NINLARO Tablets

País: Tanzânia

Língua: inglês

Origem: Tanzania Medicinces & Medical Devices Authority

Ingredientes ativos:

Ixazomib

Disponível em:

Takeda Pharma AS, Denmark, DENMARK

DCI (Denominação Comum Internacional):

Ixazomib

Dosagem:

2.3 mg

Forma farmacêutica:

Tablets

Fabricado por:

Haupt Pharma Amareg GmbH, GERMANY

Resumo do produto:

Physical description: Light pink, size 4 hard gelatin capsule, marked ‘‘Takeda’’ on the cap and ‘‘2.3 mg’’ on the body with black ink; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Status de autorização:

Registered/Compliant

Data de autorização:

2019-08-02

Características técnicas

Summary of Product Characteristics
1. Name of the medicinal product
NINLARO 2.3 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)
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.
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 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.
Dosing schedule: Ixazomib taken with lenalidomide and dexamethasone
28-day cycle (a 4-week cycle)
Week 1 Week 2 Week 3 Week 4
Day 1 Days 2
to 7
Day 8 Days 9
to 14
Day
15
Days 16
to 21
Day
22
Days
23 to
28