Leukeran (Chlorambucil)
Alkylating chemotherapy agent for lymphomas and chronic lymphocytic leukemia
Quick Facts About Leukeran
Key Takeaways About Leukeran
- Established chemotherapy: Chlorambucil has been used for over 60 years and remains a valuable treatment option for certain blood cancers and lymphomas
- Oral convenience: Unlike many chemotherapy drugs, Leukeran is taken as a tablet by mouth, making it suitable for outpatient treatment
- Regular blood monitoring required: Bone marrow suppression is the most significant side effect, requiring frequent blood tests to monitor blood cell counts
- Risk of secondary cancers: Long-term use may increase the risk of developing secondary leukemia, particularly when combined with other chemotherapy or radiation
- Fertility impact: Chlorambucil can cause infertility in both men and women; patients should discuss fertility preservation before starting treatment
What Is Leukeran and What Is It Used For?
Leukeran (chlorambucil) is a cytotoxic chemotherapy drug belonging to the alkylating agent class. It is used to treat various types of cancer affecting the blood and lymphatic system, including Hodgkin lymphoma, non-Hodgkin lymphoma, and chronic lymphocytic leukemia (CLL).
Leukeran contains the active substance chlorambucil, which belongs to a group of medicines called cytotoxic agents, also known as chemotherapy drugs. Chlorambucil is classified as an alkylating agent of the nitrogen mustard type. This class of drugs was among the first chemotherapy agents developed and has remained an important part of cancer treatment since the 1950s. Chlorambucil is particularly valued for its oral bioavailability, predictable pharmacokinetics, and relatively manageable side effect profile compared to other alkylating agents.
The mechanism of action of chlorambucil involves the formation of covalent bonds with DNA molecules within cancer cells. Specifically, it creates cross-links between and within DNA strands, primarily at the N-7 position of guanine bases. These cross-links prevent the DNA from being properly separated and replicated during cell division, ultimately triggering programmed cell death (apoptosis) in rapidly dividing cells. Because lymphoid cells are particularly sensitive to alkylating agents, chlorambucil is especially effective against cancers of the lymphatic system.
Chlorambucil is absorbed from the gastrointestinal tract and is extensively metabolized in the liver to its primary active metabolite, phenylacetic acid mustard, which also possesses cytotoxic activity. The drug has a plasma half-life of approximately 1.5 hours, while the active metabolite has a half-life of approximately 2.5 hours. This relatively short half-life contributes to its manageable toxicity profile when dosed appropriately.
Approved Indications
Leukeran is used in the treatment of various forms of serious lymphatic tissue diseases (malignant lymphomas). The specific conditions for which chlorambucil is indicated include:
- Hodgkin lymphoma (Hodgkin disease): A cancer of the lymphatic system characterized by the presence of Reed-Sternberg cells. Chlorambucil may be used as part of combination chemotherapy regimens or as a single agent in patients who cannot tolerate more aggressive treatments
- Non-Hodgkin lymphoma: A diverse group of blood cancers that develop in the lymphatic system. Chlorambucil is particularly effective in low-grade (indolent) non-Hodgkin lymphomas, including follicular lymphoma and marginal zone lymphoma
- Chronic lymphocytic leukemia (CLL): The most common type of leukemia in adults, characterized by the accumulation of abnormal lymphocytes in the blood, bone marrow, and lymphoid tissues. Chlorambucil has historically been a first-line treatment for CLL, particularly in elderly patients or those with comorbidities
According to the World Health Organization, lymphomas are the sixth most common type of cancer worldwide, and CLL accounts for approximately 25 to 30 percent of all leukemias in Western countries. While newer targeted therapies and immunotherapies have expanded treatment options for these conditions, chlorambucil remains relevant, particularly in settings where access to newer agents is limited, or in patient populations where gentler treatment approaches are preferred.
Leukeran should only be prescribed and managed by a specialist physician experienced in treating cancer. Your doctor will explain how chlorambucil can help in your specific condition and will determine the most appropriate dosing schedule based on your individual circumstances.
What Should You Know Before Taking Leukeran?
Before starting Leukeran, inform your doctor about any allergies, current medications, recent vaccinations, and whether you are pregnant or planning to become pregnant. Chlorambucil is teratogenic and must not be used during pregnancy. Regular blood tests are essential during treatment to monitor bone marrow function.
Chlorambucil is a potent cytotoxic medication that requires careful consideration before starting treatment. Your healthcare team will conduct a thorough assessment of your medical history, current health status, and other medications to determine whether Leukeran is appropriate and safe for you. Understanding the contraindications, warnings, and precautions associated with this medication is essential for minimizing risks and optimizing treatment outcomes.
Contraindications
You must not take Leukeran if:
- You are allergic (hypersensitive) to chlorambucil or any of the other ingredients in the tablet (listed in the composition section below)
If you are unsure whether any of the above applies to you, speak with your doctor before taking Leukeran.
Warnings and Precautions
Talk to your doctor or nurse before taking Leukeran if any of the following apply to you:
- Recent vaccination with a live vaccine: Chlorambucil suppresses the immune system, which can make it difficult for your body to fight infections. Live vaccines (such as oral polio vaccine, measles, mumps, and rubella) should not be given during treatment, as they may cause serious infection in immunocompromised patients
- Autologous stem cell transplant planned: Prolonged use of chlorambucil may reduce the number of stem cells available for collection, potentially compromising future transplant options. If stem cell transplantation is being considered as part of your treatment plan, discuss the timing of chlorambucil therapy with your oncologist
- Current or recent radiation therapy or chemotherapy: If you are currently receiving or have recently received other cancer treatments, your doctor needs to know, as combining chlorambucil with other myelosuppressive therapies increases the risk of severe bone marrow suppression
- Liver disease: Chlorambucil is metabolized in the liver, and impaired liver function may affect drug metabolism and increase the risk of toxicity. Your doctor may need to adjust your dose accordingly
- Kidney disease: Renal impairment can affect drug clearance and may increase the risk of certain side effects, including seizures, particularly in patients with nephrotic syndrome
- Nephrotic syndrome with high-dose pulse therapy: Patients with kidney disease (nephrotic syndrome) who receive high-dose pulse regimens of chlorambucil may be at increased risk of seizures or convulsions
- History of seizures: If you have ever had a seizure or convulsion, inform your doctor, as chlorambucil may lower the seizure threshold
The use of Leukeran, especially with prolonged treatment, may increase the risk of developing a secondary blood cancer such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In many cases, patients who developed these secondary cancers had also received other types of chemotherapy or radiation therapy. Symptoms of secondary blood cancer include unexplained fatigue, persistent fever, recurrent infections, and unusual bruising or bleeding. Report any of these symptoms to your doctor as soon as possible.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
- Pregnancy: You must not take Leukeran if you are planning to become pregnant. This applies to both men and women. Treatment with chlorambucil is not recommended during pregnancy because it may be very harmful to the unborn baby. Chlorambucil is teratogenic, meaning it can cause birth defects, and mutagenic, meaning it can cause genetic damage. Animal studies and human case reports have demonstrated serious developmental abnormalities associated with chlorambucil exposure during pregnancy
- Breastfeeding: You must not breastfeed while taking Leukeran. The drug and its metabolites may pass into breast milk and could harm a nursing infant
- Contraception: Both men and women must use reliable contraception to prevent pregnancy while either partner is taking Leukeran. Discuss appropriate contraceptive methods with your healthcare team before starting treatment
Fertility
Leukeran can affect the ovaries and sperm, potentially causing infertility (inability to have children). In women, menstruation may stop entirely (amenorrhea), and in men, a complete absence of sperm in the semen (azoospermia) may occur. These effects can be permanent, particularly after prolonged treatment or higher cumulative doses. Patients of reproductive age should discuss fertility preservation options, such as egg freezing or sperm banking, with their doctor before starting treatment.
Driving and Operating Machinery
There is no specific information available about the effects of chlorambucil on the ability to drive or use machines. However, you are responsible for assessing whether you are fit to drive or perform tasks that require alertness. The side effects of chemotherapy, including fatigue, nausea, and neurological symptoms, may impair your ability to drive safely. If you experience any symptoms that might affect your alertness or coordination, do not drive or operate machinery. Consult your doctor or pharmacist if you are uncertain.
Leukeran tablets contain lactose (anhydrous). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How Does Leukeran Interact with Other Drugs?
Leukeran can interact with live vaccines, other chemotherapy drugs (particularly fludarabine, pentostatin, and cladribine), and phenylbutazone. Inform your doctor about all medications you are taking, including over-the-counter medicines and herbal supplements, before starting treatment.
Drug interactions can significantly affect the safety and efficacy of chlorambucil. Some interactions may increase the risk of serious side effects, while others may reduce the therapeutic benefit of the medication. It is essential to tell your doctor about all medicines you are taking, have recently taken, or might take, so that potential interactions can be identified and managed appropriately.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Live vaccines (polio, measles, mumps, rubella) | Risk of generalized, potentially fatal infection due to immunosuppression | Contraindicated during treatment; discuss timing with doctor |
| Fludarabine | Potentially fatal pulmonary toxicity when combined with chlorambucil | Avoid combination; use alternative regimens |
| Pentostatin | Severe pulmonary toxicity, potentially life-threatening | Avoid combination; consider alternatives |
| Cladribine | Increased toxicity when combined with other alkylating agents | Use with caution; close monitoring required |
| Phenylbutazone | May increase the toxic effects of chlorambucil by altering metabolism | Avoid concurrent use; use alternative anti-inflammatory agents |
Additional Interaction Considerations
Beyond the specific drug interactions listed above, several general considerations apply when taking chlorambucil:
- Other myelosuppressive agents: Any drug that suppresses bone marrow function (including other chemotherapy agents, certain antibiotics, and some anti-inflammatory drugs) may have additive effects with chlorambucil, increasing the risk of severe cytopenia
- Inactivated vaccines: While safer than live vaccines during immunosuppressive therapy, inactivated vaccines may produce a diminished immune response. Your doctor will advise you on the optimal timing for any needed vaccinations
- Immunosuppressive drugs: Concurrent use of other immunosuppressants may further compromise immune function and increase infection risk
- Anticoagulants: Chlorambucil-induced thrombocytopenia may increase bleeding risk in patients taking blood-thinning medications
Always carry a list of your current medications when visiting your healthcare provider, and inform any doctor, dentist, or pharmacist that you are taking Leukeran before receiving any new prescriptions or undergoing any procedures.
What Is the Correct Dosage of Leukeran?
The dosage of Leukeran is individualized based on the type of cancer being treated, the patient's body weight, and their response to treatment. It is taken by mouth as film-coated tablets. Typical starting doses range from 0.1 to 0.2 mg per kilogram of body weight per day. Only a specialist oncologist should prescribe and adjust the dose.
Always take Leukeran exactly as your doctor has told you. If you are unsure, ask your doctor. Leukeran should only be prescribed by a specialist physician experienced in treating cancer. Your doctor will determine the appropriate dose based on your body weight, the type of cancer you have, and how you respond to the treatment. The dose may be adjusted during the course of treatment based on your blood test results and clinical response.
Leukeran can be taken with or without food, but it should be taken in the same way and at the same time each day to maintain consistent drug levels. Swallow the tablets whole with a glass of water. Do not break, crush, or chew the tablets.
Hodgkin Lymphoma
Adults and Children
The usual starting dose is 0.2 mg per kilogram of body weight per day. For example, a person weighing 70 kg would receive approximately 14 mg (seven 2 mg tablets) daily. The dose and duration of treatment are individualized based on clinical response and tolerability.
Non-Hodgkin Lymphoma
Adults and Children
The usual starting dose is 0.1 to 0.2 mg per kilogram of body weight per day. The lower end of this range may be used initially, with dose adjustments made based on the patient's response and blood count results. Treatment typically continues for several weeks to months, depending on the specific lymphoma subtype and treatment goals.
Chronic Lymphocytic Leukemia (CLL)
Adults
The usual starting dose is 0.15 mg per kilogram of body weight per day. Treatment continues until the desired reduction in blood lymphocyte count is achieved or until side effects necessitate dose reduction or treatment interruption. Alternative dosing schedules, including intermittent high-dose pulse therapy, may be used in some cases.
Dose Adjustments
Your doctor may modify your dose during treatment for several reasons:
- Blood count monitoring: Regular blood tests are performed to check the levels of different blood cells. If counts drop too low, your dose may be reduced or treatment temporarily paused
- Elderly patients: Dose adjustments may be necessary for older adults, who may be more susceptible to the drug's effects on bone marrow
- Liver impairment: Patients with liver problems may require dose modifications, as the drug is metabolized in the liver
- Kidney and liver function: These may be monitored during treatment, especially in elderly patients
Missed Dose
If you forget to take a dose of Leukeran, inform your doctor. Do not take a double dose to make up for a forgotten tablet. Your doctor will advise you on how to proceed.
Overdose
If you take more Leukeran than you should, or if a child accidentally swallows the medicine, contact your doctor, hospital, or poison control center immediately for assessment of the risk and advice. Take the medicine packaging with you, even if no tablets remain. Overdose with chlorambucil may cause reversible pancytopenia (a significant drop in all blood cell types), neurological symptoms including agitation and seizures, and gastrointestinal disturbances. There is no specific antidote; treatment is supportive.
If you need to undergo surgery, tell the anesthesiologist or surgeon that you are taking Leukeran tablets. The drug's effects on blood counts and immune function may need to be considered when planning anesthesia and surgical care.
Stopping Treatment
Do not stop taking Leukeran without consulting your doctor. Abruptly discontinuing treatment may affect the management of your condition. Your doctor will advise you on when and how to stop treatment based on your clinical response and overall health.
What Are the Side Effects of Leukeran?
The most significant side effect of Leukeran is bone marrow suppression, which reduces the production of blood cells. Other side effects include nausea, vomiting, diarrhea, mouth ulcers, skin rash, and in rare cases, severe allergic reactions, seizures, and liver damage. Long-term use may increase the risk of secondary blood cancers.
Like all medicines, Leukeran can cause side effects, although not everyone experiences them. Because chlorambucil works by damaging the DNA of rapidly dividing cells, it affects not only cancer cells but also healthy cells that divide quickly, such as those in the bone marrow, digestive tract, and hair follicles. Your doctor will perform regular blood tests to monitor the impact on your bone marrow.
Contact your specialist doctor or go to the hospital immediately if you experience any of the following: signs of fever or infection (sore throat, mouth pain, or problems urinating), unexpected bruising or bleeding (indicating too few blood cells of a certain type are being produced), sudden feeling of being unwell (even with a normal temperature), extreme fatigue, numbness or weakness in your muscles, Stevens-Johnson syndrome (a severe allergic reaction with skin blistering, ulcers in the mouth or eyes, or involving the genital area), or high fever.
Side Effects by Frequency
Very Common (affects more than 1 in 10 patients)
- Bone marrow suppression (myelosuppression): reduced production of blood cells including red blood cells, white blood cells, and platelets, leading to anemia, increased infection risk, and bleeding tendency
Common (affects up to 1 in 10 patients)
- Seizures (convulsions): particularly in children with nephrotic syndrome (kidney disease)
- Nausea and vomiting
- Diarrhea
- Mouth ulcers (oral mucositis)
- Anemia: causing tiredness, weakness, or shortness of breath
- Secondary blood cancer: such as acute myeloid leukemia or myelodysplastic syndrome
Uncommon (affects up to 1 in 100 patients)
- Skin rash
Rare (affects up to 1 in 1,000 patients)
- Allergic reactions: skin nodules, hives (urticaria), or swelling of the face, lips, tongue, or throat, sometimes with difficulty breathing or swallowing (angioedema)
- Stevens-Johnson syndrome and toxic epidermal necrolysis: severe skin reactions causing widespread blistering, peeling, and ulceration of the skin and mucous membranes
- Fever
- Seizures or convulsions (in adults without nephrotic syndrome)
- Liver damage (hepatotoxicity): including elevated liver enzymes
- Jaundice: yellowing of the skin or the whites of the eyes
Very Rare (affects up to 1 in 10,000 patients)
- Abnormal involuntary movements: tremors or muscle twitching without seizures
- Cystitis: inflammation of the bladder causing painful or frequent urination
- Irreversible bone marrow failure: the body may stop producing blood cells for an extended period
- Pulmonary fibrosis: scarring and thickening of the lungs with shortness of breath
- Peripheral neuropathy: damage to nerves causing reduced sensation, movement, or organ function
Effects on Reproductive Function
The following effects have been reported with unknown frequency:
- Amenorrhea: absence of menstrual periods in women
- Azoospermia: complete absence of sperm in the semen in men
These effects may be irreversible and can result in permanent infertility. The risk increases with higher cumulative doses and longer treatment duration. Patients of childbearing age should be counseled about these risks before initiating therapy.
Reporting Side Effects
It is important to report any suspected side effects to your healthcare provider. Reporting helps health authorities continuously monitor the benefit-risk balance of medicines. You can also report side effects directly to your national health authority or medicines regulatory agency.
How Should You Store Leukeran?
Leukeran must be stored in a refrigerator at 2 to 8 degrees Celsius. Keep the medicine out of the sight and reach of children. Do not use the tablets after the expiration date on the packaging. Unused tablets must be returned to a pharmacy for safe disposal as hazardous waste.
Proper storage of Leukeran is essential to maintain the stability and potency of the medication. Unlike many oral medications that can be stored at room temperature, chlorambucil requires refrigerated storage due to its chemical properties. Exposure to higher temperatures may degrade the active ingredient, reducing its effectiveness and potentially producing harmful breakdown products.
Store the tablets in a refrigerator at 2°C to 8°C. Keep the container tightly closed and protect from light. The expiration date refers to the last day of the indicated month. Do not use the medicine after this date.
If your doctor tells you to stop taking the tablets, it is important to return any remaining tablets to a pharmacist, who will dispose of them in accordance with hazardous substance guidelines. Only keep the tablets if your doctor tells you to do so. Cytotoxic medicines such as Leukeran should not be disposed of via household waste or wastewater, as they pose environmental and safety risks.
Because Leukeran is a cytotoxic drug, handle the tablets with care. Wash your hands after handling the medication. If a tablet is broken or crushed, avoid contact with the powder and clean any contaminated surfaces. Caregivers should consider wearing disposable gloves when handling the tablets, and the medicine should always be kept out of the reach of children.
What Does Leukeran Contain?
Each Leukeran tablet contains 2 mg of chlorambucil as the active ingredient. The tablets also contain lactose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, hypromellose, macrogol, titanium dioxide, and iron oxide as inactive ingredients.
Understanding the composition of your medication is important, particularly if you have known allergies or intolerances to specific substances. The full list of ingredients in Leukeran is provided below.
Active Ingredient
Each Leukeran film-coated tablet contains 2 mg chlorambucil. Chlorambucil is the substance responsible for the drug's therapeutic (anti-cancer) effect. It is a white to off-white crystalline powder that is slightly soluble in water.
Inactive Ingredients (Excipients)
The following inactive ingredients are used in the manufacture of Leukeran tablets:
- Lactose (anhydrous) — tablet filler; note for patients with lactose intolerance
- Microcrystalline cellulose — tablet binder and filler
- Colloidal silicon dioxide — flow agent
- Stearic acid — lubricant
- Hypromellose — film-coating agent
- Macrogol — film-coating plasticizer
- Titanium dioxide (E171) — film-coating colorant
- Iron oxide (E172) — film-coating colorant
Appearance and Packaging
Leukeran film-coated tablets are brown, round, biconvex tablets embossed with “L” on one side and “GX EG3” on the other side. The tablets are supplied in amber glass bottles with child-resistant caps, containing either 25 or 50 tablets per bottle.
Marketing Authorization Holder
Leukeran is marketed by Aspen Pharma Trading Limited, headquartered in Dublin, Ireland. The tablets are manufactured by Excella GmbH & Co. KG in Feucht, Germany.
Frequently Asked Questions About Leukeran
Leukeran (chlorambucil) is a chemotherapy medication used to treat several types of cancer affecting the blood and lymphatic system. Its primary indications include Hodgkin lymphoma, non-Hodgkin lymphoma, and chronic lymphocytic leukemia (CLL). Chlorambucil belongs to the alkylating agent class and works by damaging the DNA of rapidly dividing cancer cells, preventing them from growing and multiplying. It has been used in oncology practice for over 60 years and remains a valuable treatment option, particularly for elderly patients or those who cannot tolerate more aggressive chemotherapy regimens.
The most common side effect of Leukeran is bone marrow suppression (myelosuppression), which reduces the production of blood cells and can lead to anemia (fatigue, weakness), increased infection risk (due to low white blood cells), and bleeding problems (due to low platelets). Other common side effects include nausea, vomiting, diarrhea, and mouth ulcers. Seizures may occur in children with nephrotic syndrome. Your doctor will perform regular blood tests to monitor your blood cell counts throughout treatment.
Yes, prolonged use of Leukeran, particularly in combination with other chemotherapy drugs or radiation therapy, can increase the risk of developing secondary blood cancers such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This risk is a known consequence of alkylating agent therapy and is an important factor that oncologists consider when planning treatment. Patients should be aware of this risk and report any new or unexplained symptoms such as persistent fatigue, recurrent fever, frequent infections, or unusual bruising to their doctor promptly.
Leukeran must be stored in a refrigerator at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit). This is different from most oral medications that can be kept at room temperature. Keep the tablets out of the sight and reach of children and in the original container. Do not use the medicine after the expiration date printed on the packaging. Any unused or expired tablets should be returned to a pharmacy for proper disposal as hazardous waste — they should never be thrown in regular household waste or flushed down the drain.
Yes, Leukeran can significantly affect fertility in both men and women. In women, it may cause menstruation to stop entirely (amenorrhea), and in men, it can result in complete absence of sperm in the semen (azoospermia). These effects may be irreversible, particularly after prolonged treatment or higher cumulative doses. Both men and women of reproductive age should discuss fertility preservation options such as sperm banking or egg freezing with their healthcare team before starting treatment. Reliable contraception must be used during treatment to prevent pregnancy.
The dosage of Leukeran is individualized based on the condition being treated and the patient's body weight. For Hodgkin lymphoma, the usual starting dose is 0.2 mg per kilogram of body weight daily. For non-Hodgkin lymphoma, the dose is typically 0.1 to 0.2 mg per kilogram daily. For chronic lymphocytic leukemia (CLL), the starting dose is usually 0.15 mg per kilogram daily. Your oncologist will adjust the dose based on your blood test results and how well you respond to treatment. Regular blood monitoring is essential to ensure safe dosing.
References
- European Medicines Agency (EMA). Leukeran (chlorambucil) — Product Information. Available at: ema.europa.eu. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Chlorambucil — Prescribing Information. Approved product labeling.
- British National Formulary (BNF). Chlorambucil. National Institute for Health and Care Excellence (NICE). Updated 2025.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 2.2025.
- Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760. doi:10.1182/blood-2017-09-806398
- Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines. Ann Oncol. 2021;32(1):23-33.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Chlorambucil included as essential antineoplastic agent.
- Rai KR, Peterson BL, Appelbaum FR, et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000;343(24):1750-1757.
About the Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialists in hematology-oncology, pharmacology, and clinical medicine. Our content follows the GRADE evidence framework and is based on peer-reviewed research, international clinical guidelines (EMA, FDA, NCCN, ESMO, BNF), and established medical standards.
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