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Topoccord 1/Topoccord 4

Topoccord 1/Topoccord 4

topotecan

Manufacturer:

Intas

Distributor:

Accord Healthcare
Concise Prescribing Info
Contents
Topotecan HCl
Indications/Uses
Monotherapy for metastatic ovarian carcinoma after failure of 1st line or subsequent therapy; relapsed small cell lung cancer (SCLC) for whom re-treatment w/ 1st line regimen is not appropriate. Stage IV B disease & in combination w/ cisplatin for recurrent cervical carcinoma after RT.
Dosage/Direction for Use
Ovarian & SCLC Initially 1.5 mg/m2 daily by IV infusion over 30 min for 5 consecutive days w/ a 3-wk interval between courses. If severe neutropenia (neutrophil count <0.5 x 109/L) for ≥7 days, or associated w/ fever or infection, or fall in platelet count <25 x 109/L occurs, reduced by 0.25-1.25 mg/m2 daily (or subsequently down to 1 mg/m2 daily). Cervical carcinoma Initially 0.75 mg/m2 daily by IV infusion over 30 min on days 1, 2 & 3 followed by cisplatin 50 mg/m2 daily by IV infusion on day 1 repeated every 21 days for 6 courses or until disease progression. If severe neutropenia (neutrophil count <0.5 x 109/L) for ≥7 days, or associated w/ fever or infection, or fall in platelet count <25 x 109/L occurs, reduced by 20% (to 0.6 mg/m2 daily or subsequently down to 0.45 mg/m2 daily). Standard oncology practice for the management of neutropenia is either to administer topotecan w/ other medications (eg, G-CSF) or to reduce dose to maintain neutrophil counts. Patients w/ renal impairment (CrCl 20-39 mL/min) 0.75 mg/m2 daily for 5 consecutive days.
Contraindications
Severe hypersensitivity. Severe bone marrow depression prior to starting 1st course (baseline neutrophils of <1.5 x 109/L &/or platelet count of <100 x 109/L). Lactation.
Special Precautions
Monitor hematological toxicity & FBC including platelets regularly. Severe myelosuppression. Consider possibility of neutropenic colitis in patients w/ fever, neutropenia & compatible pattern of abdominal pain. History of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation & use of pneumotoxic drugs &/or colony-stimulating factors. Monitor for pulmonary symptoms indicative of ILD & discontinue use if a new diagnosis of ILD is confirmed. Not recommended in severe renal impairment (CrCl <20 mL/min) or severe hepatic impairment (serum bilirubin ≥10 mg/dL) due to cirrhosis. May affect ability to drive or operate machinery. Patients are advised to use an effective method of contraception during therapy. Pregnancy.
Adverse Reactions
Infection; febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leucopenia; anorexia; nausea, vomiting & diarrhoea, constipation, abdominal pain, mucositis; alopecia; pyrexia, asthenia, fatigue. Sepsis; pancytopenia; hypersensitivity reaction including rash; hyperbilirubinemia; pruritus; malaise.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE01 - topotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Topoccord 1 conc soln for IV infusion 1mg/mL
Packing/Price
1 mL x 1's
Form
Topoccord 4 conc soln for IV infusion 4mg/4mL
Packing/Price
4 mL x 1's
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