Mylotarg ® is being tested as a treatment for people with certain types of acute leukaemia.
You'll see your doctor regularly while you have this treatment so they can monitor its effects. This information should help you discuss any queries about your treatment and its side effects with your doctor or specialist nurse.
When a drug is being developed it has to go through various stages of research called clinical trials or studies. These aim to establish:
a safe dosage
the side effects the drug may have
which cancers it may be used to treat.
The trials also find out:
how effective the drug is
whether it's better than the existing treatments
whether it has extra benefits when given with these treatments.
At this stage, Mylotarg 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 to not 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 about the drug, the procedures being used and how you'll be looked after while you're taking it. If you have concerns at any time, you should ask your doctor or nurse for information and advice.
Mylotarg is a type of cancer drug known as a monoclonal antibody. It's mainly used as part of research trials to treat some types of acute myeloid leukaemia (AML). At present it has not been approved for use outside of clinical trials in the UK, so it's not generally available.
Mylotarg locks on to a specific protein called CD33, which is found on the surface of leukaemia cells and certain developing white blood cells (myeloid cells). When Mylotarg locks on to the CD33 protein, it delivers the ozogamicin, which that can damage or kill the leukaemia cells. It is hoped that this way of giving chemotherapy will have fewer side effects.
When Mylotarg is given
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At the moment, Mylotarg is only used in clinical trials to treat certain types of acute leukaemia.
What Mylotarg looks like
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Mylotarg is a colourless fluid.
Mylotarg is given as a drip into a vein (intravenous infusion) through a thin tube (cannula). It can also be given through a central line, which is inserted under the skin into a vein near the collarbone, or through a PICC line, which is inserted into a vein in the crook of your arm.
Each infusion is given over approximately two hours. As the best way to give Mylotarg is not yet known, the number of doses and how often they are given will be decided by your doctor. Mylotarg is sensitive to light and is protected from the light when being given.
Possible side effects of Mylotarg
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Each person's reaction to treatment is different. Some people have few side effects while others may experience more. The side effects described here won't affect everyone having this treatment.
We've outlined the most common side effects but haven't included those that are rare and therefore unlikely to affect you. If you notice any effects that aren't listed here, discuss them with your doctor or specialist nurse.
Side effects fall into two groups:
Early side effects
It's possible to have an allergic reaction to Mylotarg, usually during the infusion or within two hours of receiving it. The symptoms of this may be mild to moderate, or more severe. Signs of a more severe reaction may include skin rashes and itching, a feeling of having a swollen tongue or throat, irritation of the nasal passages, wheezing, a cough and breathlessness. You'll be monitored closely during and after your treatment, but it's very important to tell your nurse or doctor if you have any of these effects.
To reduce the chance of developing an allergic reaction, anti-allergy drugs are given before the infusion and may also be given afterwards. The infusion can also be slowed down or stopped until the reaction is over.
Once the treatment has ended, the reaction generally gets better within a few hours. It's most likely to occur with the first infusion. After this allergic reactions tend to be milder if they do occur.
Feeling sick (nausea) and being sick (vomiting)
Your doctor can prescribe effective anti-sickness drugs to prevent, or greatly reduce, nausea and vomiting. If the sickness isn't controlled, or if it continues, tell your doctor as they can prescribe other anti-sickness drugs that may be more effective.
You may develop flu-like symptoms. These include a high temperature, chills, weakness, sweating, muscle aches, tiredness, dizziness and a headache. These usually settle within 2-4 hours. Your doctor can prescribe medicines to help.
High or low blood pressure
This may happen during or after the infusion. Your blood pressure will be monitored during the infusion and for a while afterwards. Tell your doctor or nurse if you feel faint or dizzy.
Later side effects
Risk of infection
Mylotarg can reduce the number of white blood cells, which help to fight infection. White blood cells are produced by the bone marrow. If the number of your white blood cells is low, you'll be more prone to infections. A low white blood cell count is called neutropenia.
Contact your doctor or the hospital straight away if:
your temperature goes above 38˚C (100.4˚F)
you suddenly feel unwell, even if your temperature is normal.
You'll have a blood test before having more treatment to make sure that your cells have recovered. Occasionally it may be necessary to delay your treatment if the number of blood cells (blood count) is still low.
Bruising and bleeding
Mylotarg can reduce the production of platelets, which help the blood to clot. Tell your doctor if you have any unexplained bruising or bleeding, such as nosebleeds, bleeding gums, blood spots or rashes on the skin. You can have a platelet transfusion if your platelet count is low.
Anaemia (low number of red blood cells)
Mylotarg can reduce the number of red blood cells, which carry oxygen around the body. A low red blood count is called anemia. This may make you feel tired and breathless. Tell your doctor or nurse if you have these symptoms. You may need to have a blood transfusion if the number of red blood cells becomes too low.
Your mouth may become sore or dry, or you may notice small ulcers during this treatment. Some people find sucking on ice soothing. Drinking plenty of fluids, and cleaning your teeth regularly and gently with a soft toothbrush, can help to reduce the risk of this happening. Tell your nurse or doctor if you have any of these problems, as they can prescribe special mouthwashes and medicine to prevent or clear mouth infections.
You may notice that food tastes different. Normal taste usually comes back after treatment finishes. A dietitian or specialist nurse at your hospital can give you advice about ways of coping with this side effect. We also have some useful tips for making your food more enjoyable.
Effects on the liver
Mylotarg may cause changes in the way your liver works, although it will return to normal when treatment finishes. You're very unlikely to notice any problems, but your doctor will take regular blood samples to check that your liver is working properly.
It's important to let your doctor know straight away if you feel unwell or have any severe side effects, even it they're not mentioned above.
Additional information about Mylotarg
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Some medicines, including those that you can buy in a shop or chemist, can be harmful to take when you're having Mylotarg. Tell your doctor about any medicines you're taking, including over-the-counter drugs, complementary therapies and herbal drugs.
Your ability to become pregnant or father a child may be affected by this treatment. It is important to discuss fertility with your doctor before starting treatment.
Little is known about the effects of Mylotarg on a developing baby. Therefore, it is not advisable to become pregnant or father a child while taking this drug.
It's not known whether Mylotarg is present in semen or vaginal fluids. To protect your partner it's safest to either avoid sex or use a barrier form of contraception for about 48 hours after treatment.
There is a potential risk that Mylotarg may be present in breast milk, so women are advised not to breastfeed while taking Mylotarg and for a few months afterwards.
Non-cancer hospital admission
If you’re admitted to hospital for a reason not related to the cancer, it’s important to tell the doctors and nurses looking after you that you’re having Mylotarg treatment. You should tell them the name of your cancer specialist so that they can ask them for advice.
It’s a good idea to know who you should contact if you have any problems or troublesome side effects when you’re at home. During office hours you can contact the clinic or ward where you had your treatment. Your specialist nurse or doctor will tell you who to contact during the evening or at weekends.
This section has been compiled using information from a number of reliable sources, including:
AML 15 Trial Protocol. Medical Research Council collaborative trial in acute myeloid leukaemia. Patients under 60 treatment arm. March 2007.
AML 17 Trial Protocol. Medical Research Council collaborative trial in acute myeloid leukaemia. May 2008. (accessed 21 September 2010).
Product file (Mylotarg) Pfizer prescribing information Mylotarg. www.pfizerpro.com/content/showlabeling.asp?id=119 (accessed October 2012).
With thanks to Professor Gareth Morgan, Professor of Haematology, and the people affected by cancer who reviewed this information. Reviewing information is just one of the ways you could help when you join our Cancer Voices network.