Bendeka

Name: Bendeka

What is Bendeka (bendamustine)?

Bendamustine is a cancer medicine that interferes with the growth and spread of cancer cells 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 medicines have been tried without successful treatment of this condition.

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

How is Bendeka (bendamustine)given?

Bendamustine is injected into a vein through an IV. A healthcare provider will give you this injection.

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.

Bendamustine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

If you have ever had hepatitis B, bendamustine can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What happens if I overdose?

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

Uses of Bendeka

  • It is used to treat a type of leukemia.
  • It is used to treat a type of lymphoma.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Bendeka?

  • Tell all of your health care providers that you take Bendeka. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you smoke, talk with your doctor.
  • This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to needing a blood transfusion and very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, or sore throat; any bruising or bleeding; or if you feel very tired or weak.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Some patients have very bad side effects during the infusion. Tell your doctor if you have any bad effects during the infusion.
  • Other types of cancer may rarely happen later in life.
  • Very bad and sometimes deadly liver problems have happened with Bendeka. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
  • A very bad and sometimes deadly reaction has happened with this medicine. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 3 months after care ends. Use birth control that you can trust.
  • If you are a man and your sex partner gets pregnant while you take Bendeka or within 3 months after your last dose, call your doctor right away.
  • This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine and for 3 months after care ends.
  • If you get pregnant while taking Bendeka or within 3 months after your last dose, call your doctor right away.

What are some other side effects of Bendeka?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Belly pain or heartburn.
  • Back pain.
  • Bone or joint pain.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Not able to sleep.
  • Not hungry.
  • Weight loss.
  • Mouth irritation or mouth sores.
  • Nose and throat irritation.
  • Change in taste.
  • Anxiety.
  • Night sweats.
  • Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Contraindications

Bendeka (bendamustine hydrochloride) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. [see Warnings and Precautions (5.3)]

Overdosage

The intravenous LD50 of bendamustine hydrochloride is 240 mg/m2 in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress.

Across all clinical experience, the reported maximum single dose received was 280 mg/m2. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients) and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients.

No specific antidote for bendamustine hydrochloride overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs.

References

  1. OSHA Hazardous Drugs. OSHA. [Accessed on 09/09/2015, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
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