INLYTA axitinib 1 mg tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

axitinib, Quantity: 1 mg

Pieejams no:

Pfizer Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Axitinib

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide red

Ievadīšanas:

Oral

Vienības iepakojumā:

56 tablets, 28 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

For the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy.

Produktu pārskats:

Visual Identification: Red, oval, film-coated tablet debossed with "Pfizer" on one side and "1 XNB" on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2012-07-26

Lietošanas instrukcija

INLYTA
®
_Axitinib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INLYTA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking INLYTA
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INLYTA IS USED
FOR
_WHAT INLYTA DOES_
INLYTA is used to treat a certain
type of kidney cancer called renal
cell carcinoma (RCC).
It belongs to a group of medicines
called tyrosine kinase inhibitors.
_HOW INLYTA WORKS_
INLYTA contains the active
substance axitinib. It works by
reducing the blood supply to the
tumour and slowing down the growth
of cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INLYTA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
INLYTA is only available with a
doctor's prescription. It is not
addictive.
_USE IN CHILDREN_
The safety and efficacy of INLYTA
have not been established in children.
BEFORE YOU TAKE
INLYTA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE INLYTA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing axitinib
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR D

Produkta apraksts

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Page 1 of 20
AUSTRALIAN
PRODUCT
INFORMATION
–
INLYTA
® (AXITINIB)
1.
NAME OF THE MEDICINE
Axitinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INLYTA is supplied as red film-coated tablets containing 1 mg, 3 mg, 5
mg, or 7 mg of
axitinib.
EXCIPIENT(S) WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
INLYTA 1 MG TABLETS
Red, film-coated, oval tablets, debossed with “Pfizer” on one side
and “1 XNB” on the other.
INLYTA 3 MG TABLETS
Red, film-coated, round tablets, debossed with “Pfizer” on one
side and “3 XNB” on the other.
INLYTA 5 MG TABLETS
Red, film-coated, triangular tablets, debossed with “Pfizer” on
one side and “5 XNB” on the
other.
INLYTA 7 MG TABLETS
Red, film-coated, diamond tablets, debossed with “Pfizer” on one
side and “7 XNB” on the
other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INLYTA is indicated for the treatment of patients with advanced renal
cell carcinoma after
failure of one prior systemic therapy.
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Supersedes: pfpinlyt11019
Page 2 of 20
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
RECOMMENDED DOSE
The recommended starting oral dose of INLYTA is 5 mg twice daily.
INLYTA may be taken
with or without food.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next
prescribed dose should be taken at the usual time.
DOSAGE ADJUSTMENT
Dose increase or reduction is recommended based on individual safety
and tolerability.
Patients who tolerate the INLYTA starting dose of 5 mg twice daily
with no adverse reactions
>Grade 2 (according to the Common Toxicity Criteria for Adverse Events
[CTCAE]) for two
consecutive weeks, are normotensive, and are not receiving
anti-hypertensive medication, may
have their dose increased to 7 mg twice daily. Subsequently, using the
same criteria, patients
who tolerate the INLYTA dose of 7 mg twice daily, may have their dose
increased to a
maximum