PONVORY- ponesimod tablet, film coated PONVORY- ponesimod kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PONESIMOD (UNII: 5G7AKV2MKP) (PONESIMOD - UNII:5G7AKV2MKP)

Available from:

Janssen Pharmaceuticals, Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. PONVORY is contraindicated in patients who: - In the last 6 months, have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2)] - Have presence of Mobitz type II second-degree, third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker [see Warnings and Precautions (5.2)] Risk Summary There are no adequate and well-controlled studies of PONVORY in pregnant women. In animal studies, administration of ponesimod during pregnancy produced adverse effects on development, including embryo lethality and fetal malformations, in the absence of maternal toxic

Product summary:

PONVORY ® (ponesimod) tablet is available as round, biconvex, film-coated tablets supplied in the following dosage strengths and package configurations. Starter Pack Maintenance Dose Bottle Starter Pack Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Store in the original package. Maintenance Dose Bottle Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Store in the original package. Do not discard desiccant. Protect from moisture. Keep out of reach of children.

Authorization status:

New Drug Application

Patient Information leaflet

PONVORY- PONESIMOD
Janssen Pharmaceuticals, Inc
----------
MEDICATION GUIDE
PONVORY ®(PON-VOR-EE)
(PONESIMOD)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Approved: 09/2022
What is the most important information I should know about PONVORY?
PONVORY may cause serious side effects, including:
1.
Infections.PONVORY can increase your risk of serious infections that
can be life-threatening and
cause death. PONVORY lowers the number of white blood cells
(lymphocytes) in your blood. This
will usually go back to normal within 1 to 2 weeks of stopping
treatment. Your healthcare provider
should review a recent blood test of your white blood cells before you
start taking PONVORY.
Call your healthcare provider right away if you have any of these
symptoms of an infection during
treatment with PONVORY and for 1 to 2 weeks after your last dose of
PONVORY:
•
fever
•
tiredness
•
body aches
•
chills
•
nausea
•
vomiting
•
headache with fever, neck stiffness,
sensitivity to light, nausea, or confusion
(these may be symptoms of meningitis,
an infection of the lining around your
brain and spine)
Your healthcare provider may delay starting or may stop your PONVORY
treatment if you have an
infection.
1.
Slow heart rate (bradycardia or bradyarrhythmia) when you start taking
PONVORY.PONVORY can
cause your heart rate to slow down, especially after you take your
first dose. You should have a test
to check the electrical activity of your heart called an
electrocardiogram (ECG) before you take your
first dose of PONVORY.
Only start your treatment with PONVORY using the Starter Pack.You must
use the PONVORY
Starter Pack to slowly increase the dose over a 14-day period to help
reduce the effect of slowing of
your heart rate. It is important to follow the recommended dosing
instructions. See " How should I
take PONVORY?"
Call your healthcare provider if you experience the following symptoms
of slow heart rate:
•
dizziness
•
lightheadedness
•
feeling like your heart i

Summary of Product characteristics

PONVORY- PONESIMOD TABLET, FILM COATED
PONVORY- PONESIMOD
JANSSEN PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PONVORY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PONVORY.
PONVORY
(PONESIMOD) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.1, 5.11)
08/2023
INDICATIONS AND USAGE
PONVORY is a sphingosine 1-phosphate receptor modulator indicated for
the treatment of relapsing forms
of multiple sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active
secondary progressive disease, in adults. ( 1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating PONVORY ( 2.1)
Titration is required for treatment initiation ( 2.2)
The recommended maintenance dosage is 20 mg taken orally once daily (
2.2)
First-dose monitoring is recommended for patients with sinus
bradycardia, first- or second-degree
[Mobitz type I] atrioventricular (AV) block, or a history of
myocardial infarction or heart failure ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20
mg ( 3)
CONTRAINDICATIONS
In the last 6 months, experienced myocardial infarction, unstable
angina, stroke, transient ischemic
attack (TIA), decompensated heart failure requiring hospitalization,
or Class III/IV heart failure ( 4)
Presence of Mobitz type II second-degree, third-degree AV block, sick
sinus syndrome, or sino-atrial
block, unless the patient has a functioning pacemaker ( 4)
WARNINGS AND PRECAUTIONS
Infections: PONVORY may increase the risk of infections. Obtain a
complete blood count (CBC) before
initiating treatment. Monitor for infection during treatment and for
1–2 weeks after discontinuation. Do
not start PONVORY in patients with active infection. ( 5.1)
Bradyarrhythmia and Atrioventricular Conduction Delays: PONVORY may
result in a transient decrease
in heart rate; titration is required for treatment