Inotuzumab ozogamicin

Inotuzumab ozogamicin is a type of medicine called an antibody-drug conjugate. This means it is a lab-made antibody joined to a chemotherapy drug.

• Inotuzumab is the antibody part. It’s designed to stick to a protein called CD22. This protein is on the surface of some types of leukaemia cell.
• Ozogamicin is the chemotherapy part. Once the antibody sticks to a leukaemia cell, the chemotherapy part can then kill the cell.

The brand name for inotuzumab ozogamicin is Besponsa.

Who might have it?

Your haematology team might recommend it for you if:

• You have B-cell ALL that has not responded or has come back after treatment and
• Your leukaemia cells make the CD22 protein

Back to top

Before having inotuzumab ozogamicin, you’ll have tests and scans to make sure it’s suitable for you and that you’re fit enough to have it. This might include:

Your team will tell you if there are any other tests or scans they recommend.

Fertility

Inotuzumab ozogamicin may affect your fertility. If you might want to have children in the future, tell your doctor or nurse. They can talk to you about your options. Your haematology team may refer you to a fertility specialist. This may not be possible for everyone.

Things to tell your haematology team

Before starting treatment, you should tell your haematology team if you:

• Have any allergies or have ever had an allergic reaction
• Have or have ever had any problems with your liver, kidneys, pancreas, gallbladder or bile ducts
• Have or have ever had any problems with your heart
• Have or think you have an infection
• Have recently had or are due to have any vaccines, including travel vaccines
• Are pregnant or breastfeeding

Having a central line fitted

Treatment to lower your leukaemia cell count

Before starting inotuzumab ozogamicin, you might have treatment to lower your leukaemia cell count. This may include steroids or chemotherapy. If you need it, your team will tell you what they recommend and what to expect.

Back to top

You have inotuzumab ozogamicin through a drip into a vein. You have treatment in cycles.

Treatment cycles

You have treatment in cycles. Each cycle is usually 3 to 4 weeks. You have three doses of inotuzumab ozogamicin in each cycle. These are on:

• Day 1
• Day 8
• Day 15

After this, you have time to recover before starting the next cycle.

You may have between one and six cycles. It depends on:

• How you respond to the treatment
• If you’re having it as your only treatment, or as preparation for a different treatment

Having your dose

• About 30 to 60 minutes before having inotuzumab ozogamicin, you have medicine to help prevent reactions to the treatment. These may include:
  • A steroid
  • An antihistamine
  • Paracetamol
• You might also have medicine and fluids to help prevent a complication called tumour lysis syndrome, if you need it.
• Then you have inotozumab ozagamicin through a drip into a vein. It usually takes around an hour.
• Your team monitor you for any side effects or reactions during your treatment. And for at least an hour after the drip finishes.

Back to top

Measuring your response to treatment

During treatment you will have regular blood tests and occasional bone marrow tests to check how well your ALL is responding to treatment. What tests you have and how often depends on your individual situation.

The tests will measure:

• Your blood cell counts. This is sometimes called your haematological response. It checks if your blood cell counts have returned to normal and whether specialists can see any leukaemia cells under a microscope.
• The level of leukaemia markers or leukaemia genetic changes in your blood cells. This is called your molecular response. It can detect very low levels of leukaemia cells in your bone marrow.

Back to top

There are some precautions to be aware of when you are having inotuzumab ozogamicin.

Contraception and pregnancy

Inotuzumab ozogamicin may harm unborn babies.

Breastfeeding

Scientists do not know if inotuzumab ozogamicin passes into breast milk. If it does, it could be a risk for breastfed babies or children.

During this time, you can keep your milk supply up by expressing but you must discard the milk. You must not use it.

Driving or operating machinery

Inotuzumab ozogamicin can cause fatigue. You should avoid driving, or operating tools or heavy machinery if you feel tired or have a lack of energy.

Vaccinations

Vaccinations support your immune system and help protect against infections. There are two main types: live and non-live.

It is safe to have non-live vaccines if you are taking inotuzumab ozogamicin. But they might not work as well for you as they do in other people.

You should not have live vaccines:

• For at least 2 weeks before starting inotuzumab ozogamicin
• During inotuzumab ozogamicin
• Until your level of white blood cells called B cells has recovered after treatment

Back to top

Like all medicines, inotuzumab ozogamicin can cause side effects. Some people have very few side effects, whereas others get more serious side effects. They may differ from day to day.

Your haematology team should tell you what side effects to look out for and who to contact if you need to.

If you are getting side effects that are difficult to cope with, your haematology team might:

• Prescribe medicines to help manage some side effects
• Suggest things you can do to help you cope with side effects
• Recommend pausing or stopping treatment, if needed

Back to top

Here, we list some of the more common side effects of inotuzumab ozogamicin. These affect at least 1 in every 100 people who take it.

• Infections. Contact your team straight away if you think you have an infection. Look out for:
  • A high temperature (37.5°C or 38°C or higher)
  • Aching muscles, shivering or chills
  • Sore throat, sneezing, blocked or runny nose or earache
  • Cough, chest pain, shortness of breath, or wheezing
  • Burning or stinging when you pee, or peeing more often than usual
  • Sickness or diarrhoea
  • Headache
  • Pain or redness around any cuts, wounds, central lines or drips
• Fatigue. You may have extreme tiredness or lack of energy that doesn’t get better with rest.
• Unexpected bruising or bleeding. You may have nosebleeds, bleeding gums or heavy periods. Look out for blood in your sick or poo, or red or purple spots under your skin. This may look different on black or brown skin. Tell your team if you notice any of these.
• Mouth and tummy problems. You might get diarrhoea, constipation, tummy pain, swelling or bloating. You might feel sick or be sick. You may have mouth ulcers or a sore mouth. You may lose your appetite.
• Liver problems. You might have yellowing of the whites of your eyes or your skin. This may be harder to see on black or brown skin.
• Heart and circulation problems. You may have changes in the electrical activity in your heart. This might make you feel dizzy or faint.
• Brain and nervous system problems. You may get headaches or insomnia or feel confused. You might get sudden weakness, numbness or paralysis.

Allergic reaction

Some people develop a reaction to the drip. This is most likely to happen in your first cycle of treatment, but it can happen in later cycles. It can sometimes be serious.

Your haematology team monitor you closely for any signs of a reaction. If it happens, they’ll stop inotuzumab ozogamicin for a while. They might give you steroids or antihistamines, if you need them.

Sepsis

Inotuzumab ozogamicin can cause a severe response to an infection, called sepsis. This needs urgent treatment.

If it does happen, it can be serious, so it’s sensible to know what to look out for.

Back to top

There might be some side effects that your haematology team find during regular checks and blood tests. These include:

• Low blood pressure
• Low levels of red blood cells, white blood cells or platelets
• Changes in your liver, kidney or pancreas function
• Changes in the balance of salts and uric acid in your body
• A rapid increase in your weight or tummy size
• Changes in the electrical activity in your heart, seen on an ECG

Back to top

Some side effects of inotuzumab ozogamicin can be serious. Your team will monitor you closely for these side effects so they can manage them promptly if they happen.

Back to top

If inotuzumab ozogamicin doesn’t work well for you, or causes side effects that are serious or difficult to cope with, your doctor will discuss your options with you. They might suggest changing your dose, pausing or stopping treatment.

They will talk to you about other treatment options that might be suitable for you.

Back to top