LORVIQUA 25 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LORLATINIB

متاح من:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC رمز:

L01XE44

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LORLATINIB 25 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

المجال العلاجي:

LORLATINIB

الخصائص العلاجية:

Lorviqua is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive.

تاريخ الترخيص:

2020-03-22

نشرة المعلومات

Lorviqua 25 mg and 100 mg, PIL, CC 111121
0069626
-
2021
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
LORVIQUA
® 25 MG
LORVIQUA
® 100 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
LORLATINIB 25 MG OR 100 MG
A list of inactive ingredients and allergens in the preparation: See
section 2 under “Important
information about some of this medicine’s ingredients” and section
6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lorviqua
®
is intended for treatment of adult patients with metastatic non-small
cell lung cancer
(NSCLC) which is positive for a mutation in a gene called ALK
(anaplastic lymphoma kinase).
THERAPEUTIC GROUP: protein kinase inhibitors.
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, listed in section 6.
•
You take medicines inducing the activity of CYP3A enzyme, called
strong inducers,
such as rifampicin used to treat tuberculosis, carbamazepine and
phenytoin used to
treat epilepsy, enzalutamide used to treat prostate cancer, mitotane
used to treat
adrenal cancer, medicines containing St. John’s wort (hypericum), a
herbal
preparation. If you are not sure, refer to the doctor for the full
list of medications.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH LORVIQUA
®
, TELL YOUR DOCTOR IF:
•
you have had episodes of depression or seizures
•
you have high blood levels of cholesterol or triglycerides
•
you have problems with your heart beat
•
you have lung or bre

خصائص المنتج

Lorviqua 25 mg and 100 mg, LPD, CC 111121
2021-0069626
1
_0_
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Lorviqua
®
25 mg.
Lorviqua
®
100 mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lorviqua 25 mg film-coated tablets
Each film-coated tablet contains 25 mg of lorlatinib.
_Excipient with known effect_
Each film-coated tablet contains 1.58 mg of lactose monohydrate.
Lorviqua 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of lorlatinib.
_Excipient with known effect_
Each film-coated tablet contains 4.20 mg of lactose monohydrate.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Film-coated tablet.
1 INDICATIONS AND USAGE
LORVIQUA
®
is indicated for the treatment of adult patients with metastatic
non-small cell lung cancer
(NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
_1B_
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for the treatment of metastatic NSCLC with LORVIQUA
based on the presence of ALK
positivity in tumor specimens
_[see Indications and Usage (1) and Clinical Studies (14)]_
.
2.2
RECOMMENDED DOSAGE
The recommended dosage of LORVIQUA is 100 mg orally once daily, with
or without food, until disease
progression or unacceptable toxicity
_ [see Clinical Pharmacology (12.3)]_
.
Swallow tablets whole. No information about chewing, crushing or
splitting the tablets.
Take LORVIQUA at the same time each day. If a dose is missed, then
take the missed dose unless the next
dose is due within 4 hours. Do not take 2 doses at the same time to
make up for a missed dose.
Lorviqua 25 mg and 100 mg, LPD, CC 111121
2021-0069626
2
Do not take an additional dose if vomiting occurs after LORVIQUA but
continue with the next scheduled dose.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
The recommended dose reductions are:
•
First dose reduction: LORVIQUA 75 mg orally once daily
•
Second dose reduction: LORVIQUA 50 mg orally once daily
Permanently discontinue LORVIQUA in patients who are unable to
tolerate 50 mg orally once dail