Gemzar Dosage

Generic name: Gemcitabine hydrochloride 200mg in 5mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Antimetabolites

Medically reviewed by Drugs.com. Last updated on Mar 8, 2024.

Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of GEMZAR 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 GEMZAR administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended GEMZAR 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 GEMZAR for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment Day	Absolute Neutrophil Count (x 106/L)		Platelet Count (x 106/L)	Dosage Modification
Day 1	Greater than or equal to 1500	And	Greater than or equal to 100,000	None
Day 1	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 GEMZAR for Myelosuppression in Previous Cycle in Ovarian Cancer
Occurrence	Myelosuppression During Treatment Cycle	Dosage Modification
Initial Occurrence	Absolute neutrophil count less than 500 x 106/L for more than 5 days or Absolute neutrophil count less than 100 x 106/L for more than 3 days or Febrile neutropenia or Platelets less than 25,000x106/L or Cycle delay for more than one week due to toxicity	Permanently reduce GEMZAR 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 GEMZAR to 800 mg/m2 on Day 1 only

Breast Cancer

Recommended Dose and Schedule

The recommended dosage of GEMZAR 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 GEMZAR administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended GEMZAR 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 GEMZAR for Myelosuppression on Day of Treatment in Breast Cancer
Treatment Day	Absolute Neutrophil Count (x 106/L)		Platelet Count (x 106/L)	Dosage Modification
Day 1	Greater than or equal to 1500	And	Greater than or equal to 100,000	None
Day 1	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

Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of GEMZAR 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 GEMZAR administration.

21-day schedule

The recommended dosage of GEMZAR 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 GEMZAR administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for GEMZAR 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)].

Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of GEMZAR 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 GEMZAR 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 GEMZAR for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count (x 106/L)		Platelet Count (x 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

Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue GEMZAR for any of the following:

Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions (5.3)]
Hemolytic uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions (5.4)]
Severe hepatic toxicity [see Warnings and Precautions (5.5)]
Capillary leak syndrome (CLS) [see Warnings and Precautions (5.8)]
Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.9)]

Withhold GEMZAR 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.

Preparation

GEMZAR vials contain no antimicrobial preservatives and are intended for single use only.
GEMZAR is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Exercise caution and wear gloves when preparing GEMZAR solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if GEMZAR contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
Reconstitute the 200 mg vial with 5 mL and the 1 g vial with 25 mL of 0.9% Sodium Chloride Injection, USP to yield a GEMZAR concentration of 38 mg/mL. Reconstituted GEMZAR 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 GEMZAR 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 GEMZAR solutions if not used within 24 hours after reconstitution.
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.