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These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP.Gemcitabine for Injection, USP, Powder, Lyophilized, For Solution | GEMCITABINE HYDROCHLORIDE

04:42 EDT 27th August 2014 | BioPortfolio

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Gemcitabine for Injection should be administered intravenously at a dose of 1000 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after gemcitabine for injection 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 10/L and a platelet count ≥100,000 x 10/L prior to each cycle.

Dose Modifications

Gemcitabine for Injection dosage adjustment 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, gemcitabine for injection dosage should be modified according to guidelines in Table 1.

Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin

In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with gemcitabine for injection 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 gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine for injection in subsequent cycles should be reduced to 800 mg/m on Days 1 and 8 in case of any of the following hematologic toxicities:

Absolute granulocyte count
(x 106/L)
  Platelet count
(x 106/L)
% of full dose 
≥ 1500
And
≥ 100,000
100
1000 to 1499
and/or
75,000 to 99,999
50
< 1000
and/or
< 75,000
Hold

Gemcitabine for Injection should be administered intravenously at a dose of 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle.  Paclitaxel should be administered at 175 mg/m on Day 1 as a 3-hour intravenous infusion before gemcitabine 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 10/L and a platelet count ≥100,000 x 10/L prior to each cycle.

Dose Modifications

Gemcitabine dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy.  If marrow suppression is detected, gemcitabine dosage should be modified according to the guidelines in Table 2.

Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine in Combination with Paclitaxel

Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
 ≥ 1200
And
> 75, 000 
100
1000 to 1199
Or
50,000 to 75,000
75
700 to 999
And
≥ 50,000
50
< 700
Or
<50,000
Hold

Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, gemcitabine should be administered intravenously at 1000 mg/m over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m on Day 1 after the infusion of gemcitabine. With the 3-week schedule, gemcitabine should be administered intravenously at 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m should be administered intravenously after the infusion of gemcitabine on Day 1.  See prescribing information for cisplatin administration and hydration guidelines.

Dose Modifications

Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

Gemcitabine for Injection should be administered by intravenous infusion at a dose of 1000 mg/m over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

Dose Modifications

Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

Patients receiving gemcitabine 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 3.

Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter.  Gemcitabine for Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

Absolute granulocyte count
(x106/L)
Platelet count
(x106/L) 
% of full dose 
 ≥ 1000
And
 ≥ 100,000
100
500 to 999
Or
50,000 to 99,999
75
< 500
Or
< 50,000
Hold

Caution should be exercised in handling and preparing gemcitabine solutions. The use of gloves is recommended.  If gemcitabine solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

The recommended diluent for reconstitution of gemcitabine is 0.9% Sodium Chloride Injection without preservatives.  Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/mL.  Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

When prepared as directed, gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallization may occur.

Gemcitabine for Injection is a white to off-white lyophilized powder available in sterile single-use vials containing 200 mg, 1 g or 2 g gemcitabine.

Pulmonary toxicity has been reported with the use of gemcitabine. In cases of severe lung toxicity, gemcitabine therapy should be discontinued immediately and appropriate supportive care measures instituted [see Adverse Reactions (6.1 and 6.2)].

Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of gemcitabine. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been reported.  The majority of the cases of renal failure leading to death were due to HUS [see Adverse Reactions (6.1 and 6.2)].

Serious hepatotoxicity, including liver failure and death, has been reported in patients receiving gemcitabine alone or in combination with other potentially hepatotoxic drugs [see Adverse Reactions (6.1 and 6.2)].

Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. Suspension or modification of therapy should be considered when marrow suppression is detected [see Dosage and Administration (2.1, 2.2, 2.3, and 2.4)].

Laboratory evaluation of renal and hepatic function should be performed prior to initiation of therapy and periodically thereafter [see Dosage and Administration (2.4)].

A pattern of tissue injury typically associated with radiation toxicity has been reported in association with concurrent and non-concurrent use of gemcitabine.

Non-concurrent (given >7 days apart) - Analysis of the data does not indicate enhanced toxicity when gemcitabine is administered more than 7 days before or after radiation, other than radiation recall. Data suggest that gemcitabine can be started after the acute effects of radiation have resolved or at least one week after radiation.

 
All Patientsb
Pancreatic Cancer
Patientsc
Discontinuations
(%)d
All Grades
Grade 3
Grade 4
All Grades
Grade 3
Grade 4
All Patients
 Laboratorye
 
 
 
 
 
 
 
  Hematologic
 
 
 
 
 
 
 
   Anemia
68
7
1
73
8
2
<1
   Leukopenia
62
9
<1
64
8
1
<1
   Neutropenia
63
19
6
61
17
7
-
   Thrombocytopenia
24
4
1
36
7
<1
<1
  Hepatic
 
 
 
 
 
 
<1
   ALT
68
8
2
72
10
1
 
   AST
67
6
2
78
12
5
 
   Alkaline Phosphatase
55
7
2
77
16
4
 
   Bilirubin
13
2
<1
26
6
2
 
  Renal
 
 
 
 
 
 
<1
   Proteinuria
45
<1
0
32
<1
0
 
   Hematuria
35
<1
0
23
0
0
 
   BUN
16
0
0
15
0
0
 
   Creatinine
8
<1
0
6
0
0
 
 Non-laboratoryf
 
 
 
 
 
 
 
  Nausea and Vomiting
69
13
1
71
10
2
<1
  Fever
41
2
0
38
2
0
<1
  Rash
30
<1
0
28
<1
0
<1
  Dyspnea
23
3
<1
10
0
<1
<1
  Diarrhea
19
1
0
30
3
0
0
  Hemorrhage
17
<1
<1
4
2
<1
<1
  Infection
16
1
<1
10
2
<1
<1
  Alopecia
15
<1
0
16
0
0
0
  Stomatitis
11
<1
0
10
<1
0
<1
  Somnolence
11
<1
<1
11
2
<1
<1
  Paresthesias
10
<1
0
10
<1
0
0
 
Gemcitabine plus Cisplatinb
Cisplatinc
All Grades
Grade 3
Grade 4
All Grades
Grade 3
Grade 4
 Laboratoryd
 
 
 
 
 
 
  Hematologic
 
 
 
 
 
 
   Anemia
89
22
3
67
6
1
   RBC Transfusione
39
 
 
13
 
 
   Leukopenia
82
35
11
25
2
1
   Neutropenia
79
22
35
20
3
1
   Thrombocytopenia
85
25
25
13
3
1
   Platelet Transfusionse
21
 
 
<1
 
 
   Lymphocytes
75
25
18
51
12
5
  Hepatic
 
 
 
 
 
 
   Transaminase
22
2
1
10
1
Manufacturer

APP Pharmaceuticals, LLC

Active Ingredients

Source

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PubMed Articles [323 Associated PubMed Articles listed on BioPortfolio]

Simultaneous quantification of Gemcitabine and Irinotecan hydrochloride in rat plasma by using high performance liquid chromatography-diode array detector.

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USP9X inhibition improves gemcitabine sensitivity in pancreatic cancer by inhibiting autophagy.

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Licoricidin enhances gemcitabine-induced cytotoxicity in osteosarcoma cells by suppressing the Akt and NF-κB signal pathways.

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