Kisplyx 4mg capsules

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Lenvatinib mesilate

Հասանելի է:

Eisai Ltd

ATC կոդը:

L01XE29

INN (Միջազգային անվանումը):

Lenvatinib mesilate

Դոզան:

4mg

Դեղագործական ձեւ:

Capsule

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 08010500

Տեղեկատվական թերթիկ

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Ապրանքի հատկությունները

OBJECT 1
KISPLYX 4MG HARD CAPSULES
Summary of Product Characteristics Updated 08-Jun-2017 | Eisai 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
Kisplyx 4 mg hard capsules
Kisplyx 10 mg hard capsules
2. Qualitative and quantitative composition
Kisplyx 4 mg hard capsules
Each hard capsule contains 4 mg of lenvatinib (as mesilate).
Kisplyx 10 mg hard capsules
Each hard capsule contains 10 mg of lenvatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Kisplyx 4 mg hard capsules
A yellowish-red body and yellowish-red cap, approximately 14.3 mm in
length, marked in black ink with
“Є” on the cap, and “LENV 4 mg” on the body.
Kisplyx 10 mg hard capsules
A yellow body and yellowish-red cap, approximately 14.3 mm in length,
marked in black ink with “Є” on
the cap, and “LENV 10 mg” on the body.
4. Clinical particulars
4.1 Therapeutic indications
Kisplyx is indicated in combination with everolimus for the treatment
of adult patients with advanced
renal cell carcinoma (RCC) following one prior vascular endothelial
growth factor (VEGF)-targeted
therapy.
4.2 Posology and method of administration
Kisplyx treatment should be initiated and supervised by a health care
professional experienced in the use
of anticancer therapies.
Posology
The recommended daily dose of lenvatinib is 18 mg (one 10 mg capsule
and two 4 mg capsules) once
daily in combination with 5 mg of everolimus once daily. The daily
doses of lenvatinib and, if necessary,
everolimus are to be modified as needed according to the dose/toxicity
management plan.
If a patient misses a dose, and it cannot be taken within 12 hours,
then that dose should be skipped and the
next dose should be taken at the usual time of administration.
Treatment should continue a