100
1000–1199
or
50,000–75,000
75
700–999
and
≥50,000
50
<700
or
<50,000
Hold
In general, for severe (Grade 3 or 4) non–hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemzar should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.
Ovarian Cancer —Gemzar should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21–day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemzar administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.
Dose Modifications —Gemzar dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemzar dosage should be modified according to guidelines in Table 15.
Table 15: Day 8 Dosage Reduction Guidelines for Gemzar in Combination with Carboplatin Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
≥1500
and
≥100,000
100
1000–1499
and/or
75,000–99,999
50
<1000
and/or
<75,000
Hold
In general, for severe (Grade 3 or 4) non–hematological toxicity, except nausea/vomiting, therapy with Gemzar should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.
Dose adjustment for Gemzar in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemzar in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:
Absolute granulocyte count <500 x 106/L for more than 5 days
Absolute granulocyte count <100 x 106/L for more than 3 days
Febrile neutropenia
Platelets <25,000 x 106/L
Cycle delay of more than one week due to toxicity
If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemzar should be given on Day 1 only at 800 mg/m2.
Gemzar may be administered on an outpatient basis.
Instructions for Use/Handling
The recommended diluent for reconstitution of Gemzar is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for Gemzar upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.
To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200–mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1–g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200–mg vial or 1.3 mL for th
