Doxlox

Doxlox

doxorubicin

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
Monotherapy for metastatic breast cancer. Advanced ovarian cancer in women who have failed 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- 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 agents: Vinca alkaloid, bleomycin & standard doxorubicin or other anthracycline.
Dosage/Direction for Use
Breast/ovarian cancer 50 mg/m2 IV once every 4 wk as long as disease does not progress & patient continues to tolerate treatment. Multiple myeloma 30 mg/m2 as 1-hr infusion on day 4 of bortezomib 3-wk regimen immediately after bortezomib infusion. Bortezomib regimen: 1.3 mg/m2 on days 1, 4, 8 & 11 every 3 wk. AIDS-KS patient 20 mg/m2 IV every 2-3 wk w/ <10 days interval for 2-3 mth.
Contraindications
Hypersensitivity. AIDS-KS treated effectively w/ local therapy or systemic α-interferon.
Special Precautions
Infusion-associated reactions. Not to be given as IM, SC or bolus inj. Not to be used as undiluted soln. Not recommended in AIDS-KS patients w/ splenectomy. Cardiac disease; myelosuppression, opportunistic infections; secondary acute myeloid leukemia & myelodysplasia; secondary oral neoplasms. Diabetic patients. Frequently monitor ECG; perform LVEF measurement & endomyocardial biopsy. Periodically perform complete blood counts during & prior to each dose. Perform exam for presence of oral ulceration or discomfort indicative of secondary oral cancer at regular intervals. Concomitant use w/ other anthracyclines. May affect ability to drive & use machines. Hepatic impairment. Women of childbearing potential should use effective contraception during & for 6 mth after last dose. Not to be used during pregnancy & lactation. Ped patients <18 yr.
Adverse Reactions
Anorexia; nausea, stomatitis, vomiting; palmar-plantar erythrodysesthesia, rash; asthenia. Leukopaenia, anaemia, neutropaenia, thrombocytopaenia; paresthesia; abdominal pain, constipation, diarrhea. Breast & ovarian cancer, AIDS-related KS: Alopecia; mouth ulceration. Breast & ovarian cancer, multiple myeloma: Dyspepsia; dry skin. Breast & ovarian cancer: Pharyngitis; skin discolouration; fever, pain. Breast cancer & multiple myeloma: Fatigue. Multiple myeloma & AIDS-related KS: Dizziness; dyspnoea. Breast cancer: Mucositis NOS. Abnormal pigmentation, erythema; weakness. Ovarian cancer: Mucous membrane disorder. Somnolence. Multiple myeloma: Peripheral sensory neuropathy, neuralgia, headache; pyrexia. Herpes simplex, herpes zoster; decreased appetite; insomnia; peripheral neuropathy, neuropathy, polyneuropathy, dysgeusia; pain in extremity; decreased wt. AIDS-related KS: Oral moniliasis; retinitis; vasodilatation; glossitis; infusion-associated acute reactions; wt loss.
Drug Interactions
Potentiated toxicity of other anti-cancer therapies. AIDS patients: Exacerbated cyclophosphamide-induced haemorrhagic cystitis. Enhanced hepatotoxicity of 6-mercaptopurine. Other cytotoxic agents especially myelotoxic agents.
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Presentation/Packing
Form
Doxlox infusion conc 2 mg/mL
Packing/Price
10 mL x 1's;25 mL x 1's
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