Unilipo 20mg Injection 10ml may be used for:

• Metastatic breast cancer: It may be used as monotherapy in patients with metastatic breast cancer who have an increased risk of cardiac complications.

• Advanced ovarian cancer: It may be used in patients whose disease has not responded adequately to first-line platinum-based chemotherapy.

• Multiple myeloma: It may be used with bortezomib for progressive multiple myeloma in patients who have received at least one previous treatment and are not suitable for or have already undergone bone marrow transplantation.

• AIDS-related Kaposi's sarcoma: It may be used for extensive mucocutaneous or visceral disease in appropriate patients.

Unilipo contains doxorubicin hydrochloride in a pegylated liposomal formulation. Doxorubicin enters cancer cells and interferes with DNA replication and the production of DNA and RNA. This prevents cancer cells from multiplying and can lead to their death.

The pegylated liposome helps keep much of the doxorubicin encapsulated while it circulates in the bloodstream. This gives the formulation different distribution and pharmacokinetic properties from conventional doxorubicin. Pegylated liposomal doxorubicin should therefore not be substituted for or used interchangeably with other doxorubicin formulations.

Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you are taking.

• Other anticancer medicines: Unilipo may increase the toxicity of other anticancer treatments, particularly medicines that suppress the bone marrow.

• Other cardiotoxic medicines: Previous or concurrent treatment with medicines such as other anthracyclines, cyclophosphamide, daunorubicin or idarubicin may increase the risk of heart-related toxicity.

• 6-mercaptopurine: Concurrent use may increase the risk of liver toxicity.

• Radiotherapy: Doxorubicin may increase radiation-related toxicity, and previously irradiated skin may develop a radiation recall reaction.

• Vaccines: Tell your doctor before receiving any vaccine during treatment because chemotherapy can affect immune responses and may increase the risks associated with some vaccines.

• HIV medicines: Doxorubicin may interfere with the intracellular activation of stavudine and reduce its antiviral effect.

• Store Unilipo 20mg Injection 10ml in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in its original packaging and protect it from inappropriate storage conditions.

• The medicine is for single use only.

• Any unused portion should be discarded according to procedures for cytotoxic medicines.

• Preparation, storage and disposal of the diluted infusion should be handled by trained healthcare professionals.

Unilipo 20mg Injection 10ml should be administered only by a qualified healthcare professional under the supervision of an oncologist.

The dose is calculated according to body surface area and depends on the cancer being treated:

• For breast or ovarian cancer, the usual dose is 50 mg/m² once every 4 weeks, provided the disease has not progressed, and treatment is tolerated.

• For multiple myeloma, the usual dose is 30 mg/m² on day 4 of a 3-week bortezomib regimen.

• For AIDS-related Kaposi's sarcoma, the usual dose is 20 mg/m² every 2 to 3 weeks.

The prescribed dose must be diluted in 5% dextrose solution before intravenous infusion. It should not be given as a bolus injection or administered by the intramuscular or subcutaneous route. The medicine should not be mixed with other medicines or diluted with solutions other than the specified diluent.

The first infusion is administered slowly to reduce the risk of infusion-related reactions. If a reaction occurs, the infusion may need to be stopped and restarted at a slower rate after the symptoms have resolved.

Common or frequent side effects may include:

• Tiredness or weakness

• Nausea and vomiting

• Loss of appetite

• Diarrhoea or constipation

• Mouth sores or stomatitis

• Hair loss

• Rash or skin changes

• Hand-foot syndrome

• Anaemia

• Low white blood cell count

• Low platelet count

• Headache

• Dizziness

• Fever

• Infusion-related reactions

• Increased liver enzymes

Serious side effects

Seek immediate medical attention if you develop:

• Difficulty breathing, facial swelling, chest or throat tightness, severe rash or other signs of a serious infusion or allergic reaction.

• Fever, chills, unusual bleeding or other signs of severe infection or low blood-cell counts.

• Severe redness, pain, swelling, blistering or peeling of the palms or soles.

• Severe or persistent mouth ulcers that make eating or drinking difficult.

• New or worsening shortness of breath, dry cough or fever, which may indicate interstitial lung disease.

• Chest pain, swelling of the legs, breathlessness or other symptoms that may suggest heart problems.

• Signs of severe liver problems, such as yellowing of the skin or eyes.

• Pain, redness or swelling around the infusion site. Extravasation can cause significant local tissue injury.

Regular blood counts, liver-function tests and cardiac assessment may be required during treatment.

• Unilipo should be given only under the supervision of an experienced oncologist.

• Do not substitute Unilipo with conventional doxorubicin or another liposomal doxorubicin formulation without medical advice.

• Keep all scheduled blood tests and heart-function assessments during treatment.

• Tell your doctor about previous chemotherapy, radiotherapy and any medicines that may affect the heart or bone marrow.

• Report fever, unusual bleeding, severe mouth sores or signs of infection promptly.

• Tell your healthcare team immediately if you develop redness, burning or pain around the infusion site.

• Report painful redness, swelling, blistering or peeling of the hands and feet.

• Tell your doctor promptly about new breathing difficulties, dry cough or unexplained fever.

• Use effective contraception as advised during treatment and follow your oncologist's advice about when pregnancy can be planned after therapy.