GEMCITABINE HYDROCHLORIDE (Page 7 of 7)
14.4 Pancreatic Cancer
The efficacy of gemcitabine was evaluated in two trials (Studies 5 and 6), a randomized, single-blind, two-arm, active-controlled trial (Study 5) conducted in patients with locally advanced or metastatic pancreatic cancer who had received no prior chemotherapy and in a single-arm, open-label, multicenter trial (Study 6) conducted in patients with locally advanced or metastatic pancreatic cancer previously treated with fluorouracil or a fluorouracil-containing regimen. In Study 5, patients were randomized to receive either gemcitabine 1000 mg/m 2 intravenously over 30 minutes once weekly for 7 weeks followed by a one-week rest, then once weekly for 3 consecutive weeks every 28-days in subsequent cycles (n=63) or fluorouracil 600 mg/m 2 intravenously over 30 minutes once weekly (n=63). In Study 6, all patients received gemcitabine 1000 mg/m 2 intravenously over 30 minutes once weekly for 7 weeks followed by a one-week rest, then once weekly for 3 consecutive weeks every 28-days in subsequent cycles.
The major efficacy outcome measure in both trials was “clinical benefit response”. A patient was considered to have had a clinical benefit response if either of the following occurred:
- The patient achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card) or analgesic consumption, or a 20-point or greater improvement in performance status (Karnofsky Performance Status) for a period of at least 4 consecutive weeks, without showing any sustained worsening in any of the other parameters. Sustained worsening was defined as 4 consecutive weeks with either any increase in pain intensity or analgesic consumption or a 20-point decrease in performance status occurring during the first 12 weeks of therapy.
OR - The patient was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation.
Study 5 enrolled 126 patients. Demographics and baseline characteristics were similar between the arms (Table 22). The efficacy results are shown in Table 23 and Figure 4. Patients treated with gemcitabine had statistically significant increases in clinical benefit response, survival, and time to disease progression compared to those randomized to receive fluorouracil. No confirmed objective tumor responses were observed in either treatment arm.
a Karnofsky Performance Status. | ||
Gemcitabine (N=63) | Fluorouracil (N=63) | |
Male | 54% | 54% |
Median age, years | 62 | 61 |
Range | 37 to 79 | 36 to 77 |
Stage IV disease | 71% | 76% |
Baseline KPS a ≤70 | 70% | 68% |
a p-value for clinical benefit response calculated using the two-sided test for difference in binomial proportions. All other p-values are calculated using log rank test. | ||
Efficacy Parameter | Gemcitabine (N= 63) | Fluorouracil (N= 63) |
Clinical Benefit Response | 22.2% | 4.8% |
p-value a | p=0.004 | |
Overall Survival | ||
Median (95% CI) in months | 5.7 (4.7, 6.9) | 4.2 (3.1, 5.1) |
p-value a | p=0.0009 | |
Time to Disease Progression | ||
Median (95% CI) in months | 2.1 (1.9, 3.4) | 0.9 (0.9, 1.1) |
p-value a | p=0.0013 |
Figure 4: Kaplan-Meier Curves for Overall Survival in Study 5
15 REFERENCES
1.“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
16 HOW SUPPLIED/STORAGE AND HANDLING
Gemcitabine for Injection is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 200 mg, 1g or 2 g gemcitabine:
- 200 mg vial: NDC 16729-092-03 (No. 092)
- 1 g vial: NDC 16729-117-11 (No. 117)
- 2 g vial: NDC 16729-118-38 (No. 118)
Gemcitabine for Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients of the risks of myelosuppression Instruct patients to immediately contact their healthcare provider should any signs or symptoms of infection, including fever, or if bleeding or signs of anemia, occur [see Warnings and Precautions (5.2)].
Pulmonary Toxicity
Advise patients of the risks of pulmonary toxicity, including respiratory failure and death. Instruct patients to immediately contact their healthcare provider for development of shortness of breath, wheezing, or cough [see Warnings and Precautions (5.3)].
Hemolytic-Uremic Syndrome and Renal Failure
Advise patients of the risks of hemolytic-uremic syndrome and associated renal failure. Instruct patients to immediately contact their healthcare provider for changes in the color or volume of urine output or for increased bruising or bleeding [see Warnings and Precautions (5.4)].
Hepatic Toxicity
Advise patients of the risks of hepatic toxicity including liver failure and death. Instruct patients to immediately contact their healthcare provider for signs of jaundice or for pain/tenderness in the right upper abdominal quadrant [see Warnings and Precautions (5.5)].
Embryo-Fetal Toxicity
Advise females and males of reproductive potential that Gemcitabine for Injection can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment with Gemcitabine for Injection and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Gemcitabine for Injection and for 3 months after the final dose [see Warnings and Precaution (5.6), Use in Specific Populations ( 8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with Gemcitabine for Injection and for at least one week after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential of the potential for reduced fertility with Gemcitabine for Injection [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad — 380 054, INDIA.
10 0147 1 678621/Jul 2019
PRINCIPAL DISPLAY PANEL
NDC 16729- 092 -03
Gemcitabine For Injection USP
200 mg/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 092 -03
Gemcitabine For Injection USP
200 mg/vial Rx Only For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 092 -03
Gemcitabine For Injection USP
200 mg/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 092 -03
Gemcitabine For Injection USP
200 mg/vial Rx Only For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 117 -11
Gemcitabine For Injection USP
1 g/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 117 -11
Gemcitabine For Injection USP
1 g/vial Rx Only For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 117 -11
Gemcitabine For Injection USP
1 g/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 117 -11
Gemcitabine For Injection USP
1 g/vial Rx Only For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 118 -38
Gemcitabine For Injection USP
2 g/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 118 -38
Gemcitabine For Injection USP
2 g/vial Rx Only For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 118 -38
Gemcitabine For Injection USP
2 g/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
NDC 16729- 118 -38
Gemcitabine For Injection USP
2 g/vial
Rx Only
For intravenous use only
Sterile Single Dose Vial
Cytotoxin Agent
Lyophilized
Must be diluted
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride injection, powder, lyophilized, for solution | |||||||||||||||||
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GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride injection, powder, lyophilized, for solution | |||||||||||||||||
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GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride injection, powder, lyophilized, for solution | |||||||||||||||||
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Labeler — Accord Healthcare Inc. (604222237) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Intas Pharmaceuticals Limited | 725927649 | manufacture (16729-092), manufacture (16729-117), manufacture (16729-118), analysis (16729-092), analysis (16729-117), analysis (16729-118) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Intas Pharmaceuticals Limited | 915837971 | manufacture (16729-092), manufacture (16729-117), manufacture (16729-118), analysis (16729-092), analysis (16729-117), analysis (16729-118) |
Revised: 11/2022 Accord Healthcare Inc.
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