DSUVIA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DSUVIA (DSUVIA).

How it works

Selective, high-affinity agonist at the mu-opioid receptor, resulting in analgesia via activation of G-protein coupled inwardly rectifying potassium channels and inhibition of voltage-gated calcium channels in the central nervous system.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and CYP3A5 to fentanyl and other inactive metabolites; also undergoes metabolism by amide hydrolysis.
Excretion	Primarily renal elimination of metabolites; unchanged drug accounts for <1% of the dose. Fecal excretion is minimal. Total recovery: ~70% in urine, ~20% in feces.
Half-life	Terminal elimination half-life is approximately 23.4 hours (range 17–30 h), supporting once-daily dosing. Due to rapid redistribution, clinical effects may wane before elimination is complete.
Protein binding	Approximately 7–8% bound to plasma proteins (primarily albumin). Minimal binding ensures high free fraction.
Volume of Distribution	Mean Vd is approximately 1.5 L/kg, indicating extensive extravascular distribution. The large Vd reflects rapid and widespread tissue uptake.
Bioavailability	Sublingual: 100% bioavailable (systemic). Oral ingestion (swallowing) reduces bioavailability due to first-pass metabolism; for optimal effect, must be administered sublingually.
Onset of Action	Sublingual: 5–15 minutes to first perceptible analgesia; peak effect at 30–60 minutes.
Duration of Action	Analgesic effect lasts 4–6 hours with single sublingual dose, related to redistribution rather than elimination half-life. Duration is dose-dependent and may be prolonged in hepatic impairment.

Classification & Brands

Dosing & administration

30 mcg sublingual tablet as a single dose; may repeat once after 1 hour if needed. Maximum 2 doses per 24 hours.

Dosage form	TABLET
Renal impairment	No adjustment recommended for mild to moderate impairment (CrCl >=30 mL/min). Avoid use in severe impairment (CrCl <30 mL/min) or ESRD due to lack of data.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh C). Caution in moderate impairment (Child-Pugh B); consider alternative therapy.
Pediatric use	Not approved for use in patients under 18 years of age. Safety and efficacy not established.
Geriatric use	No specific dose adjustment recommended; use caution due to increased sensitivity to opioids and higher risk of respiratory depression. Consider lower starting doses if opioid-naive.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DSUVIA (DSUVIA).

Breastfeeding	Excreted in human milk; M/P ratio unknown. Monitor infant for respiratory depression, sedation, and withdrawal. Use caution; alternate feeding method recommended for prolonged use.
Teratogenic Risk	Insufficient human data; animal studies show embryo-fetal toxicity at maternal exposures ≥2x MRHD. Avoid in 1st trimester due to risk of neural tube defects; 2nd/3rd trimester risk of fetal opioid dependence and neonatal abstinence syndrome. Not recommended during pregnancy unless benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DSUVIA; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Significant respiratory depression","Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment","Known or suspected gastrointestinal obstruction, including paralytic ileus","Hypersensitivity to fentanyl or any component of DSUVIA"]

Clinical Precautions

Precautions

["Addiction, abuse, and misuse","Life-threatening respiratory depression","Accidental exposure","Neonatal opioid withdrawal syndrome","Risks from concomitant use with benzodiazepines or other CNS depressants","Severe hypotension","Adrenal insufficiency","Severe injection site reactions (not applicable for this formulation but product-specific: application site reactions)"]

Clinical Tips & Counseling

Drug interactions

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DSUVIA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DSUVIA (DSUVIA).

How it works

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and CYP3A5 to fentanyl and other inactive metabolites; also undergoes metabolism by amide hydrolysis.
Excretion	Primarily renal elimination of metabolites; unchanged drug accounts for <1% of the dose. Fecal excretion is minimal. Total recovery: ~70% in urine, ~20% in feces.
Half-life	Terminal elimination half-life is approximately 23.4 hours (range 17–30 h), supporting once-daily dosing. Due to rapid redistribution, clinical effects may wane before elimination is complete.
Protein binding	Approximately 7–8% bound to plasma proteins (primarily albumin). Minimal binding ensures high free fraction.
Volume of Distribution	Mean Vd is approximately 1.5 L/kg, indicating extensive extravascular distribution. The large Vd reflects rapid and widespread tissue uptake.
Bioavailability	Sublingual: 100% bioavailable (systemic). Oral ingestion (swallowing) reduces bioavailability due to first-pass metabolism; for optimal effect, must be administered sublingually.
Onset of Action	Sublingual: 5–15 minutes to first perceptible analgesia; peak effect at 30–60 minutes.
Duration of Action	Analgesic effect lasts 4–6 hours with single sublingual dose, related to redistribution rather than elimination half-life. Duration is dose-dependent and may be prolonged in hepatic impairment.

Classification & Brands

Dosing & administration

30 mcg sublingual tablet as a single dose; may repeat once after 1 hour if needed. Maximum 2 doses per 24 hours.

Dosage form	TABLET
Renal impairment	No adjustment recommended for mild to moderate impairment (CrCl >=30 mL/min). Avoid use in severe impairment (CrCl <30 mL/min) or ESRD due to lack of data.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh C). Caution in moderate impairment (Child-Pugh B); consider alternative therapy.
Pediatric use	Not approved for use in patients under 18 years of age. Safety and efficacy not established.
Geriatric use	No specific dose adjustment recommended; use caution due to increased sensitivity to opioids and higher risk of respiratory depression. Consider lower starting doses if opioid-naive.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DSUVIA (DSUVIA).

Breastfeeding	Excreted in human milk; M/P ratio unknown. Monitor infant for respiratory depression, sedation, and withdrawal. Use caution; alternate feeding method recommended for prolonged use.
Teratogenic Risk	Insufficient human data; animal studies show embryo-fetal toxicity at maternal exposures ≥2x MRHD. Avoid in 1st trimester due to risk of neural tube defects; 2nd/3rd trimester risk of fetal opioid dependence and neonatal abstinence syndrome. Not recommended during pregnancy unless benefit outweighs risk.
Fetal Monitoring