About the I-neb® AAD System®

The I-neb Adaptive Aerosol Delivery (AAD) System is a battery-powered pulmonary drug delivery system that makes it possible for patients to take their VENTAVIS® (iloprost) Inhalation Solution treatments almost anywhere. With up to 40 treatments from a single charge, the I-neb AAD System frees patients from the need to be near an electrical outlet. The Adaptive Aerosol Delivery (AAD) technology is designed to help patients receive a more accurate dose.23

Specifically designed for use with VENTAVIS

VENTAVIS is a prostacyclin analogue with a narrow therapeutic index. The AAD was designed to help provide more precise and reproducible dosing of VENTAVIS to every patient, required for the safety and efficacy of the drug.

Precision dosing with I-neb AAD

  • Smart technology from Philips Respironics
  • Designed to deliver precise doses of drug2,16
  • Generates micro-aerosol18
  • Treatment monitoring

The system uses AAD technology to precisely and reproducibly deliver VENTAVIS to every patient, at either dose (2.5 mcg or 5.0 mcg), using a single ampule of medication.2 The dose each patient receives is controlled by the medication chamber. The I-neb AAD System continuously monitors and analyzes a patient's breathing pattern and delivers pulses of aerosol into the start of each inhalation until the set dose is delivered.

Standard air-jet nebulizers/compressors or ultrasonic nebulizer systems are continuous flow systems that constantly generate aerosol. Patients typically have a 40:60 inhalation:exhalation ratio; therefore, about 60% of the drug is wasted to the environment with such devices during exhalation.2 Additionally, a variable amount of drug is inhaled by each patient because individual breathing patterns differ (e.g., short, shallow breaths to long, deep breaths).

Designed for ease of use

With the I-neb AAD System there is no need for complex assembly or disassembly. There is no daily, weekly, or monthly scheduled part replacement. The chamber lid's mesh replacement is scheduled by your specialty pharmacy. And no more than daily cleaning and a weekly boil are required.

Adapts to your patient

The I-neb AAD learns your patient's specific breathing pattern through smart technology by Philips Respironics. It adapts to the individual for accurate and consistent delivery of the prescribed dose to help your patient get the full dose of medicine.

One ampule per treatment

Only one drug treatment (either 2.5 mcg or 5.0 mcg) can be delivered from the contents of a single ampule. Reuse of any drug solution that remains after completing a drug treatment, even if the reservoir is "topped off" with fresh medication, will not give accurate dosing. Do not reuse ampules.

On the go

The I-neb AAD System is fully portable so patients may take their treatments almost anywhere. It is lightweight and small enough to fit into a purse or jacket pocket, and with 40 uses per battery charge patients can feel comfortable taking their treatments with them wherever they go. The device is also designed so that there is no spillage of medication if the device tips over.

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.

Please see full Prescribing Information.

Indication and Important Safety Information

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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.

Please see full Prescribing Information.