Antimetabolites
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Infugem Dosage

Drug Detail:Infugem (Gemcitabine [ jem-sye-ta-been ])

Generic Name: GEMCITABINE HYDROCHLORIDE 10mg in 1mL

Dosage Form: injection, solution

Drug Class: Antimetabolites

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of INFUGEM 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 INFUGEM administration. Select the INFUGEM premixed bag(s) that allow for a variance of up to 5% of the BSA-calculated dose as described in Table 5 [see Dosage and Administration (2.6)].

Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended INFUGEM 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 INFUGEM 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

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 INFUGEM 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 INFUGEM 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 INFUGEM dose to 800 mg/m2 on Day 1 only

Breast Cancer

Recommended Dose and Schedule

The recommended dosage of INFUGEM 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 INFUGEM administration. Select the INFUGEM premixed bag(s) that allow for a variance of up to 5% of the BSA-calculated dose as described in Table 6 [see Dosage and Administration (2.6)].

Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended INFUGEM 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 INFUGEM 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

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 INFUGEM 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 INFUGEM administration. Select the INFUGEM premixed bag(s) that allow for a variance of up to 5% of the BSA-calculated dose as described in Table 5 [see Dosage and Administration (2.6)].

21-day schedule

The recommended dosage of INFUGEM 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 INFUGEM administration. Select the INFUGEM premixed bag(s) that allow for a variance of up to 5% of the BSA-calculated dose as described in Table 6 [see Dosage and Administration (2.6)].

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended INFUGEM dosage modifications for myelosuppression are described in Table 4 [see Dosage and Administration (2.4), 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 INFUGEM 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.

Select the INFUGEM premixed bag(s) that allow for a variance of up to 5% of the BSA-calculated dose as described in Table 5 [see Dosage and Administration (2.6)].

Dosage Modifications

Recommended dosage modifications for INFUGEM 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 INFUGEM 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 INFUGEM 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 INFUGEM or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved.

Infusion Bag Selection and Administration

See the INFUGEM Instructions for Use for additional information concerning premixed infusion bag(s) selection and spiking the infusion bag instructions.

Infusion Bag Selection

INFUGEM is provided in premixed bags that are ready for infusion and do not require any further preparation prior to use. Do not dilute prior to use. Do not remove or add medication.

Select the INFUGEM premixed bag(s) for infusion based on the patient’s BSA range as outlined below in Table 5 for 1000 mg/m2 (ovarian cancer, non-small cell lung cancer, and pancreatic cancer) and Table 6 for 1250 mg/m2 (breast cancer, non-small cell lung cancer). The INFUGEM administered dose may vary from the BSA-calculated dose by no more than 5%.

Use another formulation of gemcitabine for patients who require a dose that is less than those listed in the Table 5 or Table 6 below (i.e., <1150 mg).

Table 5: INFUGEM Infusion Bag(s) Selection for Gemcitabine Doses of 1000 mg/m2 (Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer)

BSA Range (m2) INFUGEM Infusion Bag(s)

1.16 to 1.25

1200 mg

1.26 to 1.35

1300 mg

1.36 to 1.45

1400 mg

1.46 to 1.55

1500 mg

1.56 to 1.65

1600 mg

1.66 to 1.75

1700 mg

1.76 to 1.85

1800 mg

1.86 to 1.95

1900 mg

1.96 to 2.10

2000 mg

2.11 to 2.30

2200 mg

2.31 to 2.45

2400 mg (1200 mg and 1200 mg)

2.46 to 2.55

2500 mg (1200 mg and 1300 mg)

2.56 to 2.64

2600 mg (1300 mg and 1300 mg)a

a Suggested combination. Other possible combinations can be used to reach the appropriate dose.

Table 6: INFUGEM Infusion Bag(s) Selection for Gemcitabine Doses of 1250 mg/m2 (Breast Cancer Non-Small Cell Lung Cancer)

BSA (m2) INFUGEM
Infusion Bag(s)

1.16 to 1.24

1500 mg

1.25 to 1.32

1600 mg

1.33 to 1.40

1700 mg

1.41 to 1.47

1800 mg

1.48 to 1.56

1900 mg

1.57 to 1.68

2000 mg

1.69 to 1.84

2200 mg

1.85 to 1.96

2400 mg (1200 mg and 1200 mg)

1.97 to 2.04

2500 mg (1300 mg and 1200 mg)

2.05 to 2.12

2600 mg (1300 mg and 1300 mg)a

2.13 to 2.20

2700 mg (1200 mg and 1500 mg)a

2.21 to 2.28

2800 mg (1400 mg and 1400 mg)a

2.29 to 2.36

2900 mg (1200 mg and 1700 mg)a

2.37 to 2.44

3000 mg (1500 mg and 1500 mg)a

2.45 to 2.52

3100 mg (1200 mg and 1900 mg)a

2.53 to 2.60

3200 mg (1600 mg and 1600 mg)a

2.61 to 2.64

3300 mg (1600 mg and 1700 mg)a

a Combinations represented above are suggested combinations. Other possible combinations of bags can be used to reach the appropriate dose.

Administration

Infuse all doses of INFUGEM over 30 minutes. If two premixed infusion bags are required to achieve the prescribed dose, infuse the total volume of both bags over 30 minutes.

After removing the overwrap check for leaks by squeezing the inner bag firmly. If leaks are found, discard the bag.

INFUGEM injection is a clear, colorless solution. Visually inspect for any particulate matter or discoloration prior to use. Discard if particulate matter or discoloration is found.

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

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

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