INLYTA 5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AXITINIB

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

L01XE17

Pharmaceutical form:

FILM COATED TABLETS

Composition:

AXITINIB 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

AXITINIB

Therapeutic area:

AXITINIB

Therapeutic indications:

For the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

Authorization date:

2018-03-31

Patient Information leaflet

Inlyta 1 mg and 5 mg, PIL, Israel, CC
061220
2020-0065995
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
INLYTA
® 1 MG
INLYTA
® 5 MG
Film-coated tablets
Each tablet contains: axitinib 1 mg or 5 mg.
For 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 the medicine. If you have further questions, consult
your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Inlyta
®
is intended for the treatment of advanced renal cell carcinoma (RCC),
after the failure
of other medicinal therapy.
THERAPEUTIC GROUP: a medicine from the tyrosine kinase inhibitor
group.
2. BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients contained in the medicine, listed in section 6.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH INLYTA
®
, TELL YOUR DOCTOR IF:
•
You have high blood pressure. High blood pressure can develop during
treatment with
Inlyta
®
; blood pressure must be monitored before and during treatment with
Inlyta
®
.
•
You have a history of blood clots in your arteries or veins (types of
blood vessels),
including stroke, heart attack, or changes in vision.
•
You have a history of heart failure.
•
You are suffering from bleeding (including in the digestive system).
Inform the doctor if
bleeding occurs.
•
You plan to have surgery or have had surgery recently. Stop taking
Inlyta
®
at least 2
days before the planned surgery, and continue using it again only
after consultin

Summary of Product characteristics

Inlyta 1 mg and 5 mg, Israel, LPD, CC 061220
2020-0065995
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Inlyta
®
1 mg
Inlyta
®
5 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Inlyta 1 mg
Each film coated tablet contains 1 mg axitinib
Inlyta 5 mg
Each film coated tablet contains 5 mg axitinib
For the full list of excipients, see section "
DESCRIPTION"
.
PHARMACEUTICAL FORM
Film coated tablets
1
INDICATIONS AND USAGE
INLYTA is indicated for the treatment of advanced renal cell carcinoma
(RCC) after failure of
one prior systemic therapy.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSING
The recommended starting oral dose of INLYTA is 5 mg twice daily.
Administer INLYTA doses
approximately 12 hours apart with or without food.
Important Administration Instructions
Advise patients to swallow INLYTA whole with a full glass of water. If
the patient vomits or
misses a dose, an additional dose should not be taken. Advise the
patient to take the next
prescribed dose at the usual time.
2.2
DOSE MODIFICATION GUIDELINES
Dose increase or reduction is recommended based on individual safety
and tolerability.
Over the course of treatment, patients who tolerate INLYTA for at
least two consecutive weeks
with no adverse reactions Grade >2 (according to the Common Toxicity
Criteria for Adverse
Events [CTCAE]), are normotensive, and are not receiving
anti-hypertension medication, may
have their dose increased. When a dose increase from 5 mg twice daily
is recommended, the
INLYTA dose may be increased to 7 mg twice daily, and further to 10 mg
twice daily using the
same criteria.
Inlyta 1 mg and 5 mg, Israel, LPD, CC 061220
2020-0065995
2
Over the course of treatment, management of some adverse drug
reactions may require temporary
interruption or permanent discontinuation and/or dose reduction of
INLYTA therapy
_[see _
_Warnings and Precautions (5)]_
.
If dose reduction from 5 mg twice daily is required, the
recommended dose is 3 mg twice daily. If additional dose reduction is
required, the recommended
dose is 2 mg twice