Granisetron transdermal

You should not use granisetron if you are allergic to it.

To make sure granisetron transdermal is safe for you, tell your doctor if you have:

• a stomach or intestinal disorder;

• if you have recently had stomach or intestinal surgery; or

• if you have ever had an allergic reaction to any type of medicated skin patch.

Granisetron transdermal is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether granisetron transdermal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In the U.S.

• Sancuso

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

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 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of granisetron transdermal patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of granisetron transdermal patch have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related heart, liver, or kidney problems, which may require caution in patients receiving granisetron transdermal patch.

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.

Interactions with 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 taking granisetron, 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 granisetron 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.

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

Using granisetron 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.

• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buserelin
• Buspirone
• Butorphanol
• Carbamazepine
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Erythromycin
• Escitalopram
• Fentanyl
• Fingolimod
• Flecainide
• Fluoxetine
• Fluvoxamine
• Foscarnet
• Frovatriptan
• Furazolidone
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lopinavir
• Lorcaserin
• Lumefantrine
• Mefloquine
• Melitracen
• Meperidine
• Methadone
• Methamphetamine
• Methylene Blue
• Metronidazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Opipramol
• Oxycodone
• Oxymorphone
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentazocine
• Phenelzine
• Pimavanserin
• Pitolisant
• Posaconazole
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rasagiline
• Remifentanil
• Ribociclib
• Rizatriptan
• Salmeterol
• Selegiline
• Sertraline
• Sevoflurane
• Sibutramine
• 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
• Toremifene
• Tramadol
• Tranylcypromine
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Tryptophan
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilazodone
• Vinflunine
• Voriconazole
• Vortioxetine
• Zolmitriptan
• Zuclopenthixol

Using granisetron with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Phenobarbital

Interactions with Food/Tobacco/Alcohol

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 granisetron. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage or
• Gastric distention (enlarged abdomen)—May cover up symptoms of these stomach or bowel problems.

Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.

granisetron should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the skin patch:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
• Wash the area of skin where you will apply the patch gently with soap and warm water. Rinse completely and dry with a clean dry towel.
• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, intact skin area on your upper outer arm. Do not put the patch over rashes, cuts, or irritated skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
• Leave the patch in place for at least 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on how long you are receiving chemotherapy.
• Avoid swimming, strenuous exercise, or using a sauna or whirlpool while using granisetron.
• Do not expose the patch to direct sunlight or sunlamps. This could destroy the medicine in the patch. If you will be exposed to direct sunlight or sunlamps, cover your skin with clothing where you have the patch. Keep the clothing on this area while you are wearing it and for 10 days after you remove it.

Dosing

The dose of granisetron will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of granisetron. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (skin patch):
  • For prevention of nausea and vomiting caused by chemotherapy:
    • Adults—One patch applied at least 24 to 48 hours before chemotherapy.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

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 immediately if any of the following side effects occur:

• Difficulty having a bowel movement (stool)

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• cough
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast or irregular heartbeat
• headache
• hives or welts, itching, or skin rash
• nausea
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• slow heartbeat
• sweating
• trouble breathing
• unusual tiredness or weakness

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• diarrhea
• fear
• fever
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sleepiness or unusual drowsiness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swollen glands
• troubled breathing with exertion
• unusual bleeding or bruising
• vomiting

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:

• Decreased appetite
• hair loss or thinning of the hair
• lack or loss of strength
• pain, itching, redness, discoloration, or irritation where you applied the patch
• trouble sleeping

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.

Before using granisetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ileus, swelling).

This medication may be affected by sunlight or may make the application site more sensitive to sunlight. While wearing the patch, keep it covered (such as under clothing) to avoid exposing it to sunlight and sunlamps. Avoid tanning booths. After removing the patch, keep the application site covered for another 10 days. Tell your doctor right away if you get sunburned or have skin blisters/redness.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: apomorphine.

If you are currently using the medication listed above, tell you doctor or pharmacist before starting granisetron.

Before using this medication, tell your doctor of all prescription and nonprescription/herbal products you may use.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

Tell your doctor if you miss your dose or did not use your dose at the correct time before your scheduled chemotherapy appointment. Your treatment may need to be rescheduled.

Storage

Store the patch at room temperature between 68-77 degrees F (20-25 degrees C) in the original sealed pouch away from heat. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not open the pouch until you are ready to use the patch. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.