References

1.
Ventavis® (iloprost) full Prescribing Information. Actelion Pharmaceuticals US, Inc., April 2012.


2.
Denyer J, Nikander K, Smith NJ. Adaptive Aerosol Delivery (AAD) technology. Expert Opin Drug Deliv. 2004;1:165-176.


3.
Hardaker LE, Hatley RH. In vitro characterization of the I-neb Adaptive Aerosol Delivery (AAD) System. J Aerosol Med Pulm Drug Deliv. 2010;23(Suppl 1):S11-S20.


4.
Olschewski H, Simonneau G, Galie N, et al, for the Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002;347:322-329.


5.
McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol. 2009;53:1573-1619.


6.
Badesch DB, Abman SH, Ahearn GS, et al. Medical therapy for pulmonary hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004;126(1 Suppl):35S-62S.


7.
Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004;351:1425-1436.


8.
Tuder RM, Cool CD, Geraci MW, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med. 1999;159:1925-1932.


9.
Badesch DB, McLaughlin W, Delcroix M, et al. Prostanoid therapy for pulmonary arterial hypertension. J Am Coll Cardiol. 2004;43:56-61.


10.
Giald A, Yanagisawa M, Langleben D, et al. Expression of endothelin-1 in the lungs of patients with pulmonary hypertension. N Engl J Med. 1993;328:1732-1739.


11.
Miyauchi T, Masaki T. Pathophysiology of endothelin in the cardiovascular system. Annu Rev Physiol. 1999;61:391-415.


12.
Vane JR, Bottlin RM. Pharmacodynamic profile of prostacycline. Am J Cardiol. 1995;75:3A-10A.


13.
Rich S. Pulmonary hypertension. In: Braunwald E, Zipes DP, Libby P, eds. Heart Disease: A Textbook of Cardiovascular Medicine. 6th ed. Philadelphia, PA: W.B. Saunders Company; 2001:1908-1935.


14.
McLaughlin V, McGoon M. Pulmonary arterial hypertension. Circulation. 2006;114:1417-1431.


15.
Pavlović M, Petković D, Cvetković M, Zdjelar K, Starcević V, Bosnić O. Study of the mechanism of prostacyclin (PGI2) action on myocardial contractility. Agents Actions Suppl. 1992;37:171-175.


16.
Hoeper MM, Galie N, Simmoneau G, Rubin LJ. New treatments for pulmonary arterial hypertension. Am J Respir Crit Care Med. 2002;165:1209-1216.


17.
Clapp LH, Finney P, Turcato S, Tran S, Rubin LJ, Tinker A. Differential effects of stable prostacyclin analogs on smooth muscle proliferation and cyclic AMP generation in human pulmonary artery. Am J Respir Cell Mol Biol. 2002;26:194-201.


18.
Data on file, Actelion Pharmaceuticals; August, 2010


19.
Barst RJ, Gibbs JS, Ghofrani HA, et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54(1 Suppl):S78-S84


20.
Chin KM, Rubin LF. Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2008;51:1527-1538


21.
McLaughlin VV, Oudiz RJ, Frost A, et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med. 2006;174:1257-1263.


22.
Nikander K, Denyer J. Adaptive Aerosol Delivery (AAD) technology. In: Rathbone MJ, Hadgraft J, Roberts MS, eds. Modified-Release Drug Delivery Technology. New York, NY: Marcel Dekker, Inc. February 2011.


23.
Olschewski H, Rohde B, Berhr J, et al. Pharmacodynamics and pharmacokinetics of inhaled iloprost, aerosolized by three different devices, in severe pulmonary hypertension. Chest. 2003;124;1294-1304.


24.
Van Dyke RE, Nikander K. Delivery of iloprost inhalation solution with the Halolite, Prodose, and I-neb Adaptive Aerosol Delivery systems: an in vitro study. Respir Care. 2007;52:184-190.


25.
Badesch DB, Abman SH, Simonneau G, Rubin LJ, McLaughlin VV. Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines. Chest. 2007;131(6):1917-1928.


26.
Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009;54(1 Suppl):S43-S54.


Respironics and I-neb Adaptive Aerosol Delivery (AAD) are trademarks of or belonging to Koninklijke Philips Electronics N.V.

The Ventavis 20 mcg/mL concentration order form 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. Ventavis 10 mcg/mL ampules are still available. Ventavis should be taken 6 to 9 times daily, at least 2 hours apart.

For more information about Ventavis, please call 1-866-ACTELION (1-866-228-3546).

Indication and Important Safety Information

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Indication:

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 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

  • Hypotension leading to syncope has been observed; Ventavis should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.
  • Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.
  • Ventavis inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.
  • Serious adverse events reported at a rate of less than 3% included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating Ventavis.
  • In clinical studies, the most common adverse events occurring more often (≥6%) in Ventavis-treated patients than in patients taking placebo included vasodilation (flushing) (27% vs 9%), cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), and insomnia (8% vs 2%).
  • Ventavis has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
  • Ventavis also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.

Please see full Prescribing Information.