How does it work?

Caelyx infusion contains the active ingredient doxorubicin hydrochloride, which is a type of anticancer medicine called a cytotoxic anthracycline antibiotic.

Cancers form when some cells within the body multiply uncontrollably and abnormally. These cells then spread and destroy nearby tissues. Doxorubicin works by stopping the cancer cells from dividing and multiplying. This kills the cancer cells and stops the cancer growing.

Doxorubicin's exact mechanism of action is unknown but it seems to work in three ways. Firstly, it inserts itself into the strands of genetic material (DNA) inside the cancer 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. This stops the cancer cells growing and multiplying. Finally it can also form free radicals, which are molecules capable of damaging the cancer cells.

Unfortunately, anticancer medicines also affect normal, healthy cells, particularly those that multiply quickly such as blood, gut and hair cells. The most important side effect is usually on the bone marrow where blood cells are made. Doxorubicin can decrease the production of white blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor levels of blood cells.

The doxorubicin in this medicine is contained in tiny spheres called pegylated liposomes. These spheres allow the doxorubicin to remain in the bloodstream for longer so that a greater amount is delivered to the cancerous cells, rather than to healthy tissue. This may result in fewer side effects than standard doxorubicin.

The medicine is given through a drip into a vein (intravenous infusion).

What is it used for?

• Advanced ovarian cancer when platinum-based chemotherapy has been unsuccessful.
• AIDS-related Kaposi's sarcoma (a form of skin cancer).
• Breast cancer that has spread to other areas of the body.
• Bone marrow cancer (multiple myeloma) in combination with bortezomib, in people who have received at least one prior therapy and who have already had or are unsuitable for a bone marrow transplant.

Warning!

• If you notice any stinging or burning around the vein, or any leakage of fluid from the canula while this medicine is being given, it is important to tell the doctor or nurse immediately.
• Chemotherapy medicines 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.
• Your heart and liver function should be monitored before and during treatment with this medicine.
• This medicine can cause redness, swelling and sores on the palms of your hands and soles of your feet. This side effect is known as hand-foot syndrome and can be severe. To minimise it there are various measures you should take for 4 to 7 days after each infusion, including keeping hands and feet uncovered (avoid socks/gloves/tight-fitting shoes) and soaking them in cool water when possible, eg when watching television. Avoid exposing the skin to very hot water, eg saunas and jacuzzis, and avoid exercise that might cause damage to the skin. For more advice talk to your cancer specialist.
• This medicine may be harmful to an unborn baby. For this reason, women being treated with this medicine should use effective contraception to prevent pregnancy, and men being treated this medicine should use effective contraception to prevent fathering a child, both during treatment, and for at least six months after treatment is finished. Women should consult their doctor immediately if they become pregnant.
• Your ability to become 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.

Use with caution in

• People who have had radiotherapy treatment in the area of the chest cavity.
• People who have had treatment with other medicines that may have side effects on the heart, eg other anthracycline chemotherapy medicines.
• Heart disease.
• Decreased heart function.
• Decreased liver function.
• Diabetes.

Not to be used in

• Pregnancy.
• Breastfeeding.
• The manufacturer of this medicine has limited experience of this medicine in treating children and adolescents under 18 years of age. It is not recommended for this age group.

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 may be harmful to an unborn baby. It should not be used during pregnancy unless considered essential by your doctor. Women being treated with this medicine should use effective contraception to prevent pregnancy, and men being treated with this medicine should use effective contraception to prevent fathering a child, both during treatment, and for at least six months after treatment is finished. Consult your doctor immediately if you become pregnant.
• It is not known whether this medicine passes into breast milk. Mothers who need treatment with 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. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Painful redness, swelling, blistering or ulceration of the palms and soles (palmar-plantar erythrodysesthesia).
• Sore mouth and mouth ulcers.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Weakness or loss of strength (asthenia).
• Fatigue.
• Decrease in the number of white blood cells in the blood (leucopenia).
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Decrease in the number of red blood cells in the blood (anaemia).
• Hair loss (alopecia).
• Loss of appetite.
• Skin reactions such as rash and itch.
• Fever (pyrexia).
• Sore throat.
• Pins and needles sensations.
• Damage to the heart (cardiotoxicity), eg heart failure.

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.

How can this medicine affect other medicines?

You should tell your doctor what medicines you are taking, including those bought without a prescription and herbal medicines, before you start your chemotherapy. Likewise, always check with your doctor or pharmacist before taking any new medicines during your treatment.

There may be an increased risk of side effects if this medicine is used in combination with other anticancer medicines.

Sorafenib may increase the blood level of doxorubicin.

High doses of ciclosporin increase the blood level and risk of side effects of doxorubicin.

This medicine may decrease the effect of stavudine used to treat HIV infection.

Vaccines may be less effective in people receiving chemotherapy. This is because chemotherapy medicines reduce the activity of the immune system and can prevent the body forming adequate antibodies. Live vaccines should be postponed until at least six months after finishing chemotherapy because they may cause infection. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever and oral typhoid vaccines.

Other medicines containing the same active ingredient