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
|
| Headache | 14% | 6% |
| Constipation | 3% | 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 |
| 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 |
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Chemotherapy-Induced Nausea and Vomiting
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Number of Patients | 29 | 26 | 25 |
| Median Number of Vomiting Episodes | 2 | 3 | 1 |
| Complete Response Over 24 Hours1 | 21% | 31% | 32% |
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL