sufentanil SL (Rx)

Brand and Other Names:Dsuvia
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

sublingual tablet: Schedule II

  • 30mcg (single-dose SL applicator)

Severe Acute Pain

Indicated for severe acute pain for which alternative treatments are inadequate

30 mcg SL as needed with a minimum of 1 hr between doses

Not to exceed 360 mcg (12 tablets) daily

Dosage Modifications

Hepatic impairment

  • Extensively metabolized in the liver; clearance may decrease with hepatic impairment
  • Monitor for adverse events including respiratory depression, sedation, and hypotension in patients with hepatic impairment

Renal impairment

  • Excreted by the kidney, with no significant changes noted in patients with mild-to-moderate renal impairment
  • Monitor for adverse events including respiratory depression, sedation, and hypotension in patients with severe renal impairment

Dosing Considerations

Limitation of use

  • Not for home use or for use in children; discontinue before patient leaves the certified medically supervised healthcare setting
  • Not for use >72 hr
  • Administered only by a healthcare provider

Safety and efficacy not established

No studies were specifically performed in elderly patients, although 31% of patients were aged ≥65 yr

Adverse events increased with age, including nausea

Owing to increased risk of respiratory depression in elderly patients and the inability to titrate sufentanil SL, monitor closely for signs of CNS and respiratory depression, or consider an alternative medication with available titration

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Interactions

Interaction Checker

and sufentanil SL

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    No Interactions Found
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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Nausea (29%)

            Headache (12.1%)

            1-10%

            Vomiting (5.6%)

            Dizziness (5.6%)

            Hypotension (4.7%)

            <1%

            Cardiac disorders: Sinus tachycardia, bradycardia

            Gastrointestinal disorders: Constipation, dyspepsia, flatulence, diarrhea, dry mouth, eructation, retching, abdominal discomfort, abdominal distension, upper abdominal pain, gastritis, postoperative ileus, oral hypoesthesia

            Investigations: Oxygen saturation decreased, respiratory rate decreased, urine output decreased, AST increased, electrocardiogram abnormal, hepatic enzyme increased

            Musculoskeletal and connective-tissue disorders: Muscle spasms

            Nervous system disorders: Somnolence, sedation, presyncope, lethargy, memory impairment

            Psychiatric disorders: Insomnia, confusional state, anxiety, agitation, disorientation, euphoric mood, hallucination, mental status changes

            Renal and urinary disorders: Urinary retention, urinary hesitation, oliguria, renal failure

            Respiratory, thoracic, and mediastinal disorders: Hypoxia, bradypnea, hiccups, apnea, atelectasis, hypoventilation, respiratory distress, respiratory failure

            Skin and subcutaneous tissue disorders: Pruritus, hyperhidrosis, rash

            Vascular disorders: Hypotension, hypertension, orthostatic hypotension, flushing

            Postmarketing Reports

            Serotonin syndrome when coadministered with serotonergic drugs

            Adrenal insufficiency with opioid use duration ≥1 month

            Anaphylaxis

            Androgen deficiency with long-term use

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            Warnings

            Black Box Warnings

            Accidental exposure and Dsuvia Risk Evaluation and Mitigation Strategy (REMS) program

            • Accidental exposure to sufentanil SL or ingestion, especially in children, can result in respiratory depression and death
            • Because of this risk, sufentanil SL is only available through a restricted program called the Dsuvia REMS Program
            • REMS requirements
              • Use is only for patients in a certified medically supervised healthcare setting
              • Discontinue use before discharge or transfer from the certified medically supervised healthcare setting
              • Manage an acute opioid overdose, including respiratory depression
              • Train all relevant staff that sufentanil SL must not be dispensed for use outside of the certified healthcare setting
              • Train all relevant staff involved in administration of sufentanil SL to refer to the Directions for Use before administering
              • Establish processes and procedures to verify that sufentanil SL is not dispensed for use outside of the certified healthcare setting

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation

            Addiction, abuse, and misuse

            • Sufentanil SL 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 before prescribing, and regularly monitor for development of these behaviors or conditions

            CYP3A4 interactions

            • Coadministration with all CYP3A4 inhibitors may result in increased sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression
            • Additionally, discontinuation of a concomitantly used CYP3A4 inducer may result in increased sufentanil plasma concentrations
            • Monitor patients receiving sufentanil SL and any CYP3A4 inhibitor or inducer

            Coadministration with benzodiazepines or other CNS depressants

            • Coadministration of opioids with benzodiazepines or other CNS depressants, including alcohol, may cause profound sedation, respiratory depression, coma, and death
            • Reserve coadministration in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to the minimum required
            • Monitor for signs and symptoms of respiratory depression and sedation

            Contraindications

            Significant respiratory depression

            Acute or severe bronchial asthma in unmonitored setting or in absence of resuscitative equipment

            Known or suspected GI obstruction, including paralytic ileus

            Hypersensitivity

            Also see Black Box Warnings

            Accidental ingestion or exposure to even a single dose, especially in children, can result in respiratory depression and death due to overdose; because of this risk, a REMS program has been established

            Risk for addiction, abuse, and misuse; assess risk before prescribing and if prescribed, monitor for development of these behaviors

            Adrenal insufficiency reported with opioids, more often following use longer than 1 month

            May cause severe hypotension, including orthostatic hypotension and syncope; avoid with circulatory shock

            May cause bradycardia; monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating

            May increase seizure frequency in patients with seizure disorders; may increase seizure risk in other clinical settings associated with seizures

            Prolonged opioid use during pregnancy can result in neonatal withdrawal syndrome

            Respiratory depression

            • Serious, life-threatening, or fatal respiratory depression reported with opioids, even when used as recommended
            • Use in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated
            • Use in patients with significant COPD or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, is associated with increased risk of decreased respiratory drive including apnea
            • Life-threatening respiratory depression is more likely in elderly, cachectic, or debilitated patients who have altered pharmacokinetics or altered clearance

            Altered CNS status

            • May decrease respiratory drive in patients susceptible to intracranial effects of CO2 retention (eg, increased ICP, brain tumors)
            • May also obscure clinical course with a head injury; avoid in patients with impaired consciousness or coma

            GI conditions

            • Contraindicated with known or suspected GI obstruction, including paralytic ileus
            • May cause spasm of the sphincter of Oddi
            • Opioids may increase serum amylase
            • Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Drug interaction overview

            • Coadministration with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and/or death
            • Serotonin syndrome, which is potentially life-threatening, reported with opioids when coadministered with serotonergic drugs
            • MAO inhibitors interact with opioids and may manifest as serotonin syndrome or opioid toxicity
            • Mixed agonist/antagonist and partial agonist opioid analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms
            • Sufentanil SL may enhance neuromuscular blocking action of skeletal muscle relaxants and increase respiratory depression
            • Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
            • Coadministration with anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus
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            Pregnancy

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome

            There are no available data with sufentanil in pregnant women to inform a drug-associated risk for major birth defects and miscarriage

            Fetal/neonatal effects

            • Prolonged use of opioid analgesics during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth
            • Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight
            • Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

            Labor or delivery

            • Opioids cross the placenta and may produce respiratory depression and psychophysiologic effects in neonates
            • An opioid antagonist must be available for reversal of opioid-induced respiratory depression in the neonate

            Infertility

            • Long-term opioid use may reduce fertility in females and males of reproductive potential
            • Unknown whether effects on fertility are reversible
            • Sufentanil SL is not intended for long-term use

            Lactation

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for sufentanil SL and any potential adverse effects on the breastfed infant

            Monitor infants exposed through breast milk for excess sedation and respiratory depression

            Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Opioid receptor agonist

            Principle therapeutic actions are analgesia and sedation, although pharmacologically it also affects the GI, cardiovascular, respiratory, and endocrine systems

            Absorption

            Bioavailability: 53% (SL relative to 30-mcg IV infusion over 1 minute); if tablet swallowed, this decreases to 9%

            Peak plasma time: 1 hr

            Peak plasma concentration: 63.1 pg/mL

            AUC: 278 hr·pg/mL

            After 12 multiple hourly doses over 11 hr, mean for the AUC within a dosing interval (AUC0-60min) and peak plasma concentrations values increased by 3.7-fold and 2.3-fold greater compared with single-dose administration, respectively

            Steady-state achieved: 7 doses

            Distribution

            Protein bound: 93% (healthy males); 91% (mothers); 79% (neonates)

            Metabolism

            SL administration avoids intestinal and hepatic first-pass metabolism

            Liver and small intestine are major sites of biotransformation by CYP3A4

            Elimination

            Half-life: 13.4 hr

            Clearance: 108 L/hr

            Excretion: 80% excreted within 24 hr; 2% of drug eliminated unchanged

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            Administration

            Sublingual Administration

            Single-use applicator; do not reuse

            Administer only in certified medically supervised healthcare setting (eg, hospitals)

            Do not chew or swallow tablet

            Do not to eat or drink and minimize talking for 10 minutes after administration; provide ice chips prior to administration if patient experiences excessive dry mouth

            See prescribing information for complete instructions and diagrams

            Storage

            Housed in a single-dose applicator packaged within a tamper-evident foil pouch

            Store in a limited-access location in accordance with institutional procedures for schedule II substances

            Store at room temperature (20-25°C [68-77°F]); excursions allowed between 15-30°C (59-86°F)

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.