Ensifentrine Inhaled

Ensifentrine Inhaled is a prescription medication indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

• Ensifentrine Inhaled is available under the following different brand names: Ohtuvayre.

Common side effects of Ensifentrine Inhaled include:

• back pain
• high blood pressure
• bladder infection
• diarrhea

Serious side effects of Ensifentrine Inhaled include:

• sudden breathing problems 
• mental health problems: symptoms include thoughts of suicide or dying, new or worse anxiety, attempt to commit suicide, new or worse depression, trouble sleeping (insomnia), acting on dangerous impulses, and other unusual changes in behavior or mood

Rare side effects of Ensifentrine Inhaled include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Suspension for inhalation

• 3 mg/2.5 mg unit-dose ampule

Chronic obstructive pulmonary disease

Adult dosage

• 3 mg inhaled orally two times a day via a standard jet nebulizer with a mouthpiece

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ensifentrine Inhaled has no noted severe interactions with any other drugs
• Ensifentrine Inhaled has no noted serious interactions with any other drugs
• Ensifentrine Inhaled has no noted moderate interactions with any other drugs
• Ensifentrine Inhaled has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to Ensifentrine or any product component

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ensifentrine Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ensifentrine Inhaled?”

Cautions

• Acute bronchospasm
  • Do not use for relief of acute symptoms (ie, as rescue treatment of acute episodes of bronchospasm)
  • Safety and effectiveness have not been established for the relief of acute symptoms and extra doses should not be used for that purpose
  • Treat acute symptoms with an inhaled, short-acting bronchodilator
  • Instruct patients to seek medical attention immediately if they experience any of the following
  • Decreasing effectiveness of inhaled, short-acting beta2-agonists
  • Need for more inhalations than usual of inhaled, short-acting beta2-agonists
  • Significant decrease in lung function as outlined by health care provider
• Paradoxical bronchospasm
  • May produce paradoxical bronchospasm, which may be life-threatening
  • If paradoxical bronchospasm occurs following dosing, immediately treat with an inhaled, short-acting bronchodilator
  • Discontinued ensifentrine immediately and initiated alternant therapy
• Psychiatric events including suicidality
  • Associated with increased risk for psychiatric adverse reactions
  • Psychiatric events, including suicide-related adverse reactions, were reported in clinical studies
  • Before initiating treatment, healthcare providers should carefully weigh the risks and benefits of treatment in patients with a history of depression and/or suicidal thoughts or behavior
• Evaluate risks and benefits of continuing treatment if such events occur; advise patients, caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes
• Instruct patients/caregivers that if such changes occur to contact their healthcare provider so that risks and benefits of continuing treatment may be considered

Pregnancy and Lactation

• Data are not available regarding use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are unavailable regarding the presence in human milk, effects on breastfed children, or effects on milk production
  • There are no data from animal studies on the presence of milk