BDLYPO Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Doxorubicin HCl (pegylated liposomal)

Indications/Uses

Monotherapy for patients w/ metastatic breast cancer, where there is an 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 as 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 agents: vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).

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Dosage/Direction for Use

IV 50 mg/m² once every 4 wk. Administer 30 mg/m² on day 4 of bortezomib 3 wk regimen as a 1-hr infusion administered immediately after bortezomib infusion. Bortezomib regimen: 1.3 mg/m² on days 1, 4, 8, & 11 every 3 wk. May repeat dose as tolerated. Day 4 dosing may be delayed up to 48 hr. Doses of bortezomib should be at least 72 hr apart. Hepatic impairment Reduce normal dosage by 50% if serum bilirubin level is 1.2-3 mg/dL or by 25% if bilirubin level >3 mg/dL.

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Overdosage

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Contraindications

Hypersensitivity to doxorubicin HCl or to α-(2-[1,2-distearoyl-snglycero(3)phosphooxy]ethylcarbamoyl)-ω-methoxypoly(oxyethylen)-40 Na salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammon sulphate, sucrose, histidine, water for inj, hydrochloric acid & Na hydroxide. Not to be used to treat AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.

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Warnings

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Special Precautions

Irreversible myocardial toxicity leading to heart failure; increased risk of cardiotoxicity, also in patients who have had previous mediastinal irradiation or are receiving cyclophosphamide concurrently; acute infusion-related reactions or serious/life-threatening/fatal allergic infusion reactions; severe bone marrow depression; impaired hepatic function. History of CV disease. Not to be substituted for conventional doxorubicin on per mg basis. Monitor LFTs; cardiac function; & CBC w/ differential frequently.

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Adverse Reactions

Palmar-plantar erythrodysesthesia. Nausea, diarrhoea, neutropaenia, thrombocytopaenia, vomiting, fatigue, constipation.

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Drug Interactions

May potentiate toxicity of other anticancer therapies. Exacerbation of cyclophosphamide-induced haemorrhagic cystitis & enhancement of hepatotoxicity of 6-mercaptopurine in patients w/ AIDS. Caution in concomitant use w/ medicinal products & when giving any other cytotoxic agents especially myelotoxic agents.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

BDLYPO soln for infusion (conc) 2 mg/mL

Packing/Price

10 mL x 1's

BDLYPO

doxorubicin

Manufacturer:

BDR Pharmaceutical

Distributor:

Pharma 518

Marketer:

Ambica