XOSPATA- gilteritinib tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GILTERITINIB FUMARATE (UNII: 5RZZ0Z1GJT) (GILTERITINIB - UNII:66D92MGC8M)

Available from:

Astellas Pharma US, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials [see Adverse Reactions (6) and Description (11)] . Risk Summary Based on findings from animal studies (see Data) and its mechanism of action, XOSPATA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on XOSPATA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (AUC24 ) approximately 0.4 times the AUC

Product summary:

How Supplied XOSPATA (gilteritinib) 40 mg tablets are supplied as light yellow, round-shaped, film-coated tablets debossed with the Astellas logo and ‘235’ on the same side. XOSPATA tablets are available in the following package size: Storage Store XOSPATA tablets at 20ºC to 25ºC (68°F to 77°F); excursions permitted between 15ºC to 30ºC (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original container until dispensed. Protect from light, moisture and humidity.

Authorization status:

New Drug Application

Patient Information leaflet

Astellas Pharma US, Inc.
----------
MEDICATION GUIDE
XOSPATA® (Zoh spah' tah)
(gilteritinib)
tablets
What is the most important information I should know about XOSPATA?
XOSPATA may cause serious side effects, including:
•
Differentiation Syndrome. Differentiation syndrome is a condition that
affects your blood cells and
may be life-threatening or lead to death if not treated.
Differentiation syndrome can happen as early as
1 day after starting XOSPATA and during the first 3 months of
treatment. 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 while taking XOSPATA:
o
fever
o
cough
o
trouble breathing
o
rash
o
dizziness or lightheadedness
o
rapid weight gain
o
swelling of your arms or legs
o
decreased urination
If you develop any of these symptoms of differentiation syndrome, your
healthcare provider may treat you
with a corticosteroid medicine and may monitor you in the hospital.
See “What are the possible side effects of XOSPATA?” for more
information about side effects.
What is XOSPATA?
XOSPATA is a prescription medicine used to treat adults with acute
myeloid leukemia (AML) who have a
FMS-like tyrosine kinase 3 (FLT3) mutation:
•
when the disease has come back, or
•
has not improved after previous treatment(s).
Your healthcare provider will perform a test to make sure that XOSPATA
is right for you.
It is not known if XOSPATA is safe and effective in children.
Do not take XOSPATA if you are allergic to gilteritinib or any of the
ingredients in XOSPATA. See the end
of this Medication Guide for a complete list of ingredients in
XOSPATA.
Before taking XOSPATA, tell your healthcare provider about all of your
medical conditions, including if
you:
•
have any heart problems, including a condition called long QT
syndrome.
•
have problems with abnormal electrolytes such as sodium, potassium, or
magnesium levels.
•
are pregnant or plan to become pregnant. XOSPATA can cause harm to
your unborn baby

Summary of Product characteristics

XOSPATA- GILTERITINIB TABLET
ASTELLAS PHARMA US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XOSPATA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XOSPATA.
XOSPATA (GILTERITINIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2018
WARNING: DIFFERENTIATION SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS TREATED WITH XOSPATA HAVE EXPERIENCED SYMPTOMS OF
DIFFERENTIATION
SYNDROME, WHICH CAN BE FATAL IF NOT TREATED. IF DIFFERENTIATION
SYNDROME IS SUSPECTED,
INITIATE CORTICOSTEROID THERAPY AND HEMODYNAMIC MONITORING UNTIL
SYMPTOM RESOLUTION.
(5.1, 6.1)
INDICATIONS AND USAGE
XOSPATA is a kinase inhibitor indicated for the treatment of adult
patients who have relapsed or refractory
acute myeloid leukemia (AML) with a FLT3 mutation as detected by an
FDA-approved test. (1.1)
DOSAGE AND ADMINISTRATION
120 mg orally once daily. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to gilteritinib or any of the excipients.
Anaphylactic reactions have been observed in
clinical trials. (4, 6.1)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are transaminase increased,
myalgia/arthralgia,
fatigue/malaise, fever, mucositis, edema, rash, noninfectious
diarrhea, dyspnea, nausea, cough,
constipation, eye disorders, headache, dizziness, hypotension,
vomiting, and renal impairment. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTELLAS PHARMA US,
INC. AT 1-800-727-
7003 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
®
Posterior reversible encephalopathy syndrome (PRES): Discontinue
XOSPATA in patients who develop
PRES. (2.3, 5.2, 6.1)
Prolonged QT Interval: Interrupt and reduce XOSPATA dosage in patients
who have a QTcF >500
msec. Correct hypokalemi