COPIKTRA 15 MG

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

DUVELISIB

Доступна з:

SANOFI ISRAEL LTD

Код атс:

L01XX69

Фармацевтична форма:

CAPSULES

Склад:

DUVELISIB - 15 MG

Адміністрація маршрут:

PER OS

Тип рецепту:

Required

Виробник:

EUROAPI UK LIMITED

Терапевтична области:

LURBINECTEDIN

Терапевтичні свідчення:

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:• Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.• Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.

Дата Авторизація:

2022-06-23

Характеристики продукта

1 COPIKTRA 15 MG, COPIKTRA 25 MG
1.
NAME OF THE MEDICINAL PRODUCT
Copiktra 15 mg, Copiktra 25 mg
PATIENT SAFETY INFORMATION CARD
The marketing of Copiktra is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that the
patient should be aware of before and during treatment. Please explain
the patient the need to review the
card before starting treatment.
PRESCRIBER GUIDE
This product is marked with prescriber guide providing important
safety information. Please ensure you
are familiar with this material as it contains important safety
information.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Copiktra 15 mg
Each hard capsule contains 15 mg duvelisib (as monohydrate)
Copiktra 25 mg
Each hard capsule contains 25 mg duvelisib (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Copiktra 15 mg hard capsules
Opaque, pink, size no. 2, hard gelatin capsules marked “duv 15 mg”
in black ink. Dimensions: approx.
18 mm x 6 mm (length and diameter).
Copiktra 25 mg hard capsules
Opaque, white to off-white and orange, size no. 2, hard gelatin
capsules marked “duv 25 mg” in black
ink. Dimensions: approx. 18 mm x 6 mm (length and diameter).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
COPIKTRA is indicated for the treatment of adult patients with
relapsed or refractory CLL or SLL after
at least two prior therapies.
2
Follicular Lymphoma (FL)
COPIKTRA is indicated for the treatment of adult patients with
relapsed or refractory FL after at least
two prior systemic therapies.
Posology
The recommended dose is 25 mg duvelisib twice daily. A cycle consists
of 28 days. Treatment should
be continued until disease progression or unacceptable toxicity.
_Delayed or missed doses _
Patients should be advised that if a dose is missed by less than 6
hours, the missed dose should be
taken right away and