What Is Liposomal Doxorubicin (Caelyx)?
In this article
Liposomal Doxorubicin (Caelyx): A Comprehensive Treatment Guide
Drug Profile
- Brand names: Caelyx® (Türkiye), Doxil® (United States)
- Active ingredient: Doxorubicin hydrochloride encapsulated in pegylated liposomes
- Class: Antitumor antibiotic, anthracycline
- Route of administration: IV (intravenous injection)
- Distributor in Türkiye: Baxter
🇹🇷 Status in Türkiye (Licensing, Price, and SGK)
Caelyx is reimbursed by the Social Security Institution (SGK) for treating the following conditions:
- As monotherapy in metastatic breast cancer patients with increased cardiac risk;
- For advanced ovarian cancer in women after failure of a first-line platinum-based chemotherapy regimen;
- For AIDS-related Kaposi sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease; it may be used as first-line systemic chemotherapy or as second-line chemotherapy in AIDS-KS patients whose disease has progressed on prior combination systemic chemotherapy containing at least two of a vinca alkaloid, bleomycin, and standard doxorubicin (or another anthracycline), or who cannot tolerate such treatment.
The institution covers its cost when prescribed by a medical oncology or hematology specialist.
Indications Permitted Without Additional TİTCK Approval
Indications permitted without additional approval from the Turkish Medicines and Medical Devices Agency (TİTCK) are as follows (effective from 17.03.2023):
- Advanced Endometrial Cancer: Suitable for patients who have received at least one chemotherapy line and whose disease has progressed.
- Advanced Kaposi Sarcoma: Its use is appropriate.
Current Price (January 2026): The retail price of 1 vial of 20 mg/10 ml is 15,851.56 TL.
What Is Caelyx? How Does It Work?
Doxorubicin, an older chemotherapy drug, has been reformulated by packaging it at nanometer scale in liposomal nanoparticles using nanotechnology. This can target the drug to tumor cells while reducing adverse effects. The process works as follows:
- Liposomal encapsulation: Doxorubicin is enclosed in a liposomal capsule, allowing it to circulate longer in the body.
- Protection and binding: Liposomal encapsulation protects the drug from chemical and enzymatic degradation. It also reduces plasma protein binding and uptake into normal tissues.
- Targeted action: Doxorubicin readily penetrates the tumor tissues where it is released and exerts its effects there.
- DNA interaction: After entering tumor cells, doxorubicin binds to DNA, inhibiting its synthesis and function.
- Inhibition of transcription: Inhibiting DNA-dependent RNA polymerase stops RNA synthesis (transcription).
- Topoisomerase II inhibition: By inhibiting topoisomerase II, it forms a cleavable complex between DNA and topoisomerase II.
- Free radical formation: Cytotoxic oxygen free radicals form, causing breaks in DNA structures.
Approved Indications
Caelyx’s licensed uses / therapeutic indications in Türkiye are listed as follows:
- As monotherapy for metastatic breast cancer patients with increased cardiac risk;
- For advanced ovarian cancer in women after failure of a first-line platinum-based chemotherapy regimen;
- With bortezomib for progressive multiple myeloma in patients who have received at least one prior treatment line and have undergone stem cell transplantation or are unsuitable for transplantation;
- For AIDS-related Kaposi sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.
CAELYX may be used as first-line systemic chemotherapy or as second-line chemotherapy in AIDS-KS patients whose disease has progressed on prior combination systemic chemotherapy containing at least two of a vinca alkaloid, bleomycin, and standard doxorubicin (or another anthracycline), or who cannot tolerate such treatment.
FDA Approval History
- 1995: AIDS-related Kaposi sarcoma (first approval).
- 1999: Advanced ovarian cancer.
- 2005: Multiple myeloma (combined with bortezomib).
Administration and Dosage
- Ovarian cancer: 50 mg/m² IV every 28 days.
- Breast cancer: 50 mg/m² IV every 28 days.
- Multiple myeloma: 30 mg/m² IV, 4 days after bortezomib, with 1.3 mg/m² IV administered every 21 days on days 1, 4, 8, and 11.
- Kaposi sarcoma: 20 mg/m² IV every 21 days.
Dose Modification and Management
Dose modification is primarily based on hematological toxicity and the grade of hand–foot syndrome and mucositis. For grade 3 or 4 toxicity, dosing should be delayed until symptoms improve, followed by a 25-50% reduction according to the protocol.
Adverse Effects
- Myelosuppression: Neutropenia, thrombocytopenia, or anemia, peaking on days 10-14.
- Hand–foot syndrome: Skin rash, swelling, pain, and peeling.
- Mucositis and Diarrhea: Mouth sores and gastrointestinal adverse effects.
- Cardiotoxicity: Arrhythmias, conduction disorders, or heart failure in the chronic phase.
- Urine Color: Red-orange discoloration for 1-2 days after administration.
Special Situations and Warnings
- Liver Function: Dose reduction is necessary with liver dysfunction.
- Extravasation: If suspected, stop the infusion, elevate the area, and apply a cold compress.
- Cardiac Monitoring: Risk increases when the cumulative dose exceeds 450 mg/m². Regular echocardiography or MUGA monitoring is essential.
Pharmacokinetics and Interactions
- Distribution: Mainly confined to the intravascular compartment. It does not cross the blood–brain barrier.
- Elimination: It has a long half-life of approximately 55 hours.
- Interactions: Not well characterized to date; however, cumulative toxicity must be considered when used with other cytotoxic agents.
Adverse Effect Management Guide
For Hand–Foot Syndrome: Avoid tight shoes, do not expose hands and feet to excessively hot water, and avoid strenuous exercise during the first week after treatment.
For Oral Health: Use alcohol-free mouthwashes and avoid spicy or hard foods.
Urine Color: Remember that orange urine discoloration after the drug is temporary and harmless.
References
- T.C. Sağlık Bakanlığı, Caelyx Kısa Ürün Bilgisi (KÜB).
- SGK Sağlık Uygulama Tebliği (SUT).
- TİTCK Ek Onay Almadan Kullanılabilecek Endikasyonlar Listesi (March 2023).
- Vademecum Online 2026.
Sources
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