Dosing and uses of Ventavis (iloprost)
Adult dosage forms and 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/d PRN; >q2hr while awake
Maintenance: 2.5-5 mcg/dose; not to exceed 45mcg/day
Administration
Inhaled using Prodose® AAD® System
Use during waking hours
Pediatric dosage forms and strengths
Safety and efficacy not established
Ventavis (iloprost) adverse (side) 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 and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown, low levels of drug or metabolite in milk have been observed; not recommended
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 of Ventavis (iloprost)
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%)
