Classes
DEA Class; Rx
Common Brand Names; Ventavis
- PAH, Prostacyclin Analogs
Description
Inhaled prostacyclin derivative; vasodilator; some systemic absorption with inhibition of platelet aggregation possible
Administered via specific types of nebulizer machine
Improves symptoms in patients with pulmonary arterial hypertension.
Indications
Indicated for the treatment of pulmonary hypertension to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration in persons with WHO Group 1 pulmonary hypertension.
Contraindications
None well documented
Adverse Effects
- Flushing (18%)
- Cough (39%)
- Hypotension (11%)
- Nausea (13%)
- Headache (30%)
- Jaw pain (12%)
- Trismus (12%)
- Palpitations (7%)
- Syncope (8%)
- Insomnia (8%)
- Vomiting (7%)
- Tongue pain (4%)
- Back pain (7%)
- Muscle cramps (6%)
- GGT elevated (6%)
- Hemoptysis (5%)
- Pneumonia (4%)
Warnings
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 and Lactation
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
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
Maximum Dosage
Maximum dosage information is not available. However, in clinical trials, daily cumulative doses of up to 70 mcg resulted in significantly increased incidence of adverse effects.
Maximum dosage information is not available. However, in clinical trials, daily cumulative doses of up to 70 mcg resulted in significantly increased incidence of adverse effects.
Safe and efficacy have not been established.
Safe and efficacy have not been established.
