Leukeran

DRUG DESCRIPTION

LEUKERAN (chlorambucil) was first synthesized by Everett et al. It is a bifunctional alkylating agent of the nitrogen mustard type that has been found active against selected human neoplastic diseases. Chlorambucil is known chemically as 4-[bis(2-chlorethyl)amino]benzenebutanoic acid and has the following structural formula:

LEUKERAN® (chlorambucil) Structural Formula Illustration

Chlorambucil hydrolyzes in water and has a pKa of 5.8.

LEUKERAN (chlorambucil) is available in tablet form for oral administration. Each film-coated tablet contains 2 mg chlorambucil and the inactive ingredients colloidal silicon dioxide, hypromellose, lactose (anhydrous), macrogol/PEG 400, microcrystalline cellulose, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide.

What are the possible side effects of chlorambucil (Leukeran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using chlorambucil and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • ...

Read All Potential Side Effects and See Pictures of Leukeran »

What are the precautions when taking chlorambucil (Leukeran)?

Before taking chlorambucil, tell your doctor or pharmacist if you are allergic to it; or to other chemotherapy drugs (e.g., busulfan, cyclophosphamide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, head injury, gout, kidney stones, blood disorders (e.g., anemia, neutropenia, thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like razors or nail cutters and avoid activities such as...

Read All Potential Precautions of Leukeran »


Leukeran Consumer (continued)

SIDE EFFECTS: See also Warnings section.

Nausea, vomiting, stomach upset, diarrhea, and loss of appetite may occur. Changes in diet such as eating several small meals or limiting physical activity may help lessen the chance of nausea. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mouth sores, shaking/tremors, muscle problems (e.g., twitching, stiffness, weakness), unsteadiness, joint pain, lower back pain/side pain, frequent/painful urination, numbness/tingling of the hands or feet, swelling of the legs/feet, mental/mood changes (e.g., confusion, hallucinations), stopping of menstrual periods.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, trouble breathing, severe stomach/abdominal pain, yellowing of the skin/eyes, dark urine, inability to move arms/legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking chlorambucil, tell your doctor or pharmacist if you are allergic to it; or to other chemotherapy drugs (e.g., busulfan, cyclophosphamide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, head injury, gout, kidney stones, blood disorders (e.g., anemia, neutropenia, thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially possible infertility later in life. Children treated for a certain kidney disease (nephrotic syndrome) may be more at risk for seizures.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age and men should use reliable form(s) of birth control during treatment with this drug. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Leukeran Patient Information Including Side Effects

Brand Names: Leukeran

Generic Name: chlorambucil (Pronunciation: klor AM bue sil)

  • What is chlorambucil (Leukeran)?
  • What are the possible side effects of chlorambucil (Leukeran)?
  • What is the most important information I should know about chlorambucil (Leukeran)?
  • What should I discuss with my healthcare provider before taking chlorambucil (Leukeran)?
  • How should I take chlorambucil (Leukeran)?
  • What happens if I miss a dose (Leukeran)?
  • What happens if I overdose (Leukeran)?
  • What should I avoid while taking chlorambucil (Leukeran)?
  • What other drugs will affect chlorambucil (Leukeran)?
  • Where can I get more information?

What is chlorambucil (Leukeran)?

Chlorambucil is a cancer medication that interferes with cancer cells and slows their growth and spread in the body.

Chlorambucil is used to treat several types of cancer, including Hodgkin's disease and certain types of leukemia or lymphoma.

Chlorambucil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of chlorambucil (Leukeran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using chlorambucil and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • an unusual mass or lump;
  • fever, chills, body aches, flu symptoms, or ongoing cough;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your mouth or on your lips;
  • severe nausea, vomiting, or diarrhea; or
  • missed menstrual periods.

Less serious side effects:

  • upset stomach, mild nausea, diarrhea;
  • tremors or shaking; or
  • numbness or tingling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about chlorambucil (Leukeran)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Treatment with chlorambucil may increase your risk of developing other forms of cancer. This medication can also affect fertility (your ability to have children), whether you are a man or a woman. Talk to your doctor about your specific risks when using chlorambucil.

Chlorambucil can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with chlorambucil.

Stop using chlorambucil 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), any unusual mass or lump, fever, chills, sore throat, cough, flu-like symptoms, pale skin, easy bruising or bleeding, unusual weakness, white patches or sores inside your mouth or on your lips, or missed menstrual periods.

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