MONTREAL, June 7, 2023
/CNW/ - AbbVie (NYSE: ABBV), today announced that VRAYLAR is now
listed as a Limited Use product on the formulary of the Non-Insured
Health Benefits (NIHB)1 program for the treatment of
schizophrenia.
Information regarding the specific reimbursement criteria may be
found by consulting the link below:
- Non-Insured Health Benefits Program – Drug Benefit List
This announcement comes 13 months after the authorization of
VRAYLAR by Health Canada, bringing an additional treatment option
to Canadians living with schizophrenia.
Schizophrenia is a severe mental illness that can impact a
person's ability to function, and often presents symptoms that can
change over time. Symptoms can include hallucinations, disorganized
speech, social withdrawal, and catatonic behaviour. An estimated
300,000 Canadians are impacted by schizophrenia.2
About VRAYLAR®
(cariprazine)3
VRAYLAR is an oral, once daily atypical antipsychotic indicated
as monotherapy for the acute management of manic, mixed, and
depressive episodes associated with bipolar l disorder in adults,
as well as the treatment of schizophrenia in adults.
The mechanism of action of cariprazine in schizophrenia and
bipolar I disorder is unknown. However, the therapeutic effect of
cariprazine may be mediated through a combination of partial
agonist activity at central dopamine D3, D2 and serotonin 5-HT1A
receptors and antagonist activity at 5-HT2A receptors. Cariprazine
forms two major metabolites, desmethyl cariprazine (DCAR) and
didesmethyl cariprazine (DDCAR), that have in vitro receptor
binding and functional activity profiles similar to the parent
drug.
VRAYLAR is contraindicated in patients who are hypersensitive to
cariprazine or to any ingredient in the formulation, including any
non-medicinal ingredient, or component of the container.
VRAYLAR is also contraindicated with concomitant use with strong
and moderate CYP3A4 inhibitors / inducers. Due to the slow
elimination of cariprazine and its metabolites, treatment with
strong and moderate CYP3A4 inhibitors must be initiated at least 2
weeks after VRAYLAR discontinuation.
VRAYLAR is being developed jointly by AbbVie and Gedeon Richter
Plc, with AbbVie responsible for commercialization in the U.S.,
Canada, Japan, Taiwan
and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru
and Venezuela).
Please consult the Vraylar Product Monograph for important
safety information on serious warnings and precautions, other
warnings and precautions, adverse reactions, interactions, dosing
and conditions of use. The Product Monograph is also available by
calling 1-888-704-8271.
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1
Non-Insured Health Benefits Program.
https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407
Accessed June 5, 2023.
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2
Schizophrenia Society of Canada. Learn more about Schizophrenia.
Retrieved from
https://schizophrenia.ca/learn-more-about-schizophrenia/.
Accessed June 2023
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3 VRAYLAR
Product Monograph. AbbVie Corporation.
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VRAYLAR_PM_EN.pdf
Accessed June 2023
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter,
on Instagram or find us on LinkedIn.
SOURCE AbbVie Canada