Natdox-LP

Doxorubicin HCl

As monotherapy for patients w/ metastatic breast cancer, where there is increased cardiac risk. Advanced ovarian cancer in women who have failed a 1st-line platinum-based chemotherapy regimen. In combination w/ bortezomib for progressive multiple myeloma in patients who have received at least 1 prior therapy & who have already undergone or are unsuitable for bone marrow transplant. AIDS-related Kaposi's sarcoma (KS) in patients w/ low CD4 counts (<200 CD4 lymphocytes/mm³) & extensive mucocutaneous or visceral disease. 1st-line systemic chemotherapy, or 2nd-line chemotherapy in AIDS-KS patients w/ disease that has progressed w/, or in patients intolerant to, prior combination systemic chemotherapy comprising at least 2 of the following: vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).

Breast & ovarian cancer 50 mg/m² IV once every 4 wk as long as the disease does not progress & patient continues to tolerate treatment. Multiple myeloma 30 mg/m² on day 4 of bortezomib 3-wk regimen as 1 hr infusion administered immediately after bortezomib infusion. Bortezomib regimen: 1.3 mg/m² on days 1, 4, 8 & 11 every 3 wk. Day 4 dose of both medicinal products may be delayed up to 48 hr as medically necessary. Dose of bortezomib should be at least 72 hr apart. AIDS-related KS 20 mg/m² IV every 2-3 wk for 2-3 mth.

Hypersensitivity. Not to be used to treat AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.

Discontinue use if patient experiences early symptoms or signs of infusion reaction. Not recommended in AIDS-related KS patients w/ splenectomy. Routinely undergo frequent ECG monitoring. Risk of myocardial injury; patients w/ cardiac disease; impaired cardiac function; CHF due to cardiomyopathy; those who have received other anthracyclines; prior mediastinal irradiation or those receiving concurrent cyclophosphamide therapy. Cardiac safety profile for the dosing schedule. Myelosuppression; frequently perform periodic blood counts during course of therapy & at a min prior to each dose. Persistent severe myelosuppression may result in superinfection or haemorrhage. Secondary acute myeloid leukemias & myelodysplasias. Secondary oral cancer in long-term (>1 yr) exposure or those receiving a cumulative dose >720 mg/m². Regularly examine for presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer. Diabetic patients. May affect ability to drive & use machines. CrCl <30 mL/min. Women of childbearing potential must avoid pregnancy while they or their partner are receiving therapy & in 6 mth following discontinuation of therapy. Not to be used during pregnancy. Discontinue lactation prior to treatment. Not recommended in childn <18 yr.

Breast cancer program: Anorexia; nausea, stomatitis, vomiting; palmar-plantar erythrodysesthesia (PPE), alopecia, rash; asthenia, fatigue, mucositis NOS. Pharyngitis; leukopaenia, anaemia, neutropaenia, thrombocytopaenia; paresthesia; abdominal pain, constipation, diarrhea, dyspepsia, mouth ulceration; dry skin, skin discolouration, abnormal pigmentation, erythema; weakness, fever, pain. Ovarian cancer program: Leukopaenia, anaemia, neutropaenia, thrombocytopaenia; anorexia; constipation, diarrhoea, nausea, stomatitis, vomiting; PPE, alopecia, rash; asthenia, mucous membrane disorder. Pharyngitis; paresthesia, somnolence; abdominal pain, dyspepsia, mouth ulceration; dry skin, skin discolouration; fever, pain. Multiple myeloma program: Anaemia, neutropaenia, thrombocytopaenia; anorexia; peripheral sensory neuropathy, neuralgia, headache; nausea, diarrhoea, vomiting, constipation, stomatitis; PPE, rash; asthenia, fatigue, pyrexia. Herpes simplex & zoster; leukopaenia; decreased appetite; insomnia; peripheral neuropathy, neuropathy, paraesthesia, polyneuropathy, dizziness, dysgeusia; dyspnoea; abdominal pain, dyspepsia; dry skin; pain in extremity; decreased wt.

May potentiate toxicity of other anti-cancer therapies. Exacerbated cyclophosphamide-induced haemorrhagic cystitis & enhanced hepatotoxicity of 6-mercaptopurine. Concomitant use w/ any other cytotoxic agents especially myelotoxic agents.

Cytotoxic Chemotherapy

L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

Rx