NINLARO 4 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IXAZOMIB AS CITRATE

Available from:

TAKEDA ISRAEL LTD

ATC code:

L01XX50

Pharmaceutical form:

CAPSULES

Composition:

IXAZOMIB AS CITRATE 4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TAKEDA PHARMA A/S, DENMARK

Therapeutic area:

IXAZOMIB

Therapeutic indications:

NINLARO is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Authorization date:

2016-08-09

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
NINLARO
®
2.3 MG
NINLARO
®
3 MG
NINLARO
®
4 MG
Capsules
ACTIVE INGREDIENT:
Each capsule of Ninlaro
®
2.3 mg contains 2.3 mg of ixazomib (equivalent to 3.3 mg of
ixazomib citrate).
Each capsule of Ninlaro
®
3 mg contains 3 mg of ixazomib (equivalent to 4.3 mg of ixazomib
citrate).
Each capsule of Ninlaro
®
4 mg contains 4 mg of ixazomib (equivalent to 5.7 mg of ixazomib
citrate).
Inactive ingredients and allergens: See section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains a
summary of the information about this medicine. If you have further
questions, refer to the
physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar.
This medicine is intended for adults.
1.
WHAT IS THIS MEDICINE USED FOR?
Ninlaro in combination with lenalidomide and dexamethasone, is
indicated for the treatment of
patients with multiple myeloma (a type of cancer of the bone marrow)
who have received at
least one prior therapy
.
THERAPEUTIC GROUP: Antineoplastic agent of proteasome inhibitor class.
2.
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE THE TREATMENT WITH NINLARO, TELL YOUR PHYSICIAN ABOUT YOUR
MEDICAL
CONDITION,
INCLUDING IF:
•
you suffer from liver problems
•
you suffer from kidney problems or are on dialysis
•
you are pregnant or plan to become pregnant (see additional details in
Pregnancy
and breastfeeding section)
•
you are breastfeeding or plan to breastfeed (see additional details in
Pregnancy and breastfeeding
section
)
LABORATORY TESTS AND FOLLOW-UP During the period of treatment with the medicine, the physician will
refer you to perform blood
tests in order to monitor side effects.
DO NOT USE THIS MEDICINE IF:
You are sensitive
(

Summary of Product characteristics

The content of this leaflet was approved by the Ministry of Health in
February 2017
and updated according to the
guidelines of the Ministry of Health in March 2020
NINLARO
® 2.3 MG, 3 MG AND 4 MG
CAPSULES
CONTAINS IXAZOMIB (AS CITRATE) 2.3 MG, 3 MG AND 4 MG
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
NINLARO is indicated in combination with lenalidomide and
dexamethasone for the treatment of
patients
with multiple myeloma who have received at least one prior therapy.
2
DOSAGE AND ADMINISTRATION
2.1
DOSING AND ADMINISTRATION GUIDELINES
_NINLARO in combination with lenalidomide and dexamethasone_
The recommended starting dose of NINLARO is 4 mg administered orally
once a week on Days 1, 8, and 15
of a 28-day treatment cycle.
The recommended starting dose of lenalidomide is 25 mg administered
daily on Days 1 through 21 of a 28-
day treatment cycle.
The recommended starting dose of dexamethasone is 40 mg administered
on Days 1, 8, 15, and 22 of a 28-
day treatment cycle.
TABLE 1: DOSING SCHEDULE FOR NINLARO TAKEN WITH LENALIDOMIDE AND
DEXAMETHASONE

Take medicine
28-DAY CYCLE (A 4-WEEK CYCLE)
WEEK 1
WEEK 2
WEEK 3
WEEK 4
Day 1
Days
2-7
Day 8
Days
9-14
Day 15
Days
16-21
Day 22
Days
23-28
NINLARO



Lenalidomide


Daily


Daily


Daily
Dexamethasone




For additional information regarding lenalidomide and dexamethasone,
refer to their prescribing
information.
NINLARO should be taken once a week on the same day and at
approximately the same time for the
first
three weeks of a four week cycle. NINLARO should be taken at least one
hour before or at least
two hours
after food [
_see Clinical Pharmacology (11.3)_
]. The whole capsule should be swallowed
with water. The
capsule should not be crushed, chewed or opened [
_see How Supplied/Storage and Handling (15.3)_
].
If a NINLARO dose is delayed or missed, the dose should be taken only
if the next scheduled dose is ≥ 72
hours away. A missed dose should not be taken within 72 hours of the
next scheduled dose. A double dos