Note: This document contains side effect information about cytarabine liposomal / daunorubicin liposomal. Some dosage forms listed on this page may not apply to the brand name Vyxeos.

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

Serious side effects of Vyxeos

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, discomfort, or tightness
• 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
• 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 or stuffy nose
• scaling
• seeing, hearing, or feeling things that are not there
• skin rash
• sneezing
• sore throat
• stomach cramps or pain
• sweating
• swelling
• swelling of the face, fingers, feet, or lower legs
• tenderness
• thickening of the bronchial secretions
• trouble breathing
• 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

Other side effects of Vyxeos

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.

General

The most common adverse reactions with an incidence of 25% or greater were hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, pyrexia, hypotension, sleep disorders, and vomiting.

The most serious adverse reactions with an incidence of 5% or greater were dyspnea, myocardial toxicity, sepsis, pneumonia, febrile neutropenia, bacteremia, infection, cardiotoxicity, and hemorrhage.

Cardiovascular

Very common (10% or more): Arrhythmia (e.g., supraventricular arrhythmia, atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block first/second degree, bradycardia, right bundle branch block, extrasystole, increased heart rate, 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, atrial dilatation, ventricular dilatation, decreased ejection fraction, 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, allergic dermatitis, contact dermatitis, eczema, erythema nodosum, exfoliative rash, psoriasis, erythematous, follicular, generalized, macular, maculopapular, papular, pruritic, pustular, skin exfoliation) (54%), pruritus (15%), petechiae (11%), hyperhidrosis (10.1%)

Common (1% to 10%): Night sweats, alopecia^[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

Uncommon (0.1% to 1%): Palmar-plantar erythrodysaesthesia syndrome^[Ref]

Genitourinary

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

Hematologic

All patients developed severe neutropenia, thrombocytopenia, and anemia.

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%)

Common (1% to 10%): Anemia

Hepatic

Common (1% to 10%): Abnormal alanine aminotransferase levels

Hypersensitivity

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

Immunologic

Very common (10% or more): Hypersensitivity (including rash) (66.9%), bacteremia (excluding sepsis) (24%), fungal infection (aspergillosis, bronchopulmonary aspergillosis, candida test positive, candidiasis, fungemia, fungal infection, fungal skin infection, intertrigo candida, lower respiratory tract infection fungal, oral candidiasis, pneumonia fungal, pulmonary mycosis, sinusitis fungal, skin candida, tinea cruris, tinea infection, vulvovaginal mycotic infection, wound infection fungal, zygomycosis, mycotic aneurysm) (18), sepsis (excluding fungal) (11%)^[Ref]

Local

Very common (10% or more): Edema (51%), catheter/device/injection site reaction (16%)

Frequency not reported: Tissue necrosis^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (29%), hyponatremia (14%)

Common (1% to 10%): Hypokalemia, hypoalbuminemia, hyperbilirubinemia, tumor lysis syndrome

Frequency not reported: Copper overload^[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%), chills (23%),chest pain (chest discomfort, non-cardiac chest pain, pleuritic pain) (17%)^[Ref]

Nervous system

Very common (10% or more): Headache (33%), dizziness (dizziness postural, dizziness exertional) (18%)^[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%)

Frequency not reported: Eye conjunctivitis, dry eye, eye edema, eye swelling, eye irritation, eye pain, ocular discomfort, ocular hyperemia, periorbital edema, scleral hyperemia^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (32%), pyrexia (29.6%), transfusion reactions (11%)

Frequency not reported: Deafness, infusion-related reaction^[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (e.g., abnormal dreams, insomnia, nightmare, sleep apnea) (25%), anxiety (14%), delirium (16%)

Frequency not reported: Hallucination^[Ref]

Renal

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

Respiratory

Very common (10% or more): 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%), hypoxia (decreased oxygen saturation) (18%), upper respiratory tract infection [excluding fungal] (18%), pleural effusion (16%)

Frequency not reported: Pneumonitis^[Ref]