Aspen

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions about your illness or your medicine, ask your doctor or nurse.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1 What Alkeran is and what it is used for
2 Before you have Alkeran
3 How to have Alkeran
4 Possible side effects
5 How to store Alkeran
6 Further information

Do not have Alkeran if:

• You are allergic (hypersensitive) to melphalan or any of the other ingredients of Alkeran injection (See section 6: Further information)

Do not have Alkeran if the above applies to you. If you are not sure, talk to your doctor or nurse before having Alkeran.

Take special care with Alkeran

Before you use Alkeran, tell your doctor or nurse if:

• you have had radiotherapy or chemotherapy, now or recently
• you have a kidney problem.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Alkeran.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular, tell your doctor or nurse if you are taking any of the following:

• other cytotoxic drugs (chemotherapy)
• nalidixic acid (an antibiotic used to treat urinary tract infections)
• ciclosporin (used to prevent rejection of organs or tissues following a transplant or to treat certain skin conditions like psoriasis and eczema or to treat rheumatoid arthritis).

Having vaccines while you are taking Alkeran

If you are going to have a vaccination speak to your doctor or nurse before you have it. This is because some vaccines (like polio, measles, mumps and rubella) may give you an infection if you have them whilst you are being treated with Alkeran.

Fertility

Do not take Alkeran if you are planning to have a baby. This applies to both men and women.

• In women Alkeran may cause ovaries to stop producing eggs and periods to stop.
• In men Alkeran may cause temporary or permanent decrease in sperm count due to suppression of testicular function.

Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner is having this injection. Ask your doctor for advice.

Pregnancy and breast-feeding

Treatment with Alkeran is not recommended during pregnancy because it may cause permanent damage to a foetus. If you are pregnant, if you think you could be pregnant, or if you are planning to become pregnant, check with your doctor before you take Alkeran. Your doctor will consider the risks and benefits to you and your baby of taking Alkeran.

Do not breast-feed during treatment with Alkeran. Ask your doctor or midwife for advice.

If you have more Alkeran than you need

Your doctor will give you Alkeran so it is unlikely that you will receive too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

If you get any of the following, talk to your specialist doctor or go to hospital straight away:

• allergic reaction, the signs may include:
  • a rash, lumps or hives on the skin
  • swollen face, eyelids or lips
  • sudden wheeziness and tightness of the chest
  • collapse (due to cardiac arrest)
• any signs of a high temperature or infection (sore throat, sore mouth or urinary problems). Treatment with Alkeran can cause a lowering of the white blood cell count. White blood cells fight infection, and when there are too few white blood cells, infections can occur
• any unexpected bruising or bleeding or feeling extremely tired, dizzy or breathless, as this could mean that too few blood cells of a particular type are being produced
• if you suddenly feel unwell (even with a normal temperature)
• if your muscles are achy, stiff or weak and your urine is darker than usual or brown or red in colour - when you have Alkeran directly into your arm or leg.
• If Alkeran is injected directly in to your arm or leg it is possible that some of the drug can leak in to surrounding tissue and cause damage to that tissue. Symptoms of this include slight discomfort in the area, mild redness of the skin or a mild rash. In rare cases death of surrounding skin tissue, ulcers and damage to deeper tissue may occur.

Very common (affects more than 1 in 10 people)

• a drop in the number of blood cells and platelets
• feeling sick (nausea), being sick (vomiting) and diarrhoea
• mouth ulcers - with high doses of Alkeran
• hair loss - with high doses of Alkeran
• a tingling or warm feeling where Alkeran was injected
• problems with your muscles like wasting and aching - when you have Alkeran directly into your arm or leg

Common (affects less than 1 in 10 people)

• hair loss - with usual doses of Alkeran
• high levels of a chemical called urea in your blood - in people with kidney problems who are being treated for myeloma
• a muscle problem which can cause pain, tightness, tingling, burning or numbness - called compartment syndrome. This can happen when you have Alkeran directly into your arm or leg

Rare (affects less than 1 in 1,000 people)

• an illness where you have a low number of red blood cells as they are being destroyed prematurely - this can make you feel very tired, breathless and dizzy and can give you headaches or make your skin or eyes yellow
• lung problems which may make you cough or wheeze and make it difficult to breathe
• liver problems which may show up in your blood tests or cause jaundice (yellowing of the whites of eyes and skin)
• mouth ulcers - with normal doses of Alkeran

skin rashes or itching skin

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

It is also possible that the use of Alkeran will increase the risk of developing another type of cancer called secondary acute leukaemia (cancer of the blood) in the future. Secondary acute leukaemia causes bone marrow (tissue in your bones that produces red and white blood cells) to produce large numbers of cells that do not work properly. Symptoms of this condition include tiredness, fever, infection and bruising. The condition may also be detected by a blood test which will show if there are large numbers of cells in your blood that are not working properly and too few blood cells that are working properly.

Tell your doctor as soon as possible if you have any of these symptoms. You may need to stop taking Alkeran, but only your doctor can tell you if that is the case.

What Alkeran contains

The active ingredient is melphalan. Each Alkeran injection contains 50 mg of melphalan.

The other ingredients are povidone K12 and hydrochloric acid. Alkeran is dissolved in 10ml of solvent before being injected. The solvent contains water for injections, sodium citrate, propylene glycol and ethanol.

This medicinal product contains small amounts of ethanol less than 100mg per dose

It also contains 2mmol (or 46mg) of sodium per vial of reconstituted product, which should be taken into account by patients on a controlled sodium diet

What Alkeran looks like and contents of the pack

Each pack contains one vial of Alkeran powder and one vial of solvent. The powder vial contains 50mg of the active substance melphalan in a powder format and the solvent vial contains 10ml of a solvent in which to reconstitute (dissolve) the powder.

When a vial of Alkeran powder is reconstituted with 10ml of the solvent, the resultant solution contains 5mg/ml anhydrous melphalan.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Manufacturer: