Drug Interaction:
Interacting drugs-summary
+ Topotecan
G-CSF concomittant administartion can prolong the duration of neutropenia. If G-CSF is used,do not initiate until 6 days of the course of therapy, 24 hours after completion of treatment with topotcan
Cisplatin myelosuppression is more severe when toptecan was given in combination with cisplatin. No adequate data to define a safe and effective regimen for topotecan and ciplatin in combination
Indication:
Metastatic ovarian cancer
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Topotecan Anti-cancer(Ovarian) 15-06-1999
Adverse Reaction:
GI- nausea, vomiting,diarrhea, constipation, abdominal pain,
Dermatologic- total alopecia
CNS- headache was the most frequently reported neurologic toxicity. Paesthesia occured in 9% of patients.
Hepatic- transcient elevation in AST and ALT occured in 5 % of patients . Respiratory- dyspnea.
Contra-Indications:
Hypersensaitivity to topotecan or to of its ingredients .patients who are pregnant or breastfeeding, those with severe bone marrow depression.
Special precautions-
Monitoring- Institute frequent monitoring of peripheral blood cells counts during treatment with topotecan. Do not treat patients with susequent courses of topotecan until neutrophils recover to > 1000 cells/mm2,platelets recover to > 100,000 cwlls/mm3 and hemoglobin levels recover to 9mg/dl (with transfusion if necessary)
Extravastion- with topotecan has beenassociated with only mild local reactions such as erythema and bruising
Warnings-
Bone marrow suppression- (primary neutropenia) is the dose limiting toxicity oftopotecan.
Neutropenia is not cummulative over time.Administer topotecan only to patients with adequate bone marrow reserves, including baseline neutrophil counts of at least 1500 cells/mm3 and platelet count of at least 100,000/mm3
Neutropenia- severe (, 500 cells/mm3 ) neutropenia was most common during course 1 of treatment (60%) and occured in 40% of all courses.
Thrombocytopenia- grade 4 thrombocytopenia ( , 25,000/mm3) occured in 26% of patients and in 9% of courses, with a median duratin of 5 days and a platelet nadir at a median of 15 days.
Anemia- severe anemia occure in 40% of patients and in 16% of courses. Tranfusions were needed in 56% of patients and in 23% of the courses.
Pregnancy- warn patients to avoid being pregnant
Lactation- breastfeeding should be discontinued when administering topotecan
Children- safety and efectiveness in pediatric patients have not been established
Dosages/ Overdosage Etc:
Metastatic ovarian cancer
Dosage-
The recommended dose of topotecan is 1.5mg/m2 by IV infusion over 30 minutes daily for 5 consecutive days.
Overdosage- There is no known antidote for overdosage of topocecan. The primary complication of overdosage would consist of bone marrow suppression
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Topotecan is a semi-synthetic derivative of camptothecin and is and is anti-tumor with topoisomerase I- inhibitory activity. Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strained breaks.
Pharmacokinetics-
Topotecan undergoes a revesible pH-dependent hydrolysis of its lactone moiety..it is the lactone that is pharmacolgically active.
Pregnancy and lactation:
Pregnancy- Warn patients to avoid being pregnant
Lactation- Breastfeeding should be discontinued when administering topotecan
Children- Safety and effectiveness in pediatric patients have not been established
Manufacturer Details