Potiga
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Uses
HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first‑line chemotherapy.
HYCAMTIN for injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment.
History
There is currently no drug history available for this drug.
Other Information
HYCAMTIN (topotecan) is a semi-synthetic derivative of camptothecin and is an anti–tumor drug with topoisomerase I-inhibitory activity.
The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3’,4’:6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. It has the molecular formula C23H23N3O5•HCl and a molecular weight of 457.9. It is soluble in water and melts with decomposition at 213ºC to 218ºC.
Topotecan hydrochloride has the following structural formula:
HYCAMTIN for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. The reconstituted solution ranges in color from yellow to yellow-green and is intended for administration by intravenous infusion.
Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5.
Sources
Potiga Manufacturers
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Glaxosmithkline Llc
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Potiga | Glaxosmithkline Llc
Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].
2.1 Ovarian CancerRecommended Dose and Schedule
The recommended dose of HYCAMTIN is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21‑day course.
2.2 Small Cell Lung CancerRecommended Dose and Schedule
The recommended dose of HYCAMTIN is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
2.3 Cervical CancerRecommended Dose and Schedule
The recommended dose of HYCAMTIN is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m2 on Day 1, repeated every 21 days.
2.4 Dose ModificationsHematologic Toxicities
For single-agent use, dose reduce HYCAMTIN to 1.25 mg/m2 for:
• neutrophil counts of less than 500 cells/mm 3, or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose of HYCAMTIN. • platelet counts less than 25,000 cells/mm 3 during previous cycle.For combination use with cisplatin, dose reduce HYCAMTIN to 0.60 mg/m2 (and further to 0.45 mg/m2 if necessary) for:
• febrile neutropenia (defined as neutrophil counts less than 1,000 cells/mm 3 with temperature of greater than or equal to 38.0°C (100.4°F), or administer G‑CSF starting no sooner than 24 hours following the last dose of HYCAMTIN. • platelet counts less than 25,000 cells/mm 3 during previous cycle.Renal Impairment
For single-agent use, dose reduce HYCAMTIN to 0.75 mg/m2 in patients with moderate renal impairment (creatinine clearance [Clcr] = 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment (Clcr less than 20 mL/min) to provide a dosage recommendation for HYCAMTIN [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Preparation and Intravenous AdministrationHYCAMTIN is a cytotoxic drug. Follow applicable special handling and disposable procedures.1
Preparation and Administration
Reconstitute each 4-mg vial of HYCAMTIN with 4 mL Sterile Water for Injection, USP. Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water Injection, USP prior to administration.
Stability
Unopened vials of HYCAMTIN are stable until the date indicated on the package when stored between 20°C and 25°C (68°F and 77°F) [see USP] and protected from light in the original carton. Because the vials contain no preservative, contents should be used immediately after reconstitution.
Reconstituted vials of HYCAMTIN diluted for infusion are stable at approximately 20°C to 25°C (68°F to 77°F) and ambient lighting conditions for 24 hours.
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