Besponsa (Inotuzumab Ozogamicin)

Besponsa can cause severe hepatotoxicity, including hepatic veno-occlusive disease (VOD), which can be fatal. The medication also carries a risk of increased mortality in patients receiving hematopoietic stem cell transplant after treatment. Liver function should be monitored before and during treatment.

If you have allergies to inotuzumab ozogamicin or other medications, consult your doctor before using it. This product may contain inactive ingredients, which can cause allergic reactions. For more information on the ingredients, feel free to contact us, and we can have one of our licensed pharmacists consult you.

Please let your doctor if you have any recent or current infections or liver disease before using this medication.

A condition called QT prolongation may be caused by inotuzumab ozogamicin. If you experience a fast/irregular heartbeat or other symptoms (such as severe dizziness or fainting) caused by QT prolongation, immediately seek medical attention.

You may be more likely to experience QT prolongation if you have certain medical conditions or take other drugs that could cause it. Your doctor or pharmacist should know all the drugs you take before using inotuzumab ozogamicin, as well as any of the following conditions: heart failure, slow heartbeat, QT prolongation on the electrocardiogram), a family history of specific heart problems (QT prolongation on the electrocardiogram, sudden cardiac death). If your blood potassium or magnesium levels are low, you may also experience QT prolongation. In the case of severe sweating, diarrhea, or vomiting, your risk is higher if you are taking certain drugs (such as diuretics/”water pills”). Consult your doctor before using inotuzumab ozogamicin.

All medication (prescriptions, nonprescription, and herbal) should be disclosed to your doctor or dentist before surgery.
You may be more likely to get infections if you take inotuzumab ozogamicin, or current infections may worsen if you take it. Avoid contact with anyone with an easily spread infection (like chickenpox, COVID-19, measles, or flu). If you have been infected, speak with your doctor for more information.

Before receiving any immunizations or vaccinations, please inform your healthcare professional that you use inotuzumab ozogamicin. You should avoid contacting people who have recently received live vaccines (such as flu, inhaled through the nose).

Be careful when using sharp objects, such as razors and nail cutters, and avoid contact sports to reduce your risk of being cut, bruised, or injured.

It is possible to experience headaches, nausea/vomiting, abdominal pain, diarrhea, constipation, and mouth sores. You should tell your doctor immediately if any of these effects persist or worsen.

It is possible to experience shortness of breath, chills, fever, and rash during treatment with inotuzumab ozogamicin. It may be necessary for your healthcare professional to adjust/stop your infusion if you experience any of these symptoms.

There are serious side effects associated with this medication. As a result, your doctor has prescribed this drug to you since they believe that the benefit to you outweighs the risk of side effects. You can reduce your risk with careful monitoring by your doctor.

Due to this medication decreasing bone marrow function, there may be a decrease in the number of red, white, and platelet cells. Anemia, decreased immunity, or easy bruising/bleeding can all result from this effect. Any of the following symptoms should be reported to your doctor as soon as possible: unusual tiredness, pale skin, signs of infection (sore throats that won’t go away, fevers, chills), easy bruising or bleeding, bloody or black stools, or vomit that looks like coffee grounds.

Consult your doctor and pharmacist before taking Besponsa. Make sure they know all the drugs you are taking, including prescriptions and over-the-counter. Ensure they know if you take vitamins, herbal supplements, or other supplements. You can avoid potential interactions by sharing this information. Examples of these drugs include:

• quinidine
• amiodarone (Pacerone)
• haloperidol (Haldol)
• quetiapine (Seroquel)
• fluconazole (Diflucan)
• azithromycin (Zithromax)
• sildenafil (Viagra, Revatio)
• vardenafil
• citalopram (Celexa)
• escitalopram (Lexapro)

Alcohol and Besponsa

As part of Besponsa treatment, your doctor may recommend that you avoid or limit your alcohol consumption.

Alcohol and Besponsa are not known to interact. There is, however, a risk of liver damage associated with drinking alcohol. There is also a possibility that Besponsa can cause severe and even fatal liver problems as a side effect.

Consult your doctor if you drink alcohol during Besponsa treatment to determine how much is safe.

There are one-dose vials of Besponsa available in powder form. The powder is mixed with liquid by your doctor or another healthcare professional. In a hospital, clinic, or doctor’s office, your Besponsa dose will be administered as an IV infusion.

Besponsa is available in one strength in the United States: 0.9 milligrams (mg). Besponsa is sold in vials that contain 1 mg of the drug in countries other than the U.S., including the United Kingdom.

Typically, Besponsa is administered in 21-day or 28-day cycles. Each cycle may begin with a dose on day 1, day 8, and day 15.

Your doctor may alter your dosing schedule depending on whether or not you have side effects from Besponsa and the severity of those side effects. Your doses will likely be spaced at least six days apart to decrease the possibility of side effects.

You should tell your doctor if you are expecting a child or if you plan to become pregnant. It is not recommended that you become pregnant while taking this medication. It is possible to harm an unborn baby by administering inotuzumab ozogamicin. Your doctor should order a pregnancy test before you begin taking this medication. During treatment and for eight months following the last dose, women using this medication should ask about reliable forms of birth control. During treatment and for five months after the previous dose, men should ask about reliable forms of birth control. Discuss the risks and benefits of this medication with your doctor as soon as possible if you or your partner become pregnant.

It is unknown whether this medication passes into breast milk. Breast-feeding is not recommended while taking this drug or for the first two months after stopping treatment because of the possible risk to the infant. Breastfeeding should be discussed with your doctor.

A person who is overdosing and has severe symptoms such as passing out or difficulty breathing should call 911 immediately. In any other case, contact a poison control center directly. Residents of the United States can contact their local poison control center at 1-800-222-1222.

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