Sancuso 3.1mg/24hr Transderm Patch

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist. Serotonin 5-HT3 receptors are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. Chemotherapy induces the release of serotonin from enterochromaffin cells of the small intestine, which then activates 5-HT3 receptors, initiating the vomiting reflex. Granisetron blocks this action, preventing nausea and vomiting.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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 or dizziness
+ Passing out or 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, or 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 or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Dizziness, sleepiness, tiredness, or weakness
Diarrhea or constipation
Heartburn
Decreased appetite
Trouble sleeping
Irritation at the site of application

This is not an exhaustive list of possible side effects. 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 you are currently taking
Over-the-counter (OTC) medications
Natural products, such as herbal supplements
* Vitamins

You must verify that it is safe to take this medication with all of your existing medications and health conditions. Do not initiate, discontinue, or modify the dosage 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 using heating pads or other heating devices on the area where the medication is applied. 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.

• Apomorphine (increased risk of severe hypotension and loss of consciousness)

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, MAOIs, mirtazapine, fentanyl, lithium, tramadol, triptans) - increased risk of serotonin syndrome.
• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones) - additive QT prolongation risk.

• Nausea
• Vomiting
• Headache
• Constipation
• Diarrhea
• Dizziness
• Application site reactions (redness, itching, irritation)
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, muscle rigidity, tremor, incoordination)

Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of Sancuso transdermal system have not been established in pediatric patients.

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

• Sancuso patch offers a convenient, sustained-release option for CINV prevention, particularly useful for patients who may have difficulty with oral medications or require prolonged antiemetic coverage.
• Ensure proper application technique (clean, dry, intact skin on upper outer arm, rotate sites) to optimize absorption and minimize skin irritation.
• Advise patients to avoid external heat sources over the patch, as this can increase drug release and systemic exposure.
• While no dose adjustment is needed for renal or hepatic impairment, monitor patients with underlying cardiac conditions or electrolyte imbalances due to the potential for QT prolongation.

• Oral granisetron (Kytril)
• IV granisetron
• Oral ondansetron (Zofran)
• IV ondansetron
• Oral palonosetron (Aloxi)
• IV palonosetron
• Netupitant/palonosetron (Akynzeo) - oral or IV
• Rolapitant (Varubi) - oral or IV
• Aprepitant (Emend) - oral or IV
• Fosaprepitant (Emend) - IV
• Dexamethasone

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it happened.