HYCAMTIN

HYCAMTIN- topotecan hydrochloride injection, powder, lyophilized, for solution
GlaxoSmithKline LLC

WARNING: BONE MARROW SUPPRESSION

HYCAMTIN® can cause severe myelosuppression. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cells/mm3 and platelet counts greater than or equal to 100,000 cells/mm3. Monitor blood cell counts [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

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.

1.2 Small Cell Lung Cancer

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.

1.3 Cervical Cancer

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.

2 DOSAGE AND ADMINISTRATION

Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].

2.1 Ovarian Cancer

Recommended 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 Cancer

Recommended 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 Cancer

Recommended 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 Modifications

Hematologic Toxicities

For single-agent use, dose reduce HYCAMTIN to 1.25 mg/m2 for:

neutrophil counts of less than 500 cells/mm3 , 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/mm3 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/mm3 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/mm3 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 Administration

HYCAMTIN 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.

3 DOSAGE FORMS AND STRENGTHS

For injection: 4 mg (topotecan free base) lyophilized powder in single-use vial for reconstitution; light yellow to greenish powder.

4 CONTRAINDICATIONS

HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan.

5 WARNINGS AND PRECAUTIONS

5.1 Bone Marrow Suppression

Bone marrow suppression (primarily neutropenia) is the dose‑limiting toxicity of HYCAMTIN. Neutropenia is not cumulative over time. Severe myelotoxicity has been reported when HYCAMTIN is used in combination with cisplatin [see Drug Interactions (7)].

The following data on myelosuppression are based on an integrated safety database from 8 trials (N = 879) using HYCAMTIN injection at 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21‑day course in patients with ovarian cancer and small cell lung cancer and from one trial in patients with cervical cancer (N = 147) using HYCAMTIN 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 repeated every 21 days in combination with cisplatin 50 mg/m2 on Day 1.

Neutropenia

Monotherapy: Grade 4 neutropenia (less than 500 cells/mm3) occurred in 78% of patients, with a median duration of 7 days and was most common during Course 1 of treatment (58% of patients). Grade 4 neutropenia associated with infection occurred in 13% of patients and febrile neutropenia occurred in 5% of patients. Sepsis occurred in 4% of patients and was fatal in 1% of patients. Pancytopenia has been reported.
Combination with cisplatin: Grade 4 neutropenia occurred in 48% of patients.

Thrombocytopenia

Monotherapy: Grade 4 thrombocytopenia (less than 25,000/mm3) occurred in 27% of patients, with a median duration of 5 days.
Combination with cisplatin: Grade 4 thrombocytopenia occurred in 7% of patients.

Anemia

Monotherapy: Grade 3 or 4 anemia (less than 8 g/dL) occurred in 37% of patients.
Combination with cisplatin: Grade 3 or Grade 4 anemia occurred in 40% of patients.

Administer HYCAMTIN only to patients with a baseline neutrophil count of greater than or equal to 1,500 cells/mm3 and a platelet count greater than or equal to 100,000/mm3. Monitor peripheral blood counts frequently during treatment with HYCAMTIN. Refer to Section 2.4 for dose modification guidelines for hematological toxicities in subsequent courses. Do not treat patients with subsequent courses of HYCAMTIN until neutrophils recover to greater than 1,000 cells/mm3 , platelets recover to greater than 100,000 cells/mm3 , and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary).

5.2 Neutropenic Enterocolitis

Topotecan can cause fatal typhlitis (neutropenic enterocolitis). Consider the possibility of typhlitis in patients presenting with fever, neutropenia, and abdominal pain.

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