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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 intravenous useInitial U.S. Approval: 1993


1 INDICATIONS AND USAGE

  • 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


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


6 ADVERSE REACTIONS


6.1 Clinical Trials Experience

Headache14%6%
Constipation3%3%

6.2 Postmarketing Experience


7 DRUG INTERACTIONS


8 USE IN SPECIFIC POPULATIONS


8.1 Pregnancy


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


12 CLINICAL PHARMACOLOGY


12.1 Mechanism of Action


12.3 Pharmacokinetics

Cancer Patients
  Mean63.8* 8.95* 0.38* 3.07*
  Range18.0 to 1760.90 to 31.10.14 to 1.540.85 to 10.4
Volunteers
  21 to 42 years
  Mean64.3†4.91†0.79†3.04†
  Range11.2 to 1820.88 to 15.20.20 to 2.561.68 to 6.13
  65 to 81 years
  Mean57.0†7.69†0.44†3.97†
  Range14.6 to 1532.65 to 17.70.17 to 1.061.75 to 7.01

13 NONCLINICAL TOXICOLOGY


13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility


14 CLINICAL STUDIES


14.1 Chemotherapy-Induced Nausea and Vomiting

Number of Patients1414
Response Over 24 Hours
Complete Response293%7%<0.001
No Vomiting93%14%<0.001
No More Than Mild Nausea93%7%<0.001
Number of Patients525253
Response Over 24 Hours
Complete Response231%62%68%<0.002<0.001
No Vomiting38%65%74%<0.001<0.001
No More Than Mild Nausea58%75%79%NS0.007
High-Dose Cisplatin
Number of Patients40494847
Response Over 24 Hours
  Complete Response218%41%40%47%0.0180.0250.004
  No Vomiting28%47%44%53%NSNS0.016
  No Nausea15%35%38%43%0.0360.0190.005
Low-Dose Cisplatin
Number of Patients42414046
Response Over 24 Hours
  Complete Response229%56%58%41%0.0120.009NS
  No Vomiting36%63%65%43%0.0120.008NS
  No Nausea29%56%38%33%0.012NSNS
Number of Patients133133
Response Over 24 Hours
Complete Response268%47%<0.001
No Vomiting73%53%<0.001
No More Than Mild Nausea77%59%<0.001
Number of Patients292625
Median Number of Vomiting Episodes231
Complete Response Over 24 Hours121%31%32%

16 HOW SUPPLIED/STORAGE AND HANDLING


17 PATIENT COUNSELING INFORMATION


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL