topotecan injection Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION.

TOPOTECAN injection, for intravenous use
Initial U.S. Approval: 1996

WARNING: MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm3 and platelet count greater than or equal to 100,000/mm3. Monitor blood cell counts. (2.2, 5.1)

INDICATIONS AND USAGE

Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. (1)

DOSAGE AND ADMINISTRATION

  • Recommended dosage: 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. (2.2)
  • Renal impairment: Reduce dose for creatinine clearance (CLcr) of 20 to 39 mL/min. (2.4)

DOSAGE FORMS AND STRENGTHS

Injection: 4 mg/4 mL (1 mg/mL topotecan free base) solution in single-dose vial. (3)

CONTRAINDICATIONS

History of severe hypersensitivity reactions to topotecan. (4)

WARNINGS AND PRECAUTIONS

  • Interstitial lung disease (ILD): Fatal cases have occurred. Permanently discontinue if ILD confirmed. (5.2)
  • Extravasation and tissue injury: Severe cases have occurred. If extravasation occurs, immediately stop administration and institute recommended management procedures. (5.3)
  • Embryo-fetal toxicity: Can cause fetal harm. Advise women of potential risk to the fetus. (5.4, 8.1, 8.3)

ADVERSE REACTIONS

  • The most common Grade 3 or 4 hematologic adverse reactions (incidence >5%) were: neutropenia , anemia , thrombocytopenia, and febrile neutropenia. (6.1)
  • The most common non-hematologic adverse reactions (incidence >5%) (all grades) were asthenia, dyspnea, nausea, pneumonia, abdominal pain, and fatigue. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2019

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION.

TOPOTECAN injection, for intravenous use
Initial U.S. Approval: 1996

WARNING: MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm3 and platelet count greater than or equal to 100,000/mm3. Monitor blood cell counts. (2.2, 5.1)

INDICATIONS AND USAGE

Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. (1)

DOSAGE AND ADMINISTRATION

  • Recommended dosage: 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. (2.2)
  • Renal impairment: Reduce dose for creatinine clearance (CLcr) of 20 to 39 mL/min. (2.4)

DOSAGE FORMS AND STRENGTHS

Injection: 4 mg/4 mL (1 mg/mL topotecan free base) solution in single-dose vial. (3)

CONTRAINDICATIONS

History of severe hypersensitivity reactions to topotecan. (4)

WARNINGS AND PRECAUTIONS

  • Interstitial lung disease (ILD): Fatal cases have occurred. Permanently discontinue if ILD confirmed. (5.2)
  • Extravasation and tissue injury: Severe cases have occurred. If extravasation occurs, immediately stop administration and institute recommended management procedures. (5.3)
  • Embryo-fetal toxicity: Can cause fetal harm. Advise women of potential risk to the fetus. (5.4, 8.1, 8.3)

ADVERSE REACTIONS

  • The most common Grade 3 or 4 hematologic adverse reactions (incidence >5%) were: neutropenia , anemia , thrombocytopenia, and febrile neutropenia. (6.1)
  • The most common non-hematologic adverse reactions (incidence >5%) (all grades) were asthenia, dyspnea, nausea, pneumonia, abdominal pain, and fatigue. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2019
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