BELVIQ 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LORCASERIN HYDROCHLORIDE HEMIHYDRATE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

A08AA11

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LORCASERIN HYDROCHLORIDE HEMIHYDRATE 10.4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

EISAI CO. LTD, JAPAN

Therapeutic area:

LORCASERIN

Therapeutic indications:

Belviq is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:• 30 kg/m2 or greater (obese), or • 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

Authorization date:

2017-02-15

Patient Information leaflet

Prescriber Brochure
This Prescriber Brochure format and content has been checked and
approved by the Ministry
of Health in March 2017
BELVIQ 10 MG TABLETS
PRESCRIBER GUIDE
_THIS DOCUMENT DOES NOT INCLUDE COMPLETE DATA FOR THE PRESCRIBER. FOR
COMPLETE DATA PLEASE _
_REFER TO THE PHYSICIAN'S PRESCRIBING INFORMATION._
Belviq is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for chronic
weight management in adult patients with an initial body mass index
(BMI) of:
30 kg/m
2
or greater (obese), or
27 kg/m
2
or greater (overweight) in the presence of at least one weight related
comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)
BELVIQ SHOULD ONLY BE GIVEN FOR PERIODS UP TO TWO YEARS.
Belviq Prescriber Guide contains important information concerning the
safe and appropriate
use of Belviq.
For any further information please refer to Belviq Physician's
Prescribing Information.
Any suspected adverse events should be reported to the Ministry of
Health according to the National
Regulation by using an online form
http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEff[e-mail]
Or to Teva by e-mail Safety Israel LSO
_IMPORTANT SAFETY INFORMATION FOR THE HEALTHCARE PROVIDERS_
VALVULAR HEART DISEASE
Regurgitant cardiac valvular disease, primarily affecting the mitral
and/or aortic valves, has been
reported in patients who took serotonergic drugs with 5-HT
2B
receptor agonist activity.
In clinical trials of 1-year duration, 2.4% of patients receiving
BELVIQ and 2.0% of patients
receiving placebo developed echocardiographic criteria for valvular
regurgitation at one year (mild
or greater aortic regurgitation and/or moderate or greater mitral
regurgitation): none of these
patients was symptomatic.
The etiology of the regurgitant valvular disease is thought to be
activation of 5-HT
2B
receptors on
cardiac interstitial cells and at therapeutic concentrations, BELVIQ
is selective for 5-HT
2C
receptors as compared to 5

Summary of Product characteristics

BELVIQ Tablets 19.2.2017, ME
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
ראוני רשואמ ןולע
2017
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked and approved.” Date of
approval: January 2017
BELVIQ
_ _
(lorcaserin hydrochloride) 10 mg
_ _
film-coated tablets
_ _
1 INDICATIONS AND USAGE
BELVIQ is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight
management in adult patients with an initial body mass index (BMI) of:

30 kg/m
2
or greater (obese), or

27 kg/m
2
or greater (overweight) in the presence of at least one weight related
comorbid condition
(e.g., hypertension, dyslipidemia, type 2 diabetes)
[
_see Dosage and Administration (2)_
]
Limitations of Use:
Belviq should only be given for periods up to two years.

The safety and efficacy of coadministration of BELVIQ with other
products intended for weight loss
including prescription drugs (e.g., phentermine), over-the-counter
drugs, and herbal preparations
have not been established

The effect of BELVIQ on cardiovascular morbidity and mortality has not
been established
2 DOSAGE AND ADMINISTRATION
The recommended dose of BELVIQ is 10 mg administered orally twice
daily. Do not exceed recommended
dose [
_see Warnings and Precautions (5.4)_
].
BELVIQ can be taken with or without food.
Response to therapy should be evaluated by week 12. If a patient has
not lost at least 5% of baseline body
weight, discontinue BELVIQ, as it is unlikely that the patient will
achieve and sustain clinically meaningful
weight loss with continued treatment [
_see Clinical Studies (14)_
].
BMI is calculated by dividing weight (in kg) by height (in meters)
squared.
PRESCRIBER GUIDE
This product is marketed with prescriber guide providing important
safety information. Please ensure you
are familiar with this material as it contains important safety
information.
BELVIQ Tablets 19.2.2017, ME
A BMI chart