Ninlaro 3mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ixazomib citrate

Available from:

Takeda UK Ltd

ATC code:

L01XX50

INN (International Name):

Ixazomib citrate

Dosage:

3mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5035382000015

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NINLARO 2.3 MG HARD CAPSULES
NINLARO 3 MG HARD CAPSULES
NINLARO 4 MG HARD CAPSULES
ixazomib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 produce

Summary of Product characteristics

OBJECT 1
NINLARO 2.3 MG HARD CAPSULES
Summary of Product Characteristics Updated 09-Oct-2017 | Takeda UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 hard gelatin 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 hard gelatin capsule, marked “Takeda” on the
cap and “3 mg” on the body with black
ink.
NINLARO 4 mg hard capsules
Light orange, size 3 hard gelatin 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.
Posology
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 to 21 of a 28-day
treatment cycle.
The recommended starting dose of dexamethasone i