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Treanda

"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

CLL is a rare blood and bone marrow disease"...

Treanda

Treanda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Treanda (bendamustine hydrochloride injection) is used to treat chronic lymphocytic leukemia. It is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition. It is an antineoplastic (anticancer) medication. Common side effects include nausea, vomiting, diarrhea, tiredness, weakness, or mouth sores.

The recommended dose of Treanda is 100 mg/m administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Treanda may interact with carbamazepine, cimetidine, ciprofloxacin, fluvoxamine, omeprazole, thiabendazole, or barbiturates. Tell your doctor all medications you use. Treanda is not recommended for use during pregnancy. It may harm a fetus. Males and females must use at least 2 forms of birth control (e.g., condoms, birth control pills) during treatment and for 3 months following the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Breastfeeding while using this drug is not recommended.

Our Treanda (bendamustine hydrochloride injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Treanda in Detail - Patient Information: 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.

Read the entire detailed patient monograph for Treanda (Bendamustine Hydrochloride Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Treanda Overview - Patient Information: Side Effects

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. Also, your doctor may prescribe an additional medication. Tell your doctor right away 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.

Read the entire patient information overview for Treanda (Bendamustine Hydrochloride Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Treanda FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections of the label.

The data described below reflect exposure to TREANDA in 329 patients who participated in an actively-controlled trial (N=153) for the treatment of CLL and two single-arm trials (N=176) for the treatment of indolent B-cell NHL. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience in CLL

The data described below reflect exposure to TREANDA in 153 patients with CLL studied in an active-controlled, randomized trial. The population was 45-77 years of age, 63% male, 100% white, and were treatment nave. All patients started the study at a dose of 100 mg/m² intravenously over 30 minutes on Days 1 and 2 every 28 days.

Adverse reactions were reported according to NCI CTC v.2.0. Non-hematologic adverse reactions (any grade) in the TREANDA group that occurred with a frequency greater than 15% were pyrexia (24%), nausea (20%), and vomiting (16%). Other adverse reactions seen frequently in one or more studies included asthenia, fatigue, malaise, and weakness; dry mouth; somnolence; cough; constipation; headache; mucosal inflammation and stomatitis.

Worsening hypertension was reported in 4 patients treated with TREANDA in the CLL trial and in none treated with chlorambucil. Three of these 4 adverse reactions were described as a hypertensive crisis and were managed with oral medications and resolved.

The most frequent adverse reactions leading to study withdrawal for patients receiving TREANDA were hypersensitivity (2%) and pyrexia (1%). Table 1 contains the treatment emergent adverse reactions, regardless of attribution, that were reported in ≥ 5% of patients in either treatment group in the randomized CLL clinical study.

Table 1: Non-Hematologic Adverse Reactions Occurring in Randomized CLL Clinical Study in at Least 5% of Patients

System organ class Preferred term Number (%) of patients
TREANDA
(N=153)
Chlorambucil (N=143)
All Grades Grade 3/4 All Grades Grade 3/4
Total number of patients with at least 1 adverse reaction 121 (79) 52 (34) 96 (67) 25 (17)
Gastrointestinal disorders
  Nausea 31 (20) 1 ( < 1) 21 (15) 1 ( < 1)
  Vomiting 24 (16) 1 ( < 1) 9 (6) 0
  Diarrhea 14 (9) 2 (1) 5 (3) 0
General disorders and administration site conditions
  Pyrexia 36 (24) 6 (4) 8 (6) 2 (1)
  Fatigue 14 (9) 2 (1) 8 (6) 0
  Asthenia 13 (8) 0 6 (4) 0
  Chills 9 (6) 0 1 ( < 1) 0
Immune system disorders
  Hypersensitivity 7 (5) 2 (1) 3 (2) 0
Infections and infestations
  Nasopharyngitis 10 (7) 0 12 (8) 0
  Infection 9 (6) 3 (2) 1 ( < 1) 1 ( < 1)
  Herpes simplex 5 (3) 0 7 (5) 0
Investigations
  Weight decreased 11 (7) 0 5 (3) 0
Metabolism and nutrition disorders
  Hyperuricemia 11 (7) 3 (2) 2 (1) 0
Respiratory, thoracic and mediastinal disorders
  Cough 6 (4) 1 ( < 1) 7 (5) 1 ( < 1)
Skin and subcutaneous tissue disorders
  Rash 12 (8) 4 (3) 7 (5) 3 (2)
  Pruritus 8 (5) 0 2 0) 0

The Grade 3 and 4 hematology laboratory test values by treatment group in the randomized CLL clinical study are described in Table 2. These findings confirm the myelosuppressive effects seen in patients treated with TREANDA. Red blood cell transfusions were administered to 20% of patients receiving TREANDA compared with 6% of patients receiving chlorambucil.

Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA or Chlorambucil in the Randomized CLL Clinical Study

Laboratory Abnormality TREANDA
N=150
Chlorambucil
N=141
All Grades
n (%)
Grade 3/4
n (%)
All Grades
n (%)
Grade 3/4
n (%)
Hemoglobin Decreased 134 (89) 20 (13) 115 (82) 12 (9)
Platelets Decreased 116 (77) 16 (11) 110 (78) 14 (10)
Leukocytes Decreased 92 (61) 42 (28) 26 (18) 4 (3)
Lymphocytes Decreased 102 (68) 70 (47) 27 (19) 6 (4)
Neutrophils Decreased 113(75) 65 (43) 86 (61) 30 (21)

In the CLL trial, 34% of patients had bilirubin elevations, some without associated significant elevations in AST and ALT. Grade 3 or 4 increased bilirubin occurred in 3% of patients. Increases in AST and ALT of Grade 3 or 4 were limited to 1% and 3% of patients, respectively. Patients treated with TREANDA may also have changes in their creatinine levels. If abnormalities are detected, monitoring of these parameters should be continued to ensure that further deterioration does not occur.

Clinical Trials Experience in NHL

The data described below reflect exposure to TREANDA in 176 patients with indolent B-cell NHL treated in two single-arm studies. The population was 31-84 years of age, 60% male, and 40% female. The race distribution was 89% White, 7% Black, 3% Hispanic, 1% other, and < 1% Asian. These patients received TREANDA at a dose of 120 mg/m² intravenously on Days 1 and 2 for up to eight 21-day cycles.

The adverse reactions occurring in at least 5% of the NHL patients, regardless of severity, are shown in Table 3. The most common non-hematologic adverse reactions ( ≥ 30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most common non-hematologic Grade 3 or 4 adverse reactions ( ≥ 5%) were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration, each reported in 5% of patients.

Table 3: Non-Hematologic Adverse Reactions Occurring in at Least 5% of NHL Patients Treated with TREANDA by System Organ Class and Preferred Term (N=176)

System organ class
Preferred term
Number (%) of patients*
All Grades Grade 3/4
Total number of patients with at least 1 adverse reaction 176 (100) 94 (53)
Cardiac disorders
  Tachycardia 13 (7) 0
Gastrointestinal disorders
  Nausea 132 (75) 7 (4)
  Vomiting 71 (40) 5 (3)
  Diarrhea 65 (37) 6 (3)
  Constipation 51 (29) 1 ( < 1)
  Stomatitis 27 (15) 1 ( < 1)
  Abdominal pain 22 (13) 2 (1)
  Dyspepsia 20 (11) 0
  Gastroesophageal reflux disease 18 (10) 0
  Dry mouth 15 (9) 1 ( < 1)
  Abdominal pain upper 8 (5) 0
  Abdominal distension 8 (5) 0
General disorders and administration site conditions
  Fatigue 101 (57) 19 (11)
  Pyrexia 59 (34) 3 (2)
  Chills 24 (14) 0
  Edema peripheral 23 (13) 1 ( < 1)
  Asthenia 19 (11) 4 (2)
  Chest pain 11 (6) 1 ( < 1)
  Infusion site pain 11 (6) 0
  Pain 10 (6) 0
  Catheter site pain 8 (5) 0
Infections and infestations
  Herpes zoster  18 (10) 5 (3)
  Upper respiratory tract infection 18 (10) 0
  Urinary tract infection 17 (10) 4 (2)
  Sinusitis 15 (9) 0
  Pneumonia 14 (8) 9 (5)
  Febrile neutropenia 11 (6) 11 (6)
  Oral candidiasis 11 (6) 2 (1)
  Nasopharyngitis 11 (6) 0
Investigations
  Weight decreased 31 (18) 3 (2)
Metabolism and nutrition disorders
  Anorexia 40 (23) 3 (2)
  Dehydration 24 (14) 8 (5)
  Decreased appetite 22 (13) 1 ( < 1)
  Hypokalemia 15 (9) 9 (5)
Musculoskeletal and connective tissue disorders
  Back pain 25 (14) 5 (3)
  Arthralgia 11 (6) 0
  Pain in extremity 8 (5) 2 (1)
  Bone pain 8 (5) 0
Nervous system disorders
  Headache 36 (21) 0
  Dizziness 25 (14) 0
  Dysgeusia 13 (7) 0
Psychiatric disorders
  Insomnia 23 (13) 0
  Anxiety 14 (8) 1 ( < 1)
  Depression 10 (6) 0
Respiratory, thoracic and mediastinal disorders
  Cough 38 (22) 1 ( < 1)
  Dyspnea 28 (16) 3 (2)
  Pharyngolaryngeal pain 14 (8) 1 ( < 1)
  Wheezing 8 (5) 0
  Nasal congestion 8 (5) 0
Skin and subcutaneous tissue disorders
  Rash 28 (16) 1 ( < 1)
  Pruritus 11 (6) 0
  Dry skin 9 (5) 0
  Night sweats 9 (5) 0
  Hyperhidrosis 8 (5) 0
Vascular disorders
  Hypotension 10 (6) 2 (1)
*Patients may have reported more than 1 adverse reaction.
NOTE: Patients counted only once in each preferred term category and once in each system organ class category.

Hematologic toxicities, based on laboratory values and CTC grade, in NHL patients treated in both single arm studies combined are described in Table 4. Clinically important chemistry laboratory values that were new or worsened from baseline and occurred in > 1% of patients at Grade 3 or 4, in NHL patients treated in both single arm studies combined were hyperglycemia (3%), elevated creatinine (2%), hyponatremia (2%), and hypocalcemia (2%).

Table 4: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA in the NHL Studies

Hematology variable Percent of patients
All Grades Grades 3/4
Lymphocytes Decreased 99 94
Leukocytes Decreased 94 56
Hemoglobin Decreased 88 11
Neutrophils Decreased 86 60
Platelets Decreased 86 25

In both studies, serious adverse reactions, regardless of causality, were reported in 37% of patients receiving TREANDA. The most common serious adverse reactions occurring in ≥ 5% of patients were febrile neutropenia and pneumonia. Other important serious adverse reactions reported in clinical trials and/or postmarketing experience were acute renal failure, cardiac failure, hypersensitivity, skin reactions, pulmonary fibrosis, and myelodysplastic syndrome.

Serious drug-related adverse reactions reported in clinical trials included myelosuppression, infection, pneumonia, tumor lysis syndrome and infusion reactions [see WARNINGS AND PRECAUTIONS]. Adverse reactions occurring less frequently but possibly related to TREANDA treatment were hemolysis, dysgeusia/taste disorder, atypical pneumonia, sepsis, herpes zoster, erythema, dermatitis, and skin necrosis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling; pneumocystis jiroveci pneumonia and pneumonitis.

Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. [See WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Treanda (Bendamustine Hydrochloride Injection) »

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Treanda - User Reviews

Treanda User Reviews

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Here is a collection of user reviews for the medication Treanda sorted by most helpful. Patient Discussions FAQs

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