Pegylated liposomal doxorubicin
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-PEGYLATED-LIPOSOMAL-DOXORUBICIN |
|---|---|
| Type | Drug |
| Aliases | CaelyxDoxilLipodoxPLDliposomal doxorubicinПегільований ліпосомальний доксорубіцин |
| Status | reviewed 2026-04-27 | pending_clinical_signoff |
| Diseases | DIS-OVARIAN |
| Sources | SRC-ESMO-OVARIAN-2024 SRC-NCCN-OVARIAN-2025 |
Drug Facts
| Class | Anthracycline (PEGylated liposomal formulation) |
|---|---|
| Mechanism | Doxorubicin hydrochloride encapsulated within long-circulating unilamellar liposomes (~100 nm) whose outer surface bears methoxypolyethylene-glycol (mPEG) chains that minimize reticuloendothelial uptake (Stealth liposome technology). The prolonged plasma half-life (~75 h vs ~10 min free doxorubicin) allows preferential extravasation into tumor microvasculature via the enhanced permeability and retention (EPR) effect. Doxorubicin released from liposomes intercalates DNA, inhibits topoisomerase II, and generates reactive oxygen species → cell death. Compared with conventional doxorubicin: substantially reduced cardiac toxicity per cumulative-dose unit, reduced alopecia and nausea, and a distinctive AE profile dominated by palmar-plantar erythrodysesthesia (PPE / hand-foot syndrome) and stomatitis. Approved in recurrent ovarian cancer post-platinum (alone or with carboplatin / trabectedin)... |
| Typical dosing | Recurrent ovarian cancer monotherapy: 40-50 mg/m² IV every 4 weeks. Combination (PLD + carboplatin AUC 5): 30 mg/m² IV every 4 weeks. Multiple myeloma (combo bortezomib): 30 mg/m² IV Day 4 of 21-day cycle. Kaposi sarcoma: 20 mg/m² IV every 2-3 weeks. CRITICAL infusion rate: initial 1 mg/min for first 5-15 minutes (to minimize acute infusion reaction); if no reaction, complete over 60 minutes. NEVER administer as IV bolus or undiluted — dilute in 250 mL D5W (NOT saline — chloride disrupts liposomes). Lifetime cumulative-dose tracking required (combine with any prior conventional anthracycline; total ~550 mg/m² conventional dox equivalent ceiling, somewhat higher with PLD given lower per-dose... |
| Ukraine registered | True |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Cardiomyopathy (cumulative dose-dependent; lower per-dose risk than conventional doxorubicin but lifetime cumulative tracking essential)
- Acute infusion reactions — flushing, dyspnea, chest pain, hypotension, back pain (~10%, often cycle 1; manage by slow rate, premed)
- Severe myelosuppression
- Hepatotoxicity (bilirubin-based dose reduction required)
Notes
Cumulative anthracycline dose tracking is mandatory — combine PLD dose with any prior conventional doxorubicin / epirubicin / daunorubicin. Conventional dox equivalent ceiling ~550 mg/m²; PLD is somewhat better tolerated cardiotoxicity-wise so a higher cumulative dose may be permissible with serial LVEF, but no formal ceiling raised. PPE prophylaxis: cool compresses to hands/feet during and 24 h after infusion, avoid heat / friction / vigorous exercise / hot showers / occlusive footwear, urea 10-40% creams, pyridoxine 50 mg PO TID has historical use though evidence weak. CRITICAL: dilute in D5W only (saline disrupts liposomes); slow initial infusion rate to mitigate reactions; central line strongly preferred (vesicant). Baseline + serial LVEF (echo or MUGA) at cumulative milestones (~150, 250, 350 mg/m² and more frequently thereafter). Acute infusion reaction differs from anaphylaxis — responds to stopping infusion + supportive care, can often resume at slower rate. UA: registered; reimbursement variable — conventional doxorubicin is the more commonly НСЗУ-funded anthracycline.
Used By
Regimens
REG-CARBO-PLD-BEV-OVARIAN- Carboplatin + PLD + Bevacizumab (platinum-sensitive recurrent ovarian)REG-PLD-BEV-OVARIAN- PLD + Bevacizumab (platinum-resistant recurrent ovarian, AURELIA)REG-TRABECTEDIN-PLD-OVARIAN- Trabectedin + PLD (recurrent ovarian, OVA-301)