Actelion Pharmaceuticals Canada Introduces CARIPUL® (epoprostenol) For
Injection, A Treatment for Pulmonary Arterial Hypertension
LAVAL, QC, Sept. 16, 2013 /CNW/ - Actelion Pharmaceuticals Canada Inc.
announced today that CARIPUL®( )(epoprostenol) for Injection is now available
in Canada. CARIPUL® is a prescription medication indicated for the long-term
intravenous treatment of primary pulmonary hypertension (or idiopathic
pulmonary arterial hypertension), and secondary pulmonary hypertension due to
scleroderma spectrum of diseases in NYHA functional Class III and Class IV
patients who did not respond adequately to conventional therapy.(1)
Pulmonary arterial hypertension (PAH) is a condition that is estimated to
affect between 2,000 and 10,000 Canadians.(2) PAH affects the small blood
vessels in the lungs, and is associated with increased pressure in the blood
vessels leading to the right side of the heart.(3) An early symptom of
pulmonary arterial hypertension, dyspnea (or breathlessness), presents in a
wide range of health conditions; this can lead to delays in early diagnosis
and treatment of PAH.(3) When PAH is suspected , the diagnostic gold
standard is a right heart catheterization for assessment of hemodynamics, an
in-hospital procedure performed by specialist physicians in respirology or
Pulmonary arterial hypertension, if untreated, is usually progressive, with a
high historical mortality rate in those who are untreated.(3)
CARIPUL® Offers Key Benefits of Expanded Stability for IV Epoprostenol Therapy
CARIPUL® offers patients an expanded stability profile and the convenience of
prolonged refrigerated storage - something not available with other
epoprostenol medications currently approved in Canada. "This is one example of
our continued and long-term commitment to patients with pulmonary arterial
hypertension," said Jacques Archambault, President of Actelion Pharmaceuticals
Canada Inc. "Patients who are treated with continuously-infused IV
epoprostenol now have an option that delivers greater flexibility in their
daily lives. We are delighted to bring this product to market."
CARIPUL® offers two preparation and storage options to patients:
1-PREPARE AND USE IMMEDIATELY: Fully diluted CARIPUL® can be
administered for up to 48 hours at room temperature (25°C) at concentrations
2-PREPARE AND STORE FOR UP TO 8 DAYS IN REFRIGERATOR BEFORE USE:
Fully diluted CARIPUL® can be stored in the refrigerator (i.e., 2°C to 8°C)
for up to 8 days, and then administered at room temperature (25°C) for up to
24 hours at concentrations between 3,000 ng/mL and 15,000 ng/mL and up to 48
hours at concentrations ≥15,000 ng/mL.(*,1)
Actelion is offering CARIPUL® in 2 vial strengths, 0.5 mg and 1.5 mg. The 0.5
mg vial is recommended for patients using final concentrations of CARIPUL®
between 3,000 ng/ml and 15,000 ng/mL, and the 1.5mg vial is recommended for
final concentrations greater than 15,000 ng/mL.
CARIPUL® is available, by prescription only, exclusively from Shoppers Drug
Mart Specialty Health Network Inc., a specialty pharmacy providing home
delivery and patient support through the CARIPUL® Patient Support Program
(CARIPUL® PSP). The CARIPUL® PSP offers an enhanced level of personalized
service to patients with pulmonary hypertension, and will provide call centre,
nursing and reimbursement support services for patients using CARIPUL® and
their healthcare providers. Patients and physicians can call the CARIPUL® PSP
hotline at 1-877-CARIPUL (227-4785).
Dr. David Langleben, Director of the Center for Pulmonary Vascular Disease at
the Jewish General Hospital in Montreal and a Canadian clinical trial
investigator for CARIPUL®, remarked, "The clinical profile of CARIPUL®
represents a welcome improvement for patients with severe pulmonary arterial
hypertension. For years, patients treated with IV epoprostenol had to concern
themselves with daily preparation of their medication as well as the use ice
of packs to keep the medication cold while being administered. CARIPUL®
eliminates those requirements, which is of great benefit to PH patients."
Added Dr. John Granton, head of the PH Centre at the Toronto General Hospital
and an investigator in the CARIPUL® clinical program, "IV epoprostenol is a
life-prolonging medication for patients with severe pulmonary arterial
hypertension. A more stable formulation will provide greater flexibility for
use and storage and will make life easier for many of our patients.''
"The improved stability and convenience of CARIPUL® offers patients with
severe pulmonary arterial hypertension a better quality of life" said Frank
Poon, President of PHA Canada, a national disease association representing
patients with pulmonary hypertension.
About Actelion Pharmaceuticals Canada Inc.
Actelion Pharmaceuticals Canada Inc. is the Canadian operation of Actelion
Ltd. Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer®, an orally available dual endothelin receptor antagonist, has been
approved as a therapy for pulmonary arterial hypertension. Actelion markets
Tracleer® through its own subsidiaries in key markets worldwide, including
the United States (based in South San Francisco), the European Union, Japan,
Canada, Australia and Switzerland.
Founded in late 1997 Actelion is a leading player in innovative science
related to the endothelium - the single layer of cells separating every blood
vessel from the blood stream. Actelion's over 2,400 employees focus on the
discovery, development and marketing of innovative drugs for significant unmet
medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker
symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index
To learn more about Actelion Pharmaceuticals, visit www.actelion.com.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder
characterized by abnormally high blood pressure in the arteries between the
heart and lungs of an affected individual.(3) The symptoms of PAH are
non-specific and can range from mild breathlessness and fatigue during normal
daily activity to symptoms of right heart failure and severe restrictions on
exercise capacity and ultimately reduced life expectancy.(3)
PAH is one group within the classification of pulmonary hypertension (PH).(3)
This group includes idiopathic PAH, heritable PAH and PAH caused by factors
which include connective tissue disease, HIV infection and congenital heart
The last decade has seen significant advances in the understanding of the
pathophysiology of PAH, which has been paralleled with developments of
treatment guidelines and new therapies. Drugs targeting the 3 pathways that
have been established in the pathogenesis of PAH are endothelin receptor
antagonists (ERAs), prostacyclins and phosphodiesterase-5 inhibitors.(3) PAH
treatments have transformed the prognosis for PAH patients from symptomatic
improvements in exercise tolerance 10 years ago to delayed disease progression
today. Improved disease awareness and evidence-based guidelines developed from
randomized clinical trial data have highlighted the need for early
intervention, goal-oriented treatment and combination therapy.(3)
1. Product Monograph - CARIPUL® (epoprostenol) for Injection.
November 2012; Actelion Pharmaceuticals Canada Inc.
2. Sourced from:
3. Galiè N, Hoeper MM, Humbert M et al. Guidelines for the diagnosis
and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34
SOURCE Actelion Pharmaceuticals Canada Inc.
Actelion Canada Marie-Claude Lefebvre email@example.com
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