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BESPONSA
Inotuzumab Ozogamicin
$20770.00
1mg · 1 syringes
BrandBranded medicine· By Pfizer
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FDA boxed warningHepatotoxicity, including hepatic veno-occlusive disease (vod) (also known as sinusoidal obstruction syndrome) and increased risk of post-hematopoietic stem cell transplant (hsct) non-relapse mortality
Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA.
A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA
About BESPONSA
Overview
BESPONSA contains inotuzumab ozogamicin, an antibody linked to a cell-killing drug. It treats CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) that has returned or has not responded to treatment in adults and children aged 1 year and older. It targets cells carrying CD22 and releases a drug inside them that damages their DNA, leading to cell death.
What it treats
Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 year and older.
Safety information
Side effects
Common side effects include low platelet counts, low white blood cell counts, anemia, fever, infections, bleeding, tiredness, nausea, vomiting, headache and abdominal pain. Blood tests may also show increased liver enzymes or bilirubin. Serious risks include liver damage, including blockage of small blood vessels in the liver (veno-occlusive disease), severe reductions in blood cell counts, infections, bleeding, infusion-related reactions and changes in the heart’s electrical activity (QT interval prolongation). Contact your doctor promptly if you develop fever, signs of infection, bleeding or a reaction during or after an infusion. BESPONSA also increases the risk of death unrelated to disease relapse after a transplant. It can harm an unborn baby; effective contraception is needed for females who could become pregnant. Blood counts, heart rhythm and electrolyte levels need monitoring during treatment. Monitoring for infusion-related reactions continues for at least one hour after the infusion ends.
FDA boxed warning
Hepatotoxicity, including hepatic veno-occlusive disease (vod) (also known as sinusoidal obstruction syndrome) and increased risk of post-hematopoietic stem cell transplant (hsct) non-relapse mortality
Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA.
A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The FDA label lists no contraindications for BESPONSA. However, treatment requires monitoring for low blood cell counts, infection and bleeding. Infusion-related reactions can occur. Monitoring is needed during the infusion and for at least one hour afterward. BESPONSA can prolong the QT interval, affecting the heart’s electrical activity. ECGs and electrolyte checks are needed before and during treatment, with more frequent monitoring if other medicines that prolong the QT interval are used. BESPONSA can harm an unborn baby. Females who could become pregnant should use effective contraception. Do not breastfeed during treatment.
Using BESPONSA
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label BESPONSA (INOTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] (DailyMed, retrieved 19 September 2026).
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