How does it work?

Alkeran tablets and injection contain the active ingredientmelphalan, which is a type of chemotherapy medicine to treat cancer called analkylating agent.

Cancers form when some cells within the body multiplyuncontrollably and abnormally. These cells spread, destroying nearby tissues.Melphalan works by stopping the cancer cells from multiplying. It does this bybinding to and damaging the DNA in the cancer cells. This stops the cells fromgrowing and multiplying.

Unfortunately, melphalan 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 aremade. Melphalan can decrease the production of blood cells, leaving peoplesusceptible to infection. Regular blood tests are therefore needed to monitorthe levels of blood cells.

In most chemotherapy regimens, doses are administered in coursesat various intervals to allow normal cells to recover from the adverse effectsof the anticancer medicines between doses. However, during this period, cancercells will also recover and start to replicate again. Successful treatmentdepends on the administration of the next course of therapy before the cancerhas regrown to its previous size, with the aimed net effect to decrease theamount of cancer with each successive course of chemotherapy.

Melphalan is used in the treatment of a range of cancersincluding bone marrow cancer (multiple myeloma), advanced cancer of the ovariesand advanced breast cancer. It is also used in the management of a diseasecalled polycythaemia vera in which there are too many red cells in the blood.Melphalan can be used alone, or in combination with other anti-cancer medicinesor surgery.

Melphalan can be taken by mouth as tablets, or it can be givenby injection or infusion (drip) into a vein.

The injection can also be given via a procedure called regionalarterial perfusion, to treat melanomas or sarcomas affecting a localised areaof a limb, eg arm or leg. This is carried out under general anaesthetic. Atight band is first applied to the top of the limb to prevent the chemotherapyfrom reaching other areas of the body. The medicine is then injected into anartery in the arm or leg.

What is it used for?

• Cancer of the plasma cells in the bone marrow (multiple myeloma)
• Advanced breast cancer
• Advanced cancer of the ovaries
• Excessive levels of red blood cells in the blood (polycythaemia vera)
• Childhood neuroblastoma (by injection only)
• Localised skin cancer (malignant melanoma) affecting a limb (by regional arterial perfusion only - see above)
• Localised soft tissue sarcoma affecting a limb (by regional arterial perfusion only - see above)

Warning!

• Alkeran tablets should be swallowed whole on an empty stomach. Do not break or cut the tablets.
• The tablets should be stored in a refrigerator at 2°C to 8°C and kept dry. Make sure they are kept well out of the reach of children.
• 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.
• Tell your doctor if you get a cough, or start to feel breathless or wheezy while having treatment with this medicine.
• Long-term treatment with melphalan may increase the risk of developing developing leukaemia (cancer of the white blood cells) after many years. After your treatment you will have regular blood tests which will detect any possible leukaemic changes early, if they do occur. Your doctor or nurse can discuss the risks of this with you.
• Your ability to become pregnant or father a child may be affected by taking this drug. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• Decreased kidney function
• People who have recently had radiotherapy or other chemotherapy treatment

Not to be used in

• Known sensitivity or allergy to any ingredient

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and Breastfeeding

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

• This medicine should not be used during pregnancy, unless considered essential by your doctor, as it may be harmful to the unborn baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Seek medical advice from your doctor.
• It is not known whether this medicine passes into breast milk. Mothers who need this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

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

• Decrease in the number of white blood cells in the blood (leucopenia)
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Nausea and vomiting
• Diarrhoea
• Inflammation of the lining of the mouth (stomatitis)
• Skin reactions such as rash and itch
• Stopping or absence of menstrual periods in women (amenorrhoea)
• Hair loss (alopecia)
• Excessive breakdown of red blood cells that reduces red blood cell count (haemolytic anaemia)
• Changes to the lungs, such as inflammation or stiffening
• Liver disorders
• Sensation of warmth and/or tingling in people given high-dose Alkeran injection through a central line

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

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines duringtreatment this one, to ensure that thecombination is safe.

Chemotherapy decreases the body's immune response. This meansthat vaccines may be less effective if given during treatment, and livevaccines may cause serious infections. Live vaccines include: measles, mumps,rubella, MMR, oral polio, oral typhoid and yellow fever. If live vaccines areneeded they should be postponed until at least six months after finishingchemotherapy.

There may be an increased risk of side effects on the kidneys ifmelphalan is used in combination with ciclosporin.

There may be an increased risk of side effects if high-doseintravenous melphalan is used in combination with nalidixic acid inchildren.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain melphalan as the active ingredient.