Sancuso
- Generic Name: granisetron transdermal system
- Brand Name: Sancuso
Sancuso (Granisetron Transdermal System) side effects drug center
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- Health Resources
- Sancuso User Reviews
Sancuso Side Effects Center
Sancuso (Granisetron Transdermal System) skin patch is an anti-nauseant and antiemetic used to prevent nausea and vomiting caused by cancer chemotherapy. Common side effects of Sancuso include:
- constipation,
- diarrhea,
- nausea,
- vomiting,
- stomach pain,
- loss of appetite,
- headache,
- itching or skin irritation where the patch is worn,
- dizziness,
- drowsiness,
- anxiety,
- sleep problems (insomnia), or
- temporary hair loss
The dose of Sancuso is a single patch applied to the upper outer arm a minimum of 24 hours and a maximum of 48 hours before chemotherapy, and removed a minimum of 24 hours after chemotherapy completion. The patch can be worn up to 7 days depending on the duration of the chemotherapy. Sancuso may interact with other drugs. Tell your doctor all medications and supplements you use. Natural or artificial sunlight can cause a skin reaction where the skin patch is worn. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch. During pregnancy, Sancuso should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Sancuso (Granisetron Transdermal System) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Sancuso Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have:
- pain or swelling in your stomach;
- severe redness, itching, swelling, or other irritation where the patch is worn; or
- high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common side effects may include:
- constipation;
- headache; or
- mild skin irritation where the patch was worn.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Sancuso (Granisetron Transdermal System)
Sancuso Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Sancuso was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with patch treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.
Adverse reactions occurred in 8.7% (35/404) of patients receiving Sancuso and 7.1% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Sancuso group and 3.0% of patients in the oral granisetron group.
Table 1 lists the adverse reactions that occurred in at least 3% of patients treated with Sancuso or oral granisetron.
Table 1: Incidence of Adverse Reactions in
Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving
Chemotherapy (Events ≥ 3% in either group)
| Body System Preferred Term | Sancuso TDS N=404 (%) | Oral granisetron N=406 (%) |
| Gastrointestinal disorders | ||
| Constipation | 5.4 | 3.0 |
| Nervous system disorders | ||
| Headache | 0.7 | 3.0 |
5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 patients in a randomized, parallel group, double-blind, double-dummy study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy. QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron, and 3 (1.1%) on the patch. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.
Adverse reactions reported in clinical trials with other formulations of granisetron include the following:
Gastrointestinal: abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting
Cardiovascular: Hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely
Central Nervous System: dizziness, insomnia, headache, anxiety, somnolence and asthenia
Hypersensitivity: rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported
Other: fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia, thrombocytopenia.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Sancuso. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions: Application site reactions (pain, pruritus, erythema, rash, irritation, vesicles, burn, discoloration, urticaria); patch non-adhesion)
Cardiac Disorders: bradycardia, chest pain, palpitations, sick sinus syndrome
Read the entire FDA prescribing information for Sancuso (Granisetron Transdermal System)
&Copy; Sancuso Patient Information is supplied by Cerner Multum, Inc. and Sancuso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.