Granisetron Hydrochloride (gra-NIS-e-tron hye-droe-KLOR-ide)

Prevents nausea and vomiting caused by cancer treatments (chemotherapy or radiation), including cisplatin. Also prevents and treats nausea and vomiting that may happen after surgery.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• When this medicine is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy), it is usually given 30 minutes before the start of chemotherapy, and only on the day your cancer treatment is given.
• When this medicine is used to prevent and treat nausea and vomiting caused by surgery, it is usually given 30 seconds before anesthesia (medicine to put you to sleep before surgery) or right after surgery if nausea and vomiting begin.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using arsenic trioxide (Trisenox®), cisapride (Propulsid®), dofetilide (Tikosyn®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Levaquin®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems (such as prolonged QT interval), mineral imbalance, stomach or bowel problems, or a recent stomach surgery. Tell your doctor if you have an allergy to other similar medicines such as alosetron (Lotronex®), dolasetron (Anzemet®), ondansetron (Zofran®), or palonosetron (Aloxi®).
• This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; dizziness or lightheadedness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.
• Check with your doctor right away if you or your child start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.
• This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Check with your doctor if you are concerned.
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate.
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Shortness of breath.

If you notice these less serious side effects, talk with your doctor:

• Bad or unusual taste in your mouth.
• Constipation, diarrhea, gas, or stomach pain or upset.
• Drowsiness or weakness.
• Feeling anxious, agitated, or restless.
• Headache.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Skin rash.
• Trouble sleeping.
• Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088