Cytarabine Liposomal / Daunorubicin Liposomal Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 11, 2025.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood, heart, kidney, and liver tests are needed to check for unwanted effects before starting each cycle of treatment with this medicine.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine. Men should use an effective form of birth control during treatment and for at least 6 months after the last dose to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, excessive swelling of the hands, wrist, ankles, or feet, or trouble breathing, check with your doctor right away. These may be symptoms of a heart problem or your body keeping too much water.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine contains copper gluconate. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, yellow eyes or skin, changes in mood, blurred or double vision, difficulty in walking, headache, numbness or tingling in your fingers and toes, or trouble sleeping. These could be symptoms of copper toxicity.

This medicine may cause tissue damage at the injection site where this medicine has leaked. Talk to your doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

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:

Other side effects

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:

For healthcare professionals

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

General adverse events

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

• 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

All patients developed severe neutropenia, thrombocytopenia, and 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]

See also:

Frequently asked questions

• How is Vyxeos administered and how long do you take it for?
• Why does Vyxeos have a polymer coating?

Further information

Cytarabine liposomal/daunorubicin liposomal side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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