Dosing & Uses
Dosage Forms & Strengths
single-use ampule
- 10mcg/mL (1mL)
- 20mcg/mL (1mL)
Pulmonary Arterial Hypertension
Initial: 2.5 mcg inhaled, if well-tolerated, THEN
5 mcg subsequent doses
6-9 times/day PRN; >q2hr while awake
Maintenance: 2.5-5 mcg/dose; not to exceed 45 mcg/day
Systemic Sclerosis (Orphan)
Orphan designation for treatment of systemic sclerosis
Orphan sponsor
- Eicos Sciences, Inc., a CiVi Biopharma, Inc. affiliated company; 200 Four Falls Corporate Center, Suite 107; West Conshohocken, Pennsylvania 19528
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- lofexidine
lofexidine, iloprost. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration with other drugs that decrease pulse or blood pressure to mitigate risk of excessive bradycardia and hypotension.
Monitor Closely (16)
- aldesleukin
aldesleukin increases effects of iloprost by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- amifostine
amifostine, iloprost. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration with blood pressure lowering agents may increase the risk and severity of hypotension associated with amifostine. When amifostine is used at chemotherapeutic doses, withhold blood pressure lowering medications for 24 hr prior to amifostine; if blood pressure lowering medication cannot be withheld, do not administer amifostine.
- benazepril
iloprost, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced hypotensive effects.
- captopril
iloprost, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.
- carbidopa
carbidopa increases effects of iloprost by pharmacodynamic synergism. Use Caution/Monitor. Therapy with carbidopa, given with or without levodopa or carbidopa-levodopa combination products, is started, dosage adjustment of the antihypertensive drug may be required.
- dabigatran
dabigatran and iloprost both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.
- eluxadoline
eluxadoline increases levels of iloprost by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 substrates.
- epoprostenol
epoprostenol, iloprost. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.
- fenoldopam
fenoldopam, iloprost. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of iloprost by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- hydralazine
hydralazine, iloprost. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.
- ibrutinib
ibrutinib will increase the level or effect of iloprost by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.
- levodopa
levodopa increases effects of iloprost by pharmacodynamic synergism. Use Caution/Monitor. Consider decreasing dosage of antihypertensive agent.
- minoxidil
iloprost, minoxidil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.
- treprostinil
iloprost, treprostinil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.
- xipamide
xipamide increases effects of iloprost by pharmacodynamic synergism. Use Caution/Monitor.
Minor (10)
- agrimony
agrimony increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- brimonidine
brimonidine increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- cornsilk
cornsilk increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- forskolin
forskolin increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- maitake
maitake increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- octacosanol
octacosanol increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- reishi
reishi increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
- shepherd's purse
shepherd's purse, iloprost. Other (see comment). Minor/Significance Unknown. Comment: Theoretically, shepherd's purse may interfere with BP control.
- tizanidine
tizanidine increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.
- treprostinil
treprostinil increases effects of iloprost by pharmacodynamic synergism. Minor/Significance Unknown.
Adverse Effects
>10%
Flushing (18%)
Cough (39%)
Hypotension (11%)
Nausea (13%)
Headache (30%)
Jaw pain (12%)
Trismus (12%)
1-10%
Palpitations (7%)
Syncope (8%)
Insomnia (8%)
Vomiting (7%)
Tongue pain (4%)
Back pain (7%)
Muscle cramps (6%)
GGT elevated (6%)
Hemoptysis (5%)
Pneumonia (4%)
<1%
Kidney failure
Bronchospasm
Hypersensitivity
Supraventricular tachycardia
Warnings
Contraindications
None well documented
Cautions
Iloprost has been listed by the FDA as one of the drugs to monitor after having identified potential signs of serious risks or new safety information in the agency's Adverse Event Reporting System (AERS) database during the last 3 months of 2011. Hemoptysis has been reported with iloprost use. The FDA said that it is not suggesting that clinicians should stop prescribing any drugs on the watch list, or that patients should stop taking them. It advises patients with questions about watch-list drugs to discuss them with their clinician.
Use caution in patients experiencing other types of pulmonary diseases (i.e. COPD)
Syncope may occur with pulmonary arterial hypertension, particularly with physical exertion (adjust dose and reassess efficacy)
Risk of syncope - monitor vital signs when initiating
Use cautioin in patients with bleeding disorders
Rebound hypertension may occur with dose reductions or withdrawals
Administered only via the Prodose® AAD® System
Not for use in patients with hypotension (systolic BP <85 mm Hg)
Discontinue immediately if signs of pulmonary edema
Bleeding events are most commonly reported as epistaxis or hemoptysis
Pregnancy & Lactation
Pregnancy
Limited published data from case series and case reports in pregnant women have not identified drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with pulmonary arterial hypertension
Pulmonary arterial hypertension in pregnancy increases risk for maternal heart failure, stroke and death, miscarriage, preterm delivery, low birthweight infants, and stillbirth
Animal data
- In animal reproductive studies, administration of continuous intravenous therapy to pregnant Han-Wistar rats during organogenesis at doses 2-times recommended human dose on a mg/m2 basis resulted in adverse developmental outcomes
- However, there were no adverse developmental outcomes with intravenous administration of iloprost to pregnant Sprague- Dawley rats, rabbits and monkeys at doses 1200-, 180-, and 14-times, respectively, the recommended human dose on a mg/m2 basis
Lactation
There are no data on presence of iloprost in human milk, effects on breastfed infant, or on milk production; drug is present in rat milk; when drug present in animal milk, it is likely drug will be present in human milk
Because of potential for serious adverse reactions, advise women not to breastfeed during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Synthetic analog of prostagladin PGI2, dilates systemic & pulmonary arterial beds; suppresses vascular smooth muscle proliferation and alters pulmonary vascular resistance when used long term
Pharmacokinetics
Vd: 0.7-0.8 L/kg
Protein Bound: 60%
Duration: 30-60 min
Metabolism: Principally via beta-oxidation of carboxyl side-chain
Metabolite: Tetranor-iloprost (inactive)
Half-life: 20-30 min
Peak serum time: Within 5 min (following inhalation)
Excretion: Urine (68%); feces (12%)
Images
Patient Handout
iloprost inhalation
ILOPROST SOLUTION - INHALATION
(EYE-loe-prost)
COMMON BRAND NAME(S): Ventavis
USES: This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Iloprost helps to increase your ability to exercise and improves symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.
HOW TO USE: Read the Patient Information Leaflet available from your pharmacist. This medication comes in a glass bottle (ampule). Follow the manufacturer's instructions on how to open the ampule and how to prepare each dose. This product is used with a special breathing device (nebulizer). Ask your doctor, pharmacist or respiratory therapist how to inhale this medication properly with this equipment. Make sure you understand how to properly clean the nebulizer to prevent infections.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not mix with other medications in the nebulizer.Inhale this medication by mouth as directed by your doctor, usually 6 to 9 times daily, at least 2 hours apart. Do not drink the solution. Do not get this medication on the skin or in your eyes. If this happens, rinse the area with water. The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.To avoid not being able to use your medication, be sure to have access to a back-up nebulizer in case your regular device stops working properly.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, jaw pain, muscle spasms of the jaw, flushing, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: wheezing, sudden weight gain, worsening breathing, chest pain, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using iloprost, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, liver problems, kidney problems, bleeding problems, other breathing problems (such as asthma).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Iloprost may lower your blood pressure. Your doctor may also direct you to take other medications that may also lower your blood pressure (such as "water pills"/diuretics such as furosemide, ACE inhibitors such as captopril, calcium channel blockers such as nifedipine, other vasodilators such as nitrates). Your doctor may also prescribe "blood thinners" (such as warfarin) to prevent blood clots. Iloprost may increase your risk of bleeding if you take "blood thinners." Your doctor or pharmacist will monitor you for these possible drug interactions. Tell your doctor or pharmacist right away if you develop symptoms such as easy or unusual bleeding/bruising, severe dizziness, or fainting.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood pressure, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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