Granisetron

Granisetron is a prescription medication used to prevent nausea and vomiting caused by chemotherapy, radiation, or surgery. Granisetron belongs to a group of drugs called serotonin 5-HT3 antagonists, which block serotonin, a natural chemical in the body, from causing nausea and vomiting.

This medication comes in tablet form, a patch, and in an intravenous (IV) form. The tablet is taken 1 hour before chemotherapy or radiation, and in the case of chemotherapy, may be taken again 12 hours later. The patch is appled 24 to 48 hours before your scheduled chemotherapy treatment. The injectable form of granisetron can be given by IV within 30 minutes before chemotherapy.

Common side effects include headache, constipation, and diarrhea. Granisetron can cause drowsiness. Do not drive or operate heavy machinery until you know how it affects you.

Granisetron is a prescription medication used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy. The injectable form is also used to prevent nausea and vomiting related to surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Granisetron may be found in some form under the following brand names:

• Granisol

• Kytril

• Sancuso

• Sustol

Granisetron can cause serious side effects. See "Drug Precautions" section.

Common side effects include:

• weakness
• headache
• stomach pain
• constipation
• diarrhea
• drowsiness
• insomnia

This is not a complete list of granisetron side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)

• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)

This is not a complete list of granisetron drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with granisetron including:

Do not take granisetron if you:

• are allergic to granisetron or any inactive ingredient in granisetron
• have long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death)

Granisetron can cause drowsiness. Do not drive or operate heavy machinery until you know how granisetron affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of granisetron, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking granisetron, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• or anyone in your family has or has ever had long QT syndrome (a condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death)
• have heart disease
• have liver disease
• have an electrolyte imbalance
• have pain or swelling in your stomach area (abdomen)
• are allergic to medical adhesive tape, adhesive dressings or other skin patches (for the patch formulation only)
• are breastfeeding or plan to breastfeed. It is not known if Sancuso passes into your breast milk.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Granisetron falls into category B. There are no good studies that have been done in humans with granisetron. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

It is not known if granisetron crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using granisetron.

• Take granisetron exactly as prescribed.
• Granisetron comes in tablet form, a patch, and in an injectable (IV) form.
• The oral form is usually taken one hour before cancer chemotherapy or radiation. It can be taken twice daily if used for cancer chemotherapy.
• Apply granisetron patch 24 to 48 hours before your scheduled chemotherapy treatment.
  • Wear the patch all the time during your chemotherapy. Granisetron patch may be worn for up to 7 days, depending on how long your chemotherapy treatment lasts (up to 5 days).
  • Wait to remove the patch at least 1 day (24 hours) after your chemotherapy is finished.
• The injectable form of granisetron can be given by IV within 30 minutes before chemotherapy.
• Granisetron tablets can be taken with or without food. Take it on an empty stomach if your doctor tells you to do so.

Take granisetron exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Cancer Chemotherapy

If you take too much granisetron, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store granisetron tablets between 15º and 30ºC (59º and 86ºF). Keep container closed tightly. Protect from light.
• Keep this and all medications out of the reach of children.