Friday, September 16, 2016

bendamustine


Generic Name: bendamustine (BEN da MUS teen)

Brand Names: Treanda


What is bendamustine?

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


Bendamustine is used to treat chronic lymphocytic leukemia. Bendamustine is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition.


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


What is the most important information I should know about bendamustine?


You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol). Do not receive bendamustine if you are pregnant. It could harm the unborn baby.

Before you receive bendamustine, tell your doctor if you have a weak immune system, fever or other signs of infection, a metabolic disorder or electrolyte imbalance, liver or kidney disease, or if you smoke.


Tell your caregiver right away if you have a fever, chills, itching, or skin rash during or shortly after the injection.

Other serious side effects to tell your doctor about include fever, chills, cough, sore throat, feeling short of breath, pale skin, easy bruising or bleeding, unusual weakness, severe skin rash, weak pulse, muscle weakness, fast or slow heart rate, confusion, lower back pain, blood in your urine, urinating less than usual, or swelling, redness, or signs of where the medicine was injected.


To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.


What should I discuss with my healthcare provider before I receive bendamustine?


You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol).

To make sure you can safely receive bendamustine, tell your doctor if you have any of these other conditions:



  • a weak immune system;




  • fever or other signs of infection;




  • a metabolic disorder or electrolyte imbalance;



  • liver disease;

  • kidney disease; or


  • if you smoke.




FDA pregnancy category D. Do not receive bendamustine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether bendamustine passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Some people receiving bendamustine have developed certain types of cancers. It is not known whether this medication causes cancer. Talk with your doctor about the risks and benefits of using bendamustine.


How is bendamustine given?


Bendamustine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Bendamustine must be given slowly, and the IV infusion can take at least 30 minutes to complete.


Bendamustine is usually given for 2 days in a row every 21 to 28 days. You may receive up to 8 treatments total, depending on the condition being treated. Follow your doctor's instructions.


You may be given other medications to help prevent certain side effects of bendamustine.


Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.


What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your bendamustine injection.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, tremors, slow or shallow breathing, loss of balance or coordination, or seizure (convulsions).


What should I avoid while receiving bendamustine?


Bendamustine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bendamustine side effects


Some people receiving a bendamustine injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have fever, chills, itching, or skin rash during or shortly after the injection. 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. Tell your caregivers at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;




  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;




  • easy bruising or bleeding, purple or red pinpoint spots under your skin, unusual weakness;




  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;




  • lower back pain, blood in your urine, urinating less than usual or not at all;




  • numbness or tingly feeling around your mouth;




  • muscle weakness, tightness, or contraction, overactive reflexes;




  • fast or slow heart rate, weak pulse, confusion;




  • dry mouth, feeling very thirsty or hot, heavy sweating or hot and dry skin;




  • severe blistering, peeling, and red skin rash; or




  • pain, swelling, redness, skin changes, or signs of infection where the medicine was injected.



Less serious side effects may include:



  • mild nausea, vomiting, diarrhea, constipation, or upset stomach;




  • swelling in your hands or feet;




  • headache, dizziness, drowsiness;




  • loss of appetite, weight loss; or




  • mild skin rash.



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.


Bendamustine Dosing Information


Usual Adult Dose for Chronic Lymphocytic Leukemia:

Recommended dose: 100 mg/m2 administered intravenously on days 1 and 2 of a 28 day cycle, up to 6 cycles. Bendamustine is intended for administration as an intravenous infusion over 30 minutes.

Consider using allopurinol as prevention for patients at high risk of tumor lysis syndrome for the first few weeks of treatment.

Bendamustine administration should be delayed in the event of grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. Dose delays may be warranted.

Dose modifications for hematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on days 1 and 2 of each cycle.

Dose modifications for nonhematologic toxicity: for clinically significant grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle.

Dose reescalation in subsequent cycles may be considered at the discretion of the treating physician.

Usual Adult Dose for non-Hodgkin's Lymphoma:

Recommended dose: 120 mg/m2 intravenously on days 1 and 2 of a 21 day cycle for up to 8 cycles. Bendamustine is intended for administration as an intravenous infusion over 60 minutes.

Bendamustine administration should be delayed in the event of a grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.

Dose modifications for hematologic toxicity: for grade 4 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 4 or greater toxicity recurs, reduce the dose to 60 mg/m2 on days 1 and 2 of each cycle.

Dose modifications for nonhematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.


What other drugs will affect bendamustine?


Tell your doctor about all other medications you use, especially:



  • allopurinol (Zyloprim);




  • carbamazepine (Carbatrol, Equetro, Tegretol);




  • cimetidine (Tagamet);




  • ciprofloxacin (Cipro);




  • fluvoxamine (Luvox);




  • omeprazole (Prilosec);




  • thiabendazole (Mintezol); or




  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), phenobarbital (Solfoton), and others.



This list is not complete and other drugs may interact with bendamustine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More bendamustine resources


  • Bendamustine Side Effects (in more detail)
  • Bendamustine Dosage
  • Bendamustine Use in Pregnancy & Breastfeeding
  • Bendamustine Drug Interactions
  • Bendamustine Support Group
  • 2 Reviews for Bendamustine - Add your own review/rating


  • bendamustine Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Bendamustine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Treanda Prescribing Information (FDA)

  • Treanda Consumer Overview



Compare bendamustine with other medications


  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma


Where can I get more information?


  • Your doctor or pharmacist can provide more information about bendamustine.

See also: bendamustine side effects (in more detail)


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