What is Dzuveo® made from?
Dzuveo® is a 30 microgram sufentanil tablet.

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What is the clinical indication for Dzuveo®?
Dzuveo® is indicated for the management of acute moderate to severe pain in adult patients.

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Can I give Dzuveo® to paediatric patients?
No. The safety and efficacy of sufentanil in children and adolescents below 18 years have not been established. No data is available.

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Can Dzuveo® be given in any setting?
No, Dzuveo® must be administered by a healthcare professional in a medically monitored setting only. A medically monitored setting must have equipment and personnel trained to detect and manage hypoventilation, and availability of supplemental oxygen and opioid antagonists, such as naloxone. 

Dzuveo® should only be prescribed and administered by healthcare professionals who are experienced in the management of opioid therapy; particularly opioid adverse reactions, such as respiratory depression.

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How many doses of Dzuveo® are recommended?
Dzuveo® is provided in a disposable single-dose applicator, to be administered by a healthcare provider as needed by the individual patient, but no more than once every hour, resulting in a maximum dose of 720 micrograms /day. 

Patients with a higher pain intensity at one hour after sufentanil treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.

Dzuveo® should not be used beyond 48 hours.

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How do I administer Dzuveo® to a patient?
Dzuveo® is for sublingual use only. Please see our product ‘how to’ video for a detailed guide on administration.

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What happens if my patient swallows Dzuveo® by accident?
The dispensed sublingual tablet should dissolve under the tongue and should not be chewed or swallowed. If swallowed, the oral bioavailability of Dzuveo® is only 9% which would result in a sub- therapeutic dose.

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What are the contraindications for Dzuveo®?
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC. Patients with significant respiratory depression or pulmonary compromise.

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Is Sufentanil more effective than other opioids?
Analgesia induced by sufentanil is thought to be mediated via activation of μ-opioid receptors primarily within the CNS to alter processes affecting both the perception of and the response to pain. In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral). 

The high lipophilicity of sufentanil allows it to be administered sublingually and achieve a rapid onset of analgesic effect.

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What is the bioavailability of Dzuveo®?
Mean absolute bioavailability after a single sublingual administration of the sufentanil tablet relative to a one-minute intravenous sufentanil infusion of the same dose was 53%.

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How long does it take for Dzuveo® to work?
Dzuveo® reduces pain intensity within 15-30 minutes. Maximum concentrations of sufentanil are achieved approximately 60 minutes after a single dose; this is shortened to approximately 40 minutes following repeated hourly dosing.

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Can I use Dzuveo® in patients with renal impairment?
Sufentanil should be administered with caution to patients with moderate to severe hepatic or severe renal impairment. There is no data on Dzuveo® usage in patients with hepatic or renal failure.

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Is the device recyclable? 
Please follow your own hospital guidelines for disposal of clinical waste, which is usually incineration. 

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Why is Dzuveo® dispensed using a plastic device?
The Dzuveo® device has been designed to be lightweight and easily handled with gloves​. The tablet is very small, and the device allows to correctly position the tablet under the tongue, even in a “dirty” environment, such as at the site of a trauma or emergency. 

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Do patients need prolonged monitoring or require supplemental oxygen? 
The duration of action of Dzuveo® has been estimated to be around 3 hours. However, the pharmacokinetic study showed that the plasmatic peak of Dzuveo® occurs at 1 hour after administration. After 1 hour, the plasmatic concentration starts decreasing, it is unlikely that the patient would experience an adverse event if no adverse events occurred before 1 hour. 
Dzuveo® should only be administered in a medically monitored setting. This setting must have equipment and personnel trained to detect and manage hypoventilation, and availability of supplemental oxygen and opioid antagonists, such as naloxone.  

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Why don't you need to titrate the dose of Dzuveo®?
Titration is done to limit the high plasmatic peaks of IV opioids. Dzuveo® is released over time hence does not require a dose titration as the high plasmatic peaks do not occur and it follows a blunted plasmatic peak. 

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What is the half-life? 
The plasmatic half-life of Dzuveo® is 2.5 hours (1).