Lipodox 50 Side Effects

Generic name: doxorubicin liposomal

Medically reviewed by Drugs.com. Last updated on Nov 28, 2023.

Note: This document provides detailed information about Lipodox 50 Side Effects associated with doxorubicin liposomal. Some dosage forms listed on this page may not apply specifically to the brand name Lipodox 50.

Applies to doxorubicin liposomal: intravenous solution.

Important Warnings This medicine can cause some serious health issues

Intravenous route (Solution)

DOXOrubicin hydrochloride (HCl) liposome injection can cause myocardial damage, including acute left ventricular failure.

The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 to 550 mg/m(2).

Assess left ventricular cardiac function prior to initiation of DOXOrubicin HCl liposome and during and after treatment.

Serious, life-threatening and fatal infusion-related reactions can occur with DOXOrubicin HCl liposome.

Acute infusion-related reactions occurred in 11% of patients with solid tumors.

Withhold DOXOrubicin HCl liposome for infusion-related reactions and resume at a reduced rate.

Discontinue DOXOrubicin HCl liposome for serious or life-threatening infusion-related reactions.

Serious side effects of Lipodox 50

Along with its needed effects, doxorubicin liposomal (the active ingredient contained in Lipodox 50) 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 doxorubicin liposomal:

More common

• black, tarry stools
• blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
• blood in the urine or stools
• chills
• cough or hoarseness
• facial swelling
• fever
• headache
• loss of strength and energy
• lower back or side pain
• numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
• painful or difficult urination
• pinpoint red spots on the skin
• shortness of breath
• sore throat
• sores in the mouth and on the lips
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• pain at the injection site
• skin rash or itching

Rare

• chest pain
• decreased urine output
• dilated neck veins
• extreme fatigue
• irregular breathing
• irregular heartbeat
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• weight gain
• yellowing of the eyes and skin

Other side effects of Lipodox 50

Some side effects of doxorubicin 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

• creamy white, curd-like patches in mouth or throat
• diarrhea
• loss of appetite
• nausea
• pain when eating or swallowing
• sore throat
• swallowing problems
• vomiting

Less common

• anxiety
• back pain
• bad, unusual, or unpleasant aftertaste
• burning, dry, or itching eyes
• change in skin color
• constipation
• dizziness
• excessive tearing
• itching
• joint pain
• muscle aches
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• trouble sleeping

Rare

• abnormal thinking
• change in sense of smell
• chills
• clumsiness, unsteadiness, trembling, or problems with muscle coordination
• cough
• fever
• general feeling of discomfort or illness
• shivering
• sweating

For Healthcare Professionals

Applies to doxorubicin liposomal: intravenous dispersion, intravenous powder for injection.

General

The most common adverse reactions (occurring more than 20% of patients) are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia, and anemia.^[Ref]

Cardiovascular

• Common (1% to 10%): Cardiovascular disorder, vasodilatation, hypotension, orthostatic hypotension, flushing, hypertension, phlebitis, ejection fraction decreased, arrhythmia, cardiomyopathy, congestive heart failure, hot flushes, tachycardia, deep vein thrombosis, cardiac arrest
• Uncommon (0.1% to 1%): Venous thromboembolism (including thrombophlebitis), venous thrombosis, pericardial effusion^[Ref]

Hematologic

• Very common (10% or more): Leucopenia, anemia, neutropenia, thrombocytopenia
• Common (1% to 10%): Myelosuppression^[Ref]

Dermatologic

• Very common (10% or more): Hand-foot syndrome (51%), rash (29%), alopecia (19%), dry skin, skin discoloration, vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
• Common (1% to 10%): Nail disorder, ecchymosis
• Uncommon (0.1% to 1%): Purpura, pruritus, folliculitis
• Rare (0.01% to 0.1%): Radiation recall reaction
• Very rare (less than 0.01%): Erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation, diarrhea, nausea, stomatitis, vomiting
• Common (1% to 10%): Pharyngitis, abdominal pain, dyspepsia, mouth ulceration, esophagitis, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion, oral candidiasis, oral moniliasis, glossitis
• Uncommon (0.1% to 1%): Dyspepsia, gastric ulcer^[Ref]

Hypersensitivity

• Common (1% to 10%): Allergic reaction^[Ref]

Renal

• Common (1% to 10%): Blood creatinine increased^[Ref]

Renal insufficiency has been associated with doxorubicin-induced hyperuricemia (secondary to cell lysis). Adequate hydration, diuresis, and allopurinol can be preventative.

Animal data suggest that doxorubicin may cause glomerular basement membrane injury via production of reactive oxygen species. Administration of some antioxidants, however, have failed to reduce the urinary excretion of lysozyme and N-acetyl-glucosaminidase (markers of tubule injury) in treated animals.^[Ref]

Other

• Very common (10% or more): Asthenia, mucous membrane disorder, pain, fever, rigors
• Common (1% to 10%): Peripheral edema, chills, malaise, hyperthermia^[Ref]

Oncologic

• Postmarketing reports: Secondary oral cancers (primarily squamous cell carcinoma)^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis, retinitis^[Ref]

Genitourinary

• Common (1% to 10%): Dysuria, vaginitis
• Uncommon (0.1% to 1%): Hemorrhagic cystitis, oliguria^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (12%)
• Common (1% to 10%): Myalgia
• Uncommon (0.1% to 1%): Muscle weakness^[Ref]

Nervous system

• Very common (10% or more): Peripheral sensory neuropathy, neuralgia, headache
• Common (1% to 10%): Paresthesia, somnolence, peripheral neuropathy, paresthesia, polyneuropathy, dizziness, dysgeusia, lethargy, hypoesthesia, syncope, dysesthesia
• Uncommon (0.1% to 1%): Abnormal gait, dysphonia^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea, cough, pneumonia, nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis^[Ref]

Metabolic

• Very common (10% or more): Anorexia, weight loss
• Common (1% to 10%): Dehydration, hypocalcemia
• Uncommon (0.1% to 1%): Hyperglycemia^[Ref]

Hepatic

• Common (1% to 10%): Aspartate aminotransferase increased, alanine aminotransferase increased^[Ref]

Local

• Uncommon (0.1% to 1%): Injection site infection
• Very rare (less than 0.01%): Extravasation injury^[Ref]

Immunologic

• Very common (10% or more): Neutropenic fever, infections
• Common (1% to 10%): Herpes simplex, herpes zoster, influenza-like illness
• Uncommon (0.1% to 1%): Sepsis, pneumonitis^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia, depression
• Uncommon (0.1% to 1%): Agitation^[Ref]

Frequently asked questions

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Further information

Lipodox 50 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.

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

Medical Disclaimer