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FAQ

Please refer to the SmPC for information about Dzuveo® .
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What is Dzuveo® made from?
Dzuveo® is a 30 microgram sufentanil tablet.

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

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.

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.

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.

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.

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.

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.

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.

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%.

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.

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.

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

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. 

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.  

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. 

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

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Dzuveo® allows you to control your patient's pain urgently and non-invasively, prioritising patient care and comfort.

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Safety information

Dzuveo is to 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

References 1. Fisher DM, et al. Anesthesiology. 2018;128(5):943-952.

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