The information on this website cannot, and should not, replace the conversation between the healthcare professional and the patient. ZALVISO® is a prescription drug-device combination product. Only a healthcare professional can decide which treatment option is the most appropriate for a patient. Individual treatment results with ZALVISO® may vary. Frequently asked questions about using ZALVISO® for the treatment of postoperative pain:
What is ZALVISO® and what is it used for?
ZALVISO® is an innovative ‘drug-device’ combination product. It is a pre-programmed, non-invasive, handheld system that allows hospital patients with acute moderate to severe post-operative pain to self-dose with sufentanil sublingual tablets to manage their pain. The system is designed to help address certain problems associated with post-operative analgesia, which has been shown to cause harm to patients following surgery because of the side effects of opioids such as morphine, the invasive IV route of delivery of current systems for patient-controlled analgesia (PCA) and the complexity of infusion pumps.
How is ZALVISO® used?
ZALVISO® is available as sublingual tablets containing 15 micrograms of sufentanil. The tablets are only for use in hospital and can only be obtained with a prescription from a doctor experienced in treating patients with opioids.
The patient places the ZALVISO® tablets under their tongue when needed using a special device. The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour. The device also uses an identifier so that only the patient who has been given a special thumb tag can release tablets. The tablets must be allowed to dissolve under the tongue and must not be chewed or swallowed. Treatment is continued over a period of up to 72 hours.
For further information, see the IFU section of this website.
How does ZALVISO® work?
The active substance in ZALVISO® is sufentanil. It is a well-known medicine, which has been used to control pain for many years. When the patient places a ZALVISO® tablet under the tongue, a dose of sufentanil is rapidly absorbed into the blood stream through the blood vessels in the lining of the mouth. This allows the medicine to be transported to receptors in the brain and spinal cord where sufentanil acts to relieve pain.
What benefits of ZALVISO® have been shown in studies?
One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip. In both cases ZALVISO® was compared with placebo (a dummy treatment). The main measure of effectiveness was based on a patient score that measured the decrease in intensity of pain over 48 hours of treatment. For abdominal surgery, the average decrease in pain intensity was 50 points greater with ZALVISO® than with placebo (106 versus 56). For knee and hip surgery the decrease in pain intensity was around 88 points greater with ZALVISO® (76 versus -11) than with placebo.
A third main study compared ZALVISO® with the intravenous patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery. Of 177 patients using ZALVISO®, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine.
What are the risks associated with ZALVISO®?
The most common side effects with ZALVISO® are nausea, vomiting, fever (may affect more than 1 in 10 people).
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