Leukeran

Patient Information Leaflet

Leukeran, 2 mg, film-coated tablets
Chlorambucil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents

1. What Leukeran is and what it is used for
2. What you need to know before taking Leukeran
3. How to take Leukeran
4. Possible side effects
5. How to store Leukeran
6. Contents of the pack and other information

1. What Leukeran is and what it is used for

Leukeran contains an active substance called chlorambucil, which belongs to a group of medicines known as cytotoxic agents (also called chemotherapy). This medicine is used to treat certain types of blood and lymphatic system cancers in humans. Your doctor will be able to explain how Leukeran may help in your condition.
Leukeran is indicated for use in patients with:

• Hodgkin’s disease and non-Hodgkin’s lymphoma. Together, these form a group of diseases known as lymphomas. These are cancers arising from cells of the lymphatic system.
• chronic lymphatic leukaemia. A type of blood cancer in which the bone marrow produces a large number of abnormal white blood cells.
• Waldenström’s macroglobulinaemia. A rare lymphoma associated with uncontrolled growth of B-cells, a type of white blood cell, resulting in the release of an abnormal protein into the blood.

2. Important information before using Leukeran

When not to use Leukeran:

• if the patient is allergic to chlorambucil or any of the other ingredients of this medicine (listed in section 6).

If in doubt, consult a doctor before taking Leukeran.
Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor, pharmacist, or nurse if:

• the patient has recently been vaccinated or plans to receive a live vaccine (see "Leukeran with other medicines"), because Leukeran may reduce the body's ability to fight infections.
• the patient is a potential candidate for bone marrow transplantation (autologous stem cell transplant), because long-term use of Leukeran may reduce the number of stem cells.
• the patient is currently undergoing or has recently undergone radiotherapy or chemotherapy.
• the patient has impaired liver function.
• the patient has impaired kidney function (nephrotic syndrome), has been treated with so-called pulse therapy using high doses, or has ever experienced seizures or convulsions. If the patient has had seizures or convulsions, they may be more susceptible to experiencing seizures or convulsions while taking Leukeran.

Long-term use of Leukeran, in particular, may increase the risk of developing secondary blood cancer. In many cases, patients who developed this disease had also received other types of chemotherapy or some form of radiotherapy.
Symptoms of secondary blood cancer include fatigue, fever, infection, and bruising. Inform your doctor immediately if any of these symptoms occur (see section 4).
Leukeran with other medicines
Inform your doctor about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including:

• vaccines containing live organisms (e.g. oral polio vaccine, measles, mumps, rubella),
• fludarabine, pentostatin, or cladribine—other chemotherapy drugs used in the treatment of certain blood cancers,
• phenylbutazone (a medicine used to treat fever, pain, and inflammation in the body)—a lower dose of Leukeran may be required.

Inform your doctor if the patient is currently taking, has recently taken, or might take any other medicines, including those obtained without a prescription. This also includes herbal medicines.
Taking Leukeran with food
Leukeran should be taken on an empty stomach. See section 3.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using chlorambucil.
Do not take Leukeran if planning to have a child. This applies to both women and men.
Use of Leukeran during pregnancy is not recommended, as it may be highly harmful to the unborn child.
Do not breastfeed while taking Leukeran.
Leukeran may affect the ovaries or sperm, leading to infertility (inability to have children). Women may experience absence of menstruation (amenorrhoea), and men may experience complete absence of sperm (azoospermia).
Effective contraceptive methods should be used by either partner during treatment with Leukeran to avoid pregnancy. Consult your doctor for advice.
Driving and operating machinery
There is no data available on the effect of Leukeran on the ability to drive or operate machinery.
Leukeran contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Leukeran

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Leukeran should only be prescribed by a specialist doctor experienced in the treatment of tumours.
Your doctor will advise you on the dose and how often to take this medicine. The dose is calculated based on body weight and the disease condition.

• Leukeran tablets are taken orally and should be taken daily on an empty stomach (at least one hour before a meal or three hours after a meal).
• Swallow the tablets whole with a glass of water.
• Do not break, crush, or chew the tablets.

The dose of Leukeran depends on the type of disease (see section 1).

• Your doctor may adjust the dose during treatment according to individual needs. The dose may sometimes be adjusted in elderly patients or in patients with impaired liver function. In elderly patients, kidney or liver function may be monitored during treatment.
• While taking Leukeran, your doctor may perform regular blood tests to monitor blood cell levels, and the dose of the medicine may be adjusted accordingly.

Hodgkin's disease

• The recommended dose is 0.2 mg per kilogram of body weight per day for adults and children.

Non-Hodgkin's lymphoma

• The recommended dose is 0.1 to 0.2 mg per kilogram of body weight per day for adults and children.

Chronic lymphocytic leukaemia

• The recommended initial dose is 0.15 mg per kilogram of body weight per day for adults.

Waldenström's macroglobulinaemia

• The recommended initial dose is 6 to 12 mg per day for adults. Some patients may need to take Leukeran long-term. Follow your doctor's instructions exactly.

If you take more Leukeran than you should
Seek medical advice immediately or go to the nearest hospital. Take the medicine packaging with you, even if no tablets remain.

If you forget to take Leukeran
If you miss a dose of Leukeran, contact your doctor. Do not take a double dose to make up for a missed dose.

If you stop taking Leukeran
Do not stop taking Leukeran without consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the following symptoms occur, seek immediate medical advice
from a specialist doctor or go to hospital:

• any signs of fever or infection (sore throat, mouth pain, or problems urinating),
• any unexpected bruising or bleeding, as this may indicate that too few blood cells of a certain type are being produced,
• sudden worsening of general condition (even with normal body temperature),
• extreme tiredness,
• numbness or muscle weakness,
• skin rash, blisters on the skin, mouth or eye pain, and high temperature.

Talk to your doctor if any of the following adverse reactions occur, which may also happen during treatment with this medicine:
Very common (affects more than 1 in 10 people)

• reduction in blood cells and platelets or suppression of bone marrow function.

Common (affects at least 1 in 10 people)

• nausea, vomiting, diarrhoea, and mouth ulcers,
• secondary blood cancers (secondary haematological malignancies),
• seizures (convulsions) in children with a kidney disorder called nephrotic syndrome,
• reduction in red blood cells or anaemia, which may cause tiredness, weakness, or shortness of breath.

Uncommon (affects at least 1 in 100 people)

• rash.

Rare (affects at least 1 in 1,000 people)

• yellowing of the whites of the eyes or skin (jaundice),
• allergic reactions such as lumps, hives, or tissue swelling,
• progression of skin rash to severe conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These two forms of the same serious skin disease cause rash, skin peeling, and mucosal ulcers,
• fever,
• seizure or convulsions,
• liver damage (hepatotoxicity).

Very rare (affects at least 1 in 10,000 people)

• abnormal or recurrent body tremors or involuntary movements not associated with seizures or convulsions,
• inflammation of the urinary bladder,
• irreversible bone marrow failure – the body may temporarily stop producing blood cells,
• lung scarring and thickening causing breathing difficulties,
• interstitial lung disease,
• nerve disease leading to disturbances in sensation, movement, and organ function (peripheral neuropathy).

Frequency not known (cannot be estimated from available data)

• absence of menstruation (amenorrhea),
• absence of sperm in semen (azoospermia).

If any adverse reaction becomes serious or if you experience adverse reactions
not listed in this leaflet, inform your doctor immediately.
Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02 222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Leukeran

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Store at a temperature of 2 °C - 8 °C.
If your doctor advises you to discontinue taking these tablets, it is important to return any unused medicine to the pharmacist, who will destroy it according to guidelines for the disposal of hazardous substances. Tablets should be retained only on explicit instruction of a physician.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Leukeran contains

• The active substance is chlorambucil. Each tablet contains 2 mg of chlorambucil.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, stearic acid, and a coating (Opadry Brown YS-1-16655-A) containing: hypromellose, titanium dioxide, polyethylene glycol 400, yellow iron oxide, red iron oxide.

What Leukeran looks like and contents of the pack
Leukeran is a brown, round, biconvex coated tablet,
marked with "GX EG3" on one side and "L" on the other side.
It is supplied in an amber glass container with a screw cap, packed in a cardboard box.
Pack size: 25 tablets.
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

Information intended exclusively for healthcare professionals:

Instructions for handling the medicinal product
Before administering Leukeran, it is recommended to review the current guidelines
relating to the use of cytotoxic drugs.
Contact with Leukeran tablets does not pose a hazard, provided the outer coating
remains intact.
Leukeran tablets must not be divided.
Disposal of unused medicinal product
Any unused Leukeran tablets should be destroyed appropriately, in accordance with
applicable regulations for the disposal of hazardous substances.
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