Topotecan hydrochloride

What is Topotecan hydrochloride?

Topotecan hydrochloride (Hycamtin) is a topoisomerase inhibitor used alone or with other drugs to treat:

• Cervical cancer
• Ovarian cancer
• Small cell lung cancer

Topotecan Structural Formula V.1

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Topotecan2DACS

What are the uses of this medicine?

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?

• 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 ?

This medicine cannot be used in patients who:

• have a history of severe hypersensitivity reactions to topotecan.

What drug interactions can this medicine cause?

• 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?

• Initial U.S. Approval: 1996

How should this medicine be used?

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?

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?

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?

• 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?

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?

• 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?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TOPOTECAN HYDROCHLORIDE

Inactive ingredients:

• MANNITOL
• TARTARIC ACID
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Fresenius Kabi
• Lake Zurich, IL

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Topotecan hydrochloride
• FDA Topotecan hydrochloride

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