Brand Name

    US Brand Name

    Sancuso


    Description

    Granisetron skin patch is used to prevent nausea and vomiting that may occur after cancer treatment (chemotherapy). It is usually given to patients receiving chemotherapy for 5 consecutive days that causes moderate to severe nausea and vomiting. Granisetron works in the nervous system to block the action of a chemical that causes nausea and vomiting.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Patch, Extended Release

    Before Using

    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.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of granisetron skin 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 skin 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 this medicine.

    Breastfeeding

    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.

    Drug Interactions

    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 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
    • Bedaquiline
    • Benzhydrocodone
    • Benzphetamine
    • Brompheniramine
    • Buprenorphine
    • Buserelin
    • Buspirone
    • Butorphanol
    • Carbamazepine
    • Ceritinib
    • Chloroquine
    • Chlorpheniramine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clofazimine
    • Clomipramine
    • Clothiapine
    • Clozapine

    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:

    • Stomach or bowel blockage or
    • Stomach surgery, history of—May cover up symptoms of these stomach or bowel problems (eg, gastric distention, progressive ileus).

    Proper Use

    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.

    This medicine 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, almost hairless, intact healthy skin area on your upper outer arm. Do not put the patch over red, damaged, or irritated skin. Avoid putting the patch on areas that have been treated with other skin products (eg, creams, oils, lotions, powders).
    • Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
    • If the patch does not stick well, use medical tape around the edges to keep it in place. Do not cover the patch completely. If the patch comes more than halfway off or becomes damaged, call your doctor for instructions.
    • 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 this medicine.
    • 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.
    • Remove the patch by peeling it off from the skin gently.

    Dosing

    The dose of this medicine 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 this medicine. 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.


    Precautions

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

    Do not take other medicines containing granisetron while using Sancuso®. Using these medicines together may cause serious unwanted side effects.

    Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

    Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

    Serious skin reactions may occur while using the patch. Check with your doctor right away if you have a skin rash, itching, redness, or any skin irritation while you are wearing the patch.

    Do not use a heating pad or heat lamp near the Sancuso® patch. Avoid sunlamps and tanning beds while using this medicine.

    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

    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:

    More common

    • Severe constipation

    Incidence not known

    • Anxiety
    • arm, back, or jaw pain
    • black, tarry stools
    • bleeding gums
    • blood in the urine or stools
    • blurred vision
    • chest pain or discomfort
    • chest tightness or heaviness
    • chills
    • confusion
    • cough
    • diarrhea
    • difficulty with swallowing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • fast, slow, or irregular heartbeat
    • fever
    • headache
    • hives or welts, itching, or skin rash
    • muscle spasms or twitching
    • nausea
    • nervousness
    • painful or difficult urination
    • pain, itching, redness, irritation, blistering, burning, discoloration, or rash where the patch is applied
    • pale skin
    • pinpoint red spots on the skin
    • pounding in the ears
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • redness of the skin
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • sleepiness or unusual drowsiness
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stomach pain or swelling
    • sweating
    • swollen glands
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • 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:

    Incidence not known

    • Decreased appetite
    • hair loss or thinning of the hair
    • lack or loss of strength
    • 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.






    CON-XXXXXXXX

    عطاؤك له أثر كبير — تبرَّع الآن!

    تساهم التبرّعات، وهي قابلة للخصم الضريبي، في دعم آخر التطورات في الأبحاث وطرق الرعاية لإحداث نقلة نوعية في الطب.