Alkeran

Package Leaflet: Information for the User

Alkeran, 2 mg, coated tablets

Melfalan

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Alkeran is and what it is used for
• 2. Before you take Alkeran
• 3. How to take Alkeran
• 4. Possible side effects
• 5. How to store Alkeran
• 6. Contents of the pack and other information

1. What Alkeran is and what it is used for

Alkeran tablets contain a medicine called melfalan. This belongs to a group of medicines called cytotoxics (also known as chemotherapy) and is used to treat certain types of cancer. It works by reducing the number of abnormal cells in your body.
Alkeran tablets are used to treat multiple myeloma, a type of cancer that affects the cells in the bone marrow (the spongy tissue inside your bones), called plasma cells. Plasma cells help to fight infection and disease by producing antibodies.
If you do not feel better or your condition worsens, you should consult your doctor.

2. Before you take Alkeran

Do not take Alkeran

• if you are allergic to melfalan or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.

If you are in doubt, consult your doctor or pharmacist before taking melfalan.

Warnings and precautions

Before taking Alkeran, discuss this with your doctor or nurse:

• if you are currently having or have recently had radiotherapy or chemotherapy,
• if you have kidney problems,
• if you are going to have a vaccination or have recently been vaccinated. This is because some vaccines (e.g. against polio, measles, mumps and rubella) may cause infections if given while you are taking Alkeran.
• if you are taking combined oral contraceptives (the "pill"). This is because there is an increased risk of developing blood clots in women with multiple myeloma. In this case, women should start using a progestogen-only contraceptive (e.g. desogestrel) instead.

Women should use a progestogen-only contraceptive for at least 4 to 6 weeks after stopping combined oral contraceptives, as the increased risk of blood clots may continue during this time.
Men and women should use effective contraception during and for up to 6 months after treatment with Alkeran.

• if you or your partner are planning to have children, as there is a risk of genetic toxicity (damage to genetic information) and infertility (see section "Pregnancy, breast-feeding and fertility").

Alkeran may increase the risk of developing other types of cancer (e.g. secondary leukaemias) in a small number of patients, especially when given with lenalidomide, thalidomide and prednisone. Before prescribing Alkeran, your doctor will carefully weigh up the benefits and risks.

Alkeran with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those you have bought yourself, and any herbal medicines.
In particular, tell your doctor if you are taking:

• live vaccines (see Warnings and precautions),
• nalidixic acid (an antibiotic used for urinary tract infections),
• cyclosporin (used to prevent rejection of transplanted organs or to treat certain skin conditions, e.g. psoriasis or eczema, or rheumatoid arthritis).
• in children - busulfan (a medicine used to treat cancer).

Pregnancy, breast-feeding and fertility

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Do not take melfalan if you are planning to have a baby. This applies to both men and women. Use effective contraception to prevent pregnancy while taking this medicine.
Women should use effective contraception during and for 6 months after treatment with Alkeran.
Men should use effective contraception during and for 3 months after treatment with Alkeran.
Pregnant women must discuss this with their doctor before taking Alkeran.
Do not breast-feed while taking Alkeran. Ask your doctor for advice.
Fertility
Alkeran may affect the ovaries or sperm, leading to infertility (inability to have children). In women, this may cause absence of periods (amenorrhoea), and in men, a complete lack of sperm (azoospermia). Because of the possibility of a lack of sperm due to treatment with Alkeran, men should seek advice on storing sperm before starting treatment.

Driving and using machines

Alkeran has not been studied in patients who are taking this medicine and driving or using machines.

3. How to take Alkeran

Melfalan should only be prescribed by a specialist doctor who has experience in treating cancer.
Alkeran is a potent cytotoxic medicine and should only be taken under the supervision of a doctor who is experienced in giving this type of medicine.
Always take Alkeran exactly as your doctor has told you. It is important to take your medicine at the right times. The label on the pack will tell you how many tablets to take and how often to take them. If the label does not say or if you are not sure, ask your doctor, nurse or pharmacist.

• Swallow the tablets whole with a glass of water.
• Do not break, crush or chew the tablets.

The dose of Alkeran will depend on the type of blood disorder or cancer you are being treated for (see section 1).

• Your doctor may also change your dose during treatment, depending on your needs.
• The dose may sometimes be changed for elderly people or people with kidney problems.
• While you are taking Alkeran, your doctor will take regular blood tests to check the number of blood cells. As a result, your doctor may sometimes change the dose you are taking.

Multiple myeloma

• The usual dose is 0.15 mg per kilogram of body weight per day for 4 days. This is repeated every 6 weeks.

Children

Alkeran is rarely used to treat children. There is no information available on the use of Alkeran in children.

If you take more Alkeran than you should

If you take more Alkeran than you should, contact your doctor or go to hospital immediately, taking the pack with you.
Symptoms of overdose may include feeling sick, being sick and diarrhoea.
Thromboembolic events
Patient should receive prophylactic anticoagulation for at least the first 5 months of treatment, especially in patients with additional thrombotic risk factors. The doctor will decide what additional measures should be taken after careful assessment of all the patient's risk factors.
If any thromboembolic events occur, the patient should inform their doctor immediately, as it may be necessary to stop taking Alkeran and start standard anticoagulant treatment. After the thromboembolic events have been treated, the doctor will decide whether to restart treatment with melfalan in combination with lenalidomide and prednisone or thalidomide with prednisone or dexamethasone. The patient should continue anticoagulant treatment during the course of melfalan treatment.

If you forget to take Alkeran

Contact your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alkeran

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alkeran can cause side effects, although not everybody gets them.

If you get any of the following symptoms, contact your doctor or go to hospital immediately:

• allergic reaction - symptoms may include:
• rash, lumps or hives on the skin,
• swelling of the face, eyelids or lips,
• sudden difficulty in breathing and tightness in the chest,
• collapse (due to a sudden drop in blood pressure),
• any signs of infection (e.g. sore throat, mouth ulcers or problems passing water),
• any unusualbruising or bleeding, or feeling extremely tired, dizzy or short of breath, as this could be a sign that you have too few blood cells of a particular type,
• a suddensevere deterioration in your condition (even if your temperature is normal).

Tell your doctor if you get any of the following side effects:

Very common (affects more than 1 in 10 people)

• reduced number of blood cells and platelets,
• feeling sick, being sick and diarrhoea,
• mouth ulcers - at high doses of melfalan,
• hair loss - at high doses of melfalan.

Common (affects less than 1 in 10 people)

• hair loss - at normal doses of melfalan,
• high levels of a chemical called urea in the blood - in people with kidney problems who are being treated for multiple myeloma.

Rare (affects less than 1 in 1000 people)

• a disease where there are too few red blood cells because they are being destroyed too quickly - this can cause tiredness, breathlessness and dizziness, and also headaches or yellowing of the skin or eyes,
• lung problems, which can cause coughing or breathlessness and difficulty breathing,
• liver problems, which can be seen in blood tests or cause yellowing of the whites of the eyes or skin (jaundice),
• mouth ulcers - at normal doses of melfalan,
• skin rashes or itching.

Frequency not known (frequency cannot be estimated from the available data)

• leukaemia - a cancer of the blood,
• in women: absence of periods,
• in men: lack of sperm in the semen (azoospermia),
• deep vein thrombosis (a condition where a blood clot forms in one of the deep veins, usually in the legs) and pulmonary embolism (a condition where a blood clot forms in the lungs),
• acute kidney damage - kidney failure (a sudden and severe deterioration in kidney function) which develops in a short period of time.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alkeran

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
If your doctor decides to stop treatment, it is important that you return any remaining tablets to your pharmacist, who will dispose of them in accordance with the current guidelines for the disposal of hazardous waste. Keep the tablets only if your doctor tells you to.

6. Contents of the pack and other information

What Alkeran contains

• The active substance is melfalan. Each tablet contains 2 mg of melfalan.
• The other ingredients are microcrystalline cellulose, crospovidone, silica colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide, macrogol.

What Alkeran looks like and contents of the pack

Alkeran is a white or almost white, round, biconvex, film-coated tablet with "GX EH3" on one side and "A" on the other side.
The pack contains 25 film-coated tablets in an amber glass bottle with a child-resistant closure, in a cardboard box.

Marketing Authorisation Holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: +48 22 104 2100

Manufacturer

EXCELLA GmbH & Co. KG
Nürnberger Strasse 12
90537 Feucht
Germany
Date of last revision of the leaflet:12/2024
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Information intended for healthcare professionals only:

Precautions to be taken before handling or administering Alkeran

Before handling Alkeran, you should be familiar with the current guidelines for handling cytotoxic medicines.
Contact with Alkeran tablets does not pose a risk as long as the outer coating is not damaged.
Alkeran tablets should not be broken or crushed.

Disposal of unused Alkeran

Unused Alkeran tablets should be disposed of in accordance with local requirements for the disposal of hazardous waste.
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