Treanda

DRUG DESCRIPTION

TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-, monohydrochloride. Its empirical molecular formula is C16H21Cl2N3O2 · HCl, and the molecular weight is 394.7. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula:

TREANDA® (bendamustine hydrochloride) Structural Formula Illustration

TREANDA (bendamustine hydrochloride) for Injection is intended for intravenous infusion only after reconstitution with Sterile Water for Injection, USP, and after further dilution with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP. It is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-use vial. Each 25-mg vial contains 25 mg of bendamustine hydrochloride and 42.5 mg of mannitol, USP. Each 100-mg vial contains 100 mg of bendamustine hydrochloride and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 - 3.5.

What are the possible side effects of bendamustine (Treanda)?

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...

Read All Potential Side Effects and See Pictures of Treanda »

What are the precautions when taking bendamustine hydrochloride injection (Treanda)?

Before using bendamustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), 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: blood/bone marrow disorders, kidney problems, liver problems, recent/current infection.

Bendamustine can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid...

Read All Potential Precautions of Treanda »


Treanda Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, tiredness, weakness, or mouth sores may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, pale skin, signs of infection (e.g., persistent sore throat, cough, fever, chills), easy bruising/bleeding.

Bendamustine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Your doctor may also direct you to take another medication (allopurinol) for the first 1 to 2 weeks of treatment. Tell your doctor immediately if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

Bendamustine can commonly cause a reaction with symptoms of rash, itching, fever, and chills. This reaction is usually not serious. However, you may not be able to tell it apart from a rare allergic reaction that could be severe. Therefore, get medical help right away if you develop any of the following symptoms: 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 promptly.

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 using bendamustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), 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: blood/bone marrow disorders, kidney problems, liver problems, recent/current infection.

Bendamustine can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (e.g., chickenpox, flu). Wash your hands well to prevent the spread of infections.

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

This drug may cause tiredness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication and for 3 months after treatment. Therefore, males and females must use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) during treatment and for 3 months following the end of treatment with this drug. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. However, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Treanda Patient Information Including Side Effects

Brand Names: Treanda

Generic Name: bendamustine (Pronunciation: BEN da MUS teen)

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

What is bendamustine (Treanda)?

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 other purposes not listed in this medication guide.

What are the possible side effects of bendamustine (Treanda)?

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;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • pale skin, easy bruising or bleeding, extreme weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • nausea, vomiting, diarrhea, loss of appetite, lower back pain, urinating less than usual;
  • slow heart rate, weak pulse, muscle weakness or stiffness;
  • confusion, hallucinations; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • mild nausea, vomiting, constipation;
  • dry mouth, decreased sensation of taste;
  • drowsiness, tired feeling;
  • headache;
  • weight loss; or
  • pain, itching, swelling or other irritation around the IV needle.

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 bendamustine (Treanda)?

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

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 doctor about all other medications you use, especially carbamazepine (Carbatrol, Equetro, Tegretol), cimetidine (Tagamet), ciprofloxacin (Cipro), fluvoxamine (Luvox), omeprazole (Prilosec), thiabendazole (Mintezol), or a barbiturate such as phenobarbital (Solfoton) and others.

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

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, severe skin rash or itching, vomiting, diarrhea, pain, urinating less than usual, weak pulse, muscle weakness or stiffness, confusion, hallucinations, or white patches or sores inside your mouth or on your lips.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your blood pressure may also need to be checked. Do not miss any scheduled appointments.

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