"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
Pulmonary Arterial Hypertension
Ventavis® 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 predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Ventavis is intended to be inhaled using the I-neb® AAD® System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing should be increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. Ventavis should be taken 6 to 9 times per day (no more than once every 2 hours) during waking hours, according to individual need and tolerability. The maximum daily dose evaluated in clinical studies was 45 mcg (5 mcg 9 times per day).
Direct mixing of Ventavis with other medications in the I-neb® AAD® System has not been evaluated; do not mix with other medications. To avoid potential interruptions in drug delivery due to equipment malfunctions, the patient should have easy access to a back-up I-neb® AAD® System.
Ventavis is supplied in 1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL.
|Nebulizer||Delivered dose from ampule of :|
|10 mcg/mL||20 mcg/mL|
|I-neb® AAD®||2.5 or 5 mcg from one ampule||5 mcg from one ampule|
The 20 mcg/mL concentration is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Transitioning patients to the 20 mcg/mL concentration using the Ineb®AAD® System will decrease treatment times to help maintain patient compliance.
For each inhalation session, the entire contents of each opened ampule of Ventavis should be transferred into the I-neb® AAD® System medication chamber immediately before use [see PATIENT INFORMATION]. After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-neb® AAD® System components after each dose administration.
Vital signs should be monitored while initiating Ventavis. [see WARNINGS AND PRECAUTIONS].
Use In Patients With Pre-existing Hepatic Impairment
Because iloprost elimination is reduced in patients with impaired liver function [see Special Populations], consider increasing the dosing interval (e.g., 3-4 hours between doses depending on the patient's response at the end of the dose interval) in patients with Child-Pugh Class B or C hepatic impairment.
Use In Patients With Pre-existing Renal Impairment
Dosage Forms And Strengths
1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL.
Storage And Handling
Ventavis (iloprost) Inhalation Solution is supplied in cartons of 30 x 1 mL clear glass single-use ampules as follows:
1 mL ampule containing iloprost
10 mcg per mL, carton of 30 (NDC 66215-302-30)
1 mL ampule containing iloprost 20 mcg per mL, carton of 30 (NDC 66215-303-30)
Store at 20 – 25°C (68 – 77°F)
Excursions permitted to 15 – 30°C (59 – 86°F)
[See USP Controlled Room Temperature]
Issued November 2013. Manufactured for: Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Ste. 200 South San Francisco, CA 94080 ©2013 Actelion Pharmaceuticals US, Inc.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/12/2013
Additional Ventavis Information
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