Ensifentrine
OHTUVAYRE
What it isNebulized dual PDE3 and PDE4 inhibitor; maintenance treatment of COPD.
Why this oneIts dual action combines airway smooth-muscle relaxation with a nonsteroidal anti-inflammatory effect.
What limits itTwice-daily nebulization adds only modest benefit to existing inhalers; headache and diarrhea can limit use.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| COPD (maintenance) | Adults | Inhaled via standard jet nebulizer: 3 mg (one unit-dose ampule) BID (morning and evening) | Same | Inhaled 3 mg BID |
Renal Mild-moderate: no adjustment needed; severe: not evaluated
Hepatic Use with caution — systemic exposure increased 2.3-fold in moderate/severe hepatic impairment (no specific dose adjustment given)
Instructions
- Administer by oral inhalation using a standard jet nebulizer with mouthpiece connected to an air compressor
- Remove ampule from foil pouch only immediately before use; once pouch opened, discard unused ampules after 14 days
- Shake ampule vigorously; squeeze entire contents into nebulizer cup; discard ampule with residual content
- Do not mix with other drugs or add to solutions containing other drugs (compatibility not established)
Cautions
- Not for acute bronchospasm relief (not rescue therapy) — treat acute symptoms with an inhaled short-acting bronchodilator
- Paradoxical bronchospasm (may be life-threatening) — treat with SABA, discontinue immediately, institute alternative therapy
- Psychiatric adverse reactions incl. suicidality reported (suicide attempt and completed suicide in trials) — carefully weigh risks/benefits in patients with history of depression and/or suicidal thoughts or behavior
Adverse reactions
- >=1% and more common than placebo: back pain, hypertension, urinary tract infection, diarrhea
- Psychiatric: insomnia, anxiety, depression-related reactions
Pregnancy No human data; no adverse developmental effects in rats/rabbits at up to 79x/9x MRHDID exposure; male rat fertility effects (implantation loss, decreased live embryos) at 30x MRHDID
Lactation No human or animal milk data — weigh benefit/risk
NO BOXED WARNINGS
Principal riskModest added benefit; nebulised twice daily
Classes and tags
Clinical profile
Mechanism of action: Ensifentrine ballicule
