Besponsa (Inotuzumab Ozogamicin)
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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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Prescription Required
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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
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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