Caelyx Pegylated Liposomal: Uses, Dosage & Side Effects
A pegylated liposomal formulation of doxorubicin used to treat breast cancer, ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma
Caelyx pegylated liposomal is a chemotherapy medication containing doxorubicin hydrochloride enclosed in tiny spheres called pegylated liposomes. This advanced drug delivery system allows the active substance to circulate longer in the bloodstream and accumulate preferentially in tumor tissue, reducing exposure to healthy organs—particularly the heart. Caelyx is approved for treating metastatic breast cancer in patients at cardiac risk, advanced ovarian cancer, multiple myeloma (with bortezomib), and AIDS-related Kaposi’s sarcoma. It is administered as an intravenous infusion in a hospital setting and requires a prescription from a specialist physician.
Quick Facts: Caelyx Pegylated Liposomal
Key Takeaways
- Caelyx pegylated liposomal is a specialized form of doxorubicin encapsulated in pegylated liposomes, allowing targeted delivery to tumors with reduced cardiac toxicity compared to conventional doxorubicin.
- It is approved for four indications: metastatic breast cancer (cardiac-risk patients), advanced ovarian cancer, multiple myeloma (with bortezomib), and AIDS-related Kaposi’s sarcoma.
- Hand-foot syndrome (palmar-plantar erythrodysesthesia) is one of the most characteristic side effects and can be managed with cooling measures and vitamin B6 supplementation.
- The drug must not be used during pregnancy or breastfeeding; effective contraception is required for both women (8 months post-treatment) and men (6 months post-treatment).
- Regular blood tests and cardiac monitoring are essential throughout treatment to detect myelosuppression and potential cardiotoxicity early.
What Is Caelyx Pegylated Liposomal and What Is It Used For?
Caelyx pegylated liposomal belongs to the anthracycline class of chemotherapy agents and contains the active substance doxorubicin hydrochloride. What distinguishes Caelyx from conventional doxorubicin is its innovative drug delivery system: the doxorubicin molecules are enclosed within pegylated liposomes—tiny spheres made of a lipid bilayer coated with polyethylene glycol (PEG). This coating makes the liposomes “stealth-like,” allowing them to evade the immune system and circulate in the bloodstream for an extended period.
The pegylated liposomal formulation exploits the enhanced permeability and retention (EPR) effect. Tumor blood vessels tend to be leaky, allowing the long-circulating liposomes to pass through and accumulate in tumor tissue at concentrations several times higher than in normal tissue. This results in a more targeted delivery of the cytotoxic drug to cancer cells while significantly reducing exposure to the heart and other healthy organs. Doxorubicin works by intercalating into DNA, inhibiting the enzyme topoisomerase II, and generating cytotoxic free radicals—all mechanisms that ultimately cause cancer cell death.
Approved Indications
Metastatic breast cancer: Caelyx pegylated liposomal is indicated for the treatment of metastatic breast cancer in patients who are at increased risk for cardiac complications. This includes patients who have already received high cumulative doses of anthracyclines or who have pre-existing cardiac conditions. Clinical studies have shown that pegylated liposomal doxorubicin has comparable antitumor activity to conventional doxorubicin but with a significantly lower incidence of clinical cardiotoxicity, as demonstrated in the pivotal phase III trial published in the Journal of Clinical Oncology.
Advanced ovarian cancer: Caelyx is approved for the treatment of advanced ovarian cancer in patients who have failed first-line platinum-based chemotherapy. In this setting, the drug has demonstrated objective response rates and progression-free survival benefits supported by randomized controlled trials. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have both approved this indication based on evidence from multi-center studies.
Multiple myeloma: In combination with bortezomib, Caelyx pegylated liposomal is approved for the treatment of progressive multiple myeloma in patients who have received at least one prior therapeutic regimen. The combination has shown superior time to progression compared to bortezomib alone in the pivotal DOXIL-MMY-3001 trial, establishing it as an effective second-line treatment option endorsed by the European Society for Medical Oncology (ESMO) guidelines.
AIDS-related Kaposi’s sarcoma: Caelyx is indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients with low CD4 counts and extensive mucocutaneous or visceral disease. The drug has demonstrated the ability to flatten, lighten, and shrink Kaposi’s sarcoma lesions, with additional improvement in tumor-associated swelling. Response rates in clinical trials have ranged from 45% to 59% in this challenging patient population.
What Should You Know Before Taking Caelyx Pegylated Liposomal?
Before starting treatment with Caelyx pegylated liposomal, your oncologist will conduct a thorough assessment of your medical history, current medications, and overall health status. Several important factors must be considered to ensure safe and effective treatment. Your healthcare team will perform baseline blood tests, cardiac function assessments (typically echocardiography or MUGA scan), and liver function tests before the first infusion.
Contraindications
- You are allergic to doxorubicin hydrochloride or any of the other ingredients
- You have an allergy to peanuts or soy (the formulation contains fully hydrogenated soy phosphatidylcholine)
Hypersensitivity to doxorubicin or any excipients is an absolute contraindication. Of particular clinical importance is the soy component: Caelyx contains fully hydrogenated soy phosphatidylcholine (HSPC) as a structural lipid in the liposome bilayer. Patients with known peanut or soy allergy must not receive this medication due to the risk of serious allergic reactions, including anaphylaxis.
Warnings and Precautions
Several clinical situations require special attention and close monitoring during Caelyx therapy. Your treating physician should be informed of all relevant medical conditions prior to treatment initiation.
- Heart disease: Although pegylated liposomal doxorubicin carries a lower cardiac risk than conventional doxorubicin, cumulative anthracycline cardiotoxicity remains a concern. Cardiac function should be monitored regularly throughout treatment, including assessment of left ventricular ejection fraction (LVEF). Treatment should be discontinued if clinical signs of heart failure develop.
- Liver disease: Doxorubicin is extensively metabolized by the liver. Patients with hepatic impairment may experience increased drug exposure and toxicity. Dose adjustments may be required based on liver function parameters, particularly serum bilirubin levels.
- Diabetes: Caelyx pegylated liposomal contains sucrose, which may necessitate adjustments in diabetes management. Blood glucose levels should be monitored more frequently during treatment.
- Prior splenectomy: In patients with Kaposi’s sarcoma who have undergone splenectomy, careful monitoring is required as the altered immune status may affect drug metabolism and toxicity profiles.
- Oral mucositis: If you develop sores, discoloration, or discomfort in your mouth, report this promptly to your healthcare team. Dose modifications may be required to prevent progression of oral mucositis.
Cases of interstitial lung disease (ILD) have been observed in patients receiving pegylated liposomal doxorubicin, including fatal cases. Symptoms include cough and shortness of breath, sometimes with fever, that are not caused by physical activity. Seek immediate medical attention if you develop these symptoms.
Use in Children and Adolescents
Caelyx pegylated liposomal is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of this formulation have not been established in the pediatric population. Clinical trial data are insufficient to support its use in this age group, and the pharmacokinetic profile may differ significantly from that in adults.
Pregnancy and Breastfeeding
Doxorubicin, the active ingredient in Caelyx pegylated liposomal, is known to be teratogenic and embryotoxic in animal studies. It has the potential to cause serious birth defects and harm to the developing fetus. For this reason, strict contraceptive requirements apply during and after treatment.
- Women of childbearing potential: Must use effective contraception throughout treatment and for at least 8 months after the last dose of Caelyx. Pregnancy must be excluded before starting treatment. If pregnancy occurs during therapy, the patient must be informed about the potential risks to the fetus.
- Male patients: Must use effective contraception during treatment and for at least 6 months after the last dose to prevent their partners from becoming pregnant.
- Breastfeeding: Women must discontinue breastfeeding before starting Caelyx treatment, as doxorubicin and its metabolites may pass into breast milk and could harm the nursing infant.
Driving and Operating Machinery
Caelyx pegylated liposomal may cause fatigue, dizziness, and somnolence in some patients. If you experience tiredness or drowsiness as a result of treatment, you should not drive vehicles or operate machinery until these effects resolve. Your ability to react may be impaired during and shortly after infusion sessions.
Important Information About Excipients
Caelyx pegylated liposomal contains soy oil (as fully hydrogenated soy phosphatidylcholine). Patients with peanut or soy allergy must not use this medication.
The formulation also contains less than 1 mmol (23 mg) sodium per dose, making it essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Caelyx Pegylated Liposomal Interact with Other Drugs?
Drug interactions with Caelyx pegylated liposomal are an important clinical consideration, particularly given that many cancer patients receive multi-drug regimens. The active substance doxorubicin can interact with various medications, and the liposomal formulation may modify some of these interactions. A thorough medication review should be conducted before starting treatment.
Doxorubicin is metabolized primarily in the liver and can be affected by drugs that induce or inhibit hepatic enzymes. Although formal drug-drug interaction studies specifically with the pegylated liposomal formulation are limited, the known pharmacology of doxorubicin informs clinical practice. Particular caution is required when Caelyx is combined with other myelosuppressive agents, as the cumulative bone marrow suppression can lead to life-threatening neutropenia, thrombocytopenia, and anemia.
Key Drug Interactions
| Interacting Drug/Class | Effect | Clinical Recommendation |
|---|---|---|
| Other myelosuppressive agents | Additive bone marrow suppression; further reduction of white blood cells, red blood cells, and platelets | Close monitoring of blood counts; dose adjustments may be needed |
| Bortezomib | Approved combination for multiple myeloma; may increase hepatotoxicity risk | Monitor liver function closely; follow approved dosing schedule |
| Cardiotoxic agents (trastuzumab, cyclophosphamide) | Increased risk of cumulative cardiotoxicity | Regular cardiac monitoring (LVEF); consider cumulative anthracycline dose limits |
| CYP3A4 inhibitors (ketoconazole, erythromycin) | Potential increase in doxorubicin plasma levels | Monitor for increased toxicity; dose adjustment may be necessary |
| CYP3A4 inducers (rifampicin, phenytoin) | Potential decrease in doxorubicin efficacy | Consider therapeutic drug monitoring; avoid if possible |
| Live vaccines | Risk of vaccine-related infection due to immunosuppression | Avoid live vaccines during and for at least 6 months after treatment |
| Radiation therapy | Radiation recall reaction; inflammation at previously irradiated sites | Monitor for skin reactions; consider timing of radiation and chemotherapy |
It is essential to inform your treating physician about all medications you are currently taking, have recently taken, or might take—including prescription drugs, over-the-counter medications, herbal remedies, and dietary supplements. If you have previously received other cancer treatments, particularly those that suppress bone marrow function, this information is critical for safe dosing and monitoring.
What Is the Correct Dosage of Caelyx Pegylated Liposomal?
Caelyx pegylated liposomal is a unique pharmaceutical formulation that must not be substituted with other doxorubicin products on a milligram-for-milligram basis. The pharmacokinetic properties of pegylated liposomal doxorubicin differ significantly from conventional doxorubicin, and incorrect substitution could lead to either underdosing (reduced efficacy) or overdosing (increased toxicity). All doses are calculated based on body surface area (BSA), determined from the patient’s height and weight.
Dosage by Indication
| Indication | Dose | Schedule | Notes |
|---|---|---|---|
| Breast cancer | 50 mg/m² | Every 4 weeks | Continue as long as disease does not progress and treatment is tolerated |
| Ovarian cancer | 50 mg/m² | Every 4 weeks | Minimum 4 cycles recommended; continue if responding |
| Multiple myeloma | 30 mg/m² | Day 4 of each 21-day bortezomib cycle | Given as 1-hour infusion immediately after bortezomib; requires prior therapy |
| Kaposi’s sarcoma | 20 mg/m² | Every 2–3 weeks | Initial 2–3 months; then as needed to maintain response |
Method of Administration
Caelyx pegylated liposomal is administered exclusively as an intravenous infusion by trained healthcare professionals in a hospital or clinical setting. The drug must be diluted in 5% glucose (dextrose) solution before administration—no other diluents should be used. For doses less than 90 mg, Caelyx should be diluted in 250 ml; for doses of 90 mg or more, it should be diluted in 500 ml of 5% glucose solution.
The infusion duration typically ranges from 30 minutes to over 90 minutes, depending on the dose and whether the patient has experienced previous infusion reactions. Critically, the initial dose must be infused at a rate not exceeding 1 mg per minute to minimize the risk of infusion-related reactions. If the first infusion is tolerated without incident, subsequent infusions may be given over 60 minutes.
If early signs of an infusion reaction occur (flushing, shortness of breath, facial swelling, headache, chest pain, back pain, chest tightness, or fever), the infusion must be stopped immediately. Antihistamines and/or short-acting corticosteroids should be administered, and the infusion may be restarted at a slower rate once symptoms resolve.
Dose Modifications
Dose adjustments or treatment delays may be necessary based on toxicity. Common reasons for dose modification include significant myelosuppression (low blood counts), hand-foot syndrome (palmar-plantar erythrodysesthesia), and stomatitis (mouth sores). Your oncologist will evaluate your blood counts and clinical status before each treatment cycle and make appropriate dose adjustments according to established protocols.
Overdose
Acute overdose of Caelyx pegylated liposomal would be expected to worsen the known side effects of the drug, including severe mucositis (mouth ulcers), pronounced myelosuppression (drastically reduced blood cell counts), and potential cardiac complications. There is no specific antidote for doxorubicin overdose. Treatment is supportive and includes administration of antibiotics for infection prophylaxis, platelet transfusions for bleeding, use of colony-stimulating factors to promote white blood cell recovery, and symptomatic management of oral mucositis. The patient should be monitored closely in a hospital setting.
What Are the Side Effects of Caelyx Pegylated Liposomal?
Like all chemotherapy medications, Caelyx pegylated liposomal can cause side effects, although not everyone will experience them. The side effect profile of pegylated liposomal doxorubicin differs from conventional doxorubicin in several important ways. While cardiotoxicity is reduced with the liposomal formulation, hand-foot syndrome (palmar-plantar erythrodysesthesia) is significantly more common. Understanding the frequency and nature of potential side effects helps both patients and healthcare providers manage treatment effectively.
Infusion-Related Reactions
During the infusion itself, certain reactions may occur, particularly during the first treatment. These can include allergic reactions (facial swelling, difficulty breathing, hives), asthma-like symptoms, flushing, sweating, chills, fever, chest pain or discomfort, back pain, changes in blood pressure, rapid heartbeat, and rarely, seizures. The first infusion is given slowly to minimize these risks, and the medical team is prepared to manage any reactions that occur.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Decreased white blood cell count (neutropenia), increasing infection risk
- Anemia (reduced red blood cells) causing tiredness
- Decreased platelet count (thrombocytopenia), increasing bleeding risk
- Hand-foot syndrome (redness, swelling, peeling of palms and soles)
- Nausea and vomiting
- Mouth sores (stomatitis/mucositis)
- Diarrhea
- Decreased appetite
- Constipation
- Skin rash, including redness and allergic rashes
- Hair loss (alopecia)
- Fatigue and weakness
- Pain (muscle, joint, chest, arm, leg)
- Fever
Common
May affect up to 1 in 10 people
- Infections: sepsis, pneumonia, herpes zoster (shingles), urinary tract infections, fungal infections (including oral thrush), throat and sinus infections
- Febrile neutropenia (low white cells with fever)
- Severe weight loss and muscle wasting; dehydration
- Low potassium, sodium, or calcium levels
- Confusion, anxiety, depression, difficulty sleeping
- Nerve damage causing tingling, numbness, or pain (neuropathy)
- Headache, dizziness, drowsiness
- Eye inflammation (conjunctivitis)
- Heart palpitations; high or low blood pressure; hot flashes
- Shortness of breath, nosebleeds, cough
- Stomach lining or esophageal inflammation; difficulty swallowing; mouth pain and dryness
- Dry, flaking, or peeling skin; itching; dark skin patches; excessive sweating
- Muscle cramps and musculoskeletal pain
- Painful urination
- Flu-like illness, chills, swelling (edema), general malaise
- Weight loss
Uncommon
May affect up to 1 in 100 people
- Herpes simplex (cold sores or genital herpes); fungal infections
- Decreased counts of all blood cell types (pancytopenia)
- Allergic reactions; high potassium or low magnesium levels
- Nerve damage affecting multiple body areas
- Seizures, fainting; blurred vision, watery eyes
- Irregular heartbeat (palpitations); heart muscle disease; heart damage
- Tissue damage at injection site (necrosis); inflamed veins
- Chest discomfort; gas; inflamed gums (gingivitis)
- Skin problems: peeling, blistering, sores, hives, nail problems, acne
- Muscle weakness; breast pain
- Injection site irritation; facial swelling; high body temperature
- Radiation recall reaction (inflammation at previously irradiated sites)
Rare
May affect up to 1 in 1,000 people
- Opportunistic infections in immunocompromised patients
- Bone marrow failure
- Retinal inflammation (may cause vision changes or blindness)
- Abnormal heart rhythm; abnormal ECG findings; blue discoloration of skin (cyanosis)
- Blood vessel dilation; throat tightness
- Ulcerated/swollen tongue; lip sores
- Blistering skin rashes; vaginal infection; testicular redness
- Abnormal liver function tests; elevated blood creatinine
- Stevens-Johnson syndrome (rare but serious skin reaction with blistering around mouth, eyes, and genitals)
- Toxic epidermal necrolysis (severe, life-threatening skin peeling)
Not Known Frequency
Frequency cannot be estimated from available data
- Secondary blood cancers: acute myeloid leukemia, myelodysplastic syndrome
- Oral or lip cancer
- Interstitial lung disease (cough and breathlessness, sometimes with fever, not caused by physical activity)—can be fatal
Managing Hand-Foot Syndrome
Hand-foot syndrome (palmar-plantar erythrodysesthesia, or PPE) is one of the most characteristic side effects of Caelyx pegylated liposomal. It manifests as redness, swelling, peeling, and tenderness on the palms of the hands and/or soles of the feet. In severe cases, it can interfere with daily activities and may persist for 4 weeks or longer before full healing occurs. Several strategies can help prevent or reduce the severity of this condition:
- Soak hands and/or feet in cool water when possible (for example, while watching television or reading)
- Keep hands and feet uncovered—avoid wearing gloves, socks, or constrictive footwear when not necessary
- Stay in cool environments; take cool baths during warm weather
- Avoid vigorous activities that put pressure on the feet (such as jogging)
- Avoid exposing skin to very hot water (hot tubs, saunas)
- Avoid tight-fitting or high-heeled shoes
- Apply moisturizing creams liberally to hands and feet
Vitamin B6 is available over the counter and may help manage hand-foot syndrome. At the first signs of redness or tingling, take 50–150 mg of pyridoxine daily. Some clinical studies suggest that prophylactic pyridoxine supplementation may reduce the incidence and severity of PPE, though evidence remains mixed. Discuss this approach with your oncologist.
Cardiac Monitoring
While Caelyx pegylated liposomal has a significantly reduced risk of cardiotoxicity compared to conventional doxorubicin, cumulative anthracycline exposure can still lead to heart damage. Your oncologist will monitor your cardiac function at regular intervals, typically using echocardiography or MUGA scanning to measure left ventricular ejection fraction (LVEF). Special vigilance is warranted in patients who have previously received other anthracyclines, chest radiation, or cardiotoxic drugs such as trastuzumab.
How Should Caelyx Pegylated Liposomal Be Stored?
Caelyx pegylated liposomal must be stored under carefully controlled conditions to maintain its pharmaceutical integrity. As a hospital-administered medication, storage is typically managed by the pharmacy department, but understanding the storage requirements is important for ensuring drug quality and safety.
- Temperature: Store in a refrigerator between 2°C and 8°C (36°F–46°F).
- Freezing: Must not be frozen. Freezing disrupts the liposomal structure and renders the product unusable.
- After dilution: Chemical and physical stability has been demonstrated for 24 hours at 2°C–8°C. From a microbiological standpoint, the product should ideally be used immediately after dilution. If not used immediately, storage must not exceed 24 hours under refrigeration.
- Partially used vials: Any remaining contents in partially used vials must be discarded. The product does not contain preservatives.
- Visual inspection: Do not use if any signs of precipitation or particulate matter are observed.
- Shelf life: Do not use after the expiration date stated on the label and carton.
As with all cytotoxic medications, Caelyx should not be disposed of via household waste or sewage systems. Hospital pharmacy staff will handle the proper disposal of unused medication in accordance with institutional policies for hazardous pharmaceutical waste.
What Does Caelyx Pegylated Liposomal Contain?
Understanding the composition of Caelyx pegylated liposomal is important for identifying potential allergens and understanding the drug’s unique formulation. The product consists of doxorubicin hydrochloride encapsulated within pegylated liposomes—a sophisticated drug delivery system composed of multiple components.
Active Substance
The active substance is doxorubicin hydrochloride at a concentration of 2 mg per milliliter. Each vial is available in two sizes: 10 ml (containing 20 mg of doxorubicin) or 25 ml (containing 50 mg of doxorubicin).
Excipients (Inactive Ingredients)
- MPEG-DSPE (α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω-methoxypoly(oxyethylene)-40 sodium salt): The PEG-lipid component that forms the “stealth” coating on the liposome surface, extending circulation time.
- Fully hydrogenated soy phosphatidylcholine (HSPC): A primary structural lipid of the liposome bilayer. Contains soy—not suitable for patients with peanut or soy allergy.
- Cholesterol: Stabilizes the liposome membrane and controls drug release.
- Ammonium sulfate: Creates the transmembrane pH gradient used for active drug loading.
- Sucrose: Acts as a cryoprotectant and osmotic agent.
- Histidine: pH buffer to maintain product stability.
- Water for injections: Solvent.
- Hydrochloric acid and sodium hydroxide: For pH adjustment.
Physical Appearance
Caelyx pegylated liposomal is a sterile, translucent, red-colored dispersion supplied in glass vials. It is available as single-pack vials or packs of ten vials. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Caelyx Pegylated Liposomal
Caelyx pegylated liposomal is a chemotherapy medication used to treat four types of cancer: metastatic breast cancer in patients at risk for cardiac problems, advanced ovarian cancer after failure of first-line treatment, multiple myeloma in combination with bortezomib (in patients who have received at least one prior therapy), and AIDS-related Kaposi’s sarcoma. The drug contains doxorubicin enclosed in pegylated liposomes that deliver the medication more selectively to tumor tissue.
While both contain the same active drug (doxorubicin), Caelyx uses a unique pegylated liposomal delivery system. The doxorubicin is enclosed in tiny lipid spheres coated with polyethylene glycol (PEG), which allows the drug to circulate longer in the blood and accumulate preferentially in tumors. This results in significantly reduced cardiotoxicity compared to conventional doxorubicin, though it may cause more hand-foot syndrome. The two formulations are not interchangeable—they have different dosing schedules and toxicity profiles.
Hand-foot syndrome (palmar-plantar erythrodysesthesia) causes redness, swelling, peeling, and tenderness on the palms and soles. It is one of the most common side effects of Caelyx. Management strategies include cooling the hands and feet in cold water, avoiding heat exposure (hot baths, saunas), wearing comfortable shoes, and taking vitamin B6 (pyridoxine, 50–150 mg daily) at the first signs of redness or tingling. In severe cases, your oncologist may reduce the dose or delay the next treatment cycle.
No. Doxorubicin can cause serious birth defects and must not be used during pregnancy. Women must use effective contraception during treatment and for 8 months after the last dose. Men must use contraception during treatment and for 6 months afterward. If you suspect you may be pregnant during treatment, contact your oncologist immediately. Breastfeeding must also be stopped before starting Caelyx.
Regular monitoring is essential. This includes blood tests before each cycle to check white blood cell counts, red blood cell counts, platelet counts, and liver function. Cardiac function monitoring (echocardiography or MUGA scan) is performed at baseline and at regular intervals during treatment to detect early signs of cardiotoxicity. Your oncologist will also assess you clinically for signs of hand-foot syndrome, mucositis, and other side effects before each treatment cycle.
The infusion typically lasts between 30 and 90 minutes, depending on the dose. The very first infusion is given more slowly (at no more than 1 mg per minute) to monitor for infusion reactions. If the first dose is well tolerated, subsequent infusions can usually be completed in about 60 minutes. The infusion is delivered through a peripheral or central vein, and no in-line filter should be used.
References
- European Medicines Agency (EMA). Caelyx pegylated liposomal – Summary of Product Characteristics (SmPC). Available at: ema.europa.eu. Accessed January 2026.
- O’Brien MER, Wigler N, Inbar M, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Annals of Oncology. 2004;15(3):440–449. doi:10.1093/annonc/mdh097
- Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. Journal of Clinical Oncology. 2001;19(14):3312–3322. doi:10.1200/JCO.2001.19.14.3312
- Orlowski RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma. Journal of Clinical Oncology. 2007;25(25):3892–3901. doi:10.1200/JCO.2006.10.5718
- Northfelt DW, Dezube BJ, Thommes JA, et al. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi’s sarcoma. Journal of Clinical Oncology. 1998;16(7):2445–2451. doi:10.1200/JCO.1998.16.7.2445
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- European Society for Medical Oncology (ESMO). ESMO Clinical Practice Guidelines: Multiple Myeloma. Annals of Oncology. 2024.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, Ovarian Cancer, and Multiple Myeloma. 2025.
- Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clinical Pharmacokinetics. 2003;42(5):419–436. doi:10.2165/00003088-200342050-00002
- Lorusso D, Di Stefano A, Carone V, et al. Pegylated liposomal doxorubicin-related palmar-plantar erythrodysesthesia (hand-foot syndrome). Annals of Oncology. 2007;18(7):1159–1164. doi:10.1093/annonc/mdl477
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