Topotecan hydrochloride

What is Topotecan hydrochloride?[edit | edit source]

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

Topotecan Structural Formula V.1

Topotecan2DACS

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:

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.

Topotecan hydrochloride Resources
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