Leukeran Tablets

Leukeran Tablets (Leukeran Tablets) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.

Leukeran Tablets belongs to the group of medicines called alkylating agents. It is used to treat different types of cancer of the blood and lymph system, such as chronic lymphatic leukemia, Hodgkin's disease, and other types of lymphoma.

Leukeran Tablets interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by Leukeran Tablets, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may occur after treatment with Leukeran Tablets has been stopped.

Before you begin treatment with Leukeran Tablets, you and your doctor should talk about the benefits Leukeran Tablets will do as well as the risks of using it.

Leukeran Tablets is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Leukeran Tablets is used in certain patients with the following medical conditions:

• Cancer of the lymph system that affects the skin.
• Cancer of the ovaries.
• Hairy cell leukemia (a cancer of the blood and bone marrow).
• Histiocytosis X (a certain type of cancer found primarily in children).
• Nephrotic syndrome (a kidney disease).
• Tumors in the uterus (womb).
• Waldenström's macroglobulinemia (a certain type of cancer of the blood).

Adults: Hodgkin's Disease: Used as a single agent in the palliative treatment of advanced disease, a typical dosage is 0.2 mg/kg/day for 4-8 weeks.

Leukeran Tablets is usually included in combination therapy and a number of regimens have been used.

Leukeran Tablets has been used as an alternative to nitrogen mustard with a reduction in toxicity but similar therapeutic results.

Non-Hodgkin's Lymphoma: Used as a single agent, the usual dosage is 0.1-0.2 mg/kg/day for 4-8 weeks initially; maintenance therapy is then given either by a reduced daily dosage or intermittent courses of treatment.

Leukeran Tablets is useful in the management of patients with advanced diffuse lymphocytic lymphoma and those who have relapsed after radiotherapy.

There is no significant difference in the overall response rate obtained with Leukeran Tablets as a single agent and combination chemotherapy in patients with advanced non-Hodgkin's lymphocytic lymphoma.

Chronic Lymphocytic Leukemia: Treatment with Leukeran Tablets is usually started after the patient has developed symptoms or when there is evidence of impaired bone marrow function (but not marrow failure) as indicated by the peripheral blood count.

Initially, Leukeran Tablets is given at a dosage of 0.15 mg/kg/day until the total leukocyte count has fallen to 10,000/microliter. Treatment may be resumed 4 weeks after the end of the 1st course and continued at a dosage of 0.1 mg/kg/day.

In a proportion of patients, usually after about 2 years of treatment, the blood leukocyte count is reduced to the normal range, enlarged spleen and lymph nodes become impalpable and the proportion of lymphocytes in the bone marrow is reduced to <20%.

Patients with evidence of bone marrow failure should first be treated with prednisolone and evidence of marrow regeneration should be obtained before commencing treatment with Leukeran Tablets.

Intermittent high-dose therapy has been compared with daily Leukeran Tablets but no significant difference in therapeutic response or frequency of side effects was observed between the 2 treatment groups.

Waldenstrom's Macroglobulinemia: Leukeran Tablets is the treatment of choice in this indication.

Starting doses of 6-12 mg daily until leukopenia occurs are recommended followed by 2-8 mg daily indefinitely.

Children: Leukeran Tablets may be used in the management of Hodgkin's disease and non-Hodgkin's lymphomas in children. The dosage regimens are similar to those used in adults.

Special Populations: Renal Impairment: Dose adjustment is not necessary in renally impaired patients.

Hepatic Impairment: Patients with hepatic impairment should be closely monitored for signs and symptoms of toxicity. Since Leukeran Tablets is primarily metabolized in the liver, dose reduction should be considered in patients with severe hepatic impairment. However, there are insufficient data in patients with hepatic impairment to provide a specific dosing recommendation.

Administration: Leukeran Tablets is administered orally and should be taken daily on an empty stomach (at least 1 hr before meals or 3 hrs after meals).

See also:
What is the most important information I should know about Leukeran Tablets?

Do not use Leukeran Tablets if you are pregnant. It could harm the unborn baby.

Taking Leukeran Tablets may increase your risk of developing other types of cancer. Leukeran Tablets may also affect fertility (your ability to have children), whether you are a man or a woman. Ask your doctor about your individual risk.

Leukeran Tablets can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with Leukeran Tablets, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease.

Stop taking Leukeran Tablets and call your doctor at once if you have a seizure, red or peeling skin rash, severe nausea or stomach pain, jaundice (yellowing of your skin or eyes), fever, chills, sore throat, ongoing cough, flu symptoms, mouth sores, easy bruising or bleeding, or any unusual mass or lump.

Use Leukeran Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Leukeran Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Leukeran Tablets works best if it is taken at the same time each day.
• Drinking extra fluids while you are taking Leukeran Tablets is recommended. Check with your doctor for instructions.
• If you miss a dose of Leukeran Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Leukeran Tablets.

Use: Labeled Indications

Chronic lymphocytic leukemia: Management of chronic lymphocytic leukemia

Hodgkin lymphoma: Management of Hodgkin lymphoma

Non-Hodgkin lymphoma: Management of non-Hodgkin lymphomas

Off Label Uses

Idiopathic membranous nephropathy

Data from a multicenter, randomized, controlled study support the use of Leukeran Tablets (alternating with prednisolone) for the treatment of progressive idiopathic membranous nephropathy in patients with a decline in renal function.

See also:
What other drugs will affect Leukeran Tablets?

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals.

Animal studies indicate that patients who receive phenylbutazone may require a reduction of the standard Leukeran Tablets doses because of the possibility of enhanced Leukeran Tablets toxicity.

See also:
What are the possible side effects of Leukeran Tablets?

For Leukeran Tablets, there is no modern clinical documentation, which can be used for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the dose received and also when given in combination with other therapeutic agents.

The following convention has been used for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000).

Benign, Malignant and Unspecified Neoplasms (Including Cysts and Polyps): Common: Acute secondary hematologic malignancies (especially leukemia and myelodysplastic syndrome), particularly after long-term treatment.

Blood and Lymphatic System Disorders: Very Common: Leukopenia, neutropenia, thrombocytopenia, pancytopenia or bone marrow suppression. Common: Anemia. Very Rare: Irreversible bone marrow failure.

Although bone marrow suppression frequently occurs, it is usually reversible if Leukeran Tablets is withdrawn early enough.

Immune System Disorders: Uncommon: Rash. Rare: Allergic reactions eg, urticaria and angioneurotic edema following initial or subsequent dosing. Stevens-Johnson syndrome and toxic epidermal necrolysis.

On rare occasions, skin rash has been reported to progress to serious conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Nervous System Disorders: Common: Seizures in children with nephrotic syndrome. Rare: Seizures (patients with a history of seizure disorder may be particularly susceptible), focal and/or generalized in children and adults receiving therapeutic daily doses or high pulse dosing regimens of Leukeran Tablets. Very Rare: Movement disorders including tremor, twitching and myoclonia in the absence of convulsions. Peripheral neuropathy.

Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Interstitial pulmonary fibrosis, interstitial pneumonia.

Severe interstitial pulmonary fibrosis has occasionally been reported in patients with chronic lymphocytic leukemia on long-term Leukeran Tablets therapy. Pulmonary fibrosis may be reversible on withdrawal of Leukeran Tablets.

Gastrointestinal Disorders: Common: Gastrointestinal disturbances eg, nausea and vomiting, diarrhea and oral ulceration.

Hepatobiliary Disorders: Rare: Hepatotoxicity, jaundice.

Skin and Subcutaneous Tissue Disorders: Uncommon: Rash. Rare: Allergic reactions eg, urticaria and angioneurotic edema following initial or subsequent dosing. Stevens-Johnson syndrome and toxic epidermal necrolysis.

On rare occasions, skin rash has been reported to progress to serious conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Renal and Urinary Disorders: Very Rare: Sterile cystitis.

General Disorders and Administration Site Conditions: Rare: Drug fever.

A nitrogen mustard alkylating agent used as antineoplastic agent for the treatment of various malignant and nonmalignant diseases. Although it is less toxic than most other nitrogen mustards, it has been listed as a known carcinogen in the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (Merck Index, 11th ed)