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GRANISETRON HYDROCHLORIDE

WOCKHARDT USA LLC

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 intravenous use Initial U.S. Approval: 1993INDICATIONS AND USAGE3 Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. (1) DOSAGE AND ADMINISTRATION Prevention of chemotherapy-induced nausea and vomiting (2.1): Recommended dosage is 10 mcg/kg intravenously within 30 minutes before initiation of chemotherapy Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg DOSAGE FORMS AND STRENGTHS Injection 0.1 mg/mL (free base). (3) CONTRAINDICATIONS Hypersensitivity to granisetron or to any of its components. (4) WARNINGS AND PRECAUTIONS Granisetron hydrochloride injection does not stimulate gastric or intestinal peristalsis and should not be used instead of nasogastric suction. (5.1) QT prolongation has been reported with granisetron hydrochloride injection. Use with caution in patients with pre-existing arrhythmias or cardiac conduction disorders. (5.2)      Hypersensitivity reactions, such as anaphylaxis, shortness of breath, hypotension, and urticaria, may occur in patients with known hypersensitivity to other selective 5-HT3 receptor antagonists. (5.3) Side Effects Chemotherapy-induced nausea and vomiting (≥3%): Headache, and constipation (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Granisetron hydrochloride injection has been administered safely with benzodiazepines, neuroleptics, and anti-ulcer medications. (7) Does not appear to interact with emetogenic cancer chemotherapies. (7) Inducers or inhibitors of CYP450 enzymes may change the clearance and therefore the half-life of granisetron. (7) Coadministration of granisetron hydrochloride injection with drugs known to prolong the QT interval and/or are arrhythmogenic may result in clinical consequences. (7) USE IN SPECIFIC POPULATIONS Pregnancy: Use only if clearly needed. (8.1) Nursing mothers: Caution should be exercised when administered to a nursing woman. (8.3) Geriatric use: No differences in responses between the elderly and younger patients were observed in reported clinical experience. (8.5)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

3
  • The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

2 DOSAGE AND ADMINISTRATION


2.1 Prevention of Chemotherapy-Induced Nausea and Vomiting

Adult Patients


Infusion Preparation


Stability




Pediatric Patients
[see Clinical Studies (14)].

3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1 Gastric or Intestinal Peristalsis

5.2 Cardiovascular Events


5.3 Hypersensitivity Reactions

3

6 ADVERSE REACTIONS


[see Warnings and Precautions (5.2) and Drug Interactions (7)].

6.1 Clinical Trials Experience



Chemotherapy-Induced Nausea and Vomiting


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%
1





Hepatic:

Cardiovascular:

Central Nervous System:

Hypersensitivity:

Other:

6.2 Postmarketing Experience



[see Warnings and Precautions (5.2) and Drug Interactions (7)].

7 DRUG INTERACTIONS

in vitroin vitro

in vitroin vivo

8 USE IN SPECIFIC POPULATIONS


8.1 Pregnancy

Pregnancy Category B
22

8.3 Nursing Mothers

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.

8.4 Pediatric Use

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.

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

3endo18244
GRANISETRON HYDROCHLORIDE



12 CLINICAL PHARMACOLOGY


12.1 Mechanism of Action

3311A1B/C21221

333



12.3 Pharmacokinetics

Chemotherapy-Induced Nausea and Vomiting

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

†

Distribution


Metabolism
In vitro3

Elimination


Subpopulations

Gender
max

Elderly


Pediatric Patients


Renal Failure Patients


Hepatically Impaired Patients

13 NONCLINICAL TOXICOLOGY


13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

222222222

[see Indications and Usage (1) and Dosage and Administration (2)].

in vitroin vivoin vitroex vivoin vitroin vitro

2

14 CLINICAL STUDIES


14.1 Chemotherapy-Induced Nausea and Vomiting

Single-Day Chemotherapy
Cisplatin-Based Chemotherapy


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
122
2

2

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
12
2

22

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
12
2



Moderately Emetogenic Chemotherapy
222

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
1
2



Repeat-Cycle Chemotherapy


Pediatric Studies
2222

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%
1

2

16 HOW SUPPLIED/STORAGE AND HANDLING








17 PATIENT COUNSELING INFORMATION



3





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GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64679-662
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GRANISETRON HYDROCHLORIDE GRANISETRON 0.1 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 VIAL, SINGLE-USE
2 NDC:64679-662-02 1 in 1 CARTON
3 NDC:64679-662-01 5 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078566 2008-03-03


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