Ohtuvayre 3mg/2.5ml Inh Suspension
It is used to treat COPD (chronic obstructive pulmonary disease).Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Bronchodilator; Anti-inflammatory
Pharmacologic Class
Phosphodiesterase 3 (PDE3) and Phosphodiesterase 4 (PDE4) Inhibitor
Pregnancy Category
Not available
FDA Approved
Jun 2024
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ohtuvayre is an inhaled medicine used to help people with Chronic Obstructive Pulmonary Disease (COPD) breathe easier. It works by relaxing the muscles around your airways and reducing inflammation in your lungs, which helps to open up your air passages. It is given using a nebulizer, which turns the liquid medicine into a fine mist that you breathe in.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You will inhale this medication through your mouth using a special machine called a nebulizer. Your doctor will teach you how to use the nebulizer properly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
Important Administration Instructions
Do not swallow this medication.
Do not mix this medication with any other liquid medications.
Do not add other medications to the nebulizer.
Do not open the ampule until you are ready to take a dose.
After opening, discard any unused portion of the ampule.
Shake the solution well before use. The solution should appear cloudy and yellow to pale yellow. Do not use if the solution changes color or appears cloudy, leaking, or contains particles.
Nebulizer Care and Maintenance
Follow the instructions for cleaning the nebulizer carefully. Each ampule is for single use only. After using an ampule, dispose of it in the trash, out of the reach of children, as it may pose a choking hazard.
Taking Multiple Inhaled Medications
If you are taking more than one inhaled medication, consult with your doctor to determine the best order for taking your medications.
Continuing Treatment
Continue using this medication as directed by your doctor or healthcare provider, even if you feel well.
Storage and Disposal
Store this medication at room temperature, away from heat and sunlight. Do not freeze. Keep unused containers in their foil pouches until use.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You will inhale this medication through your mouth using a special machine called a nebulizer. Your doctor will teach you how to use the nebulizer properly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
Important Administration Instructions
Do not swallow this medication.
Do not mix this medication with any other liquid medications.
Do not add other medications to the nebulizer.
Do not open the ampule until you are ready to take a dose.
After opening, discard any unused portion of the ampule.
Shake the solution well before use. The solution should appear cloudy and yellow to pale yellow. Do not use if the solution changes color or appears cloudy, leaking, or contains particles.
Nebulizer Care and Maintenance
Follow the instructions for cleaning the nebulizer carefully. Each ampule is for single use only. After using an ampule, dispose of it in the trash, out of the reach of children, as it may pose a choking hazard.
Taking Multiple Inhaled Medications
If you are taking more than one inhaled medication, consult with your doctor to determine the best order for taking your medications.
Continuing Treatment
Continue using this medication as directed by your doctor or healthcare provider, even if you feel well.
Storage and Disposal
Store this medication at room temperature, away from heat and sunlight. Do not freeze. Keep unused containers in their foil pouches until use.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Continue to avoid smoking and exposure to secondhand smoke, as this is crucial for managing COPD.
- Follow your healthcare provider's instructions for using your nebulizer correctly.
- Do not stop using Ohtuvayre without talking to your doctor, even if you feel better.
- Maintain regular physical activity as tolerated and recommended by your doctor.
- Get recommended vaccinations (e.g., flu, pneumonia) to prevent respiratory infections.
- Attend all scheduled follow-up appointments with your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
3 mg (one 2.5 mL ampule) administered twice daily via nebulizer
Dose Range:
3 - 3 mg
Condition-Specific Dosing:
COPD:
3 mg (one 2.5 mL ampule) administered twice daily via nebulizer
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Not studied; use with caution
Dialysis:
Not studied; use with caution
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Not studied; use with caution
Pharmacology
Mechanism of Action
Ensifentrine is a first-in-class, non-selective phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) inhibitor. By inhibiting both PDE3 and PDE4, ensifentrine increases intracellular cyclic adenosine monophosphate (cAMP) levels in airway smooth muscle cells and inflammatory cells. Increased cAMP leads to bronchodilation by activating protein kinase A (PKA), which relaxes smooth muscle. It also exerts anti-inflammatory effects by modulating immune cell function and reducing the release of pro-inflammatory mediators.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 13% (absolute bioavailability after inhalation)
Tmax:
Approximately 0.5 to 1 hour post-dose
FoodEffect:
Not applicable for inhaled administration
Distribution:
Vd:
Approximately 1000 L (suggests extensive tissue distribution)
ProteinBinding:
Approximately 90-95%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6-10 hours
Clearance:
Approximately 100 L/hour
ExcretionRoute:
Primarily fecal (approximately 80%), with minor renal excretion (approximately 10%)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
Within 15-30 minutes
PeakEffect:
Approximately 1-2 hours
DurationOfAction:
Up to 12 hours (supports twice-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
New or worsening behavioral or mood changes, such as:
+ Depression
+ Thoughts of suicide
Trouble sleeping
Bladder irritation
Pain while urinating
Frequent urination
Respiratory Emergency
This medication can cause severe breathing problems, which may be life-threatening, shortly after taking a dose. If you experience trouble breathing, worsening breathing, wheezing, or coughing after using this medication, use a rescue inhaler and seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Back pain
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
New or worsening behavioral or mood changes, such as:
+ Depression
+ Thoughts of suicide
Trouble sleeping
Bladder irritation
Pain while urinating
Frequent urination
Respiratory Emergency
This medication can cause severe breathing problems, which may be life-threatening, shortly after taking a dose. If you experience trouble breathing, worsening breathing, wheezing, or coughing after using this medication, use a rescue inhaler and seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Back pain
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden worsening of breathing problems (dyspnea)
- Increased cough or changes in sputum color/amount
- Signs of infection (fever, chills)
- Severe or persistent headache
- Unusual or severe nausea or diarrhea
- Any new or worsening chest pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems you have, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems you have, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience any worsening of your breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of use of your rescue inhaler, contact your doctor immediately. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Exaggerated adverse effects (e.g., severe headache, nausea, vomiting, diarrhea)
- Cardiovascular effects (e.g., tachycardia, palpitations, hypotension)
- Central nervous system effects (e.g., dizziness, tremor)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase ensifentrine exposure. Use with caution.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): May decrease ensifentrine exposure. Use with caution.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy
Patient's symptom burden (e.g., dyspnea, cough)
Rationale: To establish baseline and monitor therapeutic response.
Timing: Prior to initiation of therapy
Routine Monitoring
Pulmonary Function Tests (FEV1)
Frequency: Periodically, as clinically indicated (e.g., every 3-6 months)
Target: Improvement from baseline
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation of treatment plan
Adverse effects (e.g., headache, cough, nausea, diarrhea)
Frequency: Regularly, especially during initial weeks of therapy and with dose changes
Target: Absence or tolerability of side effects
Action Threshold: Persistent or severe adverse effects warrant dose adjustment or discontinuation
COPD symptom control
Frequency: At each follow-up visit
Target: Reduction in frequency and severity of symptoms
Action Threshold: Worsening symptoms or increased exacerbations require reassessment
Symptom Monitoring
- Worsening dyspnea
- Increased cough or sputum production
- Chest tightness
- Signs of respiratory infection
- Headache
- Nausea
- Diarrhea
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Ohtuvayre in pregnant women. Animal studies have not shown evidence of developmental toxicity. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific data; theoretical risk based on animal studies is low.
Second Trimester:
No specific data; theoretical risk based on animal studies is low.
Third Trimester:
No specific data; theoretical risk based on animal studies is low.
Lactation
It is not known whether ensifentrine is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ohtuvayre and any potential adverse effects on the breastfed infant from Ohtuvayre or from the underlying maternal condition.
Infant Risk:
Unknown; potential for systemic effects in infant is low due to low systemic absorption in mother, but caution is advised.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for COPD. Ohtuvayre is not indicated for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger adult patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Ohtuvayre is a novel, first-in-class dual PDE3/PDE4 inhibitor, offering both bronchodilator and anti-inflammatory effects in a single inhaled medication.
- It is administered via nebulizer, which may be beneficial for patients who struggle with inhaler technique or have severe airflow limitation.
- Unlike inhaled corticosteroids, ensifentrine is a non-steroidal anti-inflammatory agent, potentially offering an alternative for patients who cannot tolerate or do not respond well to steroids.
- It is approved for maintenance treatment of COPD and should not be used for acute bronchospasm.
- Patients should be instructed on proper nebulizer use and maintenance.
Alternative Therapies
- Long-acting beta-agonists (LABAs) e.g., salmeterol, formoterol, indacaterol, olodaterol
- Long-acting muscarinic antagonists (LAMAs) e.g., tiotropium, aclidinium, glycopyrronium, umeclidinium
- Inhaled corticosteroids (ICS) e.g., fluticasone, budesonide, mometasone (often in combination with LABA)
- Combination LABA/LAMA inhalers
- Combination ICS/LABA inhalers
- Oral phosphodiesterase-4 inhibitors (e.g., roflumilast)
- Oral corticosteroids (for exacerbations)
- Theophylline (less common due to narrow therapeutic index)
Cost & Coverage
Average Cost:
Not available per 30 ampules
Insurance Coverage:
Tier 2 or 3 (likely specialty tier initially due to new drug status)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.