Note: This document contains side effect information about bendamustine. Some dosage forms listed on this page may not apply to the brand name Belrapzo.

Applies to bendamustine: intravenous powder for solution, intravenous solution.

Serious side effects of Belrapzo

Along with its needed effects, bendamustine (the active ingredient contained in Belrapzo) 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
• trouble breathing
• 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
• chest tightness
• 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
• trouble swallowing

Incidence not known

• Back pain
• blistering, flaking, or peeling of the skin
• bluish color
• blurred vision
• changes in skin color
• confusion
• dizziness
• drowsiness
• pain, tenderness, or swelling of the foot or leg
• pain or discomfort in the arms, jaw, back, or neck
• persistent non-healing sore
• pink growth
• 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
• reddish patch or irritated area
• seizures
• shiny bump
• sweating
• thickening of bronchial secretions
• weakness
• white, yellow, or waxy scar-like area

Other side effects of Belrapzo

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

For Healthcare Professionals

Applies to bendamustine: intravenous powder for injection, intravenous solution.

Hematologic

Very common (10% or more): Decreased lymphocytes (up to 99%), decreased leukocytes (up to 94%), decreased hemoglobin (up to 89%), decreased neutrophils (up to 86%), decreased platelets (up to 86%), lymphocytopenia (up to 74%), neutropenia (up to 45%), thrombocytopenia (up to 39%), anemia (up to 38%), leukopenia (up to 37%)

Common (1% to 10%): Febrile neutropenia, hemorrhage, lymphopenia

Very rare (less than 0.01%): Hemolysis

Postmarketing reports: Pancytopenia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 77%), diarrhea (up to 42%), vomiting (up to 40%), constipation (up to 31%), stomatitis (up to 21%), abdominal pain (up to 14%), dyspepsia (up to 14%), gastroesophageal reflux disease (up to 11%)

Common (1% to 10%): Dry mouth, upper abdominal pain, abdominal distension, oral candidiasis

Very rare (less than 0.01%): Gastrointestinal hemorrhage, hemorrhagic esophagitis^[Ref]

Other

Very common (10% or more): Fatigue (up to 64%), infectious episodes (up to 37%), pyrexia (up to 36%), chills (up to 14%), asthenia (up to 13%), herpes zoster (up to 12%), mucosal inflammation

Common (1% to 10%): Pain, infection, herpes simplex, amenorrhea, epididymitis, thirst, cytomegalovirus infection

Uncommon (0.1% to 1%): Sepsis

Very rare (less than 0.01%): Infertility, multi-organ failure

Frequency not reported: Septic shock, general physical health deterioration

Postmarketing reports: Progressive multifocal leukoencephalopathy^[Ref]

Hepatic

Very common (10% or more): Elevated bilirubin (up to 34%), increased creatinine, increased urea

Common (1% to 10%): Increased AST, increased ALT, increased alkaline phosphatase

Frequency not reported: Hepatitis, hepatic failure, gallbladder pain^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 24%), decreased weight (up to 20%), dehydration (up to 15%), decreased appetite (up to 13%), hypokalemia (up to 11%)

Common (1% to 10%): Hyperuricemia, tumor lysis syndrome, hypomagnesemia^[Ref]

Respiratory

Very common (10% or more): Cough (up to 22%), dyspnea (up to 17%), upper respiratory tract infection (up to 10%), pharyngolaryngeal pain (up to 10%)

Common (1% to 10%): Nasopharyngitis, sinusitis, pneumonia, wheezing, nasal congestion, pulmonary dysfunction

Very rare (less than 0.01%): Pulmonary fibrosis

Frequency not reported: Lung neoplasm, lung infiltration, pleural effusion

Postmarketing reports: Pneumocystis jiroveci pneumonia, pneumonitis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 21%), dizziness (up to 15%), dysgeusia (up to 11%)

Rare (less than 0.1%): Somnolence, aphonia

Very rare (less than 0.01%): Paresthesia, peripheral sensory neuropathy, anticholinergic syndrome, neurological disorders, ataxia, encephalitis

Frequency not reported: Paraplegia, neuralgia^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 16%), erythema (up to 16%), skin allergic reactions (up to 15%)

Common (1% to 10%): Pruritus, dry skin, night sweats, hyperhidrosis, alopecia, skin disorders

Rare (less than 0.1%): Dermatitis, macular-papular rash

Frequency not reported: Toxic skin reactions, bullous exanthema, urticaria

Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), non-melanoma skin cancer (NMSC), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 15%)

Common (1% to 10%): Anxiety, depression^[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (up to 14%)

Common (1% to 10%): Tachycardia, chest pain, hypotension, cardiac dysfunction (palpitations, angina pectoris, arrhythmia), hypertension

Uncommon (0.1% to 1%): Pericardial effusion

Rare (less than 0.1%): Myocardial infarction, acute circulatory failure, cardiac failure

Very rare (less than 0.01%): Phlebitis

Frequency not reported: Vasculitis

Postmarketing reports: Atrial fibrillation, congestive heart failure^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 14%)

Common (1% to 10%): Arthralgia, extremity pain, bone pain, myalgia

Frequency not reported: Sacral pain^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 11%)^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions

Rare (less than 0.1%): Anaphylaxis, anaphylactoid reaction

Very rare (less than 0.01%): Anaphylactic shock^[Ref]

Local

Common (1% to 10%): Infusion site pain, catheter site pain

Frequency not reported: Extravasation injury, infusion reactions, injection site reactions^[Ref]

Ocular

Frequency not reported: Retinal detachment^[Ref]

Oncologic

Frequency not reported: Pre-malignant and malignant diseases/secondary tumors^[Ref]

Renal

Frequency not reported: Acute renal failure^[Ref]