NINLARO 3 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 3 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:

2021-07-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a 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 concise
information about this medicine. If you have any further questions,
consult your
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 to
yours.
This medicine is intended for adults.
1.
WHAT IS THIS MEDICINE INTENDED 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
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any other
ingredients that this
medicine contains (see section 6: “Additional information”).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING 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
under Pregnancy and
breastfeeding)
•
you are breastfeeding or plan to breastfeed (see additional details
under Pregnancy and breastfeeding)
TESTS AND FOLLOW-UP
Your physician will refer you for

Summary of Product characteristics

Ninlaro PI Oct 2022_ USPI LOU Apr 2022
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. The importance of carefully
following all dosage instructions should be
discussed with patients starting treatment. Instruct patients to take
the recommended dosage as directed,
because overdosage has led to deaths
_[see Overdosage (9)]._
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 (14)_
].
If a NINLARO dose is delayed or missed, the dose should be taken only
if the next scheduled dose i