Besponsa (Inotuzumab Ozogamicin)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
inotuzumab ozogamicin
Drug Class
antineoplastic agent
Used For
acute lymphoblastic leukaemia (ALL) in adults
How Taken
intravenous infusion over 1 hour, once weekly for 3 weeks per cycle

What Is Besponsa Used For?

Besponsa is a specialized cancer treatment that targets specific cancer cells in your blood. It’s designed to help fight a particular type of blood cancer.

Primary Uses

Besponsa is used to treat adults with acute lymphoblastic leukaemia (ALL). ALL is a cancer of the blood where white blood cells that normally help protect your body from infection grow uncontrollably.

How It Works

This medicine works by stopping the abnormal growth of cancer cells and destroying them. It belongs to a group of medicines called antineoplastic agents that specifically target cancer cells.

How to Take Besponsa

Besponsa is given by healthcare professionals in a hospital or clinic setting. You cannot take this medicine at home.

Dosage Instructions

Besponsa is given in treatment cycles. One cycle consists of a single dose given each week for 3 weeks. A doctor or nurse will give you the medicine gradually over 1 hour through a drip in your vein. Your doctor will calculate the exact amount you need based on your height, weight, condition, and how you’ve responded to previous treatments. Before each treatment, you’ll receive other medicines to help reduce side effects like fever, chills, or hot flushes.

What If You Miss a Dose?

If you miss a scheduled treatment, contact your doctor or nurse as soon as possible to make a new appointment.

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • nausea (feeling sick)
  • vomiting
  • diarrhoea
  • constipation
  • decreased appetite
  • headache
  • general weakness
  • mouth ulcer, redness or pain

Seek immediate medical attention if you experience:

  • rapid weight gain, pain in upper right side of stomach, yellowish color of eyes and skin (signs of venoocclusive liver disease)
  • changes in heart rhythm
  • decreased urine, blood in urine
  • muscle spasms, weakness, cramps
  • fever, sweating, chills (signs of infection)
  • bruising easily or regular nose bleeds
  • lightheadedness
  • rash or trouble breathing shortly after receiving injection
  • shortness of breath, wheezing, swelling of face/lips/tongue (allergic reaction)

Important Warnings

Besponsa has serious warnings that you need to understand before starting treatment.

Who Should Not Take Besponsa

Do not receive Besponsa if you: have had severe confirmed venoocclusive disease (a condition where blood vessels in the liver become damaged and blocked by blood clots), have serious ongoing liver disease (such as cirrhosis, nodular regenerative hyperplasia, or active hepatitis), or are allergic to inotuzumab ozogamicin or any ingredients in the medicine.

Medical Conditions to Discuss

Tell your doctor if you have: liver problems, heart problems, an infection or fever, or if you bruise easily or get nose bleeds regularly. Also inform your doctor about any other medicines you’re taking.

Pregnancy and Breastfeeding

You must avoid becoming pregnant or fathering a child while receiving Besponsa. Use effective birth control during treatment and for at least 8 months (women) or 5 months (men) after your last dose. Do not breastfeed during treatment and for at least 2 months after your last dose, as the medicine may harm your baby.

Black Box Warning: Hepatotoxicity, including fatal and life-threatening hepatic venoocclusive disease has occurred in patients treated with Besponsa. An increased risk of post-stem cell transplant non-relapse mortality has been observed.

Drug Interactions

Some medicines may interfere with Besponsa or affect how well it works.

  • Live vaccines are not recommended during certain periods before, during, and after Besponsa treatment

Alcohol & Driving

Besponsa may affect your ability to drive or operate machinery safely.

Alcohol

Tell your doctor if you drink alcohol. No specific information is available about alcohol interactions with Besponsa.

Driving and Operating Machinery

This medicine may cause fatigue in some people. If you feel tired, do not drive, operate machinery, or do anything else that could be dangerous. Be careful before you drive or use any machines or tools until you know how Besponsa affects you.

Storage

Besponsa must be kept in the original packaging in a refrigerator, protected from light, before it’s time to use it. Your doctor, nurse, or pharmacist will prepare the infusion for you before you receive it. They may give it to you straight away or within 8 hours after preparation begins.

Overdose Information

It’s unlikely you’ll receive too much Besponsa since your dose is calculated and given by healthcare professionals in a specialized setting. If you think you’ve been given too much, you may need urgent medical attention. If you can’t reach your treating doctor, go to the emergency department at your nearest hospital.

Frequently Asked Questions

If you’re going to receive a stem cell transplant, you may receive 2-3 cycles maximum. If you’re not receiving a transplant, you may receive up to 6 cycles maximum. If you don’t respond within 3 cycles, treatment will be stopped.

Before each treatment, you’ll receive other medicines (premedication) to help reduce symptoms like fever, chills, or hot flushes, and other possible side effects.

Your doctor will take regular blood tests to make sure Besponsa is working and to check for side effects. Your blood counts and liver function will be checked before each treatment.

Tell all doctors, dentists, surgeons, and pharmacists that you are receiving Besponsa. If you’re having surgery, inform the surgeon or anaesthetist about your treatment.

Your doctor will monitor your heart rhythm, blood levels of electrolytes (calcium, magnesium, potassium), and enzyme levels (amylase and lipase). They may adjust your dose, interrupt, or stop treatment based on side effects.

Contact your doctor right away if you experience fever, chills, hot flush, dizziness, rash, trouble breathing, nausea, vomiting, changes in heartbeat, decreased urine, blood in urine, or muscle weakness during or after treatment.

Live vaccines are not recommended during certain periods before, during, and after Besponsa treatment. Your doctor will advise you about vaccinations.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.