Treanda

Last updated on RxList: 3/17/2021
Treanda Side Effects Center

What Is Treanda?

Treanda (bendamustine hydrochloride injection) is an antineoplastic (anticancer) medication used to treat chronic lymphocytic leukemia. Treanda is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition.

What Are Side Effects of Treanda?

Common side effects of Treanda include:

Dosage for Treanda

The recommended dose of Treanda is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

What Drugs, Substances, or Supplements Interact with Treanda?

Treanda may interact with carbamazepine, cimetidine, ciprofloxacin, fluvoxamine, omeprazole, thiabendazole, or barbiturates. Tell your doctor all medications you use.

Treanda During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Treanda Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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;
  • liver problems--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed if you have certain side effects.

Common side effects may include:

  • fever, cough, mouth sores, trouble breathing;
  • low blood cell counts;
  • nausea, vomiting, diarrhea, constipation;
  • headache, tiredness;
  • rash; or
  • loss of appetite, weight loss.

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)

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Treanda Professional Information

SIDE EFFECTS

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

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Infusion Reactions [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Other Malignancies [see WARNINGS AND PRECAUTIONS]
  • Extravasation Injury [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

Chronic Lymphocytic Leukemia

The data described below reflect exposure to TREANDA in 153 patients. TREANDA was studied in an activecontrolled, randomized trial. The population was 45-77 years of age, 63% male, 100% white, and had treatment naive CLL. 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. In the randomized CLL clinical study, 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 randomized CLL clinical study 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

Body System/ Adverse Reaction 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 (1) 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 randomized 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.

Non-Hodgkin Lymphoma

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 (N=176)

Body System/ Adverse Reaction 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 adverse reaction category and once in each body system 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 Grade 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.

Blood and lymphatic systems disorders: Pancytopenia

Cardiovascular disorders: Atrial fibrillation, congestive heart failure (some fatal), myocardial infarction (some fatal), palpitation

General disorders and administration site conditions: Injection site reactions (including phlebitis, pruritus, irritation, pain, swelling), infusion site reactions (including phlebitis, pruritus, irritation, pain, swelling)

Immune system disorders: Anaphylaxis

Infections and infestations: Pneumocystis jiroveci pneumonia

Respiratory, thoracic and mediastinal disorders: Pneumonitis

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, Toxic epidermal necrolysis, DRESS (Drug reaction with eosinophilia and systemic symptoms). [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

Effect Of Other Drugs On TREANDA

CYP1A2 Inhibitors

The coadministration of TREANDA with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with TREANDA [see CLINICAL PHARMACOLOGY]. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with TREANDA.

CYP1A2 Inducers

The coadministration of TREANDA with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of TREANDA [see CLINICAL PHARMACOLOGY]. Consider alternative therapies that are not CYP1A2 inducers during treatment with TREANDA.

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

© Treanda Patient Information is supplied by Cerner Multum, Inc. and Treanda Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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