XPOVIO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SELINEXOR

Available from:

PROMEDICO LTD

ATC code:

L01XX66

Pharmaceutical form:

TABLETS

Composition:

SELINEXOR 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

KARYOPHARM THERAPEUTICS INC., USA

Therapeutic area:

SELINEXOR

Therapeutic indications:

Multiple Myeloma• Xpovio® in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti- CD38 monoclonal antibody (mAb).Diffuse Large B-Cell LymphomaXPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

Authorization date:

2021-04-04

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XPOVIO®
TABLES 20 MG
NAME OF ACTIVE INGREDIENT AND QUANTITY IN A DOSAGE UNIT:
Selinexor 20 mg
For a list of inactive ingredients and allergens in this medicine see
section 6,
‘Additional information’ in this leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
XPOVIO in combination with bortezomib and dexamethasone is intended to
treat
adult patients with multiple myeloma who have received at least one
prior
therapy.
•
XPOVIO in combination with dexamethasone is intended to treat adults
with
relapsed or refractory multiple myeloma (RRMM), who have received at
least 3
prior therapies, and whose disease was refractory to at least one
proteasome
inhibitor (PI) therapy, one immunomodulatory agent (IMiD), and an
anti-CD38
monoclonal antibody (mAb).
•
XPOVIO is intended to treat adults with relapsed or refractory diffuse
large B-cell
lymphoma (DLBCL) not otherwise specified, including diffuse large
B-cell
lymphoma arising from follicular lymphoma, after at least 2 lines of
systemic
therapy.
THERAPEUTIC GROUP: used to treat certain types of cancer by inhibiting
XPO1.
EXPOVIO inhibits the transporter exportin 1 (XPO1). XPO1 inhibition
leads to
accumulation of tumor-suppressor proteins in the nucleus, reduction in
several
cancer proteins in cells, and death of cancer cells.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
Red

Summary of Product characteristics

1
FULL PRESCRIPTION INFORMATION
NAME OF THE MEDICINAL PRODUCT
Xpovio
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of selinexor
PHARMACEUTICAL FORM
Tablet, PER OS
1.
INDICATIONS AND USAGE
1.1 MULTIPLE MYELOMA
Xpovio in combination with bortezomib and dexamethasone is indicated
for the treatment of adult patients with multiple
myeloma who have received at least one prior therapy.
Xpovio in combination with dexamethasone
is indicated
for the treatment of adult patients with relapsed refractory
multiple myeloma (RRMM) who have received at least three prior
therapies and whose disease is refractory to at
least one proteasome inhibitor (PI), at least one immunomodulatory
agent (IMiD), and an anti-CD38 monoclonal
antibody (mAb).
1.2 DIFFUSE LARGE B-CELL LYMPHOMA
Xpovio is indicated for the treatment of adult patients with relapsed
or refractory diffuse large B-cell lymphoma
(DLBCL), not otherwise specified, including DLBCL arising from
follicular lymphoma, after at least 2 lines of systemic
therapy.
2. DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE FOR MULTIPLE MYELOMA
In Combination with Bortezomib and Dexamethasone (SVd)
The recommended dosage of XPOVIO is 100 mg taken orally once weekly on
Day 1 of each week until
disease progression or unacceptable toxicity in combination with:
• Bortezomib 1.3 mg/m2 administered subcutaneously once weekly on
Day 1 of each week for 4 weeks
followed by 1 week off.
• Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of
each week.
Refer to Clinical Studies (14.1) and the prescribing information of
bortezomib and dexamethasone for
additional dosing information.
In Combination with Dexamethasone(Sd)
The recommended dosage of Xpovio is 80 mg taken orally on Days 1 and 3
of each week until disease
progression or unacceptable toxicity. In combination with
dexamethasone 20 mg orally taken with each
dose of Xpovio on Days 1 and 3 of each week.
For additional information regarding the administration of
dexamethasone, refer to its prescribing
informat