ZONTIVITY- vorapaxar tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VORAPAXAR SULFATE (UNII: IN66038E6C) (VORAPAXAR - UNII:ZCE93644N2)

Available from:

Aralez Pharmaceuticals Us Inc.

INN (International Name):

vorapaxar sulfate

Composition:

vorapaxar 2.08 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZONTIVITY ® is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR). ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population [see Adverse Reactions (6)] . Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH [see Adverse Reactions (6.1) and Clinical Studies (14)] . ZONTIVITY is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] . Risk Summary Based on the potenti

Product summary:

ZONTIVITY tablets, 2.08 mg vorapaxar, are yellow, oval-shaped, film-coated tablets with "351" on one side and the Merck logo on the other side. They are supplied as follows: Storage of bottles Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store tablets in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture. Storage of blisters Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store in the original package until use.

Authorization status:

New Drug Application

Patient Information leaflet

ZONTIVITY- VORAPAXAR TABLET, FILM COATED
Aralez Pharmaceuticals Us Inc.
----------
MEDICATION GUIDE
ZONTIVITY ® (ZON-TIV-ITI)
(VORAPAXAR)
TABLETS
Read this Medication Guide before you start taking ZONTIVITY and each
time you get a refill. There
may be new information. This information does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about ZONTIVITY?
ZONTIVITY is used to lower your chance of having another serious
problem with your heart or blood
vessels, but ZONTIVITY (and similar drugs) can cause bleeding that can
be serious and lead to death.
Call your doctor right away if you have any of these signs or symptoms
of bleeding while taking
ZONTIVITY:
•
bleeding that is severe or that you cannot control
•
pink, red, or brown urine
•
vomiting blood or your vomit looks like "coffee grounds"
•
red or black stools (looks like tar)
•
coughing up blood or blood clots.
While you take ZONTIVITY and for about 4 weeks after your treatment
with ZONTIVITY is stopped:
•
you may bruise and bleed more easily (nose bleeds may be common)
•
it will take longer than usual for any bleeding to stop.
Do not take ZONTIVITY if you:
•
have had a stroke or "mini stroke" (also known as transient ischemic
attack or TIA)
•
have had bleeding in your brain
•
currently have unusual bleeding, such as bleeding in your head,
stomach or intestines (an ulcer).
If you have a stroke, TIA, or bleeding in your brain while taking
ZONTIVITY your doctor should stop
your treatment with ZONTIVITY. Follow your doctor's instructions about
stopping ZONTIVITY.
Do not stop taking ZONTIVITY without talking to the doctor who
prescribed it for you.
What is ZONTIVITY?
ZONTIVITY is a prescription medicine used to treat people who have
•
had a heart attack or
•
reduced blood flow in their legs (peripheral arterial disease).
ZONTIVITY is used with aspirin and/or clopidogrel to lower your chance
of having another serious
problem with your heart o

Summary of Product characteristics

ZONTIVITY- VORAPAXAR TABLET, FILM COATED
ARALEZ PHARMACEUTICALS US INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZONTIVITY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZONTIVITY.
ZONTIVITY (VORAPAXAR) TABLETS 2.08 MG*, FOR ORAL USE
*EQUIVALENT TO 2.5 MG VORAPAXAR SULFATE
INITIAL U.S. APPROVAL: 2014
WARNING: BLEEDING RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT USE ZONTIVITY IN PATIENTS WITH A HISTORY OF STROKE, TRANSIENT
ISCHEMIC ATTACK
(TIA), OR INTRACRANIAL HEMORRHAGE (ICH); OR ACTIVE PATHOLOGICAL
BLEEDING. ( 4.1, 4.2)
ANTIPLATELET AGENTS, INCLUDING ZONTIVITY, INCREASE THE RISK OF
BLEEDING, INCLUDING ICH
AND FATAL BLEEDING. ( 5.1)
INDICATIONS AND USAGE
ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist
indicated for the reduction of thrombotic
cardiovascular events in patients with a history of myocardial
infarction (MI) or with peripheral arterial
disease (PAD). ZONTIVITY has been shown to reduce the rate of a
combined endpoint of cardiovascular
death, MI, stroke, and urgent coronary revascularization. ( 1.1)
DOSAGE AND ADMINISTRATION
One tablet of ZONTIVITY orally once daily. ( 2.1)
Use with aspirin and/or clopidogrel according to their indications or
standard of care. There is limited
clinical experience with other antiplatelet drugs and none with
ZONTIVITY as the only antiplatelet agent.
( 2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.08 mg vorapaxar. ( 3)
CONTRAINDICATIONS
History of stroke, TIA, or ICH. ( 4.1)
Active pathologic bleeding. ( 4.2)
WARNINGS AND PRECAUTIONS
Like other antiplatelet agents, ZONTIVITY increases the risk of
bleeding. ( 5.1)
Avoid use with strong CYP3A inhibitors or inducers. ( 5.2)
ADVERSE REACTIONS
Bleeding, including life-threatening and fatal bleeding, is the most
commonly reported adverse
reaction. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ARALEZ PHARMACEUTICALS
AT 1-833-694-
8235 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
USE I