Ninlaro

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ixazomib citrate

Available from:

Takeda Pharma A/S

ATC code:

L01XG03

INN (International Name):

ixazomib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Multiple Myeloma

Therapeutic indications:

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

Product summary:

Revision: 17

Authorization status:

Authorised

Authorization date:

2016-11-21

Patient Information leaflet

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NINLARO 2.3 MG HARD CAPSULES
NINLARO 3 MG HARD CAPSULES
NINLARO 4 MG HARD CAPSULES
ixazomib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NINLARO is and what it is used for
2.
What you need to know before you take NINLARO
3.
How to take NINLARO
4.
Possible side effects
5.
How to store NINLARO
6.
Contents of the pack and other information
1.
WHAT NINLARO IS AND WHAT IT IS USED FOR
WHAT NINLARO IS
NINLARO is a cancer medicine that contains ixazomib, a ‘proteasome
inhibitor’.
NINLARO is used to treat a cancer of the bone marrow called multiple
myeloma. Its active substance
ixazomib works by blocking the action of proteasomes. These are
structures inside the cell that digest
proteins and are important for cell survival. Because myeloma cells
produce a lot of proteins, blocking
the action of proteasomes can kill the cancerous cells.
WHAT NINLARO IS USED FOR
NINLARO is used to treat adults with multiple myeloma. NINLARO will be
given to you together
with lenalidomide and dexamethasone, which are other medicines used to
treat multiple myeloma.
WHAT MULTIPLE MYELOMA IS
Multiple myeloma is a cancer of the blood which affects a type of
cell, called the plasma cell. A
plasma cell is a blood cell that normally produces proteins to fight
infections. People with multiple
myeloma have cancerous plasma cells, also called myeloma cells, which
can damage the bones.
Protein produced by myeloma cells can damage the kidneys. Tr

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NINLARO 2.3 mg hard capsules
NINLARO 3 mg hard capsules
NINLARO 4 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NINLARO 2.3 mg hard capsules
Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib
citrate)
NINLARO 3 mg hard capsules
Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate)
NINLARO 4 mg hard capsules
Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
NINLARO 2.3 mg hard capsules
Light pink, size 4 gelatin hard capsule, marked “Takeda” on the
cap and “2.3 mg” on the body with
black ink.
NINLARO 3 mg hard capsules
Light grey, size 4 gelatin hard capsule, marked “Takeda” on the
cap and “3 mg” on the body with
black ink.
NINLARO 4 mg hard capsules
Light orange, size 3 gelatin hard capsule, marked “Takeda” on the
cap and “4 mg” on the body with
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NINLARO in combination with lenalidomide and dexamethasone is
indicated for the treatment of
adult patients with multiple myeloma who have received at least one
prior therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of a
physician experienced in the
management of multiple myeloma.
3
Posology
The recommended starting dose of ixazomib 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 to 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.
For additional information regarding lenalidomide and dexamethasone,
refer to the Summary of
Product Characteristics (SmPC) for these medicinal products.
Prior to initiating a new cycle of therapy:
•
Absolute neutrophil count should be �