Topotecan Actavis

Topotecan Actavis

topotecan

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Topotecan HCl
Indications/Uses
As monotherapy for the treatment of metastatic carcinoma of the ovary after failure of 1st-line or subsequent therapy & relapsed small cell lung cancer (SCLC) wherein re-treatment w/ 1st-line regimen is not considered appropriate. In combination w/ cisplatin for the treatment of carcinoma of the cervix recurrent after radiotherapy & for stage IV B disease.
Dosage/Direction for Use
Ovarian & SCLC Initially 1.5 mg/m2 BSA/day by IV infusion over 30 min daily for 5 consecutive days w/ a 3-wk interval between the start of each course. If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 x 109/L) ≥7 days, or associated w/ fever or infection, or who have had treatment delayed due to neutropenia, reduced dose by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1 mg/m2/day if necessary). Cervical carcinoma Initially 0.75 mg/m2/day as 30-min IV infusion daily on days 1, 2 & 3. Cisplatin is administered as IV infusion on day 1 at a dose of 50 mg/m2/day following topotecan dose repeated every 21 days for 6 courses. Treatment may continue until disease progression. If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 x 109/L) ≥7 days, or associated w/ fever or infection, or who have had treatment delayed due to neutropenia, reduced dose by 20% to 0.6 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary). In all doses, reduce dose if platelet count falls below 25 x 109/L.
Contraindications
Hypersensitivity. Severe bone marrow depression (baseline neutrophils <1.5 x 109/L &/or a platelet count of <100 x 109/L). Lactation.
Special Precautions
Regular monitoring of FBC including platelets. Severe myelosuppression. Neutropenic colitis. Interstitial lung disease. Increased incidence of complications eg, fever, infection & sepsis. Severe renal & hepatic impairment. May affect ability to drive or operate machinery. Pregnancy. Childn.
Adverse Reactions
Febrile neutropenia, neutropenic colitis, thrombocytopenia, anaemia, leukopenia, nausea, vomiting, diarrhoea, constipation, abdominal pain, mucositis, alopecia, anorexia, infection, pyrexia, asthenia, fatigue. Pancytopenia, pruritus, sepsis, malaise, hyperbilirubinaemia, hypersensitivity.
ATC Classification
L01XX17 - topotecan ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Topotecan Actavis powd for concentrate for soln for infusion 4 mg
Packing/Price
1's
Form
Topotecan Actavis powd for concentrate for soln for infusion 1 mg
Packing/Price
1's
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