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These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intraveno | GRANISETRON HYDROCHLORIDE [WOCKHARDT LIMITED] | BioPortfolio

12:33 EST 27th January 2019 | BioPortfolio

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Table 1 Principal Adverse Reactions in Clinical Trials-Single-Day Chemotherapy
Percent of Patients With Reaction
Granisetron Hydrochloride Injection
40 mcg/kg
(n=1268)
Comparator1

(n=422)
Headache 14% 6%
Constipation 3% 3%

It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when granisetron hydrochloride injection is administered to a nursing woman.

Chemotherapy-Induced Nausea and Vomiting [See Dosage and Administration (2)]  for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Table 2 Pharmacokinetic Parameters in Adult Cancer Patients Undergoing Chemotherapy and in Volunteers, Following a Single Intravenous 40 mcg/kg Dose of Granisetron Hydrochloride Injection
Peak Plasma Concentration
(ng/mL)
Terminal Phase Plasma Half-Life
(h)
Total Clearance
(L/h/kg)
Volume of Distribution
(L/kg)
Cancer Patients
  Mean 63.8* 8.95* 0.38* 3.07*
  Range 18.0 to 176 0.90 to 31.1 0.14 to 1.54 0.85 to 10.4
Volunteers
  21 to 42 years
  Mean 64.3 4.91 0.79 3.04
  Range 11.2 to 182 0.88 to 15.2 0.20 to 2.56 1.68 to 6.13
  65 to 81 years
  Mean 57.0 7.69 0.44 3.97
  Range 14.6 to 153 2.65 to 17.7 0.17 to 1.06 1.75 to 7.01
Table 3 Prevention of Chemotherapy-Induced Nausea and Vomiting-Single-Day Cisplatin Therapy1
Granisetron Hydrochloride Injection Placebo P-Value
Number of Patients 14 14
Response Over 24 Hours
Complete Response2 93% 7% <0.001
No Vomiting 93% 14% <0.001
No More Than Mild Nausea 93% 7% <0.001
Table 4 Prevention of Chemotherapy-Induced Nausea and Vomiting-Single-Day High-Dose Cisplatin Therapy1
Granisetron Hydrochloride Injection
(mcg/kg)
P-Value
(vs. 2 mcg/kg)
2 10 40 10 40
Number of Patients 52 52 53
Response Over 24 Hours
Complete Response2 31% 62% 68% <0.002 <0.001
No Vomiting 38% 65% 74% <0.001 <0.001
No More Than Mild Nausea 58% 75% 79% NS 0.007
Table 5 Prevention of Chemotherapy-Induced Nausea and Vomiting-Single-Day High-Dose and Low-Dose Cisplatin Therapy1
Granisetron Hydrochloride Injection
(mcg/kg)
P-Value
(vs. 5 mcg/kg)
5 10 20 40 10 20 40
High-Dose Cisplatin
Number of Patients 40 49 48 47
Response Over 24 Hours
  Complete Response2 18% 41% 40% 47% 0.018 0.025 0.004
  No Vomiting 28% 47% 44% 53% NS NS 0.016
  No Nausea 15% 35% 38% 43% 0.036 0.019 0.005
Low-Dose Cisplatin
Number of Patients 42 41 40 46
Response Over 24 Hours
  Complete Response2 29% 56% 58% 41% 0.012 0.009 NS
  No Vomiting 36% 63% 65% 43% 0.012 0.008 NS
  No Nausea 29% 56% 38% 33% 0.012 NS NS
Table 6 Prevention of Chemotherapy-Induced Nausea and Vomiting-Single-Day Moderately Emetogenic Chemotherapy
Granisetron Hydrochloride Injection Chlorpromazine1 P-Value
Number of Patients 133 133
Response Over 24 Hours
Complete Response2 68% 47% <0.001
No Vomiting 73% 53% <0.001
No More Than Mild Nausea 77% 59% <0.001
Table 7 Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Granisetron Hydrochloride Injection Dose (mcg/kg)
10 20 40
Number of Patients 29 26 25
Median Number of Vomiting Episodes 2 3 1
Complete Response Over 24 Hours1 21% 31% 32%

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

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Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...


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