GRANISOL (granisetron hcl)

There are 0 contraindications.

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Congenital long QT syndrome
Doxorubicin-induced cardiomyopathy
Hypokalemia
Hypomagnesemia
Neuroleptic malignant syndrome
Prolonged QT interval
Serotonin syndrome

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Gastrointestinal hypomotility

There are 17 severe adverse reactions.

More Frequent	Less Frequent
None.	Fever

Rare/Very Rare
Anaphylaxis Atrial fibrillation Bradycardia Cardiac arrhythmia Chest pain Dyspnea Hypersensitivity drug reaction Increased alanine transaminase Increased aspartate transaminase Prolonged QT interval Pruritus of skin Serotonin syndrome Sick sinus syndrome Skin rash Syncope Urticaria

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Constipation Fatigue	Abnormal hepatic function tests Agitation Diarrhea Dizziness Drowsy Dysgeusia Dyspepsia Flushing General weakness Headache disorder Hypertension Hypotension Insomnia Symptoms of anxiety

Rare/Very Rare
Palpitations

There are no available clinical data regarding the use of granisetron in pregnant women to assess potential drug-related risks. In animal studies, no evidence of impaired fertility or fetal harm was observed when pregnant rats received IV doses of granisetron up to 9 mg/kg per day (equivalent to 146 times the recommended human dose based on body surface area (BSA)), or when pregnant rabbits were given IV doses up to 3 mg/kg per day (96 times the human dose based on BSA). Similarly, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron during organogenesis at IV doses up to 61 and 41 times, respectively, the maximum recommended human dose (MRHD) of subcutaneous granisetron 10 mg/week and at IV doses up to 24 times and 16 times, respectively, the MRHD delivered by the granisetron transdermal system based on BSA.

No evidence of impaired fertility or fetal harm was observed when pregnant rats received oral doses of granisetron up to 125 mg/kg per day (equivalent to 507 times the recommended human dose based on BSA), or when pregnant rabbits were given oral doses up to 32 mg/kg per day (255 times the human dose based on BSA). Use granisetron during pregnancy only when clearly needed.

It is not known whether granisetron is distributed into human milk; its effects on milk production or on the breast-fed infant are also unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug in addition to any possible adverse effects on the nursing infant from the drug or underlying maternal condition. Use with caution when administered during lactation.

In CINV clinical trials, 713 patients receiving IV granisetron were >=65 years of age; safety and effectiveness of the drug were similar in patients of various ages. Amongpatients who received IV granisetron in PONV clinical trials, 168 patients were >=65 years of age, of which 47 were >=75 years of age. Clinical studies of IV granisetron did not include sufficient numbers of subjects >=65 years of age to determine whether they respond differently from younger patients.

Other reported clinical experience has not identified differences in responses between geriatric and younger patients. Among patients receiving granisetron tablets in clinical trials, 325 were >=65 years of age,298 were 65-74 years of age, and 27 were >=75 years of age. Efficacy and safety were maintained with increasing age.

Among the 738 patients receiving subcutaneous granisetron in clinical trials, 177 (24%) were >=65 years of age and 39 (5%) were >=75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Clinical studies of granisetron transdermal system did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, select dosage with caution in geriatric patients because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pharmacokinetic parameters in geriatric patients were generally similar to younger patients.