Topotecan PhaRes infusion
Topotecan
4mg/4ml
ZAS Corporation
| Pack size | 1 vial |
|---|---|
| Unite Price | 9500.00 BDT |
Indications
Topotecan PhaRes infusion is used for:
Ovarian cancer, Small cell lung cancer, Cervical cancer
Adult Dose
Intravenous
Ovarian carcinoma, Small cell lung cancer
Adult: 1.5 mg/m2/day by IV infusion over 30 min on days 1-5 of a 21-day cycles.
Min: 4 courses to be given (provided blood counts and haemoglobin have adequately recovered).
Cervical cancer
Adult: As combination therapy with cisplatin: 0.75 mg/m2, by IV infusion over 30 min on days 1, 2 and 3 of a 21-day cycles;
Cisplatin 50 mg/m2 as IV infusion after topotecan on day 1.
Hepatic Impairment
Intravenous:
Ovarian carcinoma,Small cell lung cancer: Severe: Avoid.
Cervical cancer: Severe: avoid.
Child Dose
Renal Dose
Renal impairment
IV infusion (monotherapy)
Mild (CrCl 40-60 mL/min): No dosage adjustment necessary
Moderate (CrCl 20-39 mL/min): Decrease dose to 0.75 mg/m² PO qDay
Severe (CrCl <20 mL/min): Safety and efficacy has not been established
Administration
IV Preparation
No preservatives-reconstitute immediately prior to use
Reconstitute in 4 mL SWI to obtain a 1 mg/mL solution
No preservatives-use immediately
Dilute in 50-250 mL NS or D5W; stability is pH dependent although topotecan may be further diluted in NS
IV Administration
Infuse over 30 min
Contra Indications
Hypersensitivity reactions to drug or any components. Severe bone marrow depression (e.g. baseline neutrophil count of <1500 cells/mm3 and platelet count <100,000/mm3). Pregnancy, lactation, severe renal or hepatic impairment.
Precautions
Administer only to patients with baseline neutrophil counts of 1500 cells/mm³or higher and a platelet count of 100,000 cells/mm³ or higher; monitor blood cell counts.
To assess the occurrence of bone marrow suppression, blood cell counts should be monitored.
Administer to patients with bone marrow suppression only if patient has adequate bone marrow reserves; monitor peripheral blood counts and adjust dose as needed.
Avoid use in pregnancy; can cause fetal harm; advise women of potential risk to fetus.
Neutropenia: pancytopenia has been reported.
Grade 4 thrombocytopenia and grade 3-4 anemia reported; withhold and reduce dose based on neutrophil counts, platelet counts and hemoglobin levels.
Fatal cases of interstitial lung disease have occurred; permanently discontinue for confirmed ILD.
Monitor patients presenting with cough, fever, dyspnea and/or hypoxia and a history of lung disease as fatalities due to interstitial lung disease have been reported.
Pregnancy-Lactation
Pregnancy
Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; there are no available clinical data on use of therapy in pregnancy; drug caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose.); advise pregnant women of potential risk to fetus
Verify pregnancy status of females of reproductive potential prior to initiating therapy
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for 6 months after last dose
Infertility
Females: Therapy can have both acute and long-term effects on fertility
Males: Effects on spermatogenesis occurred in animals administered topotecan; therapy may damage spermatozoa, resulting in possible genetic and fetal abnormalities; advise males with a female partner of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
Lactation
There are no data on presence of drug or its metabolites in human milk or their effects on breastfed infant or on milk production; lactating rats excrete high concentrations of drug in milk
Because of potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after last dose
Interactions
Increased clearance with phenytoin. G-CGF to be given 24 hr after completion of treatment with topotecan as concurrent admin may prolong duration of neutropenia. Increased bone marrow suppression with other cytotoxic drugs (e.g. cisplatin) so dose reduction may be needed.
Side Effects
Side effects of Topotecan :
>10%
IV infusion
Ovarian cancer
Neutropenia, grade 4 (80%)
Anemia, grade 3 or 4 (41%)
Thrombocytopenia, grade 4 (27%)
Febrile neutropenia (23%)
Small cell lung cancer
Neutropenia, grade 4 (70%)
Anemia, grade 3 or 4 (42%)
Thrombocytopenia. grade 4 (29%)
Cervical cancer (Combination therapy with cisplatin)
Constitutional, grade 3 or 4 (69%)
Pain, grade 3 or 4 (59%)
Neutropenia, grade 4 (48%)
Vomiting, grade 3 or 4 (40%)
Anemia, grade 3 (34%)
Thrombocytopenia, grade 3 (26%)
Neutropenia, grade 3 (26%)
1-10%
IV infusion
Ovarian cancer
Nausea, grade 3 or 4 (10%)
Vomiting, grade 3 or 4 (10%)
Fatigue, grade 3 or 4 (7%)
Dyspnea, grade 3 or 4 (6%)
Diarrhea, grade 3 or 4 (6%)
Sepsis, grade 3 or 4 (5%)
Abdominal pain, grade 3 or 4 (5%)
Constipation, grade 3 or 4 (5%)
Intestinal obstruction, grade 3 or 4 (5%)
Asthenia, grade 3 or 4 (5%)
Pain, grade 3 or 4 (5%)
Small cell lung cancer
Neutropenia, grade 4 (9%)
Asthenia, grade 3 or 4 (9%)
Pneumonia, grade 3 or 4 (8%)
Nausea, grade 3 or 4 (8%)
Abdominal pain, grade 3 or 4 (6%)
Fatigue, grade 3 or 4 (6%)
Sepsis, grade 3 or 4 (5%)
Cervical cancer (Combination therapy with cisplatin)
Thrombocytopenia, grade 4 (7%)
Stomatitis-pharyngitis, grade 3 or 4 (6%)
Mode of Action
Topotecan, an alkaloid, is a semi-synthetic derivative of camptothecin which inhibits topoisomerase I, preventing DNA replication and translocation. It acts in the S phase of DNA synthesis.
Note
Topotecan PhaRes 4mg/4ml infusion generic name is Topotecan. Topotecan PhaRes 4mg/4ml infusion is manufactured by ZAS CorporationTopotecan PhaRes is availble in all over Bangladesh.
Mes BD drug index information on Topotecan PhaRes infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.