XALKORI crizotinib 250 mg capsule blister pack

Main information

  • Trade name:
  • XALKORI crizotinib 250 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XALKORI crizotinib 250 mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190965
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190965

XALKORI crizotinib 250 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

27/09/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. XALKORI crizotinib 250 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

16/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XALKORI is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al laminated with

PVC/paper

36 Months

Store below 30

degrees Celsius

Not recorded

Store at room

temperature

Pack Size/Poison information

Pack Size

Poison Schedule

60 capsules

(S4) Prescription Only Medicine

Components

1. XALKORI crizotinib 250 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule with pink opaque body and cap, printed with black ink

Pfizer on the cap, CRZ 250 on the body.

Active Ingredients

Crizotinib

250 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 10:36:57 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

XALKORI

®

crizotinib

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about XALKORI.

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 XALKORI

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 XALKORI is

used for

XALKORI is used to treat rare types

of lung cancer caused by defects in a

gene called anaplastic lymphoma

kinase (ALK) or a gene called ROS1.

XALKORI may slow or stop the

growth of these types of lung cancer.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

XALKORI is only available with a

doctor's prescription.

It is not addictive.

Use in Children

The safety and efficacy of

XALKORI in children have not been

established.

Before you take

XALKORI

When you must not take it

Do not take XALKORI if you have

an allergy to:

crizotinib (the active ingredient in

XALKORI)

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 XALKORI 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.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have ever had any of the following

medical conditions:

any other lung problems

problems with your heart rate or

heart rhythm, including

prolonged QT interval

liver problems

kidney problems

inflammation of the

gastrointestinal tract

cancer that has spread to the

stomach or intestines

Tell your doctor if you are

pregnant, plan to become pregnant

or plan to father a child.

XALKORI may affect the

developing baby.

Tell your doctor if you are breast-

feeding.

You should not breastfeed if you are

being treated with XALKORI.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

XALKORI or may affect how well it

works.

Tell your doctor or pharmacist if

you are taking any of the following

medicines:

itraconazole, ketoconazole or

voriconazole, medicines to treat

fungal infections

atazanavir, efavirenz, indinavir,

ritonavir or saquinavir, medicines

to treat HIV infection/AIDS

clarithromycin, troleandomycin,

moxifloxacin or ciprofloxacin,

medicines to treat bacterial

infections

XALKORI

carbamazepine, phenobarbital or

phenytoin, medicines to treat

epilepsy, seizures or fits

rifabutin or rifampicin, medicines

to treat tuberculosis and some

other infections

St. John's wort, a herbal medicine

to treat anxiety or depression

ergotamine, a medicine to treat

migraine and some other types of

headache

chlorpromazine, amisulpride,

droperidol, haloperidol or

ziprasidone, medicines to treat

mental illness

amitriptyline, citalopram,

escitalopram, fluoxetine,

imipramine or other medicines to

treat depression

midazolam, a medicine used for

sedation or to cause sleepiness

alfentanil, fentanyl or methadone,

medicines to treat pain

ciclosporin, sirolimus or

tacrolimus, medicines used in

transplant patients

amiodarone, digoxin, diltiazem,

disopyramide, verapamil,

bisoprolol, carvedilol or sotalol,

medicines to treat heart problems

and/or high blood pressure

clonidine, atenolol, labetalol,

metoprolol, nebivolol,

oxprenolol, pindolol or

propranolol, medicines to treat

high blood pressure and/or other

heart problems

colchicine, a medicine to treat

gout

dabigatran, a medicine to prevent

blood clots

bupropion, a medicine to help

people stop smoking

pravastatin, a medicine to treat

high cholesterol

metformin, a medicine to treat

diabetes

mefloquine or quinine, medicines

to prevent or treat malaria

You may need to take different

amounts of your medicines or you

may need to use different medicines.

Your doctor will advise you.

How to take XALKORI

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How much to take

Your doctor will tell you how many

capsules you need to take each day.

This may depend on your condition

and whether you are taking any other

medicines.

The usual dose of XALKORI is one

capsule of 250 mg taken twice a day.

Your doctor may change your dose

during treatment.

How to take it

Swallow the capsule whole with a

glass of water.

When to take it

Take the capsules at about the

same time each day.

If your doctor has told you to take

the capsules twice a day, take one

capsule in the morning and one

capsule in the evening, about

12 hours apart.

Taking them at the same time each

day will help you to remember when

to take them.

It does not matter if you take

XALKORI before or after food.

If you vomit after taking a dose of

XALKORI, do not take an extra

dose, just take your next dose at the

usual time.

How long to take it

Continue taking XALKORI for as

long as your doctor tells you.

If you forget to take it

If it is less than 6 hours before your

next dose, skip the dose you missed

and take your next dose when you

are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking XALKORI as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(Phone 13 11 26) for advice or go to

Accident and Emergency at the

nearest hospital, if you think you

or anyone else may have taken too

much XALKORI.

Do this even if there are no signs of

discomfort or poisoning.

While you are using

XALKORI

Things you must do

Make sure you follow your

doctor's instructions and keep all

appointments.

Your doctor will check your

progress. You will also have blood

tests and other tests to check for side

effects.

Tell your doctor immediately if

you or your partner become

pregnant while taking XALKORI.

Use contraception (birth control)

to prevent pregnancy while you are

being treated with XALKORI.

Women who could become pregnant

or men who could father a child must

use a reliable method of

contraception during treatment with

XALKORI

XALKORI and for at least 90 days

after taking the last dose.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

Tell any doctor, dentist or

pharmacist who treats you that

you are taking XALKORI.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking XALKORI.

Things you must not do

Do not take XALKORI to treat

any other complaints unless your

doctor tells you to.

Do not give XALKORI to anyone

else, even if their condition seems

similar to yours.

Do not stop taking XALKORI or

change the dosage without

checking with your doctor.

Things to be careful of

Avoid eating grapefruit or

drinking grapefruit juice while you

are being treated with XALKORI.

Grapefruit and grapefruit juice may

change the amount of XALKORI in

your body.

Be careful driving or operating

machinery until you know how

XALKORI affects you.

XALKORI may cause dizziness and

tiredness and changes in vision in

some people. If you have any of

these symptoms, do not drive,

operate machinery or do anything

else that could be dangerous.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

XALKORI.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

It can be difficult to tell whether side

effects are the result of taking

XALKORI, effects of your condition

or side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

Medicines can affect people in

different ways.

Ask your doctor or pharmacist to

answer any questions you may

have.

Do not be alarmed by the list of

possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist if

you notice any of the following:

blurred vision, flashes of light,

floaters in eye, double vision

nausea (feeling sick) or vomiting

diarrhoea, constipation

swelling of hands, feet or legs

tiredness

loss of appetite

dizziness

tingling or numbness of hands or

feet; pins and needles

change in sense of taste

soreness or redness of mouth, lips

or tongue

skin rash

slow heart rate

pain in back, side or upper

stomach.

heartburn, belching, indigestion

reduced sex drive in men,

difficulty in getting an erection

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

difficulty breathing, shortness of

breath, cough, coughing up

pinkish mucus or blood, rapid

weight gain, fluid retention,

swollen ankles

infection, fever

dizziness, fainting, chest pain,

rapid or irregular heartbeat

pain on right side of stomach,

feeling more tired than usual,

weakness, dark urine, itchy skin,

yellowing of the skin or eyes,

bleeding or bruising more easily

than usual

severe stomach pain

loss of vision

The above side effects may be

serious. You may need urgent

medical attention.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some patients.

Some side effects might only be

found when your doctor does blood

tests or other tests. These tests could

show a change in the liver, kidney,

levels of blood cells or changes in

heart rhythm.

After using XALKORI

Storage

Keep XALKORI capsules in the

original container until it is time to

take them.

Store XALKORI in a cool dry

place where the temperature stays

below 30°C.

Do not leave XALKORI or any

other medicine in the car or on

window sills.

Do not store XALKORI or any

other medicine in the bathroom or

near a sink.

Heat and dampness can destroy some

medicines.

Keep the capsules where children

cannot reach them.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

XALKORI

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

capsules that are left over.

Product description

What it looks like

XALKORI 200 mg capsules have a

pink cap and white body and are

printed with "Pfizer" on the cap and

"CRZ 200" on the body in black ink.

XALKORI 250 mg capsules have a

pink cap and body and are printed

with "Pfizer" on the cap and "CRZ

250" on the body in black ink.

XALKORI is supplied in blister

packs containing 60 capsules.

Ingredients

XALKORI capsules contain 200 mg

or 250 mg of crizotinib as the active

ingredient.

The capsules also contain:

microcrystalline cellulose

calcium hydrogen phosphate

sodium starch glycollate

magnesium stearate

colloidal anhydrous silica

gelatin

titanium dioxide (E171)

red iron oxide (E172)

XALKORI capsules do not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

XALKORI is supplied in Australia

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free number: 1800 675 229

Australian registration

numbers

XALKORI 200 mg:

AUST R 190964 (blister pack)

XALKORI 250 mg:

AUST R 190965 (blister pack)

Date of preparation

This leaflet was prepared in April

2019.

® = Registered Trademark

© Pfizer Australia Pty Ltd

XALKORI