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QT prolongation has been reported with KYTRIL (see PRECAUTIONS and DRUG INTERACTIONS).

Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received KYTRIL (granisetron) Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

In patients receiving KYTRIL (granisetron) Tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.

Table 4 Principal Adverse Events in Clinical Trials1

  Percent of Patients With Event
KYTRIL (granisetron) 1 Tablets
1 mg twice a day
(n=978)
KYTRIL (granisetron) 1 Tablets
2 mg once a day
(n=1450)
Comparator2
(n=599)
Placebo
(n=185)
Headache3 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%
1 Adverse events were recorded for 7 days when KYTRIL (granisetron) Tablets were given on a single day and for up to 28 days when KYTRIL (granisetron) Tablets were administered for 7 or 14 days.
2 Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.

Other adverse events reported in clinical trials were:

Gastrointestinal: In single-day dosing studies in which adverse events were collected for 7 days, nausea (20%) and vomiting (12%) were recorded as adverse events after the 24hour efficacy assessment period.

Hepatic: In comparative trials, elevation of AST and ALT ( > 2 times the upper limit of normal) following the administration of KYTRIL (granisetron) Tablets occurred in 5% and 6% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2%; ALT: 9%).

Cardiovascular: Hypertension (1%); hypotension, angina pectoris, atrial fibrillation, and syncope have been observed rarely.

Central Nervous System: Dizziness (5%), insomnia (5%), anxiety (2%), somnolence (1%). One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported in a patient treated with KYTRIL (granisetron) Tablets.

Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported.

Other: Fever (5%). Events often associated with chemotherapy also have been reported: leukopenia (9%), decreased appetite (6%), anemia (4%), alopecia (3%), thrombocytopenia (2%).

Over 5000 patients have received injectable KYTRIL (granisetron) in clinical trials.

Table 5 gives the comparative frequencies of the five commonly reported adverse events ( ≥ 3%) in patients receiving KYTRIL (granisetron) Injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following KYTRIL (granisetron) Injection administration.

Table 5 : Principal Adverse Events in Clinical Trials — Single-Day Chemotherapy

  Percent of Patients with Event
KYTRIL (granisetron) Injection1
40 mcg/kg
(n=1268)
Comparator2
(n=422)
Headache 14% 6%
Asthenia 5% 6%
Somnolence 4% 15%
Diarrhea 4% 6%
Constipation 3% 3%
1 Adverse events were generally recorded over 7 days post-KYTRIL (granisetron) Injection administration.
2 Metoclopramide/dexamethasone and phenothiazines/dexamethasone

In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to KYTRIL (granisetron) , except for headache, which was clearly more frequent than in comparison groups.

Radiation-Induced Nausea and Vomiting

In controlled clinical trials, the adverse events reported by patients receiving KYTRIL (granisetron) Tablets and concurrent radiation were similar to those reported by patients receiving KYTRIL (granisetron) Tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.

Postmarketing Experience

QT prolongation has been reported with KYTRIL (see PRECAUTIONS and DRUG INTERACTIONS).