Ventavis 20mcg/ml Inh Sol, 1ml
It is used to treat high blood pressure in the lungs.
Drug Class
Agents for pulmonary hypertension
Pharmacologic Class
Prostacyclin analog; Vasodilator
Pregnancy Category
Category C
FDA Approved
Aug 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ventavis is an inhaled medicine used to treat high blood pressure in the lungs, a condition called pulmonary arterial hypertension (PAH). It works by relaxing the blood vessels in your lungs, making it easier for your heart to pump blood and improving your ability to exercise and breathe.
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. This medication is for inhalation only, using the I-neb® AAD® system. Do not swallow it, and do not mix it with other medications in the nebulizer.
After each dose, discard any remaining medication in the chamber to prepare it 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.
To minimize exposure to others, avoid breathing out the medication near babies or pregnant individuals.
Storage and Disposal
Store this 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 use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using the I-neb® AAD® system. Do not swallow it, and do not mix it with other medications in the nebulizer.
After each dose, discard any remaining medication in the chamber to prepare it 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.
To minimize exposure to others, avoid breathing out the medication near babies or pregnant individuals.
Storage and Disposal
Store this 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.
Lifestyle & Tips
- Adhere strictly to the prescribed dosing schedule (6-9 times daily, at least 2 hours apart) to maintain therapeutic effect.
- Do not suddenly stop taking Ventavis, as this can lead to a dangerous worsening of your pulmonary hypertension.
- Learn and practice the correct inhalation technique using the specific nebulizer device (I-neb AAD System or Prodose AAD System) provided.
- Clean and maintain your nebulizer device as instructed by your healthcare provider or the device manual.
- Avoid activities that significantly worsen your symptoms without prior discussion with your doctor.
- Report any new or worsening symptoms, especially dizziness, fainting, chest pain, or severe shortness of breath, immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mcg or 5 mcg per inhalation session, 6 to 9 times daily, during waking hours, at least 2 hours apart.
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
initialDose:
Start with 2.5 mcg per inhalation session. If 2.5 mcg is well tolerated, increase to 5 mcg per inhalation session. If 5 mcg is not tolerated, reduce to 2.5 mcg.
frequency:
6 to 9 times daily, 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 adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Consider starting with 2.5 mcg per inhalation session and titrate carefully due to increased systemic exposure.
Dialysis:
Consider starting with 2.5 mcg per inhalation session and titrate carefully due to increased systemic exposure.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider starting with 2.5 mcg per inhalation session and titrate carefully due to increased systemic exposure.
Severe:
Consider starting with 2.5 mcg per inhalation session and titrate carefully due to increased systemic exposure.
Pharmacology
Mechanism of Action
Iloprost is a synthetic analog of prostacyclin (PGI2). It binds to prostacyclin receptors, leading to increased intracellular cyclic AMP (cAMP) levels. This results in vasodilation of the pulmonary and systemic arterial beds, and inhibition of platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (inhalation, local effect with systemic absorption)
Tmax:
15-30 minutes (systemic plasma concentration)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
Approximately 15 L
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-30 minutes (systemic terminal half-life)
Clearance:
High systemic clearance (approximately 20 L/hr)
ExcretionRoute:
Primarily renal (68%) and fecal (32%) as metabolites.
Unchanged:
< 1% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid, within minutes of inhalation.
PeakEffect:
Within 15-30 minutes.
DurationOfAction:
Effects typically last 45-60 minutes after inhalation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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. While many people may not experience any side effects or only minor ones, it's 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 persist, contact your doctor for guidance:
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. Your doctor can provide medical advice on managing side effects.
Although rare, some people may experience severe and potentially life-threatening side effects while 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. While many people may not experience any side effects or only minor ones, it's 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 persist, contact your doctor for guidance:
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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or lightheadedness
- Fainting (syncope)
- Chest pain
- Severe shortness of breath
- Unusual bleeding or bruising
- Swelling in the ankles or legs (edema)
- Rapid or irregular heartbeat
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 your treatment.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss all your health problems with your doctor to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
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 your treatment.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss all your health problems with your doctor to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
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, be cautious when driving or engaging in activities that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be mindful when using stairs to avoid accidents.
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Always have a backup system readily available in case of an emergency.
As this medication may increase your risk of bleeding, take precautions to avoid injury. Use a soft-bristled toothbrush and an electric razor for shaving to minimize the risk of cuts.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
When starting this medication, be cautious when driving or engaging in activities that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be mindful when using stairs to avoid accidents.
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Always have a backup system readily available in case of an emergency.
As this medication may increase your risk of bleeding, take precautions to avoid injury. Use a soft-bristled toothbrush and an electric razor for shaving to minimize the risk of cuts.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Flushing (redness and warmth of the skin)
- Severe headache
- Nausea
- Vomiting
- Diarrhea
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
What to Do:
Seek immediate medical attention. Treatment is supportive. Monitor vital signs (blood pressure, heart rate) and provide symptomatic relief. Call 1-800-222-1222 (Poison Control) or your local emergency services.
Drug Interactions
Major Interactions
Moderate Interactions
- Beta-blockers: May blunt reflex tachycardia.
- Diuretics: May exacerbate hypotension.
Monitoring
Baseline Monitoring
Diagnosis of Pulmonary Arterial Hypertension (PAH)
Rationale: Confirm indication for therapy.
Timing: Prior to initiation
Baseline Exercise Capacity (e.g., 6-minute walk distance)
Rationale: To assess disease severity and monitor treatment response.
Timing: Prior to initiation
Vital Signs (Blood Pressure, Heart Rate)
Rationale: To establish baseline and monitor for hypotensive effects.
Timing: Prior to initiation
Liver and Renal Function Tests
Rationale: To assess organ function, especially if impairment is suspected, as dose adjustments may be needed.
Timing: Prior to initiation
Routine Monitoring
Vital Signs (Blood Pressure, Heart Rate)
Frequency: At each clinic visit, especially during dose titration.
Target: Individualized, maintain within safe limits.
Action Threshold: Significant hypotension or symptomatic bradycardia/tachycardia.
Symptoms of PAH (dyspnea, fatigue, syncope, chest pain)
Frequency: Regularly, at each clinic visit.
Target: Improvement or stabilization of symptoms.
Action Threshold: Worsening of symptoms, new onset of syncope or chest pain.
Exercise Capacity (e.g., 6-minute walk distance)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Improvement or stabilization.
Action Threshold: Significant decline in exercise capacity.
Adverse Effects (e.g., flushing, headache, nausea, jaw pain, cough, hypotension)
Frequency: Regularly, at each clinic visit.
Target: Minimization of side effects.
Action Threshold: Intolerable or severe adverse effects requiring dose adjustment or discontinuation.
Symptom Monitoring
- Worsening dyspnea
- Increased fatigue
- Syncope (fainting)
- Chest pain
- Peripheral edema
- Signs of right heart failure (e.g., jugular venous distension, ascites)
- Severe dizziness or lightheadedness
- Unusual bleeding or bruising
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies have shown adverse effects on fetal development (e.g., skeletal abnormalities, increased fetal deaths) at doses higher than human therapeutic doses. Risk in humans is unknown.
Second Trimester:
Risk in humans is unknown.
Third Trimester:
Risk in humans is unknown.
Lactation
L3 (Moderately safe). It is not known whether iloprost is excreted in human milk. Due to the low oral bioavailability of iloprost, infant exposure via breast milk is expected to be low. However, caution should be exercised when Ventavis is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ventavis and any potential adverse effects on the breastfed infant from Ventavis or from the underlying maternal condition.
Infant Risk:
Low potential for infant exposure due to low oral bioavailability, but unknown effects. Monitor for diarrhea or other adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No specific dose adjustment is required based on age alone. However, use with caution in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more sensitive to the hypotensive effects of iloprost.
Clinical Information
Clinical Pearls
- Ventavis must be administered using a specific nebulizer device (I-neb AAD System or Prodose AAD System) that delivers the drug in a controlled manner. Do not use other nebulizers.
- Patients should be instructed on the proper use, cleaning, and maintenance of their nebulizer device.
- Sudden discontinuation of iloprost can lead to a rapid and dangerous worsening of pulmonary hypertension (rebound pulmonary hypertension). Doses should be tapered gradually under medical supervision if discontinuation is necessary.
- Common side effects include flushing, headache, nausea, jaw pain, and cough. These are often transient and may lessen with continued use or dose adjustment.
- Patients should be advised to sit or lie down during and immediately after inhalation to minimize the risk of symptomatic hypotension or syncope.
Alternative Therapies
- Other prostacyclin analogs (e.g., epoprostenol, treprostinil)
- Endothelin receptor antagonists (e.g., bosentan, ambrisentan, macitentan)
- Phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil)
- Soluble guanylate cyclase stimulators (e.g., riociguat)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month supply
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays/coinsurance)
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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.