsa contains the following FDA Boxed Warning:
      • Liver problems, including fatal and life-threatening hepatic veno-occlusive disease (VOD), can occur
      • Patients receiving Besponsa had a higher post-hematopoietic stem cell transplant non-relapse mortality rate
    • Before you start treatment with Besponsa, tell your doctor about:
      • All the prescription and over-the-counter medications you take
      • Your allergies
      • Your current health problems and past medical history
      • Your pregnancy or breastfeeding status
    • Besponsa is associated with the following warnings and precautions:
      • Myelosuppression, or decreased activity of the bone marrow
      • Infusion-related reactions
      • An abnormal heart rhythm known as QT prolongation
      • Harm to an unborn baby. Effective contraception is recommended for females during Besponsa treatment and for at least 8 months after the final dose. Males with female partners should be advised to use effective contraception during treatment and for at least 5 months after the final dose.

    Side Effects

    Abnormal blood cell counts, infection, anemia, fatigue, bleeding, fever, nausea, headache, increased liver function tests, abdominal pain, increased gamma-glutamyltransferase, and increased bilirubin levels are common side effects associated with Besponsa; however, other side effects may also occur. Immediately tell your doctor about any side effects that bother you or won’t go away.

    Ask your doctor about Besponsa.

    Reference:

    Besponsa. Philadelphia, PA: Wyeth Pharmaceuticals LLC; 2018



    Dr Savannah Muncy
    About Dr. Savannah Muncy (Page Author)


    Dr. Muncy (PharmD) studied science and education as an undergraduate before attending the Appalachian College of Pharmacy where she completed her PharmD in three years. She is currently using her pharmacy and healthcare expertise to write medical content for clients all around the world. She is focused on delivering the most current, accurate, and engaging information to healthcare professionals and patients. Read More....


    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 : 14557

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