Onkotrone (mitoxantrone)

How does it work?

Onkotrone intravenous infusion contains the active ingredient mitoxantrone (previously spelt mitozantrone in the UK), which is a type of anticancer medicine called a cytotoxic anthracycline antibiotic. (NB. Mitoxantrone is also available without a brand name, ie as the generic medicine.)

Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. Mitoxantrone works by stopping the cancer cells from multiplying. Its exact mechanism of action is unknown but it seems to work in two ways.

Mitoxantrone inserts itself into the strands of genetic material (DNA) inside the cancerous cells and binds them together. This prevents the cells from making genetic material (DNA and RNA) and proteins. It also appears to interfere with an enzyme called topoisomerase II, which is involved in DNA replication. These actions prevent the cancerous cells from growing and multiplying and therefore shrink the cancer.

In most chemotherapy regimens, doses are administered in courses at various intervals to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has regrown to its previous size and the net effect is to decrease the amount of cancer with each successive course.

Unfortunately, mitoxantrone can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells and hair cells. The most important side effect is on the bone marrow, where blood cells are made. Mitoxantrone decreases the production of normal healthy blood cells, which can leave people susceptible to infection. Regular blood tests are needed to monitor the levels of blood cells.

Mitoxantrone can be used either on its own or in combination with other anticancer medicines. It is administered by a drip into a vein (intravenous infusion).

What is it used for?

Breast cancer that has spread to other areas of the body (metastatic breast cancer)

Non-Hodgkin's lymphoma

Acute non-lymphocytic leukaemia in adults

Primary liver cancer that cannot be treated with surgery.

Warning!

This medicine should not be injected into the spinal column (intrathecal injection).

While this medicine is being given, it is important to tell your doctor or nurse immediately if you notice any pain, redness, stinging or burning around the vein being used to administer the drip, or any leakage of fluid from the canula.

This medicine can turn your urine a blue/green colour for 24 hours after administration. This is normal and nothing to worry about - it is due to the colour of the medicine.

Chemotherapy medicines such as this one can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.

This type of chemotherapy medicine can sometimes have side effects on the heart. For this reason, your doctor will want to monitor your heart function before and during your treatment, particularly if you have any existing heart trouble, you have previously had any treatments that could affect your heart, or if you are having high doses or prolonged treatment with this medicine. Monitoring of your heart may involve an electrocardiogram or other tests.

Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.

This medicine may be harmful to an unborn baby, and for this reason you should use effective contraception to avoid getting pregnant or fathering a child during treatment. You should continue to use contraception to prevent pregnancy for at least six months after stopping this medicine. Women should consult their doctor immediately if they get pregnant during treatment.

Use with caution in

Decreased blood cell production by the bone marrow

Decreased liver function

Heart disease

People who have previously had radiotherapy to the chest area

People who have had previous therapy with other anthracycline type anticancer medicines or other medicines that can have side effects on the heart.

Not to be used in

Pregnancy

Breastfeeding

Allergy to other anthracycline medicines, eg daunorubicin, doxorubicin, idarubicin, epirubicin.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be given to pregnant women because it is likely to be harmful to the developing baby. Seek medical advice from your doctor.

You should use an effective method of contraception to avoid getting pregnant or fathering a child during treatment with this medicine. You should continue to use contraception to prevent pregnancy for at least six months after stopping this medicine. Women should consult their doctor immediately if they get pregnant during treatment.

Significant amounts of this medicine may pass into breast milk and this may have serious side effects on a nursing infant. Mothers who need treatment with this medicine should stop breastfeeding and bottlefeed instead. Discuss this with your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Blue/green coloration of urine

Decrease in the number of white blood cells in the blood (leucopenia)

Decrease in the number of red blood cells in the blood (anaemia)

Decrease in the number of platelets in the blood (thrombocytopenia)

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Loss of appetite

Inflammation of the lining of the mouth (stomatitis)

Alteration in taste

Hair loss (reversible on stopping treatment)

Fatigue and weakness

Inflammation of the vein (phlebitis) used for administering the drip

Confusion

Anxiety

Fever (pyrexia)

Stopping of menstrual periods (amenorrhoea)

Blue discoloration of the skin, nails or whites of the eyes (this is temporary and due to the colour of the medicine)

Rash

Shortness of breath

Changes in liver function

Bleeding in the stomach or intestines

Heart failure

Irregular heart beats (arrhythmias)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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