Recommended Topic Related To:

Ventavis

"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...

Ventavis

Ventavis

INDICATIONS

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

Recommended Dosing

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.

Monitoring

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

Dose adjustment is not required in patients who are not on dialysis. The effect of dialysis on iloprost is unknown [see Special Populations].

HOW SUPPLIED

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)

Storage

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.

Last reviewed on RxList: 12/12/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Ventavis - User Reviews

Ventavis User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ventavis sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations