TIBSOVO- ivosidenib tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ivosidenib (UNII: Q2PCN8MAM6) (ivosidenib - UNII:Q2PCN8MAM6)

متاح من:

Servier Pharmaceutical LLC

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

TIBSOVO is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy [see Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14.1)]. TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14.2)] . TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration (2.1), Clinical Pharmacolog

ملخص المنتج:

How Supplied 250 mg tablet: Blue oval-shaped film-coated tablet debossed "IVO" on one side and "250" on the other side. Storage 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

Servier Pharmaceutical LLC
----------
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Revised: OCT 2023
MEDICATION GUIDE
TIBSOVO® (tib-SOH-voh)
(ivosidenib) tablets
What is the most important information I should know about TIBSOVO?
TIBSOVO may cause serious side effects, including:
•
Differentiation Syndrome. Differentiation syndrome is a common
condition that affects your
blood cells and may be life-threatening or lead to death.
Differentiation syndrome in adults with
acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) has
happened as early as
1 day and up to 3 months after starting TIBSOVO. Call your healthcare
provider or go to the
nearest hospital emergency room right away if you develop any of the
following symptoms of
differentiation syndrome during treatment with TIBSOVO:
•
fever
•
cough
•
trouble breathing
•
rash
•
decreased urination
•
dizziness or lightheadedness
•
rapid weight gain
•
swelling of your arms or legs
If you develop signs and symptoms of differentiation syndrome, your
healthcare provider may treat you
with a corticosteroid medicine or a medicine called hydroxyurea and
may monitor you in the hospital.
See "What are the possible side effects of TIBSOVO?" for more
information about side effects.
What is TIBSOVO?
TIBSOVO is a prescription medicine used to treat adults with an
isocitrate dehydrogenase-1 (IDH1)
mutation with:
•
acute myeloid leukemia (AML):
•
with newly diagnosed AML treated in combination with azacitidine, or
alone, who are 75
years or older or who have health problems that prevent the use of
certain chemotherapy
treatments.
•
when the disease has come back or has not improved after previous
treatment(s).
•
myelodysplastic syndrome (MDS):
•
when the disease has come back or has not improved after previous
treatment(s).
•
bile duct cancer (cholangiocarcinoma):
•
with bile duct cancer that has spread and
•
who have already received previous treatment(s).
Your healthcare provider will perform a test

خصائص المنتج

TIBSOVO- IVOSIDENIB TABLET, FILM COATED
SERVIER PHARMACEUTICAL LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIBSOVO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TIBSOVO.
TIBSOVO (IVOSIDENIB TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2018
WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS TREATED WITH TIBSOVO HAVE EXPERIENCED SYMPTOMS OF
DIFFERENTIATION
SYNDROME, WHICH CAN BE FATAL. IF DIFFERENTIATION SYNDROME IS
SUSPECTED, INITIATE
CORTICOSTEROID THERAPY AND HEMODYNAMIC MONITORING UNTIL SYMPTOM
RESOLUTION (5.1,
6.1).
RECENT MAJOR CHANGES
Indications and Usage, Relapsed or Refractory MDS (1.3)
10/2023
Dosage and Administration, Patient Selection (2.1)
10/2023
Dosage and Administration, Recommended Dosage (2.2)
10/2023
INDICATIONS AND USAGE
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated
for patients with a susceptible IDH1
mutation as detected by an FDA-approved test with:
Newly Diagnosed Acute Myeloid Leukemia (AML)
In combination with azacitidine or as monotherapy for the treatment of
newly diagnosed AML in adults
75 years or older, or who have comorbidities that preclude use of
intensive induction chemotherapy
(1.1).
Relapsed or refractory AML
For the treatment of adult patients with relapsed or refractory AML
(1.2).
Relapsed or refractory Myelodysplastic Syndromes (MDS)
For the treatment of adult patients with relapsed or refractory
myelodysplastic syndromes (1.3).
Locally Advanced or Metastatic Cholangiocarcinoma
For the treatment of adult patients with locally advanced or
metastatic cholangiocarcinoma who have
been previously treated (1.4).
DOSAGE AND ADMINISTRATION
500 mg orally once daily with or without food until disease
progression or unacceptable toxicity (2.2). Avoid
a high-fat meal.
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
QTc Interval Prolongation: Monitor elec