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Safety Profile

DSUVIA has a demonstrated safety profile for
treating moderate-to-severe acute pain1

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.

The safety of DSUVIA was demonstrated across a range of patients in multiple clinical studies

A total of 646 patients were followed in controlled and uncontrolled studies of DSUVIA or equivalent doses of sublingual sufentanil. The largest controlled study of DSUVIA was the abdominal surgery pivotal trial (N=161).1

Low rate of discontinuation for adverse events

Fewer DSUVIA-treated patients (1 of 107) discontinued treatment due to adverse events compared to placebo-treated patients (2 of 54) in the abdominal surgery pivotal trial. Reasons for discontinuation were oxygen desaturation (DSUVIA group) and dizziness, hemiparesis, somnolence, and syncope (placebo group).1,2

Adverse reactions generally mild to moderate

No serious adverse reactions were reported in the DSUVIA group in the abdominal surgery pivotal trial. Two serious adverse reactions (syncope and hemiparesis) were reported in the placebo group.2

MOST COMMON ADVERSE REACTIONS1,2*
  DSUVIA (n=107) Placebo (n=54)
Nausea 29.0% 22.2%
Headache 12.1% 11.1%
Vomiting 5.6% 1.9%
Dizziness 5.6% 3.7%
Hypotension 4.7% 3.7%

*Occurring in ≥2% of patients and at a rate higher for DSUVIA than placebo in the abdominal surgery pivotal trial.

IV morphine 1 mg was allowed as rescue medication.

study design

The abdominal surgery pivotal trial was a controlled study of 161 post-operative adult patients. The primary efficacy endpoint was time-weighted summed pain intensity difference to baseline over 12 hours (SPID12). Safety assessments included adverse events and use of concomitant medications, periodic monitoring of vital signs, and continuous monitoring of oxygen saturation.1,2

DSUVIA Risk Evaluation and Mitigation Strategy (REMS)

In order to prevent respiratory depression resulting from accidental exposure, DSUVIA is available only through a restricted program called the DSUVIA REMS. Healthcare settings must be certified through the DSUVIA REMS in order to dispense DSUVIA.

Special precautions are needed in specific populations and with certain medications

Use of DSUVIA in specific populations1

Pregnant women

The risk for birth defects or miscarriage from the use of DSUVIA is unknown. DSUVIA is not recommended for use in pregnant women during or immediately prior to labor.

Lactating women

The mother’s clinical need for DSUVIA should be considered along with the benefits of breastfeeding and the potential for adverse effects on the infant from DSUVIA or the underlying maternal condition.

Geriatric patients

No special population studies were conducted for DSUVIA in geriatric patients. Monitor geriatric patients closely for adverse events, or consider an alternate medication that can be titrated.

Organ-impaired patients

Clearance of DSUVIA is not significantly affected by mild-to-moderate renal impairment. Patients with severe renal impairment or with hepatic impairment should be monitored closely for adverse events.

Metabolism of DSUVIA

Sufentanil is metabolized by hepatic enzyme CYP3A4 and produces no
active metabolites.3,4

DRUG INTERACTIONS WITH DSUVIA1

CYP3A4 inhibitors

(e.g., erythromycin, ketoconazole, ritonavir)
Concomitant use can increase sufentanil plasma concentrations, resulting in increased or prolonged effects. If concomitant use is necessary, consider an alternate medication that permits dose titration.

CYP3A4 inducers

(e.g., rifampin, carbamazepine, phenytoin)
Concomitant use can decrease sufentanil plasma concentrations, resulting in decreased efficacy. If concomitant use is necessary, consider an alternate medication that permits dose titration.

Central nervous system depressants

(e.g., alcohol, benzodiazepines, other opioids)
Concomitant use can increase risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant use for patients for whom alternative treatment options are inadequate, and follow patients closely.

Serotonergic drugs

(e.g., SSRIs, tramadol, MAO inhibitors)
Concomitant use can result in serotonin syndrome. If concomitant use is warranted, carefully observe the patient and discontinue DSUVIA if serotonin syndrome is suspected.
DRUG INTERACTIONS WITH DSUVIA1
CYP3A4 inhibitors
(e.g., erythromycin, ketoconazole, ritonavir)

Concomitant use can increase sufentanil plasma concentrations, resulting in increased or prolonged effects. If concomitant use is necessary, consider an alternate medication that permits dose titration.
CYP3A4 inducers
(e.g., rifampin, carbamazepine, phenytoin)

Concomitant use can decrease sufentanil plasma concentrations, resulting in decreased efficacy. If concomitant use is necessary, consider an alternate medication that permits dose titration.
Central nervous system depressants
(e.g., alcohol, benzodiazepines, other opioids)

Concomitant use can increase risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant use for patients for whom alternative treatment options are inadequate, and follow patients closely.
Serotonergic drugs
(e.g., SSRIs, tramadol, MAO inhibitors)

Concomitant use can result in serotonin syndrome. If concomitant use is warranted, carefully observe the patient and discontinue DSUVIA if serotonin syndrome is suspected.
Prescribing Information

Additional information about risks and precautions with DSUVIA is available in the full Prescribing Information.

More information on DSUVIA
 
For a Range
of Patients

Learn about the different
settings and populations
included in open-label
studies of DSUVIA

 
 
Case Studies:
Emergency Department

See which types of patients
with trauma or injury may
be right for DSUVIA

 
 
Case Studies:
Recovery Room

See which types of
post-operative patients
may be right for DSUVIA

 
References:
  1. DSUVIA [package insert]. Redwood City, CA: AcelRx Pharmaceuticals, Inc; 2018.
  2. Minkowitz HS, Leiman D, Melson T, Singla N, DiDonato KP, Palmer PP. Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery: a randomized, placebo-controlled, phase-3 study. Pain Pract. 2017;17(7):848-858.
  3. Fisher DM, Chang P, Wada DR, Dahan A, Palmer PP. Pharmacokinetic properties of a sufentanil sublingual tablet intended to treat acute pain. Anesthesiology. 2018;128(5):943-952.
  4. Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015;37(1):145-155.
IMPORTANT SAFETY INFORMATION

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.
  • 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.

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