In the U.S.—

In Canada—

• Antiemetic

Granisetron ( gra-NI-se-tron) is used to prevent the nausea and vomiting that may occur after treatment with anticancer medicines (chemotherapy) or with radiation therapy.

Granisetron is to be given only by or under the immediate supervision of your doctor. It is available in the following dosage forms:

Oral
• Tablets (U.S. and Canada)

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For granisetron, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to granisetron, dolasetron, or ondansetron. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Granisetron has not been studied in pregnant women. However, granisetron has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether granisetron passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children 2 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Dosing—

The dose of granisetron will be different for different patients. The following information includes only the average doses of granisetron.

• For prevention of nausea and vomiting caused by anticancer medicine:
  • For oral dosage form (tablets):
    • Adults and teenagers—Dose is usually 1 milligram (mg) taken up to one hour before the anticancer medicine. The 1-mg dose is taken again twelve hours after the first dose. Alternatively, 2 mg may be taken as one dose, up to one hour before the anticancer medicine.
    • Children—Dose must be determined by your doctor.
  • For injection dosage form:
    • Adults and children 2 years of age or older—Dose is based on body weight and must be determined by your doctor. It is usually 10 micrograms (mcg) per kilogram (kg) (4.5 mcg per pound) of body weight. It is injected into a vein over a period of five minutes, beginning within thirty minutes before the anticancer medicine is given.
    • Children up to 2 years of age—Dose must be determined by your doctor.
• For prevention of nausea and vomiting caused by radiation therapy:
  • For oral dosage form (tablets):
    • Adults and teenagers—Dose is 2 milligrams (two 1 milligram tablets) taken within 1 hour of radiation.
    • Children—Dose must be determined by your doctor.

Check with your doctor if severe nausea and vomiting occur after receiving the anticancer medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Fever 
  
  

• Rare
  • Chest pain;  fainting;  irregular heartbeat;  shortness of breath;  skin rash, hives, and itching 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal pain;  constipation;  diarrhea;  headache;  unusual tiredness or weakness 
  
  

• Less common
  • Agitation;  dizziness;  drowsiness;  heartburn;  indigestion;  sour stomach;  trouble in sleeping;  unusual taste in mouth 
  
  

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, granisetron injection is used in certain patients to prevent the nausea and vomiting that may occur after cancer radiation treatment in patients undergoing bone marrow transplantation.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.