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Cytarabine liposomal / daunorubicin liposomal Side Effects

For the Consumer

Applies to cytarabine liposomal / daunorubicin liposomal: intravenous suspension reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Swelling.
  • Chest pain.
  • Feeling very sleepy.
  • Anxiety.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Hearing loss.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling very tired or weak.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Mouth irritation or mouth sores.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Muscle pain.
  • Feeling tired or weak.
  • Stomach pain.
  • Headache.
  • Not hungry.
  • Feeling sleepy.
  • Not able to sleep.
  • Dizziness.
  • Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Some side effects of cytarabine liposomal / daunorubicin liposomal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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