DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic
and for which alternative treatments are inadequate.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DSUVIA
Accidental Exposure and DSUVIA Risk Evaluation and Mitigation Strategy (REMS) Program
Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA
is only available through a restricted program called the DSUVIA REMS Program.
- DSUVIA must only be dispensed to patients in a certified medically supervised healthcare setting.
- Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised healthcare setting.
Addiction, Abuse, and Misuse
Because the use of DSUVIA exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to
prescribing DSUVIA, and reassess all patients regularly for the development of these behaviors
or conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS)
depressants, including alcohol, may result in profound sedation, respiratory depression,
coma, and death. Reserve concomitant prescribing of DSUVIA and benzodiazepines or other
CNS depressants for use in patients for whom alternative treatment options are inadequate.
Cytochrome P450 3A4 Interaction
The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an
increase in sufentanil plasma concentrations, which could increase or prolong adverse drug
reactions and may cause potentially fatal respiratory depression. In addition, discontinuation
of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil
plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or
inducer.
Contraindications
Use of DSUVIA is contraindicated in patients with:
- Significant respiratory depression.
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
- Known hypersensitivity to sufentanil or components of DSUVIA.
Warnings and Precautions
- DSUVIA is for use in adult patients only in a certified medically supervised healthcare setting.
Use of DSUVIA outside of this setting can increase the risk of accidental exposure in others
for whom it is not prescribed, causing fatal respiratory depression. Discontinue use of
DSUVIA prior to discharge or transfer from the certified medically supervised healthcare
setting. DSUVIA is not for home or pediatric use.
- DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA
exposes users to the risks of addiction, abuse, and misuse.
- Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA)
and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent
fashion. In patients who present with CSA, consider minimizing the use of DSUVIA and
carefully monitor the patient for signs of respiratory depression.
- Accidental ingestion or exposure to even one dose of DSUVIA, especially in children, can
result in respiratory depression and death due to an overdose of sufentanil.
- Profound sedation, respiratory depression, coma, and death may result from the concomitant
use of DSUVIA with benzodiazepines or other CNS depressants, including alcohol (e.g.,
non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants,
general anesthetics, antipsychotics, other opioids). Because of these risks, reserve
concomitant prescribing of these drugs for use in patients for whom alternative treatment
options are inadequate.
- Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs
when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of
the current opioid analgesic, or opioid rotation.
- A potentially life-threatening condition could result from concomitant serotonergic drug
administration. Discontinue DSUVIA if serotonin syndrome is suspected.
- Life-threatening respiratory depression in patients with chronic pulmonary disease or
in elderly, cachectic and debilitated patients: monitor patients closely, particularly when
initiating DSUVIA therapy and when DSUVIA is used with other drugs that depress respiration.
Management of respiratory depression may include close observation, supportive measures,
and use of opioid antagonists, depending on the patient’s clinical status.
- Cases of adrenal insufficiency have been reported with opioid use (usually > 1 month).
Presentation and symptoms are non-specific and include nausea, vomiting, anorexia,
fatigue, weakness, dizziness and low blood pressure. Confirm diagnosis with testing as
soon as possible and, if confirmed, treat with physiologic replacement of corticosteroids
and wean patient from opioid.
- As with all opioids, sufentanil may produce bradycardia or hypotension in some patients.
Therefore DSUVIA should be used with caution in patients with bradyarrhythmias or
hypovolemia.
- DSUVIA should not be used in patients who may be particularly susceptible to the intracranial
effects of CO2 retention, such as those with evidence of increased intracranial pressure,
impaired consciousness or coma.
- Prolonged use of DSUVIA during pregnancy can result in withdrawal in the neonate, which
can be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome
and manage accordingly. Advise pregnant women using opioids for a prolonged period of
this risk and ensure that appropriate treatment will be available.
- Insufficient data are available on the use of DSUVIA in patients with severe liver or kidney
impairment. DSUVIA should be used with caution in such patients due to the importance
of these organs in the metabolism and excretion of sufentanil.
Adverse Reactions
Adverse reactions are described, or described in greater detail, in other sections of the Prescribing Information:
- Addiction, Abuse, and Misuse [see Warnings and Precautions (5.3)]
- Life-Threatening Respiratory Depression [see Warnings and Precautions (5.4)]
- Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)]
- Adrenal Insufficiency [see Warnings and Precautions (5.10)]
- Severe hypotension [see Warnings and Precautions (5.11)]
- Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13)]
- Seizures [see Warnings and Precautions (5.14)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.16)]
The most commonly reported adverse reactions (≥ 2% and higher than placebo) were nausea, headache, vomiting, dizziness, and hypotension.
Medical Information
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact Vertical Pharmaceuticals, LLC at 1-855-925-8476 or [email protected].
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including BOXED WARNING and Directions for Use.
