Zontivity

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

vorapaxar sulfate

Available from:

Merck Sharp Dohme Limited

ATC code:

B01

INN (International Name):

vorapaxar

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Myocardial Infarction

Therapeutic indications:

Zontivityis indicated for the reduction of atherothrombotic events in adult patients with- a history of myocardial infarction (MI)co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or- symptomatic peripheral arterial disease(PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel.

Product summary:

Revision: 2

Authorization status:

Withdrawn

Authorization date:

2015-01-19

Patient Information leaflet

26
B. PACKAGE LEAFLET
Medicinal product no longer authorised
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZONTIVITY 2 MG FILM-COATED TABLETS
vorapaxar
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zontivity is and what it is used for
2.
What you need to know before you take Zontivity
3.
How to take Zontivity
4.
Possible side effects
5.
How to store Zontivity
6.
Contents of the pack and other information
1.
WHAT ZONTIVITY IS AND WHAT IT IS USED FOR
WHAT ZONTIVITY IS
Zontivity contains an active substance called vorapaxar, and it
belongs to a group of medicines called
‘anti-platelet medicines.’
Platelets are blood cells that help with normal blood clotting.
Zontivity prevents platelets from sticking
together. This reduces the chance of a blood clot forming and blocking
the arteries, such as the arteries
in the heart.
WHAT ZONTIVITY IS USED FOR
Zontivity is used in adults who have had a heart attack or have a
condition known as "peripheral
arterial disease" (also known as poor circulation in the legs).
Zontivity is used to lower your chance of:
•
having another heart attack or stroke
•
dying from a heart attack
•
needing an urgent operation to open blocked arteries in the heart.
Your doctor will also give you instructions about acetylsa

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zontivity 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.08 mg of vorapaxar (as vorapaxar
sulfate).
Excipient(s) with known effect:
Each film-coated tablet contains 66.12 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76
mm, with “351” on one side and
the MSD logo on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zontivity is indicated for the reduction of atherothrombotic events in
adult patients with
-
a history of myocardial infarction (MI), co-administered with
acetylsalicylic acid (ASA) and,
where appropriate, clopidogrel; or
-
symptomatic peripheral arterial disease (PAD), co-administered with
acetylsalicylic acid (ASA)
or, where appropriate, clopidogrel.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MI
The recommended dose of Zontivity is 2.08 mg to be taken once daily.
Zontivity should be initiated at
least 2 weeks after a MI and preferably within the first 12 months
from the acute event (see
section 5.1). A delayed onset of action (at least 7 days) should be
expected when starting therapy with
Zontivity. There are limited data on the efficacy and safety of
Zontivity beyond 24 months. Continued
therapy after this time must be based on a re-evaluation of the
benefits and risks for the individual of
further therapy.
Medicinal product no longer authorised
3
PAD
The recommended dose of Zontivity is 2.08 mg to be taken once daily.
For patients being started on
Zontivity due to symptomatic PAD, therapy may be initiate