2.1 Ovarian Cancer
Recommended Dose and Schedule
The recommended dose of Gemzar 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 Gemzar administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.
Dose Modifications
Recommended Gemzar dose modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
Table 1: Dosage Reduction Guidelines for Gemzar for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment Day
Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
Day 1
≥1500
<1500
and
or
≥100,000
<100,000
100%
Delay Treatment Cycle
Day 8
≥1500
1000-1499
<1000
and
or
or
≥100,000
75,000-99,999
<75,000
100%
50%
Hold
Table 2: Gemzar Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer
Occurrence
Myelosuppression During Treatment Cycle
Dose Modification
Initial Occurrence
Absolute granulocyte count less than 500 x 106/L for more than 5 days
Absolute granulocyte count less than 100 x 106/L for more than 3 days
Febrile neutropenia
Platelets less than 25,000x106/L
Cycle delay of 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 dose to 800 mg/m2 on Day 1 only
2.2 Breast Cancer
Recommended Dose and Schedule
The recommended dose of Gemzar 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 Gemzar administration.
Dose Modifications
Recommended dose modifications for Gemzar for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
Table 3: Recommended Dose Reductions for Gemzar for Myelosuppression on Day of Treatment in Breast Cancer
Treatment Day
Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
Day 1
≥1500
and
≥100,000
100%
less than 1500
or
less than 100,000
Hold
Day 8
≥1200
and
>75,000
100%
1000-1199
or
50,000-75,000
75%
700-999
and
≥50,000
50%
<700
or
<50,000
Hold
2.3 Non-Small Cell Lung Cancer
Recommended Dose and Schedule
Every 4-week schedule
The recommended dose of Gemzar 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 Gemzar.
Every 3-week schedule
The recommended dose of Gemzar 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 Gemzar.
Dose Modifications
Recommended dose modifications for Gemzar myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for Gemzar recommendations for non-hematologic adverse reactions.
2.4 Pancreatic Cancer
Recommended Dose and Schedule
The recommended dose of Gemzar is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule is as follows:
Weeks 1-8: 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.
Dose Modifications
Recommended dose modifications for Gemzar for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
Patients receiving Gemzar should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.
Table 4: Recommended Dose Reductions for Gemzar for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
≥1000
And
≥100,000
100%
500-999
Or
50,000-99,999
75%
<500
Or
<50,000
Hold
2.5 Dose Modifications for Non-Hematologic Adverse Reactions
Permanently discontinue Gemzar for any of the following:
Unexplained dyspnea or other evidence of severe pulmonary toxicity
Severe hepatic toxicity
Hemolytic-uremic syndrome
Capillary leak syndrome
Posterior reversible encephalopathy syndrome
Withhold Gemzar or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.
2.6 Preparation and Administration Precautions
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. For further guidance on handling Gemzar go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
2.7 Preparation for Intravenous Infusion Administration
Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.
Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a Gemzar concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of Gemzar. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.
Reconstituted Gemzar is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemzar solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
