Common Adverse Reactions
Adverse events† in AIR pivotal trial occurring in ≥3% of patients treated with VENTAVIS1 | |||||
---|---|---|---|---|---|
Adverse event | VENTAVIS (n=101) % |
Placebo (n=102) % |
Placebo Subtracted % |
||
Vasodilation (flushing) | 27 | 9 | 18 | ||
Cough increased | 39 | 26 | 13 | ||
Headache | 30 | 20 | 10 | ||
Trismus | 12 | 3 | 9 | ||
Insomnia | 8 | 2 | 6 | ||
Nausea | 13 | 8 | 5 | ||
Hypotension | 11 | 6 | 5 | ||
Vomiting | 7 | 2 | 5 | ||
Alk phos increased | 6 | 1 | 5 | ||
Flu syndrome | 14 | 10 | 4 | ||
Back pain | 7 | 3 | 4 | ||
Tongue pain | 4 | 0 | 4 | ||
Palpitations | 7 | 4 | 3 | ||
Syncope | 8 | 5 | 3 | ||
GGT increased | 6 | 3 | 3 | ||
Muscle cramps | 6 | 3 | 3 | ||
Hemoptysis | 5 | 2 | 3 | ||
Pneumonia | 4 | 1 | 3 |
†Adverse events reported by at least 4 VENTAVIS® (iloprost) Inhalation Solution patients and reported at least 3% more frequently for VENTAVIS patients than placebo patients in a 12-week study.
INDICATION
VENTAVIS® (iloprost) Inhalation Solution is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk of Syncope
- Vital signs should be monitored while initiating VENTAVIS. Hypotension leading to syncope has been observed; VENTAVIS should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.
Pulmonary Venous Hypertension
- Stop VENTAVIS immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.
Bronchospasm
- VENTAVIS inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.
ADVERSE REACTIONS
Serious Adverse Events
- Serious adverse events reported include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
Adverse Events
- Adverse events reported in a Phase 3 clinical trial occurring with a ≥3% difference between VENTAVIS patients and placebo patients were vasodilation (flushing) (27% vs 9%), increased cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), insomnia (8% vs 2%), nausea (13% vs 8%), hypotension (11% vs 6%), vomiting (7% vs 2%), alkaline phosphatase increased (6% vs 1%), flu syndrome (14% vs 10%), back pain (7% vs 3%), tongue pain (4% vs 0%), palpitations (7% vs 4%), syncope (8% vs 5%), GGT increased (6% vs 3%), muscle cramps (6% vs 3%), hemoptysis (5% vs 2%), and pneumonia (4% vs 1%).
DRUG INTERACTIONS
Antihypertensives and Vasodilators
- VENTAVIS has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
Anticoagulants and Platelet Inhibitors
- VENTAVIS also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants or platelet inhibitors.
SPECIFIC POPULATIONS
Lactation
- Advise not to breastfeed during treatment with VENTAVIS.
Please see full Prescribing Information.
cp-134777v3