In the emergency
department
Consider DSUVIA for your adult patients who require an opioid for acute pain
DSUVIA is indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults. DSUVIA is for use in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments.
Please see Limitations of Use and BOXED WARNING under Important Safety Information below.
Effective pain relief, efficiently delivered.1,2
Noninvasive Option
DSUVIA offers a noninvasive analgesic option when IV access is difficult or delayed, or isn’t otherwise needed.1
Sublingual Delivery
Sublingual delivery may circumvent the risks associated with IV lines, such as infiltration and phlebitis.1,3
Prefilled Applicator
A prefilled, single-dose applicator delivers one tablet of DSUVIA, so there’s no leftover drug to waste and witness.1,4
Single Fixed Dosage
DSUVIA comes in one strength and avoids calculations that can complicate dosing and lead to errors.1,5
Extended Redosing Interval
DSUVIA showed an average of 3 hours between doses over a 12-hour period, with a minimum redosing interval of 1 hour.2*†
Timely Pain Reduction
DSUVIA showed a greater pain intensity difference to baseline vs placebo (P=0.002) at 15 minutes, the first assessment.2*
*The efficacy and safety of DSUVIA were demonstrated in a pivotal trial of 161 post-operative abdominal surgery patients. The primary endpoint was time-weighted summed pain intensity difference to baseline over 12 hours (SPID12). A secondary endpoint was pain intensity difference to baseline at each evaluation time point. Redosing interval (time between doses) was also recorded.1,2
†Patients may require more frequent redosing (minimum interval 1 hour) than the 3-hour average when initiating DSUVIA.1
Which of your adult patients with acute pain may be right for DSUVIA?
DSUVIA offers a noninvasive option when opioids are needed in a medically supervised setting. The prefilled single-dose applicator delivers 1 micro-sized tablet under the tongue, with a minimum of 1 hour between doses.1
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Dislocated shoulder with acute pain
Patient needs IV only for analgesia
Hip fracture with acute pain
Patient has difficult-to-access veins
Acute low-back pain from trauma
Patient has history of hematoma
Ankle sprain/fracture with acute pain
Patient has severe needle phobia
Dislocated shoulder
with acute pain
Patient needs IV only for analgesia
- 43-year-old female
- 115 lb (BMI 20)
- No relevant medical history
- Pain score at triage: 9/10
Physician attempts reduction without analgesia. Patient experiences increased pain and muscle contraction, and attempt fails. Physician orders IV placement for procedural analgesia.
Consider DSUVIA
a noninvasive option
Hip fracture
with acute pain
Patient has difficult-to-access veins
- 65-year-old female
- 190 lb (BMI 35)
- History of hypertension
- Pain score at triage: 8/10
Nurse attempts IV cannulation for fluids and analgesia. After 2 failed attempts, she calls another nurse for assistance. Patient’s blood pressure rises rapidly as they wait for second nurse to arrive and place the IV.
Consider DSUVIA
a noninvasive option
Acute low-back pain
from trauma
Patient has history of hematoma
- 72-year-old male
- 210 lb (BMI 29)
- Current medications include anticoagulant
- Pain score at triage: 7/10
Patient fell at home and has severe low-back muscle spasm. Physician orders IV placement for analgesia, but patient is concerned about severe bruising based on recent experience after blood draw.
Consider DSUVIA
a noninvasive option
Ankle sprain/fracture
with acute pain
Patient has severe needle phobia
- 36-year-old male
- 145 lb (BMI 21)
- No relevant medical history
- Pain score at triage: 6/10
After physician evaluation, nurse attempts IV cannulation for analgesia while patient waits for X-ray. Patient shows signs of needle phobia, heart rate drops sharply, and syncope occurs.
Consider DSUVIA
a noninvasive option
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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.
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.
Addiction, Abuse, and Misuse
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 monitor all patients regularly for the development of these behaviors or conditions.
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.
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 for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
Indications and Usage
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.
Limitations of Use:
- Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting.
- Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied.
- Only to be administered by a healthcare provider.
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
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
- 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.
- 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.
- 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. (revised per 2019 opioid class labeling)
- DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA exposes users to the risks of addiction, abuse, and misuse.
- Profound sedation, respiratory depression, coma, and death may result from the concomitant use of DSUVIA with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
- 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.
- A potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DSUVIA if serotonin syndrome is suspected. 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:
- Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
- Addiction, Abuse, and Misuse [see Warnings and Precautions (5.4)]
- Adrenal Insufficiency [see Warnings and Precautions (5.9)]
- Severe hypotension [see Warnings and Precautions (5.10)]
- Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)]
- Seizures [see Warnings and Precautions (5.13)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.15)]
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 the AcelRx Medical Information Contact Center at 1-855-925-8476 or AcelRxMedInfo@rmpdc.org.
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 and Directions For Use.
