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Granisetron Hydrochloride

Breckenridge Pharmaceutical, Inc.
Natco Pharma Limited

GRANISETRON HYDROCHLORIDE TABLETS, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RX Only


GRANISETRON HYDROCHLORIDE DESCRIPTION


endo18244
Granisetron Hydrochloride
                                                 granisetron hydrochloride



Tablets for Oral Administration

Each white, triangular, biconvex, film-coated granisetron hydrochloride tablet contains 1.12 mg granisetron hydrochloride,USP equivalent to granisetron 1 mg.Inactive ingredients are: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.

CLINICAL PHARMACOLOGY


3311A1B/C21221

333



Pharmacokinetics


Table 1.

Table 1 Pharmacokinetic Parameters (Median [range]) Following Granisetron Hydrochloride Tablets
N.D. Not determined.
 
* Not determined after oral administration; following a single intravenous dose of 40 mcg/kg, terminal phase half-life was determined to be 8.95 hours.
 
Peak Plasma Concentration
(ng/mL)
Terminal Phase Plasma Half-Life
(h)
Volume of Distribution
(L/kg)
Total Clearance
(L/h/kg)
Cancer Patients
1 mg bid, 7 days
(n=27)
5.99
[0.63 to 30.9]
N.D.*
N.D.
0.52
[0.09 to 7.37]
Volunteers
single 1 mg dose
(n=39)
 3.63
[0.27 to 9.14]
6.23
[0.96 to 19.9]
3.94
[1.89 to 39.4]
0.41
[0.11 to 24.6]




max







In vitro3







Gender

max



Elderly



Renal Failure Patients



Hepatically Impaired Patients



Pediatric Patients

CLINICAL TRIALS

Chemotherapy-Induced Nausea and Vomiting


Moderately Emetogenic Chemotherapy


22Table 2

Table 2 Prevention of Nausea and Vomiting 24 Hours Post-Chemotherapy*
*Chemotherapy included oral and injectable cyclophosphamide, carboplatin, cisplatin (20 mg/m2 to 50 mg/m2), dacarbazine, doxorubicin, epirubicin.
† No vomiting, no moderate or severe nausea, no rescue medication.
‡ Statistically significant (P<0.01) vs. 0.25 mg bid.
§ Statistically significant (P<0.01) vs. 0.5 mg bid.
 
Percentages of Patients
Granisetron hydrochloride Tablet Dose

Efficacy
Measures 		0.25 mg twice a day
(n=229)
%
0.5 mg twice a day
(n=235)
%
1 mg twice a day
(n=233)
%
2 mg twice a day
(n=233)
%

Complete
Response† 		61
 70‡
81‡§
72‡
No Vomiting
 66
 77‡
88‡
79‡
No Nausea
 48
 57
 63‡
54

Table 3

Table 3 Prevention of Nausea and Vomiting 24 Hours Post-Chemotherapy*
* Moderately emetogenic chemotherapeutic agents included cisplatin (20 mg/m2 to 50 mg/m2), oral and intravenous cyclophosphamide, carboplatin, dacarbazine, doxorubicin.
†Historical control from a previous double-blind granisetron hydrochloride trial.
‡ No vomiting, no moderate or severe nausea, no rescue medication.
No vomiting, no nausea, no rescue medication.
§ Statistically significant (P<0.05) vs. prochlorperazine historical control.
 
Percentage of Patients
Efficacy Measures
Granisetron
Hydrochloride
1 mg twice  a day
(n = 354)
%
Granisetron Hydrochloride Tablets
2 mg once a day
(n = 343)
%
Prochlorperazine†
10 mg twice a day
(n=111)
%
Complete
Response‡
69 §
64 §
41
No Vomiting
 82 §
77 §
48
No Nausea
 51 §
53 §
35
Total Control
51 §
50 §
33


Table 3.

Cisplatin-Based Chemotherapy


2



Radiation-Induced Nausea and Vomiting


Total Body Irradiation

3





Fractionated Abdominal Radiation

2



GRANISETRON HYDROCHLORIDE INDICATIONS AND USAGE




  • Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
  • Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

GRANISETRON HYDROCHLORIDE CONTRAINDICATIONS


PRECAUTIONS




Drug Interactions


in vitroin vitro

in vitroin vivo

Carcinogenesis & Mutagenesis & Impairment Of Fertility


222222222

INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION

in vitroin vivoin vitroex vivoin vitroin vitro

2

Pregnancy




Pregnancy Category B

22

Nursing Mothers



Pediatric Use



Geriatric Use

GRANISETRON HYDROCHLORIDE ADVERSE REACTIONS


PRECAUTIONS  Drug Interactions).

Chemotherapy-Induced Nausea and Vomiting




Table 4.

Table 4 Principal Adverse Events in Clinical Trials
* Adverse events were recorded for 7 days when granisetron hydrochloride tablets were given on a single day and for up to 28 days when granisetron hydrochloride tablets were administered for 7 or 14 days.
† Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.
 
Percent of Patients With Event
Granisetron Hydrochloride Tablets*
1 mg twice a day
(n=978)
Granisetron Hydrochloride Tablets*
2 mg once a day
(n=1450)
Comparator†
(n=599)
Placebo
(n=185)
Headache
 21%
 20%
 13%
 12%
Constipation
 18%
 14%
 16%
 8%
Asthenia
 14%
 18%
 10%
 4%
Diarrhea
 8%
 9%
 10%
 4%
Abdominal pain
 6%
 4%
 6%
 3%
Dyspepsia
 4%
 6%
 5%
 4%



Gastrointestinal:

Hepatic:

Cardiovascular:

Central Nervous System:

Hypersensitivity:

Other:

Table 5

Table 5 Principal Adverse Events in Clinical Trials — Single-Day Chemotherapy
*Adverse events were generally recorded over 7 days post-granisetron hydrochloride Injection administration.
† Metoclopramide/dexamethasone and phenothiazine/dexamethasone.
 
 Percent of Patients with Event
Granisetron
hydrochloride Injection*
40 mcg/kg
(n=1268)
Comparator†
(n=422)
Headache
 14%
 6%
Asthenia
 5%
 6%
Somnolence
 4%
 15%
Diarrhea
 4%
 6%
Constipation
 3%
 3%


Radiation-Induced Nausea and Vomiting


Postmarketing Experience


PRECAUTIONS Drug Interactions

OVERDOSAGE


GRANISETRON HYDROCHLORIDE DOSAGE AND ADMINISTRATION


Emetogenic Chemotherapy



Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients

CLINICAL PHARMACOLOGY: Pharmacokinetics

Pediatric Use



Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)



Pediatric Use



Use in the Elderly

HOW SUPPLIED


















PRINCIPAL DISPLAY PANEL - 1.12 mg Tablet Carton

NDC 51991-735-20

Breckenridge
Pharmaceutical, Inc.

20 (2×10) Unit Dose Tablets

Granisetron Hydrochloride Tablets, USP

1 mg*

*Each tablet contains 1.12 mg granisetron hydrochloride USP
equivalent to granisetron, 1 mg

This unit-dose package is not-child-resistant.
For institutional use only.

Rx Only

Granisetron Hydrochloride

Granisetron Hydrochloride

Granisetron Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51991-735
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GRANISETRON HYDROCHLORIDE GRANISETRON 1 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
polysorbate 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm 1GN TRIANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 2 in 1 BLISTER PACK
3 NDC:51991-735-32 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078969 2009-06-22


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