How does it work?

This medicine contains the active ingredient doxorubicin hydrochloride, which is an anticancer (cytotoxic) medicine. It is contained inside fat molecules known as liposomes. By containing the medicine within liposomes some of the adverse effects from the medicine are not as severe. Cancers form when some cells within the body multiply uncontrollably and abnormally. There are main two types of cancer. Firstly, solid cancers where a lump forms, eg the bone, muscle, brain cells etc divide and multiply abnormally. The second type are leukaemias and lymphomas where the blood cells divide and multiply abnormally. Other characteristics of cancer besides uncontrolled growth include the ability of these abnormal cells to invade other tissues next to them or to break away from the original site, travel through the blood or lymph, and establish a new cancer at a different site of the body. These are called metastases. Like normal healthy cells, cancer cells go through a continuous process of change. Each cell divides into two daughter cells. These cells grow, rest and then divide again. The medicines used in chemotherapy are powerful chemicals designed to interupt this cycle and stop cells from growing. Several different types of anticancer medicines are used in chemotherapy. Each type kills cells at a different stage of the cell's life cycle. Each does its job in a different way. Doxorubicin belongs to a group of medicines called cytotoxic anthracycline antibiotics. These are synthetic medicines that have been derived from compounds found in certain bacteria and fungi. Doxorubicin's exact mechanism of action is unknown but it seems to work in three ways. It inserts itself into the strands of genetic material (DNA) inside the cell and binds them together. This prevents the cell 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. Finally it can also form free radicals which are molecules capable of damaging cells. All this prevents the cell from growing and therefore it dies. Unfortunately, anticancer medicines will also affect the growth and division of normal, healthy cells, eg blood, gut and hair cells, in the same way. This causes several of the side effects seen with chemotherapy, eg hair loss, and suppression of the immune system increasing the risk of infections, due to decreased numbers of white blood cells. 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. The liposomal formulation of doxorubicin is administered by intravenous infusion. It is used to treat a form of skin cancer called Kaposi's sarcoma, which often occurs in AIDS. It is also used for advanced cancer of the ovaries in women whose cancer still persists despite a course of platinum-based chemotherapy.

What is it used for?

Advanced ovarian cancer in which other treatments have failed

AIDS-related Kaposi's sarcoma (a form of skin cancer)

Warning!

It is recommended that people taking this medicine have regular blood tests to monitor their liver function.

People taking this medicine should have regular blood tests to check the levels of their blood components.

This medicine is vesicant, ie it can cause severe local reactions such as blistering, ulceration and death to skin and tissue should it leak out of the vein (extravasation). Great care must be taken to avoid extravasation when administering this medicine.

Special precautions must be taken by those preparing and handling cytotoxic medicines, in order to prevent self-contamination.

An electrocardiogram (ECG) is recommended before, during and after treatment. Other methods to assess the functioning of heart such as an echocardiogram or radionuclide studies are also advisable.

The safety of this medicine has not been established in children and adolescents under the age of 18.

Effective contraception should be used by women who themselves, or whose male partners, are receiving treatment with this medicine. Contraception should be continued for at least 6 months after the medicine is stopped. Consult your doctor immediately if you become pregnant.

Use with caution in

Current or previous radiotherapy treatment in the area of the chest cavity

Decreased heart function

Decreased liver function

Diabetes

History of disease involving the heart and blood vessels

Previous therapy with other anthracycline type anticancer medicines or other medicines potentially toxic to the heart

Not to be used in

Breastfeeding

Pregnancy

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 must not be used during pregnancy, as it may be harmful to the unborn baby. Effective contraception should be used by women who themselves, or whose male partners, are receiving treatment with this medicine. Contraception should be continued for at least 6 months after the medicine is stopped. Consult your doctor immediately if you become pregnant.

It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from 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.

Rash

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

Allergic reaction to active ingredient

Hair loss (alopecia)

Fever (pyrexia)

Low red blood cell count (anaemia)

Loss of appetite

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

Inflammation of the lining of the mouth (stomatitis)

Damage to the heart (cardiotoxicity)

Weakness or loss of strength (asthenia)

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

Painful redness, swelling, blistering or ulceration of the palms and soles (palmar-plantar erythrodysesthesia)

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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