gemcitabine injection solution Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1000 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 Injection administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection 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 1500

And

Greater than or equal to 100,000

None

Less than 1500

Or

Less than 100,000

Delay Treatment Cycle

Day 8

Greater than or equal to 1500

And

Greater than or equal to 100,000

None

1000 to 1499

Or

75,000 to 99,999

50% of full dose

Less than 1000

Or

Less than 75,000

Hold

Table 2: Recommended Dosage Modifications for Gemcitabine Injection 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 Injection 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 Injection dose to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1250 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 Injection administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection 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 1500

And

Greater than or equal to 100,000

None

Less than 1500

Or

Less than 100,000

Hold

Day 8

Greater than or equal to 1200

And

Greater than 75,000

None

1000 to 1199

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 Injection is 1000 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 Injection administration.

21-day schedule

The recommended dosage of Gemcitabine Injection is 1250 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 Injection administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection is 1000 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 Injection 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 Injection 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 1000

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 Injection 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 Injection 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 Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Exercise caution and wear gloves when preparing Gemcitabine Injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine Injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.

Preparation for Intravenous Infusion Administration

•
Withdraw the calculated dose from the vial and discard any unused portion.
•
Prior to administration, dilute the appropriate amount of drug with 0.9% Sodium Chloride Injection to a minimum final concentration of at least 0.1 mg/mL.
•
Store diluted Gemcitabine Injection solution for no more than 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard if not used within 24 hours after dilution.
•
Visually inspect for particulate matter or discoloration prior to administration and discard if particulate matter or discoloration is observed.
•
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

Find gemcitabine injection solution medical information:

Find gemcitabine injection solution medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

gemcitabine injection solution Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1000 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 Injection administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection 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 1500

And

Greater than or equal to 100,000

None

Less than 1500

Or

Less than 100,000

Delay Treatment Cycle

Day 8

Greater than or equal to 1500

And

Greater than or equal to 100,000

None

1000 to 1499

Or

75,000 to 99,999

50% of full dose

Less than 1000

Or

Less than 75,000

Hold

Table 2: Recommended Dosage Modifications for Gemcitabine Injection 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 Injection 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 Injection dose to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1250 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 Injection administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection 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 1500

And

Greater than or equal to 100,000

None

Less than 1500

Or

Less than 100,000

Hold

Day 8

Greater than or equal to 1200

And

Greater than 75,000

None

1000 to 1199

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 Injection is 1000 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 Injection administration.

21-day schedule

The recommended dosage of Gemcitabine Injection is 1250 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 Injection administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection 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 Injection is 1000 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 Injection 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 Injection 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 1000

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 Injection 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 Injection 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 Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Exercise caution and wear gloves when preparing Gemcitabine Injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine Injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.

Preparation for Intravenous Infusion Administration

•
Withdraw the calculated dose from the vial and discard any unused portion.
•
Prior to administration, dilute the appropriate amount of drug with 0.9% Sodium Chloride Injection to a minimum final concentration of at least 0.1 mg/mL.
•
Store diluted Gemcitabine Injection solution for no more than 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard if not used within 24 hours after dilution.
•
Visually inspect for particulate matter or discoloration prior to administration and discard if particulate matter or discoloration is observed.
•
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.