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Cytarabine liposomal / daunorubicin liposomal Side Effects

For the Consumer

Applies to cytarabine liposomal / daunorubicin liposomal: intravenous powder for solution

Along with its needed effects, cytarabine liposomal/daunorubicin liposomal 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 cytarabine liposomal/daunorubicin liposomal:

More common
  • Bleeding gums
  • blood in the urine or stools
  • blurred vision
  • body aches or pain
  • chest pain or discomfort
  • chills
  • confusion as to time, place, or person
  • cough
  • coughing up blood
  • deafness
  • decreased frequency or amount of urine
  • diarrhea
  • difficulty in breathing or swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • facial swelling
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • general feeling of discomfort or illness
  • headache
  • holding false beliefs that cannot be changed by fact
  • increased blood pressure
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • itching of the genitals or other skin areas
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nervousness
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • paralysis
  • pinpoint red spots on the skin
  • pounding in the ears
  • prolonged bleeding from cuts
  • rapid, shallow breathing
  • red or black, tarry stools
  • red or dark brown urine
  • runny nose
  • scaling
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • sneezing
  • sore throat
  • stomach cramps
  • stomach pain
  • sweating
  • swelling
  • swelling of the face, fingers, feet, or lower legs
  • tenderness
  • thickening of the bronchial secretions
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual excitement, nervousness, or restlessness
  • unusual tiredness or weakness
  • vomiting
  • watery or bloody diarrhea
  • weakness
  • weight gain

Some side effects of cytarabine liposomal / daunorubicin liposomal 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
  • Anxiety
  • belching
  • bleeding after having a bowel movement
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • bone and muscle pain
  • burning, dry, or itching of the eyes
  • changes in vision
  • constipation
  • cracked lips
  • decreased appetite
  • discharge, excessive tearing
  • heartburn
  • indigestion
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • small red or purple spots on the skin
  • stomach discomfort or upset
  • trouble sleeping
  • uncomfortable swelling around the anus

For Healthcare Professionals

Applies to cytarabine liposomal / daunorubicin liposomal: intravenous powder for injection

Hematologic

Very common (10% or more): Hemorrhage (anal hemorrhage, blood blister, blood urine present, breast hematoma, catheter site bruise, catheter site hemorrhage, CNS hemorrhage, cerebral hematoma, cerebral hemorrhage, coagulopathy, conjunctival hemorrhage, contusion, ecchymosis, enterocolitis hemorrhagic, epistaxis, GI hemorrhage, gingival bleeding, hematemesis, hematochezia, hematoma, hematuria, hemoptysis, intracranial hemorrhage, subcutaneous hemorrhage, urinary tract hemorrhage, hemorrhoidal hemorrhage, lip hematoma/hemorrhage, melena, mouth/mucosal hemorrhage, periorbital hematoma/hemorrhage, pharyngeal hematoma/hemorrhage, post procedural contusion/hematoma/hemorrhage, pulmonary hemorrhage, purpura, rectal hemorrhage, retinal hemorrhage, scleral hemorrhage, scrotal hematoma, skin ulcer hemorrhage, small intestinal hemorrhage, stomatitis hemorrhagic, subdural hematoma/hemorrhage, subgaleal hematoma, tongue hemorrhage, traumatic hematoma, urethral hemorrhage, vaginal hemorrhage, vessel puncture site hemorrhage, vitreous hemorrhage (70%), febrile neutropenia (68%), thrombocytopenia (28%), neutropenia (17%), petechiae (11%)

Hypersensitivity

Frequency not reported: Hypersensitivity (including anaphylaxis)[Ref]

Immunologic

Very common (10% or more): Bacteremia (excluding sepsis) (24%), fungal infection (18%), sepsis (excluding fungal) (11%)[Ref]

Local

Very common (10% or more): Catheter/device/injection site reaction (16%)
Frequency not reported: Tissue necrosis[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., arthralgia, back pain, bone pain, coccydynia, limb discomfort, musculoskeletal chest pain, myalgia, neck pain, pain in extremity, jaw pain) (38%)[Ref]

Ocular

Very common (10% or more): Visual impairment (e.g., photophobia, photopsia, photosensitivity reaction, retinal tear, scintillating scotoma, uveitis, vision blurred, visual acuity reduced, visual impairment, vitreous detachment, vitreous floaters) (11%)
Common (1% to 10%): Conjunctivitis, dry eye, eye edema, eye swelling, eye irritation, eye pain, ocular hyperemia, periorbital edema, scleral hyperemia[Ref]

Metabolic

Very common (10% or more): Decreased appetite (29%), hyponatremia (14%)
Common (1% to 10%): Hypokalemia, hyperbilirubinemia
Frequency not reported: Copper overload[Ref]

Psychiatric

Very common (10% or more): Sleep disorders (e.g., abnormal dreams, insomnia, nightmare, sleep apnea) (25%), delirium (16%), anxiety (14%)
Common (1% to 10%): Hallucinations[Ref]

Genitourinary

Frequency not reported: Penile edema, scrotal edema[Ref]

Respiratory

Very common (10% or more): Epistaxis (36%), cough (33%), dyspnea (acute respiratory distress syndrome, acute respiratory failure, bronchospasm, exertional dyspnea, respiratory distress/failure, wheezing) (32%), pneumonia [excluding fungal] (e.g., bacterial, klebsiella, pseudomonas aeruginosa, viral) (26%), upper respiratory tract infection [excluding fungal] (18%), pleural effusion (16%)
Common (1% to 10%): Pneumonitis[Ref]

Other

Very common (10% or more): Fatigue/asthenia (32%), pyrexia (17%)
Common (1% to 10%): Deafness[Ref]

Nervous system

Very common (10% or more): Chills (23%)[Ref]

Renal

Very common (10% or more): Renal insufficiency (e.g., azotemia, oliguria, acute/chronic renal failure) (11%)

Cardiovascular

Very common (10% or more): Edema (51%), arrhythmia (e.g., supraventricular arrhythmia, atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block first/second degree, bradycardia, bundle branch block right, extrasystole, heart rate increased, nodal arrhythmia, sinus arrhythmia/arrest, sinus bradycardia/tachycardia, supraventricular tachycardia, ventricular extrasystole, ventricular tachycardia) (30%), hypotension (20%), nonconduction cardiotoxicity (e.g., acute coronary syndrome, acute endocarditis, acute myocardial infarction, angina pectoris, aortic valve incompetence, cardiac arrest, cardiac failure, cardiac failure congestive, cardiac murmur, cardiogenic shock, cardiomegaly, cardiomyopathy, cytotoxic cardiomyopathy, diastolic dysfunction, dilatation atrial, Dilatation ventricular, Ejection fraction decreased, Endocarditis, Left ventricular dysfunction, mitral valve incompetence, myocardial infarction, pericardial effusion, pericarditis, restrictive cardiomyopathy, right ventricular hypertrophy) (20%), hypertension (18%), chest pain (17%), pleural effusion (16%)[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis contact, eczema, erythema nodosum, exfoliative rash, psoriasis, erythematous, follicular, generalized, macular, maculopapular, papular, pruritic, pustular, skin exfoliation) (54%), pruritus (15%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (47%), diarrhea/colitis (e.g., cecitis, colitis, enterocolitis, ileitis, neutropenic colitis, enteritis) (45%), mucositis (e.g., anal erosion, anorectal discomfort, duodenitis, gastric ulcer, GI inflammation, gingival pain, gingival swelling, gingivitis, glossodynia, laryngeal inflammation, lip ulceration, mouth ulceration, mucosal inflammation, mucosal ulceration, odynophagia, mouth edema, esophageal ulcer, esophagitis, oral mucosa erosion, oral mucosal blistering, oral mucosal erythema, pharyngeal ulceration, proctalgia, proctitis, rectal ulcer, stomatitis, tongue ulceration, oropharyngeal pain) (44%), constipation (40%), abdominal pain (33%), vomiting (24%), hemorrhoids (11%)
Common (1% to 10%): Dyspepsia[Ref]

References

1. "Product Information. Vyxeos (cytarabine liposomal-daunorubicin liposomal)." Jazz Pharmaceuticals, Palo Alto, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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