VELSIPITY- etrasimod tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ETRASIMOD ARGININE (UNII: MXE5EMA09L) (ETRASIMOD - UNII:6WH8495MMH)

متاح من:

Pfizer Laboratories Div Pfizer Inc

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is contraindicated in patients who:       Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to VELSIPITY during pregnancy. Pregnant females exposed to VELSIPITY and healthcare providers are encouraged to contact the pregnancy registry by calling 1-800-616-3791. Risk Summary Based on findings from animal studies, VELSIPITY may cause fetal harm when administered to a pregnant woman. Available data from reports of pregnancies from the clinical development program with VELSIPITY are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with increased disease activity in women with inflammatory bowel disease during pregnancy (see Clinical Considerations). In animal reproduction studies, administration

ملخص المنتج:

How Supplied VELSIPITY tablet is available as a round, green film-coated 2 mg etrasimod tablet, debossed with “ETR” on one side and “2” on the other side. VELSIPITY tablets are packed in a child-resistant 100 mL white, round, high-density polyethylene (HDPE) bottle containing 4 g of silica gel desiccant integrated directly into the 45 mm polypropylene (PP) cap. Dosage Form Strength Description NDC Number Tablets 2 mg of etrasimod 30 count bottle 0069-0274-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

الوضع إذن:

New Drug Application

نشرة المعلومات

Pfizer Laboratories Div Pfizer Inc
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This Medication Guide has been approved by the U.S. Food and Drug
Administration. Issued: October
2023
MEDICATION GUIDE
VELSIPITY™ (Vel-sip-itee)
(etrasimod)
tablets, for oral use
Read this Medication Guide before you start taking VELSIPITY and each
time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking with your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about VELSIPITY?
VELSIPITY can cause serious side effects, including:
1.
Infections. VELSIPITY can increase your risk of serious infections.
These infections can be life-
threatening and cause death.
VELSIPITY lowers the number of white blood cells (lymphocytes) in your
blood. This usually
returns to normal within 4 to 5 weeks after you stop taking VELSIPITY.
Your healthcare provider
will test your blood before you start taking VELSIPITY. Call your
healthcare provider right away
if you have any of these symptoms of an infection during treatment
with VELSIPITY, and for 5
weeks after you stop taking VELSIPITY:
•
fever or high temperature
•
tiredness
•
flu-like symptoms
•
pain when peeing or peeing more often
than usual. These can be signs of a
urinary tract infection.
•
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 or stop your VELSIPITY treatment if
you have an infection.
2.
Slow heart rate (also known as bradyarrhythmia) when you start taking
VELSIPITY. VELSIPITY
may cause your heart rate to temporarily slow down especially after
you take your first dose. You
will have a test called an electrocardiogram (ECG) to check the
electrical activity of your heart
before you take your first dose of VELSIPITY.
Call your healthcare provider if you experience these symptoms of slow
heart rate:
•
feeling dizzy
•
feeling lighthea

خصائص المنتج

VELSIPITY- ETRASIMOD TABLET, FILM COATED
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VELSIPITY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VELSIPITY.
VELSIPITY™ (ETRASIMOD) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated
for the treatment of moderately to
severely active ulcerative colitis in adults. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg of etrasimod (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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ADVERSE REACTIONS
Assessments are required prior to initiating VELSIPITY. (2.1)
The recommended dosage is 2 mg orally once daily. (2.2)
In the last 6 months, experienced myocardial infarction, unstable
angina pectoris, stroke, transient
ischemic attack, decompensated heart failure requiring
hospitalization, or Class III or IV heart failure.
(4, 5.2)
History or presence of Mobitz type II second-degree or third-degree
atrioventricular (AV) block, sick
sinus syndrome, or sino-atrial block, unless the patient has a
functioning pacemaker. (4, 5.2)
Infections: May increase the risk of infections. Obtain a complete
blood count (CBC) before initiation of
treatment. Monitor for infection during treatment and for 5 weeks
after discontinuation. Consider
interruption of treatment if a serious infection develops. Avoid use
of live _attenuated_ vaccines during
and for up to 5 weeks after treatment. (5.1)
Bradyarrhythmia and Atrioventricular Conduction Delays: May result in
a transient decrease in heart
rate and AV conduction delays. Obtain an electrocardiogram (ECG) to
assess for preexisting cardiac
conduction abnormalities before starting treatment. Consider
cardiology consultation for conduction
abnormalities or concomitant use with other drugs that decrease heart
rate. (2.1, 5.2, 7)
Liver Injury: Elevations of aminotransferases