DSUVIA Dosage & Rx Info | Uses, Side Effects

Dsuvia Generic Name & Formulations

Legal Class

CII

General Description

Sufentanil 30mcg; sublingual tabs (housed in a disposable, single-dose applicator); contains mannitol.

Pharmacological Class

Opioid agonist.

How Supplied

SL tabs—10

Manufacturer

AcelRx Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

Sufentanil is an opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principle therapeutic action of sufentanil is analgesia and sedation, thought to be mediated through opioid specific receptors throughout the CNS.

Dsuvia Indications

Indications

For use in adults in a certified medically supervised healthcare setting (eg, hospitals, surgical centers, 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 children; discontinue treatment before leaving supervised healthcare setting. Not for use >72hrs. Only for administration by healthcare provider. Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration); reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to provide analgesia.

Dsuvia Dosage and Administration

Adult

Do not chew or swallow tab. Avoid eating, drinking, talking for 10mins after dose. Administer via single-dose applicator by healthcare provider. 30mcg SL as needed with ≥1hr between doses; max 12 tabs in 24hrs. Max cumulative daily dose: 360mcg (12 tabs).

Children

Not established.

Dsuvia Contraindications

Contraindications

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Dsuvia Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Dsuvia: Accidental exposure and Dsuvia Risk Evaluation and Mitigation Strategy (REMS) program; Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with benzodiazepines or other CNS depressants; Cytochrome P450 3A4 interaction.

Dsuvia Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression; monitor and consider non-opioid analgesics. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. CNS depression. Impaired consciousness, coma, shock; avoid. Seizure disorders. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Hepatic or severe renal impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.

REMS

YES

Dsuvia Pharmacokinetics

Absorption

Sublingual bioavailability: ~53% relative to a 1-min IV sufentanil infusion of 30mcg. Mean maximum plasma concentration: 63.1 pg/mL. Median time to maximum plasma concentration: 1 hour.

Distribution

Plasma protein bound: ~93% (males); 91% (females); 79% (neonates).

Metabolism

Hepatic, small intestine.

Elimination

Half-life: 13.4 hours. Apparent plasma clearance: 108 L/hour.

Dsuvia Interactions

Interactions

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT₃ antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors); monitor. Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin); monitor. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Dsuvia Adverse Reactions

Adverse Reactions

Nausea, headache, vomiting, dizziness, hypotension; respiratory depression, syncope, OIH and allodynia.

Dsuvia Clinical Trials

See Literature

Dsuvia Note

Not Applicable

Dsuvia Patient Counseling