Ventavis 10mcg/ml Inhalation Sol
It is used to treat high blood pressure in the lungs.
Drug Class
Pulmonary Hypertension Agent; Prostacyclin Analog
Pharmacologic Class
Prostacyclin Receptor Agonist; Vasodilator
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ventavis is an inhaled medicine used to treat a serious lung condition called pulmonary arterial hypertension (PAH). It works by relaxing the blood vessels in your lungs, which helps to lower blood pressure in the lungs and makes it easier for your heart to pump blood. This can improve your ability to exercise and reduce symptoms like shortness of breath.
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. Use the I-neb® AAD® system to inhale the medication into your lungs only. Do not swallow the medication, and avoid mixing it with other drugs in the nebulizer. After each dose, discard any remaining medication in the chamber to prepare for the next dose. Clean the equipment as directed by your doctor.
If the medication comes into contact with your eyes or skin, rinse the affected area with water. When inhaling the medication, avoid exposing others, especially babies and pregnant individuals.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (less than 2 hours), skip the missed dose and resume your regular schedule. Do not take two doses at once or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the I-neb® AAD® system to inhale the medication into your lungs only. Do not swallow the medication, and avoid mixing it with other drugs in the nebulizer. After each dose, discard any remaining medication in the chamber to prepare for the next dose. Clean the equipment as directed by your doctor.
If the medication comes into contact with your eyes or skin, rinse the affected area with water. When inhaling the medication, avoid exposing others, especially babies and pregnant individuals.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (less than 2 hours), skip the missed dose and resume your regular schedule. Do not take two doses at once or take extra doses to make up for the missed one.
Lifestyle & Tips
- Always use the specific nebulizer device (e.g., I-neb AAD System or Prodose AAD System) prescribed for Ventavis, as other nebulizers may not deliver the correct dose.
- Adhere strictly to the prescribed dosing schedule (6-9 times daily) to maintain therapeutic effects, as the drug has a short duration of action.
- Avoid sudden changes in position (e.g., standing up quickly) to minimize the risk of dizziness or fainting due to potential drops in blood pressure.
- Do not mix Ventavis with any other medications in the nebulizer.
- Store Ventavis vials in the refrigerator and protect from light. Once opened, use immediately and discard any unused portion.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 2.5 mcg (delivered at the mouthpiece) per inhalation session, 6 to 9 times daily. If 2.5 mcg is well-tolerated, the dose should be increased to 5 mcg per inhalation session. Doses should be spaced at least 2 hours apart.
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
Pulmonary Arterial Hypertension (PAH):
Administer via specific nebulizer (e.g., I-neb AAD System or Prodose AAD System). Start with 2.5 mcg per inhalation session, 6-9 times daily. If tolerated, increase to 5 mcg per inhalation session. Doses should be spaced at least 2 hours apart.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution.
Dialysis:
Not available; caution advised due to potential for increased systemic exposure.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Reduce initial dose to 2.5 mcg per inhalation session, 3-4 times daily. Titrate carefully based on individual response and tolerability.
Severe:
Reduce initial dose to 2.5 mcg per inhalation session, 3-4 times daily. Titrate carefully based on individual response and tolerability.
Pharmacology
Mechanism of Action
Iloprost is a synthetic analog of prostacyclin (PGI2). It exerts its vasodilatory effects by binding to prostacyclin receptors (IP receptors) on vascular smooth muscle cells. This binding activates adenylate cyclase, leading to an increase in intracellular cyclic AMP (cAMP) levels. Increased cAMP causes relaxation of vascular smooth muscle, resulting in vasodilation of the pulmonary and systemic arterial beds. Iloprost also inhibits platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 20% (systemic bioavailability after inhalation due to first-pass metabolism)
Tmax:
Approximately 10-20 minutes (plasma concentration after inhalation)
FoodEffect:
Not applicable (inhalation solution)
Distribution:
Vd:
Approximately 0.7 L/kg
ProteinBinding:
Approximately 60% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-30 minutes (terminal half-life after inhalation)
Clearance:
Approximately 10 L/min (total plasma clearance)
ExcretionRoute:
Primarily renal (approximately 80% within 24 hours), fecal (approximately 20%)
Unchanged:
Less than 1% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Within minutes
PeakEffect:
Approximately 10-20 minutes
DurationOfAction:
Approximately 45-60 minutes (hemodynamic effects), requiring frequent dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Severe dizziness or fainting
Fast or abnormal heartbeat
Unexplained bruising or bleeding
New or worsening trouble breathing
Coughing up blood
Difficulty opening your mouth
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Flushing
Upset stomach or vomiting
Jaw pain or tightness
Back pain
Cough
Muscle cramps
Trouble sleeping
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Severe dizziness or fainting
Fast or abnormal heartbeat
Unexplained bruising or bleeding
New or worsening trouble breathing
Coughing up blood
Difficulty opening your mouth
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Flushing
Upset stomach or vomiting
Jaw pain or tightness
Back pain
Cough
Muscle cramps
Trouble sleeping
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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:
- Severe dizziness or fainting (syncope)
- Significant drop in blood pressure (hypotension)
- Worsening shortness of breath or chest pain
- Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding)
- Severe headache
- Nausea or vomiting that is severe or persistent
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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have low blood pressure, as this may affect the safety of taking this medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, to ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your existing health problems
This information will help your doctor determine if it is safe for you to take this medication with 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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have low blood pressure, as this may affect the safety of taking this medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, to ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your existing health problems
This information will help your doctor determine if it is safe for you to take this medication with 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.
When starting this medication, avoid operating a vehicle or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Always have a backup system readily available in case of an emergency.
This medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
When starting this medication, avoid operating a vehicle or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Always have a backup system readily available in case of an emergency.
This medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe hypotension (low blood pressure)
- Flushing
- Severe headache
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Limb pain
What to Do:
In case of suspected overdose, immediately seek emergency medical attention. Call 911 or your local emergency number. Management is supportive and symptomatic. Monitor vital signs and provide fluid resuscitation if hypotension is severe. There is no specific antidote.
Drug Interactions
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding due to iloprost's antiplatelet effects.
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding due to additive antiplatelet effects.
- Vasodilators (e.g., calcium channel blockers, nitrates, other pulmonary vasodilators): Increased risk of systemic hypotension.
- Antihypertensive agents (e.g., beta-blockers, ACE inhibitors, diuretics): Increased risk of systemic hypotension.
Monitoring
Baseline Monitoring
Pulmonary Arterial Hypertension (PAH) symptoms assessment
Rationale: To establish baseline severity and track response to therapy.
Timing: Prior to initiation of therapy
Vital Signs (Blood Pressure, Heart Rate)
Rationale: To establish baseline and monitor for systemic hypotension or tachycardia.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially important for dose adjustment in hepatic impairment.
Timing: Prior to initiation of therapy
Renal Function Tests (Creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy
Routine Monitoring
Pulmonary Arterial Hypertension (PAH) symptoms assessment
Frequency: Regularly (e.g., every 3-6 months or as clinically indicated)
Target: Improvement or stabilization of symptoms (e.g., dyspnea, fatigue)
Action Threshold: Worsening symptoms may indicate need for dose adjustment or alternative therapy.
Vital Signs (Blood Pressure, Heart Rate)
Frequency: Regularly (e.g., at clinic visits, or as needed if symptomatic)
Target: Maintain within patient's normal range, avoid symptomatic hypotension
Action Threshold: Symptomatic hypotension (e.g., dizziness, syncope) or persistent low blood pressure may require dose reduction or discontinuation.
6-Minute Walk Distance (6MWD)
Frequency: Every 3-6 months
Target: Improvement or stabilization of walk distance
Action Threshold: Decline in 6MWD may indicate disease progression or inadequate response.
Echocardiogram (ECHO) or Right Heart Catheterization (RHC)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Improvement or stabilization of pulmonary hemodynamics (e.g., pulmonary artery pressure, cardiac index)
Action Threshold: Worsening hemodynamics may indicate need for therapy escalation.
Symptom Monitoring
- Dyspnea (shortness of breath)
- Chest pain
- Dizziness or lightheadedness
- Syncope (fainting)
- Flushing
- Headache
- Nausea
- Jaw pain
- Cough
- Bleeding (e.g., nosebleeds, bruising)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities observed in animal studies.
Second Trimester:
Potential for developmental abnormalities observed in animal studies.
Third Trimester:
Potential for developmental abnormalities observed in animal studies.
Lactation
It is not known whether iloprost is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately Safe - No human data, but animal data suggest possible risk or drug is a known risk in humans but benefits may outweigh risks).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in pediatric patients is generally not recommended.
Geriatric Use
No specific dose adjustment is required based on age alone. However, caution should be exercised in elderly patients due to the higher likelihood of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Monitor for adverse effects, particularly hypotension.
Clinical Information
Clinical Pearls
- Ventavis requires a specific nebulizer device (e.g., I-neb AAD System or Prodose AAD System) for proper delivery. Patients must be trained on its correct use.
- Due to its very short half-life, strict adherence to the frequent dosing schedule (6-9 times daily) is crucial for maintaining therapeutic effects and preventing rebound pulmonary hypertension.
- Patients should be advised to sit or lie down during and immediately after inhalation to minimize the risk of dizziness or syncope from systemic vasodilation.
- Common side effects include flushing, headache, jaw pain, and cough, which are often related to the vasodilatory effects.
- Iloprost is a potent vasodilator; monitor blood pressure closely, especially at initiation and during dose titration.
Alternative Therapies
- Other inhaled prostacyclin analogs (e.g., Treprostinil inhalation - Tyvaso, Orenitram)
- Oral prostacyclin receptor agonists (e.g., Selexipag - Uptravi)
- Endothelin Receptor Antagonists (ERAs) (e.g., Bosentan - Tracleer, Ambrisentan - Letairis, Macitentan - Opsumit)
- Phosphodiesterase-5 (PDE5) Inhibitors (e.g., Sildenafil - Revatio, Tadalafil - Adcirca)
- Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat - Adempas)
- Parenteral prostacyclin analogs (e.g., Epoprostenol - Flolan, Veletri; Treprostinil - Remodulin, Tyvaso, Orenitram)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month per 10mcg/ml 2ml vial (60 vials/month)
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.