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11.12.2019 | Products

FIBRISTAL® - Oral medication indicated for uterine fibroids - now publically funded for medical management by Ontario, Alberta and Saskatchewan

Markham, ON - November 12, 2019 — Allergan Canada Inc. is pleased to announce PrFIBRISTAL® (ulipristal acetate, 5mg), a first-in-class medical treatment for uterine fibroids, is now publicly funded through the Ontario Drug Benefit (ODB) Formulary, Alberta Drug Benefit List (ADBL), and Saskatchewan Formulary.  Almost one-in-three Canadian women of reproductive age have uterine fibroids;i it is the most common gynecological tumour,ii and a leading cause of surgeries in Canada.iii

In October 2019, the Society of Obstetricians and Gynaecologists of Canada (SOGC) updated their clinical practice guidelines recommendations for Medical Management of Symptomatic Uterine Leiomyomas. Top-line changes in disease management practice included: medical management of fibroid symptoms is safe and effectiveiv; and attempts should be made to correct anemia (hemoglobin <120 g/dl) prior to elective gynaecologic surgeryv.

“Uterine fibroids can cause significant physical and emotional impact on a woman’s life, causing debilitating symptoms like heavy uterine bleeding, anemia, pain and in some cases infertility,” said Dr. Ally Murji, gynecologist at Mount Sinai Hospital, Assistant Professor at the University of Toronto and co-author of the updated SOGC Medical Management of Symptomatic Uterine Leiomyomas guidelines.  “Having provincial access and coverage to effective clinical treatment options like FIBRISTAL® supports improved care for women in these provinces.”

SOGC guidelines recommend treatment may be a good alternative to other more invasive treatment modalities, particularly for clinical scenarios such as bridging the gap until menopause, or in the younger patient, to minimize symptoms until pregnancy is desired.vi

“Allergan is committed to supporting women’s health across Canada.  We applaud the Ontario, Alberta and Saskatchewan governments for improving medication access for women managing the severe symptoms of uterine fibroids and supporting improved care with FIBRISTAL®,” said Peter Dale, Business Unit Lead, Women’s Health & Established Brands at Allergan Canada Inc.

About uterine fibroids
Seventy to eighty per cent of Canadian women of reproductive age have uterine fibroids, which are the leading cause of hysterectomies in Canada.[vi] The most common symptom of uterine fibroids is abnormal uterine bleeding, which causes pain and heavy, prolonged periods.[vii] If left untreated, uterine fibroids can impact fertility and cause complications during pregnancy.[viii] In a Canadian survey of over 11,000 women aged 20 to 49, those who had uterine fibroids with moderate to severe symptoms experienced a significantly heavier burden of illness, lost productivity and reduced quality of life.[ix] Symptoms of uterine fibroids usually resolve with menopause, at which time treatments are stopped.

About FIBRISTAL®
FIBRISTAL® belongs to a class of medications called selective progesterone receptor modulators (SPRMs). It is an oral partial progesterone antagonist that exerts a direct effect on the endometrium to control excessive bleeding, and on fibroids where it inhibits cell proliferation and induces apoptosis (cell death) to reduce their size.[x] FIBRISTAL® is indicated for: preoperative treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.vii The duration of each treatment course is 3 months.  Each course of FIBRISTAL® is three months of continuous use followed by a treatment-free interval of two menstrual cycles and continued with intermittent courses as necessary.[xi] Patients should have liver function tests before during and after treatment.

The efficacy of FIBRISTAL® was evaluated in two long-term Phase III studies, PEARL III and PEARL IV, involving 132 and 451 patients respectively. Both studies confirmed the efficacy and safety of the intermittent long-term use of FIBRISTAL®.[xii],[xiii]

The results of the PEARL IV study included control of uterine bleeding, reduction in fibroid volume, reduction in pelvic pain, correction in anemia and improvement in quality of life.  The most common adverse drug reactions (≥ 5 per cent) in the clinical trials for women receiving FIBRISTAL® were hot flashes and headaches.  Most adverse drug reactions were mild or moderate, decreased with repeated courses, and did not lead to discontinuation of the medication.[xiv]

To date, more than 800,000 women in 57 countries have been treated with FIBRISTAL®.[xv]
For more information, visit Allergan’s website at www.Allergan.ca or see FIBRISTAL® product monograph.

FIBRISTAL® coverage
FIBRISTAL® is covered by most private insurance plans.  It is also covered by many provincial drug plan for patients eligible for surgery.  The provincial drug plans in Ontario, Alberta and Saskatchewan now provide coverage for medical management of uterine fibroids for women who don’t need surgery or who want to avoid surgery.  FIBRISTAL® has been publicly covered in Quebec since 2014.


iSOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
iiIBID
iiiIBID
ivSOGC Clinical Practice Guidelines J Obstet Gynaecol Can 2019;41(10).
vIBID
viSOGC Clinical Practice Guidelines J Obstet Gynaecol Can 2019;41(10).
[vi]Vilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
[vii]IBID
[viii]Carranza-mamane B, Havelock J, Hemmings R, et al, et al. The management of uterine fibroids in women with otherwise unexplained infertility. J Obstet Gynaecol Can. 2015;37(3):277-88.
[ix]Vilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
[x]FIBRISTAL® Product Monograph, July 3, 2019. 
viiFIBRISTAL® Product Monograph, July 3, 2019.
[xi]IBID
[xii]Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril 2014;101(6):1565-73.
[xiii]Donnez, J; Hudecek, R; Donnez, O. et al. Efficacy and Safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril 2015; 103(2):519-27.
[xiv]FIBRISTAL® Product Monograph, July 3, 2019.
[xv]Allergan data on file.