gemcitabine injection powder 2GM Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with carboplatin AUC 4 administered intravenously on Day 1 after gemcitabine administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine dosage modifications for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 1: Recommended Dosage Modifications for Gemcitabine for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment DayAbsolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Day 1

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

Less than 1,500

Or

Less than 100,000

Delay Treatment Cycle

Day 8

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

1,000 to 1,499

Or

75,000 to 99,999

50% of full dose

Less than 1,000

Or

Less than 75,000

Hold

Table 2: Recommended Dosage Modifications for Gemcitabine for Myelosuppression in Previous Cycle in Ovarian Cancer
OccurrenceMyelosuppression During Treatment CycleDosage Modification

Initial Occurrence

•
Absolute neutrophil count less than 500 × 106/L for more than 5 days or
•
Absolute neutrophil count less than 100 × 106/L for more than 3 days or
•
Febrile neutropenia or
•
Platelets less than 25,000 × 106/L or
•
Cycle delay for more than one week due to toxicity

Permanently reduce gemcitabine to 800 mg/m2 on Days 1 and 8

Subsequent Occurrence

If any of the above toxicities occur after the initial dose reduction:

Permanently reduce gemcitabine to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before gemcitabine administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine dosage modifications for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 3: Recommended Dosage Modifications for Gemcitabine for Myelosuppression on Day of Treatment in Breast Cancer
Treatment DayAbsolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Day 1

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

Less than 1,500

Or

Less than 100,000

Hold

Day 8

Greater than or equal to 1,200

And

Greater than 75,000

None

1,000 to 1,199

Or

50,000 to 75,000

75% of full dose

700 to 999

And

Greater than or equal to 50,000

50% of full dose

Less than 700

Or

Less than 50,000

Hold

2.3 Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

21-day schedule

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for gemcitabine myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

2.4 Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:

•
Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest.
•
After week 8: weekly dosing on Days 1, 8, and 15 of each 28-day cycle.

Dosage Modifications

Recommended dosage modifications for gemcitabine for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 4: Recommended Dosage Modifications for Gemcitabine for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Greater than or equal to 1,000

And

Greater than or equal to 100,000

None

500 to 999

Or

50,000 to 99,999

75% of full dose

Less than 500

Or

Less than 50,000

Hold

2.5 Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue gemcitabine for any of the following:

•
Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.3)]
•
Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions (5.4)]
•
Hemolytic uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions (5.5)]
•
Severe hepatic toxicity [see Warnings and Precautions (5.6)]
•
Capillary leak syndrome (CLS) [see Warnings and Precautions (5.9)]
•
Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.10)]

Withhold gemcitabine or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

2.6 Preparation

•
Gemcitabine vials contain no antimicrobial preservatives and are intended for single dose only.
•
Gemcitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
•
Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
•
Reconstitute the 2 g vial with 50 mL of 0.9% Sodium Chloride Injection, USP to yield a gemcitabine concentration of 38 mg/mL. Reconstituted gemcitabine is a clear, colorless to light straw-colored solution.
•
Visually inspect reconstituted product for particulate matter and discoloration. Discard if particulate matter or discoloration is observed.
•
Withdraw the calculated dose from the vial and discard any unused portion.
•
Prior to administration, dilute the reconstituted solution with 0.9% Sodium Chloride Injection, USP to a minimum final concentration of at least 0.1 mg/mL.
•
Store gemcitabine solutions (reconstituted and diluted) at controlled room temperature of 20°C to 25°C (68°F to 77°F). Do not refrigerate as crystallization can occur. Discard gemcitabine solutions if not used within 24 hours after reconstitution.
•
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with carboplatin AUC 4 administered intravenously on Day 1 after gemcitabine administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine dosage modifications for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 1: Recommended Dosage Modifications for Gemcitabine for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment DayAbsolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Day 1

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

Less than 1,500

Or

Less than 100,000

Delay Treatment Cycle

Day 8

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

1,000 to 1,499

Or

75,000 to 99,999

50% of full dose

Less than 1,000

Or

Less than 75,000

Hold

Table 2: Recommended Dosage Modifications for Gemcitabine for Myelosuppression in Previous Cycle in Ovarian Cancer
OccurrenceMyelosuppression During Treatment CycleDosage Modification

Initial Occurrence

•
Absolute neutrophil count less than 500 × 106/L for more than 5 days or
•
Absolute neutrophil count less than 100 × 106/L for more than 3 days or
•
Febrile neutropenia or
•
Platelets less than 25,000 × 106/L or
•
Cycle delay for more than one week due to toxicity

Permanently reduce gemcitabine to 800 mg/m2 on Days 1 and 8

Subsequent Occurrence

If any of the above toxicities occur after the initial dose reduction:

Permanently reduce gemcitabine to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before gemcitabine administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine dosage modifications for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 3: Recommended Dosage Modifications for Gemcitabine for Myelosuppression on Day of Treatment in Breast Cancer
Treatment DayAbsolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Day 1

Greater than or equal to 1,500

And

Greater than or equal to 100,000

None

Less than 1,500

Or

Less than 100,000

Hold

Day 8

Greater than or equal to 1,200

And

Greater than 75,000

None

1,000 to 1,199

Or

50,000 to 75,000

75% of full dose

700 to 999

And

Greater than or equal to 50,000

50% of full dose

Less than 700

Or

Less than 50,000

Hold

2.3 Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

21-day schedule

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for gemcitabine myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

2.4 Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:

•
Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest.
•
After week 8: weekly dosing on Days 1, 8, and 15 of each 28-day cycle.

Dosage Modifications

Recommended dosage modifications for gemcitabine for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 4: Recommended Dosage Modifications for Gemcitabine for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count
(× 106/L)		Platelet Count
(× 106/L)		Dosage Modification

Greater than or equal to 1,000

And

Greater than or equal to 100,000

None

500 to 999

Or

50,000 to 99,999

75% of full dose

Less than 500

Or

Less than 50,000

Hold

2.5 Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue gemcitabine for any of the following:

•
Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.3)]
•
Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions (5.4)]
•
Hemolytic uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions (5.5)]
•
Severe hepatic toxicity [see Warnings and Precautions (5.6)]
•
Capillary leak syndrome (CLS) [see Warnings and Precautions (5.9)]
•
Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.10)]

Withhold gemcitabine or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

2.6 Preparation

•
Gemcitabine vials contain no antimicrobial preservatives and are intended for single dose only.
•
Gemcitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
•
Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
•
Reconstitute the 2 g vial with 50 mL of 0.9% Sodium Chloride Injection, USP to yield a gemcitabine concentration of 38 mg/mL. Reconstituted gemcitabine is a clear, colorless to light straw-colored solution.
•
Visually inspect reconstituted product for particulate matter and discoloration. Discard if particulate matter or discoloration is observed.
•
Withdraw the calculated dose from the vial and discard any unused portion.
•
Prior to administration, dilute the reconstituted solution with 0.9% Sodium Chloride Injection, USP to a minimum final concentration of at least 0.1 mg/mL.
•
Store gemcitabine solutions (reconstituted and diluted) at controlled room temperature of 20°C to 25°C (68°F to 77°F). Do not refrigerate as crystallization can occur. Discard gemcitabine solutions if not used within 24 hours after reconstitution.
•
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
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