Ventavis 10mcg/ml Inh Sol, 1ml
It is used to treat high blood pressure in the lungs.
Drug Class
Pulmonary Hypertension Agent
Pharmacologic Class
Prostacyclin Analog; Vasodilator
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iloprost is a medicine inhaled through a special nebulizer to help relax and widen the blood vessels in your lungs. This makes it easier for your heart to pump blood through your lungs, which can improve your breathing and exercise ability if you have pulmonary hypertension (high blood pressure in the lungs).
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 breathe 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 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. When using this medication, avoid exposing others to it, especially babies and 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 have access to 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 less than 2 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the I-neb® AAD® system to breathe 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 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. When using this medication, avoid exposing others to it, especially babies and 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 have access to 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 less than 2 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Use the nebulizer exactly as prescribed, typically 6 to 9 times a day, every day. Do not miss doses.
- Do not abruptly stop taking iloprost, as this can lead to a rapid worsening of your pulmonary hypertension.
- Always use the specific nebulizer device (I-neb AAD System or Prodose AAD System) provided with Ventavis, as other nebulizers may not deliver the correct dose.
- Store vials in the refrigerator and protect from light. Once opened, use immediately and discard any unused solution.
- Report any new or worsening symptoms, especially dizziness, fainting, or increased shortness of breath, to your doctor immediately.
- Avoid activities that could lead to excessive bleeding if you are also taking blood thinners.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mcg (delivered) per inhalation session, 6 to 9 times daily. If 2.5 mcg is well tolerated, the dose should be increased to 5 mcg (delivered) per inhalation session.
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
pulmonary_arterial_hypertension:
Administer via I-neb AAD System or Prodose AAD System. Inhalation sessions 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 needed.
Moderate:
No specific dose adjustment needed.
Severe:
No specific dose adjustment needed.
Dialysis:
No specific dose adjustment needed; iloprost is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
Consider starting with 2.5 mcg and titrate carefully.
Moderate:
Start with 2.5 mcg (delivered) per inhalation session, 6 to 9 times daily. Titrate carefully based on individual response and tolerability.
Severe:
Start with 2.5 mcg (delivered) per inhalation session, 6 to 9 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 effects by binding to prostacyclin receptors, leading to an increase in intracellular cyclic AMP (cAMP). This increase in cAMP results in direct vasodilation of pulmonary and systemic arterial beds, and inhibition of platelet aggregation. In pulmonary hypertension, it reduces pulmonary vascular resistance and pulmonary arterial pressure.
Pharmacokinetics
Absorption:
Bioavailability:
Low (due to extensive first-pass metabolism)
Tmax:
10-20 minutes (plasma after inhalation)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
Approximately 15 L
ProteinBinding:
Approximately 60% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-30 minutes (plasma)
Clearance:
High systemic clearance
ExcretionRoute:
Renal (68%) and fecal (32%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of inhalation)
PeakEffect:
10-20 minutes (hemodynamic effects)
DurationOfAction:
45-60 minutes (hemodynamic effects), requiring frequent dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention 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 help 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
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 unusual 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, 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. Your doctor can provide medical advice about side effects and help you manage any concerns.
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 help 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
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 unusual 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, 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. Your doctor can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (syncope)
- Sudden worsening of shortness of breath or chest pain
- Unusual bleeding or bruising (e.g., nosebleeds, blood in urine/stools, excessive bruising)
- Swelling in the ankles or legs (edema)
- Severe headache
- 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 the safety and efficacy of the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, this medication may interact with other medications or health conditions. Therefore, 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
Any existing health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other medications and health conditions.
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 and efficacy of the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.
Additionally, this medication may interact with other medications or health conditions. Therefore, 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
Any existing health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other medications and health conditions.
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 and avoid driving or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be particularly careful 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. Take precautions to avoid injury, and adopt gentle personal care habits, such as using a soft-bristled toothbrush and an electric razor.
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 and avoid driving or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be particularly careful 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. Take precautions to avoid injury, and adopt gentle personal care habits, such as using a soft-bristled toothbrush and an electric razor.
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 (low blood pressure)
- Flushing
- Headache
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
What to Do:
Seek immediate medical attention. Treatment is symptomatic and supportive. Monitor vital signs closely. If hypotension occurs, elevate legs and consider fluid replacement. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
Moderate Interactions
- Vasodilators (e.g., calcium channel blockers, nitrates, other prostacyclin analogs, PDE5 inhibitors, alpha-blockers): Increased risk of systemic hypotension due to additive vasodilatory effects.
- Antihypertensive agents: Increased risk of systemic hypotension.
Monitoring
Baseline Monitoring
Pulmonary function tests
Rationale: To assess baseline lung health and rule out other respiratory conditions.
Timing: Prior to initiation
6-minute walk distance (6MWD)
Rationale: To establish baseline exercise capacity, a key efficacy endpoint in PAH.
Timing: Prior to initiation
Echocardiogram
Rationale: To assess right ventricular function and pulmonary artery pressures.
Timing: Prior to initiation
Right heart catheterization
Rationale: For definitive diagnosis and baseline hemodynamic assessment (e.g., pulmonary vascular resistance, cardiac output).
Timing: Prior to initiation
Routine Monitoring
Blood pressure and heart rate
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal range, avoid symptomatic hypotension.
Action Threshold: Symptomatic hypotension or significant drop from baseline; consider dose reduction or discontinuation.
Symptoms of PAH (dyspnea, fatigue, syncope, chest pain)
Frequency: At each clinical visit and patient self-monitoring.
Target: Improvement or stabilization of symptoms.
Action Threshold: Worsening symptoms may indicate disease progression or inadequate response; consider re-evaluation.
Exercise capacity (e.g., 6-minute walk test)
Frequency: Every 3-6 months or as clinically indicated.
Target: Improvement or stabilization of 6MWD.
Action Threshold: Decline in 6MWD may indicate disease progression; consider re-evaluation and treatment adjustment.
Signs of bleeding (e.g., bruising, petechiae, GI bleeding)
Frequency: Regularly, especially if co-administered with anticoagulants/antiplatelets.
Target: Absence of abnormal bleeding.
Action Threshold: Presence of abnormal bleeding; consider dose reduction or discontinuation of iloprost or concomitant agents.
Symptom Monitoring
- Headache
- Flushing
- Nausea
- Vomiting
- Jaw pain
- Cough
- Dyspnea
- Hypotension
- Dizziness
- Syncope
- Edema
- Bleeding (e.g., epistaxis, hemoptysis)
Special Patient Groups
Pregnancy
Iloprost is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities observed in animal studies at high doses.
Second Trimester:
Limited human data; use with caution.
Third Trimester:
Limited human data; use with caution. Potential for effects on fetal circulation due to prostaglandin effects.
Lactation
It is unknown 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:
Risk unknown; potential for adverse effects on infant cardiovascular system or other systems. Caution advised.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in this population.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, elderly patients may be more sensitive to the effects of iloprost, particularly hypotension. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Iloprost requires frequent dosing (6-9 times daily) due to its short half-life, which can impact patient adherence.
- Proper use of the specific nebulizer device (I-neb AAD System or Prodose AAD System) is critical for effective drug delivery. Patients must be thoroughly trained.
- Abrupt discontinuation of iloprost can lead to rebound pulmonary hypertension and clinical deterioration; doses should be tapered if discontinuation is necessary.
- Patients should be advised to sit or lie down during inhalation to minimize the risk of symptomatic hypotension.
- Cough is a common side effect, often transient, but can sometimes limit tolerability.
Alternative Therapies
- Epoprostenol (Flolan, Veletri) - IV prostacyclin
- Treprostinil (Remodulin - IV/SC, Tyvaso - inhaled, Orenitram - oral) - prostacyclin analog
- Selexipag (Uptravi) - oral prostacyclin receptor agonist
- Bosentan (Tracleer) - oral endothelin receptor antagonist (ERA)
- Ambrisentan (Letairis) - oral ERA
- Macitentan (Opsumit) - oral ERA
- Sildenafil (Revatio) - oral/IV PDE5 inhibitor
- Tadalafil (Adcirca) - oral PDE5 inhibitor
- Riociguat (Adempas) - oral soluble guanylate cyclase stimulator
Cost & Coverage
Average Cost:
Very expensive (e.g., $10,000 - $20,000+ per month) per 30ml (30 x 1ml vials)
Insurance Coverage:
Specialty Tier (requires prior authorization and often step therapy)
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.