ZYKADIA 150 MG

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

CERITINIB

Fáanlegur frá:

NOVARTIS ISRAEL LTD

ATC númer:

L01XE28

Lyfjaform:

HARD GELATIN CAPSULES

Samsetning:

CERITINIB 150 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Lækningarsvæði:

CERITINIB

Ábendingar:

ZYKADIA is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.23.04.2018 בקשה לשינוי משטר מינון - Dose modification for patients with severe hepatic impairment (Child-Pugh C), reduce the dose of ZYKADIA by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength- New starting dose - 450 mg taken orally once daily with food (instead of 750mg taken on empty stomach).First dose reduction due to adverse reactions- 300 mg taken orally once daily with food, second dose reduction - 150 mg taken orally once daily with food. Discontinue ZYKADIA for patients unable to tolerate 150 mg daily with food.

Leyfisdagur:

2020-04-30

Upplýsingar fylgiseðill

ZYK APL FEB22 V5
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
ZYKADIA™ 150 MG
HARD GELATIN CAPSULES
ACTIVE INGREDIENT:
Each capsule contains ceritinib 150 mg
Inactive ingredients– see section 6 ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
The medicine is intended for use in adults, 18 years of age and older.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Zykadia is indicated for the treatment of people with non-small cell
lung cancer (NSCLC) that is
caused by a defect in a gene called anaplastic lymphoma kinase (ALK)
and has spread to other
parts of the body.
THERAPEUTIC GROUP:
Zykadia belongs to a class of drugs called antineoplastics that stop
the development of new
cancer cells when the cancer is caused by a defect in a gene called
anaplastic lymphoma kinase
(ALK). Zykadia slows down the growth and spread of NSCLC that is ALK
positive.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine. For a list of the inactive ingredients, see section 6
‘Additional information’.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE YOU TAKE ZYKADIA, TELL YOUR DOCTOR ABOUT YOUR MEDICAL
CONDITION, INCLUDING IF:
-
you have liver problems
-
you have problems with your lungs or problems breathing
-
you have diabetes or high blood sugar
-
you have heart problems, including a condition called long QT syndrome
-
you have or have had inflammation of the pancreas (pancreatitis)
-
you are pregnant, planning to become pregnant or are breastfeeding
(see also below under
‘Preg

Vara einkenni

ZYK SPI 20FEB22 CL V5
USPI October 2021
ZYKADIA
®
150 MG HARD GELATIN CAPSULES
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
ZYKADIA is indicated for the treatment of patients with metastatic
non- small
cell lung cancer (NSCLC) whose
tumors are anaplastic lymphoma kinase (ALK)-positive.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for treatment of metastatic NSCLC with ZYKADIA based
on the presence of ALK positivity in
tumor specimens
_[see Clinical Studies (14.1)]_
.
2.2 RECOMMENDED DOSAGE
The recommended dosage of ZYKADIA is 450 mg orally once daily with
food until disease progression or
unacceptable toxicity.
_[see Clinical Pharmacology (12.3)]_
.
If a dose of ZYKADIA is missed, make up that dose unless the next dose
is due within 12 hours.
If vomiting occurs during the course of treatment, do not administer
an additional dose and continue with
the next scheduled dose of ZYKADIA.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
Recommendations for dose modifications of ZYKADIA for adverse
reactions are provided in Table 2.
Discontinue ZYKADIA for patients unable to tolerate 150 mg daily with
food.
TABLE 1: ZYKADIA DOSE REDUCTION INCREMENTS
DOSE REDUCTION SCHEDULE
DOSE LEVEL
Starting dose
450 mg taken orally once daily with food
First dose reduction
300 mg taken orally once daily with food
Second dose reduction
150 mg taken orally once daily with food
TABLE 2: ZYKADIA DOSE MODIFICATIONS FOR ADVERSE REACTIONS
ADVERSE REACTION
ZYKADIA DOSE MODIFICATION
GASTROINTESTINAL ADVERSE REACTIONS
ZYK SPI 20FEB22 CL V5
USPI October 2021
Lipase or amylase elevation greater than 2
times ULN
Withhold and monitor serum lipase and amylase.
Resume ZYKADIA with a 150 mg dose reduction after
recovery to less than 1.5 times ULN.
Severe or intolerable nausea, vomiting or
diarrhea despite optimal antiemetic or
antidiarrheal therapy
Withhold until improved, then resume ZYKADIA with a
150 mg dose reduction.
HYPERGLYCEMIA
Persistent hyperglycemia greater than 250 mg/dL
despite optimal antihyperglycemic therapy