Pronunciation:

gra-NIS-e-tron hye-droe-KLOR-ide

Brand Names:

• Kytril

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Granisetron

Uses of This Medicine:

Granisetron injection is used to prevent nausea and vomiting that may occur after treatment with cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.

Granisetron is a selective 5-HT3 receptor antagonist. It works in the stomach to block the signals to the brain that cause nausea and vomiting.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of granisetron injection in children with cancer. However, safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects granisetron injection for the prevention and treatment of nausea and vomiting after surgery in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of granisetron injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine
• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anagrelide
• Anileridine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Benzhydrocodone
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buserelin
• Buspirone
• Butorphanol
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Encorafenib
• Entrectinib
• Erythromycin
• Escitalopram
• Ethylmorphine
• Etrasimod
• Fenfluramine
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fostemsavir
• Frovatriptan
• Furazolidone
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Iproniazid
• Isocarboxazid
• Ivabradine
• Ivosidenib
• Ketobemidone
• Ketoconazole
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lopinavir
• Lorcaserin
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Metronidazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Mobocertinib
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Nicomorphine
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentazocine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Piritramide
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Remifentanil
• Ribociclib
• Rizatriptan
• Safinamide
• Selegiline
• Selpercatinib
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tapentadol
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Tilidine
• Toremifene
• Tramadol
• Tranylcypromine
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Tryptophan
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vortioxetine
• Zolmitriptan
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to selective 5-HT3 receptor antagonists (such as alosetron [Lotronex®], dolasetron [Anzemet®], ondansetron [Zofran®], or palonosetron [Aloxi®])—Use with caution. It is likely you will also be allergic to granisetron.

• Bowel blockage or
• Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or bowel problems, especially in patients who had a recent abdominal or stomach surgery.

• Electrolyte imbalance or
• Heart disease—May increase risk to have prolonged QT interval.

• Heart rhythm problems (e.g., arrhythmia, prolonged QT interval)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

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.

Precautions While Using This Medicine:

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

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 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.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This 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 or nurse immediately if any of the following side effects occur:

Less common

Blurred vision

fever

nervousness

pounding in the ears

slow or fast heartbeat

Rare

Arm, back, or jaw pain

chest pain or discomfort

chest tightness or heaviness

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

irregular heartbeat

nausea

shortness of breath

skin rash, hives, and itching

sweating

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

diarrhea

difficulty having a bowel movement (stool)

headache

lack or loss of strength

unusual tiredness or weakness

vomiting

Less common

Agitation

dizziness

drowsiness

fear

heartburn

indigestion

sleepiness or unusual drowsiness

sour stomach

trouble with sleeping

unusual taste in the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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