Bendamustine

Name: Bendamustine

Uses of Bendamustine

Bendamustine is a prescription medication used to treat chronic lymphocytic leukemia (CLL). CLL is a type of cancer of the white blood cells. Bendamustine is also used to treat a type of non-Hodgkins lymphoma (NHL). NHL is a cancer that begins in a type of white blood cell that normally fights infection .

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Bendamustine side effects

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

Serious and sometimes fatal skin reactions may occur during treatment with bendamustine. Tell your caregivers right away if you have any type of skin rash after being treated with bendamustine.

Call your doctor at once if you have:

  • fever, chills, or itching during or shortly after the injection;

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

  • severe ongoing nausea, vomiting, or diarrhea;

  • pain or burning when you urinate;

  • cough, chest pain, trouble breathing;

  • liver problems--upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low blood cell counts--fever, flu symptoms, swollen glands, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding;

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, muscle weakness or limp feeling;

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urination; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, confusion, fainting; or

  • severe skin reaction--new or worsening symptoms of fever, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • fever, cough, mouth sores, trouble breathing;

  • nausea, vomiting, diarrhea, constipation;

  • headache, tiredness, dizziness;

  • swelling in your hands or feet;

  • 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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Chest pain or pressure.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Low mood (depression).
  • Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Index Terms

  • Bendamustine HCl
  • Bendamustine Hydrochloride
  • Cytostasan
  • SDX-105

Contraindications

Known hypersensitivity (eg, anaphylactic or anaphylactoid reactions) to bendamustine or any component of the formulation. Bendeka is also contraindicated in patients with hypersensitivity to polyethylene glycol 400, propylene glycol, or monothioglycerol.

Dosing Geriatric

Refer to adult dosing.

Dosing Obesity

American Society of Clinical Oncology (ASCO) Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient's actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, abdominal pain, heartburn, back pain, bone pain, joint pain, constipation, diarrhea, dizziness, fatigue, headache, lack of appetite, mouth sores, mouth irritation, rhinitis, change in taste, anxiety, night sweats, sweating a lot, insomnia, or weight loss. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, tachycardia, increased thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting), angina, shortness of breath, depression, bruising, bleeding, severe loss of strength and energy, excessive weight gain, swelling of arms or legs, severe injection site pain, redness, edema, burning, or irritation, signs of tumor lysis syndrome (tachycardia or abnormal heartbeat; any passing out; urinary retention; muscle weakness or cramps; nausea, vomiting, diarrhea or lack of appetite; or feeling sluggish), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

For the Consumer

Applies to bendamustine: intravenous powder for solution, intravenous solution

Along with its needed effects, bendamustine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking bendamustine:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough or hoarseness
  • diarrhea
  • fever
  • headache
  • joint pain, stiffness, or swelling
  • lack or loss of strength
  • lower back, side, or stomach pain
  • muscle aches
  • nausea
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • stuffy or runny nose
  • swelling of the feet or lower legs
  • swollen glands
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
Less common
  • Burning or stinging of the skin
  • fast heartbeat
  • hives, itching, or rash
  • irritation
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • redness of the skin
  • stiffness or swelling
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
Incidence not known
  • Blistering, flaking, or peeling of the skin
  • bluish color
  • changes in skin color
  • dizziness
  • pain, tenderness, or swelling of the foot or leg
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • weakness

Some side effects of bendamustine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased weight

Liver Dose Adjustments

-Mild Liver Dysfunction: Use with caution.
-Moderate Liver Dysfunction (AST or ALT 2.5 to 10 x Upper Limit of Normal and Total Bilirubin 1.5 to 3 x ULN): Not recommended.
-Severe Liver Dysfunction (Total Bilirubin greater than 3 x ULN): Not recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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