Xalkori

Main information

  • Trade name:
  • Xalkori Hard Capsules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Xalkori Hard Capsules
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL12095102, MAL12095103
  • Last update:
  • 28-05-2018

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

Pfizer Confidential

Consumer Medication Information Leaflet (RiMUP)

1

PIL Title

: XALKORI 200 MG & 250 MG HARD CAPSULES

PIL Date

: 10 August 2017

Country

: Malaysia

Reference

: Xalkori 200 mg & 250 mg hard capsules Malaysia LPD dated 28 November 2016

Reason for Change

: To align with current effective Malaysia LPD

Pfizer Confidential

Consumer Medication Information Leaflet (RiMUP)

XALKORI

®

HARD CAPSULES

Crizotinib (200 mg, 250 mg )

2

What is in this leaflet

What XALKORI is used for

How XALKORI works

Before you use XALKORI

How to use XALKORI

While you are using XALKORI

Side effects

Storage and disposal of

XALKORI

Product description

Manufacturer and Product

Registration Holder

Date of Revision

Read this leaflet before you start

taking XALKORI and each time you

get a refill. There may be new

information. This information does

not take the place of talking to your

doctor about your condition or

treatment.

This leaflet provides the most

important information about

XALKORI. If you would like to

know more about XALKORI, talk

with your doctor or pharmacist.

What XALKORI is used for

XALKORI is a prescription medicine

that is used to treat people with non-

small cell lung cancer (NSCLC) that

is advanced or that has spread to other

parts of the body and is caused by a

defect in a gene called ALK

(anaplastic lymphoma kinase).

It is not known if XALKORI is safe

and effective in children.

How XALKORI works

XALKORI is in a class of

medications called protein kinase

inhibitors. When XALKORI block

these kinases, it prevents disruption

that may happen to a gene’s

sequence. Any disruptions in gene

sequence can cause the production of

cancer-causing fusion proteins. These

cancer-causing fusion proteins results

in the dysregulation of the gene

function which can cause continued

cell multiplication and survival of

cancer tumours. XALKORI has

shown effectiveness in blocking these

cancer-causing proteins in various

testing methods.

Before you use XALKORI

- When you must not use it

- Do not take XALKORI if you are

allergic (hypersensitive) to crizotinib

or any other ingredients in

XALKORI.

- Do not take XALKORI if you have

severe liver impairment.

- Do not use XALKORI for a

condition for which it was not

prescribed.

- Before you start to use it

Tell your doctor if you:

have liver or kidney problems

have any other medical conditions

are pregnant, or plan to become

pregnant. XALKORI may harm

your unborn baby.

Women who are able to

become pregnant and men with

partners who may potentially

become pregnant should use

adequate birth control methods

during treatment with

XALKORI and for 3 months

after stopping XALKORI.

Talk to your doctor about the

birth control methods that may

be right for you.

If you or your partner becomes

pregnant, tell your doctor right

away.

are breastfeeding or plan to

breastfeed. It is not known if

XALKORI passes into your breast

milk, and the potential effects on

your infant. Because of the

potential side effects to your infant,

do not breast feed during treatment

with XALKORI and for 45 days

after your final dose. You and your

doctor should decide if you will

take XALKORI or breastfeed. You

should not do both.

- Taking other medicines

Tell your doctor about the medicines

you take, including prescription

medicines, non-prescription

medicines, vitamins, and herbal

supplements.

You should inform your doctor if you

are taking medicines for:

mental problem (St. John’s Wort)

anxiety (midazolam)

fungal infections (ketoconazole)

bacterial infections (rifampin)

organ transplant rejection

prevention (tacrolimus,

cyclosporine)

gastric (esomeprazole)

seizures (carbamazepine,

phenobarbital, phenytoin)

This is not a complete list of medicine

interactions.

Know the medicines you

take. Keep a list of them to show

your doctor or pharmacist when you

get a new medicine.

How to use XALKORI

- How much to use

Take XALKORI exactly as your

doctor tells you to take it.

The recommended dose of

Crizotinib is 250 mg orally, twice

daily.

For individuals with severe kidney

impairment, doctor may reduce to

250 mg once dailyYour doctor will

tell you how much XALKORI to

take and when to take it. Do not

change your dose of XALKORI

unless your doctor tells you to.

Your doctor may also change your

dose, temporarily stop, or

permanently stop treatment with

XALKORI if you have certain side

effects. Do not stop taking

XALKORI unless your doctor tells

you to.

Pfizer Confidential

Consumer Medication Information Leaflet (RiMUP)

3

Follow all directions given to

you by your doctor and

pharmacist carefully. They may

differ from the information

contained in this leaflet. If you

do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

Swallow XALKORI capsules

whole.

Do not crush, dissolve, or open

capsules.

You may take XALKORI with or

without food.

- When to use it

Use as directed by your doctor or

pharmacist.

- How long to use it

Continue to take XALKORI for

as long as your doctor

recommends.

- If you forget to use it

If a dose of XALKORI is missed

or vomited, then it should be

taken as soon as you remember

unless it is less than 6 hours until

the next dose, in which case you

should not take the missed dose

and just take your next dose at

your regular time. You should

not take 2 doses at the same time

to make up for a missed dose.

- If you use too much (overdose)

Call your doctor right away if

you take too much XALKORI.

Your doctor will check your blood

and heart while you are taking

XALKORI.

While you are using XALKORI

- Things you must do

XALKORI may cause serious side

effects, such as:

Lung problems (pneumonitis) -

XALKORI may cause life-threatening

swelling (inflammation) of the lungs

during treatment. Symptoms may be

similar to those symptoms from lung

cancer. Tell your doctor right away if

you have any new or worsening

symptoms, including:

trouble breathing or shortness

of breath

cough with or without mucous

fever

Liver problems - XALKORI may

cause life-threatening liver injury that

may lead to death. Your doctor should

do blood tests at least every month to

check your liver while you are taking

XALKORI. Tell your doctor right

away if you get any of the following

new or worsening symptoms:

yellowing of your skin or the

white part of your eyes.

your urine turns dark or brown

(tea color)

you have pain on the right side of

your stomach

you bleed or bruise more easily

than normal

you have itching

Heart problems - XALKORI may

cause very slow, very fast, or

abnormal heartbeats. Your doctor

may check your heart during

treatment with XALKORI. Tell your

doctor right away if you feel dizzy or

faint or have abnormal heartbeats.

Vision problems. - Vision problems

are common with XALKORI. These

problems usually happen within 1

week of starting treatment with

XALKORI. Vision problems with

XALKORI can be severe and may

cause partial or complete loss of

vision in one or both eyes. Your

doctor may stop XALKORI and refer

you to an eye doctor if you develop

severe vision problems during

treatment with XALKORI. Tell your

doctor right away if you have any loss

of vision or any change in vision,

including:

Double vision

Seeing flashes of light

Blurry vision

Light hurting your eyes

New or increased floaters

- Things you must not do

You should not drink grapefruit juice

or eat grapefruit during your

treatment with XALKORI. It may

increase the amount of XALKORI in

your blood

to a harmful level.

Do not give it to other people, even if

they have the same symptoms as you.

It may harm them.

- Things to be careful of

XALKORI can cause changes in

your vision, dizziness, and

tiredness. If you have these

symptoms, use caution when

driving a car, using machinery,

or doing anything that needs you

to be alert.

Side effects

The most common side effects of

XALKORI include:

Vision problems

nausea

diarrhea

vomiting

swelling

constipation

Increase liver function blood test

results.

Tiredness

Decreased appetite

Upper respiratory infection

Dizziness

Feeling of numbness or tingling in

the extremities

XALKORI may cause decreased

fertility in females and males. In

females, this could affect your ability to

become pregnant. In males, this could

affect your ability to father a child. Talk

to your healthcare provider if you have

concerns about fertility.

Tell your doctor if you have any side

effect that bothers you or that does

not go away.

These are not all of the possible side

effects of XALKORI. For more

information, ask your doctor or

pharmacist.

Pfizer Confidential

Consumer Medication Information Leaflet (RiMUP)

4

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel:

03-78835550, or visiting the website

npra.moh.gov.my (Public

Reporting Medicinal Problems / Side

Effects / AEFI / Vaccine Safety).

Storage and Disposal of XALKORI

- Storage

Store XALKORI below 30°C.

Keep XALKORI in the original

container, and keep the container closed

tightly.

Keep XALKORI and all medicines out

of reach of children.

- Disposal

Do not throw away any medicines via

wastewater or household waste. Ask

your pharmacist how to throw away

medicines you no longer use. These

measures will help protect the

environment

Product Description

- What it looks like

XALKORI 200mg hard capsule is a

white opaque/pink opaque

hard gelatin capsule, containing a

white to pale yellow powder with

CRZ 200 and Pfizer (logo) printed on

the capsule in black ink.

XALKORI 250mg hard capsule is a

pink opaque/pink opaque hard gelatin

capsule, containing a white to pale

yellow powder with CRZ 250 and

Pfizer (logo) printed on

the cap in black ink.

- Ingredients

- Active ingredient

Crizotinib.

- Inactive ingredients

Colloidal silicon dioxide,

microcrystalline cellulose, anhydrous

dibasic calcium phosphate, sodium

starch glycolate, and magnesium

stearate.

Pink opaque capsule shell contains:

gelatin, titanium dioxide, and red iron

oxide.

White opaque capsule shell contains:

gelatin and titanium dioxide.

Printing ink contains: shellac,

propylene glycol, strong ammonia

solution, potassium hydroxide, and

black iron oxide.

- MAL number:

XALKORI 200mg Hard Capsule-

MAL12095102AZ

XALKORI 250mg Hard Capsule-

MAL12095103AZ

Manufacturer

Pfizer Manufacturing Deutschland

GmbH

Betriebsstätte Freiburg,

Mooswaldallee 1,

79090 Freiburg, Germany.

Product Registration Holder

Pfizer (Malaysia) Sdn. Bhd.

Level 9-2, 10 & 11, Wisma Averis

(Tower 2), Avenue 5, Bangsar South,

No. 8, Jalan Kerinchi, 59200

Kuala Lumpur.

Date of revision

- 10/08/2017

PIL-XALKORI-0817

Serial Number

NPRA(R4/1)020817/00188