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This information is about a new treatment called tositumomab, commonly known as BEXXAR®. It is being tested as a treatment for people with certain types of non-Hodgkin lymphoma|.
When a drug is being developed it has to go through various stages of research, called clinical trials| or studies. These aim to establish:
The trials also find out:
At this stage, BEXXAR is only available to a small number of people in the UK, usually in clinical trials. In certain circumstances it may also be given to individual patients who have been selected by their doctor as suitable - this is called a named-patient basis.
Many drugs that are thought to be promising may be found not to be as good as existing treatments or to have side effects that outweigh any benefits. For this reason, doctors and other medical staff carry out frequent and careful checks on the progress of each patient who is having one of these developmental drugs. If you're taking a developmental drug, your doctor will explain all about the drug, the procedures being used and how you'll be looked after while you are taking it. If at any time you have concerns, you should ask your doctor or nurse for information and advice.
BEXXAR can only be given in hospitals with the appropriate specialist facilities. As a result you may need to travel to another hospital to receive it.
BEXXAR belongs to a group of cancer drugs known as monoclonal antibodies|.
Monoclonal antibodies recognise and lock on to specific proteins on the surface of cancer cells. This helps the body's immune system recognise the cancer cells and destroy them. Monoclonal antibodies are sometimes called targeted therapies because they're designed to target cancer cells.
BEXXAR is a special type of monoclonal antibody known as a radiolabelled monoclonal antibody. This means it's made up of a monoclonal antibody (tositumomab) with a radioactive substance (Iodine-131, or I-131) attached to it. The radiation from I-131 is strong enough to destroy cancer cells. It can also affect normal cells.
BEXXAR locks on to a protein called CD20, which is found on the surface of one of the main types of white blood cells called B-lymphocytes or B-cells. CD20 is present both on normal B-cells and on the abnormal (malignant) B-cells found in many types of non-Hodgkin lymphoma.
When BEXXAR locks onto the B-cells it releases radiation that damages or kills them. Both normal and abnormal B-cells are killed, but the body can replace the normal white blood cells that are damaged.
At the moment, BEXXAR is only used in clinical trials to treat certain types of B-cell non‑Hodgkin lymphoma (NHL) that have come back after previous treatment.
BEXXAR is given as a drip into a vein (intravenous infusion). It's usually given in the nuclear medicine department of the hospital.
You'll usually need to make four visits over 1-2 weeks. The first three visits (between days one and seven) are needed to calculate how much radioactivity you will be given. On the fourth visit (between days seven and 14) you'll be given the treatment dose of BEXXAR.
Before you start treatment, and for two weeks after it is finished, you'll need to take a daily iodine supplement. This is taken as tablets or liquid drops, and it helps protect the thyroid gland from the radioactive iodine.
On the first day of treatment you'll be given two drips. The first, which is an infusion of the monoclonal antibody tositumomab, is given over an hour. The second infusion contains tositumomab with a very small amount of radioactive iodine (I-131) and takes about 20 minutes.
You'll then have a body scan. This takes about 15-30 minutes.
On your second and third visit you'll have two more body scans. The scans show how the radiation is spread around your body. This helps the doctors to calculate exactly how much radioactive iodine (I-131) to add to your treatment dose of BEXXAR.
On the fourth visit you'll be given the actual treatment. You'll have two infusions. The first one of tositumomab is given over an hour. The second infusion is tositumomab with the treatment dose of radioactive iodine (I-131). This is given over 20 minutes.
You'll need to stay in hospital for a few days after this treatment because of the possibility of radiation exposure to other people. The risk to other people is small and most of the radiation will leave your body in your sweat and urine within a week.
Certain restrictions will be needed during this time. You will probably be looked after in a room of your own or with someone else having similar treatment. Lead screens will be placed at either side of your bed to absorb any radiation that's given out. Visiting times will be restricted, and pregnant women and children will not be allowed to visit. However, you should feel well and can bring books and magazines into your room, watch TV or listen to the radio to help pass the time.
BEXXAR is still a relatively new drug so it is too early to know all of the possible side effects. Those listed below appear to be the most common. If you notice any effects that aren't listed here, discuss them with your doctor or specialist nurse.
The treatment doesn't usually cause many problems. However, it is possible to have an allergic reaction to the monoclonal antibody in BEXXAR.
Signs of an allergic reaction include a skin rash, itching, swelling of the tongue or throat, irritation of the nasal passages, wheezing, a cough and breathlessness|. You'll be monitored closely during your treatment, but tell a nurse or doctor if you have any of these symptoms.
To reduce the chance of developing an allergic reaction, you'll be given medicines such as antihistamines before the infusion. If a reaction does occur, the BEXXAR infusion can be slowed down or stopped until the reaction is over.
These may include fever, chills, sweating, headaches, itching and joint and muscle aches. These effects may occur a few hours after the drug is given, but they don't usually last for more than a day or two.
Some people feel sick|, are sick or have tummy pains in the first few days after the treatment. Let your nurse or doctor know if you are affected, as they can prescribe medicines to help.
This may occur a few days after treatment. It can usually be controlled with medicine but let your doctor know if it is severe or continues. It's important to drink plenty of fluids if you have diarrhoea|.
BEXXAR can reduce the number of white blood cells in your body, making you more prone to infection|. Your resistance to infection usually reaches its lowest point 4–7 weeks after the first dose of BEXXAR and remains low for about a month. Your white blood cell levels then increase steadily and usually return to normal over several weeks.
Contact your doctor or the hospital straight away if:
You'll have regular blood tests to check your blood cell count.
BEXXAR can reduce the production of platelets, which help the blood clot. Tell your doctor know if you have any abnormal bruising or bleeding. They will advise you about this and any precautions you should take.
You may become anaemic while having treatment with BEXXAR. This may make you feel tired and breathless. Red blood cell numbers usually recover in 3-4 weeks. Other side effects include weakness, pain, headaches and feeling sick.
There is a risk that BEXXAR may cause a second cancer to develop. Your doctor should discuss this risk with you.
It's important to let your doctor know straight away if you feel unwell or have any severe side effects, even if they're not mentioned above.
BEXXAR makes you slightly radioactive for a few days after your treatment. You may still have a very small amount of radiation in your body when you go home, but it will disappear over the next few days. Your doctor or nurse will advise you about any precautions you need to take during this time.
You may be advised to stay up to two metres (six feet) away from others, particularly children, for a few days. What precautions you need to take and for how long will depend on the dose of radiation you're given. They may also vary according to hospital guidelines.
It's not known what effects BEXXAR may have on your ability to have children in the future. If you have concerns about this, it's important to discuss them with your doctor before beginning treatment.
It's not advisable to become pregnant or father a child during treatment with BEXXAR or for one year afterwards. This is because it may harm the developing baby. It's important to use effective contraception during treatment. You can discuss this with your doctor.
Some medicines should only be used under the supervision of your doctor while you have BEXXAR treatment. This includes blood thinners (anticoagulants) and drugs such as aspirin and ibuprofen.
BEXXAR can affect the thyroid gland in some people. You will have a yearly blood test to check your thyroid gland is working normally.
If you are travelling by air it's possible you could set off radiation detectors at airports for some weeks after treatment with BEXXAR. You may be questioned by security staff, so it's a good idea to have a doctor's letter that explains that you have recently had radioactive iodine treatment.
This section has been compiled using information from a number of reliable sources including:
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