Caelyx

Pegylated liposomal doxorubicin HCl

As monotherapy for patients w/ metastatic breast cancer, where there is an increased cardiac risk. Treatment of advanced ovarian cancer in women who have failed a 1st-line platinum-based chemotherapy regimen. In combination w/ bortezomib for the treatment of progressive multiple myeloma in patients who have received at least 1 prior therapy & who have already undergone or are unsuitable for bone marrow transplant. Treatment of 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 as 2nd-line chemotherapy in AIDS-KS patients w/ disease that has progressed w/, or who are intolerant to, prior combination systemic chemotherapy comprising at least 2 of the following agents: vinca alkaloid, bleomycin & standard doxorubicin (or other anthracyclines).

IV infusion Breast/ovarian cancer 50 mg/m² once every 4 wk until disease progression or treatment intolerance. Multiple myeloma 30 mg/m² on day 4 of bortezomib 3-wk regimen as 1-hr infusion immediately after bortezomib infusion. Bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8 & 11 every 3 wk. Day 4 dosing of both medicinal products may be delayed up to 48 hr as medically necessary. AIDS-related KS 20 mg/m² every 2-3 wk. Treatment for 2-3 mth is recommended to achieve therapeutic response.

Hypersensitivity to pegylated liposomal doxorubicin, peanut or soya. Must not be used to treat AIDS-KS that may be effectively treated w/ local therapy or systemic α-interferon.

Must not be used interchangeably w/ other formulations of doxorubicin HCl. Do not administer as bolus inj or undiluted dispersion. Do not use w/ in-line filters. Do not give by IM or SC route. Risk of cardiac toxicity. Monitor cardiac performance during anthracycline therapy (ie, ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy). Exercise caution in patients w/ impaired cardiac function. Potential for myelosuppression. Perform periodic blood counts during therapy, & at a min, prior to each dose of Caelyx. Persistent severe myelosuppression may result in superinfection or haemorrhage. Reports of secondary acute myeloid leukemias & myelodysplasias; very rare cases of secondary oral cancer. Risk of serious & sometimes life-threatening infusion reactions; palmar plantar erythrodysaesthesia syndrome. Caelyx pegylated liposomal contains sucrose & the dose is administered in 5% glucose soln for infusion; caution in DM patients. Reduce dose in patients w/ hepatic impairment. Evaluate hepatic function prior to Caelyx administration. Not recommended in AIDS-related KS patients w/ splenectomy. Should not be used during pregnancy unless clearly necessary. Women of child-bearing potential must avoid pregnancy while they or their male partner are receiving Caelyx pegylated liposomal & in the 6 mth following discontinuation. Mothers must discontinue nursing prior to beginning Caelyx treatment. Not recommended in childn <18 yr.

Leukopaenia, neutropaenia, lymphopaenia, anaemia (including hypochromic); decreased appetite; stomatitis, nausea, vomiting, diarrhoea, constipation; palmar plantar erythrodysaesthesia syndrome, rash (including erythematous, maculo-papular, & papular), alopecia; musculoskeletal pain (including musculoskeletal chest pain, back pain, pain in extremity); pyrexia, fatigue. Sepsis, pneumonia, Pneumocystis jirovecii pneumonia, cytomegalovirus infection including cytomegalovirus chorioretinitis, Mycobacterium avium complex infection, candidiasis, herpes zoster, UTI, infection, URTI, oral candidiasis, folliculitis, pharyngitis, nasopharyngitis; thrombocytopaenia, febrile neutropaenia; cachexia, dehydration, hypokalaemia, hyponatraemia, hypocalcaemia; confusional state, anxiety, depression, insomnia; peripheral neuropathy, peripheral sensory neuropathy, neuralgia, paraesthesia, hypoaesthesia, dysgeusia, headache, lethargy, dizziness; conjunctivitis; tachycardia; HTN, hypotension, flushing; dyspnoea, dyspnoea exertional, epistaxis, cough; gastritis, aphthous stomatitis, mouth ulceration, dyspepsia, dysphagia, oesophagitis, abdominal pain, upper abdominal pain, oral pain, dry mouth; skin exfoliation, blister, dry skin, erythema, pruritus, hyperhidrosis, skin hyperpigmentation; muscle spasms, myalgia, arthralgia, bone pain; dysuria; infusion-related reaction, pain, chest pain, flu-like illness, chills, mucosal inflammation, asthenia, malaise, oedema, oedema peripheral; decreased wt.

May potentiate the toxicity of other anti-cancer therapies. Exacerbation of cyclophosphamide-induced haemorrhagic cystitis & enhancement of the hepatotoxicity of 6-mercaptopurine have been reported w/ standard doxorubicin HCl.

Cytotoxic Chemotherapy

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

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