Sancuso Transdermal System

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist. Chemotherapy and radiation therapy are associated with the release of serotonin from the enterochromaffin cells of the small intestine, which then stimulates 5-HT3 receptors located on vagal afferent neurons to initiate the vomiting reflex. Granisetron blocks this stimulation, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone, thereby preventing nausea and vomiting.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Stomach pain
Swelling of the belly
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek immediate medical attention if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Headache
Dizziness
Drowsiness
Fatigue
Weakness
Diarrhea or constipation
Heartburn
Decreased appetite
Trouble sleeping
* Irritation at the site of application

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
If you are taking apomorphine, as this may interact with this medication.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize potential risks, avoid applying heat to the treated area using heating pads or other heating devices. Additionally, limit your exposure to the sun, sunlamps, and tanning beds, as this medication may be less effective or cause skin irritation under these conditions. To protect your skin, keep the patch covered with clothing and cover the area where the patch was applied for 10 days after removal. Consult your doctor for further guidance. Until you understand how this medication affects you, be cautious when driving or engaging in activities that require your full attention. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, MAOIs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Although granisetron has minimal effect on QT interval, caution is advised.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease granisetron plasma concentrations.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase granisetron plasma concentrations.

• Nausea
• Vomiting
• Headache
• Constipation
• Diarrhea
• Fever
• Insomnia
• Anxiety
• Dizziness
• Skin irritation at patch site (redness, itching, burning)
• Symptoms of serotonin syndrome (agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

Use during pregnancy only if clearly needed. Animal studies have not shown harm, but there are no adequate and well-controlled studies in pregnant women. The transdermal system may offer advantages by avoiding oral administration in patients with severe nausea/vomiting.

Caution is advised. It is not known whether granisetron is excreted in human milk, but it is excreted in the milk of lactating rats. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients under 18 years of age have not been established. Not recommended for this population.

No dosage adjustment is necessary for elderly patients. Clinical studies did not identify differences in efficacy or safety between elderly and younger patients.

• Sancuso is the only transdermal 5-HT3 receptor antagonist, offering a convenient option for patients who may have difficulty with oral medications or require prolonged antiemetic coverage.
• The patch should be applied 24-48 hours before chemotherapy to ensure adequate plasma levels at the start of treatment.
• Avoid applying the patch to areas that will be exposed to heat, as this can increase drug absorption and potentially lead to adverse effects.
• Ensure proper disposal of used patches to prevent accidental exposure to children or pets.
• Consider Sancuso for patients receiving multi-day chemotherapy regimens or those with anticipated prolonged emesis.

• Ondansetron (oral, IV, ODT)
• Palonosetron (IV)
• Dolasetron (oral, IV)
• Netupitant/Palonosetron (oral)
• Rolapitant (oral, IV)
• Aprepitant (oral)
• Fosaprepitant (IV)
• Dexamethasone (oral, IV)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.