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Infugem Dosage

Generic name: GEMCITABINE HYDROCHLORIDE 10mg in 1mL
Dosage form: injection, solution

Medically reviewed by Drugs.com. Last updated on Oct 25, 2018.

Ovarian Cancer

Recommended Dose and Schedule

The recommended dose of INFUGEM is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after INFUGEM administration on Day 1 of each 21-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)].


Refer to the carboplatin prescribing information for additional information.


Dosage Modifications

Recommended INFUGEM dosage modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to the dosage modifications recommendations 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 Modification 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 of 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 dose of INFUGEM is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion 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 the 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 dosage modification recommendations 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

Every 4-week schedule

The recommended dose of INFUGEM is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of INFUGEM. 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)].

Every 3-week schedule

The recommended dose of INFUGEM is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of INFUGEM. 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 the 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 dosage modifications recommendations for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Pancreatic Cancer

Recommended Dose and Schedule

The recommended dose of INFUGEM is 1000 mg/m2 over 30 minutes intravenously. 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 28-day cycles.

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 dosage modifications recommendations for non-hematologic adverse reactions [see Dosage and Administration (2.5)].


Table 4: Recommended INFUGEM Dosage Modifications 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

Dose Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue INFUGEM for any of the following:

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

Withhold INFUGEM or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity 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.


Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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