Topotecan hydrochloride
(Redirected from Topotecan Hydrochloride)
What is Topotecan hydrochloride?[edit | edit source]
Topotecan hydrochloride (Hycamtin) is a topoisomerase inhibitor used alone or with other drugs to treat:
What are the uses of this medicine?[edit | edit source]
Topotecan hydrochloride (Hycamtin) is used to treat:
- Cervical cancer that is metastatic, has recurred (come back), or cannot be cured with other therapy. It is used with cisplatin.
- Ovarian cancer that is metastatic. It is used alone in patients whose cancer got worse during or after other chemotherapy.
- Small cell lung cancer that is platinum sensitive. It is used alone in patients whose cancer got worse after first-line chemotherapy.
How does this medicine work?[edit | edit source]
- The hydrochloride salt of a semisynthetic derivative of camptothecin with antineoplastic activity.
- Camptothecin is a cytotoxic quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata.
- Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks.
- During the S phase of the cell cycle, topotecan selectively stabilizes topoisomerase I-DNA covalent complexes, inhibiting religation of topoisomerase I-mediated single-strand DNA breaks and producing potentially lethal double-strand DNA breaks when complexes are encountered by the DNA replication machinery.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients who:
- have a history of severe hypersensitivity reactions to topotecan.
What drug interactions can this medicine cause?[edit | edit source]
- Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.
Is this medicine FDA approved?[edit | edit source]
- Initial U.S. Approval: 1996
How should this medicine be used?[edit | edit source]
Recommended dosage: Recommended Dosage for Ovarian Cancer: The recommended dosage of topotecan hydrochloride is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity.
Recommended Dosage for Small Cell Lung Cancer (SCLC):
- The recommended dosage of topotecan hydrochloride is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.
Recommended Dosage for Cervical Cancer:
- The recommended dosage of topotecan hydrochloride 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, of a 21-day cycle.
Renal impairment:
- Reduce dose if creatinine clearance (CLcr) 20 to 39 mL/min.
Administration:
- Topotecan comes as a liquid to be given intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or clinic.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form: As injection: 4 mg (free base) lyophilized powder in a single-dose vial.
This medicine is available in fallowing brand namesː
- Hycamtin
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include: In Ovarian cancer:
- neutropenia
- anemia
- thrombocytopenia
- febrile neutropenia
- nausea
- vomiting
- fatigue
- diarrhea
- dyspnea
In SCLC:
- neutropenia
- anemia
- thrombocytopenia
- febrile neutropenia
- asthenia
- dyspnea
- nausea
- pneumonia
- abdominal pain
- fatigue
In Cervical cancer:
- neutropenia
- anemia
- thrombocytopenia
- pain
- vomiting
- infection/febrile neutropenia
What special precautions should I follow?[edit | edit source]
- Interstitial lung disease (ILD), including fatalities, can occur with topotecan hydrochloride. Fatal cases have occurred. Permanently discontinue if ILD confirmed.
- Extravasation, including severe cases, can occur with topotecan hydrochloride. Severe cases have occurred. If extravasation occurs, immediately stop administration and institute recommended management procedures.
- Based on animal data, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk to the fetus and to use effective contraception.
- Topotecan hydrochloride can cause severe myelosuppression. Withhold and reduce dose of topotecan hydrochloride based on neutrophil counts, platelet counts and hemoglobin levels.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- myelosuppression
- Elevated hepatic enzymes
- mucositis
- gastrointestinal toxicity
- skin toxicity
Management of overdosage:
- If an overdose is suspected, monitor the patient closely for myelosuppression and institute supportive-care measures as appropriate.
Can this medicine be used in pregnancy?[edit | edit source]
- Based on animal data and its mechanism of action, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman.
- There are no available clinical data on the use of topotecan hydrochloride in pregnancy.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- TOPOTECAN HYDROCHLORIDE
Inactive ingredients:
- MANNITOL
- TARTARIC ACID
- HYDROCHLORIC ACID
- SODIUM HYDROXIDE
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by:
- Fresenius Kabi
- Lake Zurich, IL
What should I know about storage and disposal of this medication?[edit | edit source]
- Store at 20° to 25°C (68° to 77°F).
- Protect from light; product is light-sensitive.
- Retain in carton.
- Handle and dispose of topotecan hydrochloride for injection consistent with recommendations for the handling and disposal of hazardous drugs.
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