Tasigna 150mg Capsule

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Available from:
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
INN (International Name):
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Units in package:
28capsule Capsules; 112capsule Capsules; 28capsule Capsules; 112capsule Capsules
Manufactured by:
NOVARTIS PHARMA STEIN AG
Authorization number:
MAL11105040ARZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

27-12-2019

Consumer Medication Information Leaflet (RiMUP)

TASIGNA

®

Nilotinib

50mg, 150mg and 200mg Hard Capsules

What is in this leaflet

1.

What Tasigna is used for

2.

How Tasigna works

3.

Before you use Tasigna

4.

How to use Tasigna

5.

While you are using Tasigna

6.

Side effects

7.

Storage and Disposal of Tasigna

8.

Product Description

9.

Manufacturer and Product

Registration Holder

10.

Date of Revision

What Tasigna is used for

Tasigna is used to treat a type of

leukaemia called Philadelphia

chromosome positive chronic myeloid

leukaemia (Ph-positive CML). CML is a

cancer of the blood which makes the body

produce too many abnormal white blood

cells.

Tasigna is used in adult and paediatric

patients with newly diagnosed CML or in

patients with CML who are no longer

benefiting from previous treatment

including imatinib. It is also used in adult

and paediatric patients who experienced

serious side effects with previous

treatment and are not able to continue

taking it.

How Tasigna works

In patients with CML, a change in DNA

(genetic material) triggers a signal that

tells the body to produce abnormal white

blood cells. Tasigna blocks this signal,

and thus stops the production of these

cells.

Monitoring during Tasigna

treatment

Regular tests, including blood tests, will

be performed during treatment. These

tests will monitor:

the amount of blood cells (white blood

cells, red blood cells and platelets) in

your body to see how Tasigna is

tolerated.

pancreas and liver function in the

body to see how Tasigna is tolerated.

the electrolytes in the body

(potassium, magnesium). These are

important in the functioning of the

heart.

the level of sugar and fats in the blood.

The heart rate will also be checked using

a machine that measures electrical

activity of the heart (a test called an

“ECG”).

If you have any questions about how

Tasigna works or why it has been

prescribed for you or your child, ask your

doctor.

Before you use Tasigna

Follow all the doctor’s instructions

carefully. They may differ from the

general information contained in this

leaflet.

When you must not use it

If you are allergic to nilotinib or any of

the other ingredients of this medicine

(listed at

Ingredients

under Product

Description). If you think you may be

allergic, tell your doctor before taking

Tasigna.

Pregnancy and breast-feeding

Tasigna is not recommended during

pregnancy unless clearly necessary. If

you are pregnant or think that you may

be, tell your doctor who will discuss

with you whether you can take this

medicine during your pregnancy.

Women who might get pregnant

advised to use effective contraception

during treatment and for up to two

weeks after ending treatment.

Breast-feeding is not recommended

during treatment with Tasigna and for

two weeks after the last dose. Tell your

doctor if you are breast-feeding.

If you are pregnant or breast-feeding,

think you may be pregnant or are

planning to have a baby, ask your doctor

or pharmacist for advice before taking

this medicine.

Before you start to use it

Talk to your doctor or pharmacist before

taking Tasigna:

if you have suffered prior

cardiovasuclar events such as a heart

attack, chest pain (angina), problems

with the blood supply to your brain

(stroke) or problems with the blood

flow to your leg (claudication) or if you

have risk factors for cardiovascular

disease such as high blood pressure

(hypertension), diabetes or problems

with the level of fats in your blood

(lipid disorders).

if you have a heart disorder, such as an

abnormal electrical signal called

“prolongation of the QT interval”.

if you are being treated with medicines

that affect the heart beat (anti-

arrhythmics) or the liver (see

Taking

other medicines

if you suffer from lack of potassium or

magnesium.

if you have a liver or pancreas disorder.

if you have symptoms such as easy

bruising, feeling tired or short of breath

or have experienced repeated

infections.

if you have had a surgical procedure

involving the removal of the entire

stomach (total gastrectomy).

if you have ever had or might now have

a hepatitis B infection. This is because

Tasigna could cause hepatitis B to

become active again, which can be fatal

in some cases. Patients will be carefully

checked by their doctor for signs of this

infection before treatment is started.

If any of these apply to you or your child,

tell your doctor.

Children and adolescents

Tasigna is a treatment for children and

adolescents with CML. There is no

experience with the use of this medicine

in children below 2 years of age. There is

no experience with the use of Tasigna in

newly diagnosed children below 10 years

of age and limited experience in patients

below 6 years of age who are no longer

benefiting from previous treatment for

CML. The long-term effects of treating

children with Tasigna for long periods of

time are not known.

Some children and adolescents taking

Tasigna may have slower than normal

growth. The doctor will monitor growth

at regular visits.

Taking other medicines

Tasigna may interfere with some other

medicines.

Tell your doctor

or pharmacist if you are

taking, have recently taken or might take

any other medicines. This includes in

particular:

antiarrhythmics – used to treat irregular

heart beat;

chloroquine, halofantrine,

clarithromycin, haloperidol,

methadone, moxifloxacin - medicines

Consumer Medication Information Leaflet (RiMUP)

that may have an unwanted effect on

the electrical activity of the heart;

ketoconazole, itraconazole,

voriconazole, clarithromycin,

telithromycin – used to treat infections;

ritonavir – a medicine from the class

“ antiproteases” used to treat HIV;

carbamazepine, phenobarbital,

phenytoin – used to treat epilepsy;

rifampicin – used to treat tuberculosis;

St. John’s Wort – a herbal product used

to treat depression and other conditions

(also known as

Hypericum

perforatum

midazolam – used to relieve anxiety

before surgery;

alfentanil and fentanyl – used to treat

pain and as a sedative before or during

surgery or medical procedures;

cyclosporine, sirolimus and tacrolimus

– medicines that suppress the “self-

defence” ability of the body and fight

infections and are commonly used to

prevent the rejection of transplanted

organs such as the liver, heart and

kidney;

dihydroergotamine and ergotamine –

used to treat dementia;

lovastatin, simvastatin – used to treat

high level of fats in blood;

warfarin – used to treat blood

coagulation disorders (such as blood

clots or thromboses);

astemizole, terfenadine, cisapride,

pimozide, quinidine, bepridil or ergot

alkaloids (ergotamine,

dihydroergotamine).

These medicines should be avoided

during your treatment with Tasigna. If

you are taking any of these, your doctor

might prescribe other alternative

medicines.

In addition, tell your doctor or pharmacist

before taking Tasigna if you are taking

any antacids, which are medicines against

heartburn. These medicines need to be

taken separately from Tasigna:

H2 blockers, which decrease the

production of acid in the stomach. H2

blockers should be taken approximately

10 hours before and approximately

2 hours after you take Tasigna;

antacids such as those containing

aluminium hydroxide, magnesium

hydroxide and simethicone, which

neutralise high acidity in the stomach.

These antacids should be taken

approximately 2 hours before or

approximately 2 hours after you take

Tasigna.

You should also tell your doctor if you

are already taking Tasigna

and you are

prescribed a new medicine that you have

not taken previously during Tasigna

treatment.

Taking Tasigna with food and drink

Do not take Tasigna with food. Food may

enhance the absorption of Tasigna and

therefore increase the amount of Tasigna

in the blood, possibly to a harmful level.

Do not drink grapefruit juice or eat

grapefruit. It may increase the amount of

Tasigna in the blood, possibly to a

harmful level.

How to use Tasigna

Always take this medicine exactly as your

doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are

not sure.

How much to use

Use in adults

Patients newly diagnosed with CML: The

recommended dose is 600 mg per day.

This dose is achieved by taking two hard

capsules of 150 mg twice a day.

Patients who are no longer benefiting

from previous treatment for CML: The

recommended dose is 800 mg per day.

This dose is achieved by taking two hard

capsules of 200 mg twice a day.

Use in children and adolescents

The dose given to your child will depend

on your child’s body weight and height.

The doctor will calculate the correct dose

to use and tell you which and how many

capsules of Tasigna to give to your child.

The total daily dose you give to your

child must not exceed 800 mg.

Your doctor may prescribe a lower dose

depending on how you respond to

treatment.

Older people (age 65 years and over)

Tasigna can be used by people aged

65 years and over at the same dose as for

other adults.

When to use it

Take the hard capsules:

twice a day (approximately every

12 hours);

at least 2 hours after any food;

then wait 1 hour before eating again.

If you have questions about when to take

this medicine, talk to your doctor or

pharmacist. Taking Tasigna at the same

time each day will help you remember

when to take your capsules.

How to use Tasigna

Swallow the hard capsules whole with

water.

Do not take any food together with the

hard capsules.

Do not open the hard capsules unless

you are unable to swallow them. If so,

you may sprinkle the content of each

capsule in one teaspoon of apple sauce

and take it immediately. Do not use

more than one teaspoon of apple sauce

for each capsule and do not use any

food other than apple sauce.

How long to use it

Continue taking Tasigna every day for as

long as your doctor tells you. This is a

long-term treatment. Your doctor will

regularly monitor your condition to check

that the treatment is having the desired

effect.

If you have questions about how long to

take Tasigna, talk to your doctor.

If you forget to use Tasigna

If you miss a dose, take your next dose as

scheduled. Do not take a double dose to

make up for the forgotten capsules.

If you use too much (overdose)

If you have taken more Tasigna than you

should have, or if someone else

accidentally takes your hard capsules,

contact a doctor or hospital for advice

straight away. Show them the pack of

capsules and this package leaflet. Medical

treatment may be necessary.

If your doctor recommends that you

discontinue treatment with Tasigna

Your doctor will regularly evaluate your

treatment and decide whether you should

continue to take this medicine. If you are

told to discontinue this medicine, your

doctor will continue to monitor your

CML and may tell you to re-start Tasigna

if your condition indicates that this is

necessary.

If you have any further questions on the

use of this medicine, ask your doctor or

pharmacist.

While you are using Tasigna

Things you must do

During treatment with Tasigna:

If you faint (loss of consciousness) or

have an irregular heart beat while

taking this medicine, tell your doctor

immediately as this may be a sign of

a serious heart condition.

Prolongation of the QT interval or an

irregular heart beat may lead to

Consumer Medication Information Leaflet (RiMUP)

sudden death. Uncommon cases of

sudden death have been reported in

patients taking Tasigna.

if you have sudden heart

palpitations, severe muscle

weakness or paralysis, seizures or

sudden changes in your thinking or

level of alertness, tell your doctor

immediately as this may be a sign

of a fast breakdown of cancer cells

called tumour lysis syndrome.

Rare cases of tumour lysis

syndrome have been reported in

patients treated with Tasigna.

if you develop chest pain or

discomfort, numbness or

weakness, problems with walking

or with your speech, pain,

discolouration or a cool feeling in

a limb, tell your doctor

immediately as this may be a sign

of a cardiovascular event. Serious

cardiovascular events including

problems with the blood flow to

the leg (peripheral arterial

occlusive disease), ischaemic heart

disease and problems with the

blood supply to the brain

(ischaemic cerebrovascular

disease) have been reported in

patients taking Tasigna. Your

doctor should assess the level of

fats (lipids) and sugar in your

blood before initiating treatment

with Tasigna and during treatment.

if you develop swelling of the feet

or hands, generalised swelling or

rapid weight gain tell your doctor

as these may be signs of severe

fluid retention. Uncommon cases

of severe fluid retention have been

reported in patients treated with

Tasigna.

If you are the parent of a child who is

being treated with Tasigna, tell the doctor

if any of the above conditions apply to

your child.

Things you must not do

Do not stop taking this medicine unless

your doctor tells you to. Stopping Tasigna

without your doctor’s recommendation

places you at risk for worsening of your

disease which could have life-threatening

consequences. Be sure to discuss with

your doctor, nurse, and/or pharmacist if

you are considering stopping Tasigna.

Things to be careful of

Driving and using machines

If you experience side effects (such as

dizziness or visual disorders) with a

potential impact on the ability to safely

drive or use any tools or machines after

taking this medicine, you should refrain

from these activities until the effect has

disappeared.

Tasigna contains lactose

This medicine contains lactose (also

known as milk sugar). If you have been

told by your doctor that you have an

intolerance to some sugars, contact your

doctor before taking this medicine.

Side effects

Like all medicines, this medicine can

cause side effects, although not

everybody gets them. Most of the side

effects are mild to moderate and will

generally disappear after a few days to a

few weeks of treatment.

Some side effects could be serious.

These side effects are very common (may

affect more than 1 in 10 people), common

(may affect up to 1 in 10 people),

uncommon (may affect up to 1 in

100 people) or have been reported with

frequency not known (cannot be

estimated from the available data):

rapid weight gain,

swelling of hands,

ankles, feet or face (signs of water

retention)

chest pain or discomfort, high or low

blood pressure, irregular heart rhythm

(fast or slow), palpitations (sensation of

rapid heartbeat), fainting,

blue

discolouration of the lips, tongue or

skin (signs of heart disorders)

difficulty breathing or painful

breathing, cough, wheezing with or

without fever, swelling of the feet or

legs (signs of lung disorders)

fever, easy bruising or unexplained

bleeding, severe or frequent infections,

unexplained weakness (signs of blood

disorders)

weakness or paralysis of the limbs or

face, difficulty speaking, severe

headache, seeing, feeling or hearing

things that are not there, changes in

eyesight, loss of consciousness,

confusion, disorientation, trembling,

sensation of tingling, pain or numbness

in fingers and toes (signs of nervous

system disorders)

thirst, dry skin, irritability, dark urine,

decreased urine output, difficulty and

pain when urinating, exaggerated

sense of needing to urinate, blood in

urine, abnormal urine colour (signs of

kidney or urinary tract disorders)

visual disturbances including blurred

vision, double-vision or perceived

flashes of light, decreased sharpness

or loss of vision, blood in eye,

increased sensitivity of the eyes to

light, eye pain, redness, itching or

irritation, dry eye, swelling or itching

of the eyelids (signs of eye disorders)

swelling and pain in one part of the

body (signs of clotting within a vein)

abdominal pain, nausea, vomiting of

blood, black or bloody stools,

constipation, heartburn, stomach acid

reflux, swollen abdomen (signs of

gastrointestinal disorders)

severe upper (middle or left)

abdominal pain (sign of pancreatitis)

yellow skin and eyes, nausea, loss of

appetite, dark-coloured urine (signs of

liver disorders)

painful red lumps, skin pain, skin

reddening, peeling or blisters (signs of

skin disorders)

pain in joints and muscles (signs of

musculoskeletal pain)

excessive thirst, high urine output,

increased appetite with weight loss,

tiredness (signs of high level of sugar

in the blood)

fast heartbeat, bulging eyes, weight

loss, swelling at the front of the neck

(signs of overactive thyroid gland)

weight gain, tiredness, hair loss,

muscle weakness, feeling cold (signs

of underactive thyroid gland)

severe headache often accompanied

by nausea, vomiting and sensitivity to

light (signs of migraine)

dizziness or spinning sensation (signs

of vertigo)

nausea, shortness of breath, irregular

heartbeat, clouding of urine, tiredness

and/or joint discomfort associated

with abnormal results of blood tests

(such as high levels of potassium, uric

acid and phosphorous and low levels

of calcium)

pain, discomfort, weakness or

cramping in the leg muscles, which

may be due to decreased blood flow,

ulcers on the legs or arms that heal

slowly or not at all and noticeable

changes in colour (blueness or

paleness) or temperature (coolness) of

the legs or arms, as these symptoms

could be signs of artery blockage in

the affected limb (leg or arm) and

digits (toes orfingers)

recurrence (reactivation) of hepatitis B

infection when you have had hepatitis

B in the past (a liver infection).

Some side effects are very common (may

affect more than 1 in every 10 people)

diarrhoea

headache

tiredness, lack of energy

Consumer Medication Information Leaflet (RiMUP)

muscle pain

itching, rash

nausea

abdominal pain

constipation

vomiting

hair loss

musculoskeletal pain, muscle pain, pain

in extremity, pain in joints, bone pain

and spinal pain upon discontinuing

treatment with Tasigna

slowing of growth in children and

adolescents

Some side effects are common (may

affect up to 1 in 10 people)

upper respiratory tract infections

stomach discomfort after meals,

flatulence, swelling or bloating of the

abdomen

bone pain, pain in joints, muscle

spasms, muscle weakness

pain including back pain, neck pain and

pain in extremity, pain or discomfort in

the side of the body

dry skin, acne, wart, decreased skin

sensitivity, hives

loss of appetite, disturbed sense of

taste, weight decrease or increase

insomnia, depression, anxiety

night sweats, excessive sweating

generally feeling unwell

voice disorder

nose bleed

frequent urine output

During Tasigna treatment, you may also

have some abnormal blood test results

such as

- low level of blood cells (white cells, red

cells, platelets) or haemoglobin

- increase in the number of platelets or

white cells, or specific types of white

cells (eosinophils) in the blood

- high blood level of lipase or amylase

(pancreas function)

- high blood level of bilirubin or liver

enzymes (liver function)

- high blood level of creatinine or urea

(kidney function)

- low or high blood level of insulin (a

hormone regulating blood sugar level)

- low or high level of sugar, or high level

of fats (including cholesterol) in the

blood.

- high blood level of parathyroid hormone

(a hormone regulating calcium and

phosphorus level)

- change in blood proteins (low level of

globulins or presence of paraprotein)

- high blood levels of enzymes (alkaline

phosphatase, lactate dehydrogenase or

creatine phosphokinase)

- high blood level of potassium, calcium,

phosphorus or uric acid

- low blood level of magnesium,

potassium, sodium, calcium, or

phosphorus

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel: 03-

78835490, or visiting the website

npra.gov.my [Consumers → Reporting

Side Effects to Medicines (ConSERF) or

Vaccines (AEFI)].

Storage and disposal of Tasigna

Storage

Keep this medicine out of the sight and

reach of children.

Do not use this medicine after the

expiry date which is stated on the

carton and blister. The expiry date

refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to

protect from moisture.

Do not use this medicine if you notice

that the pack is damaged or shows signs

of tampering.

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

Tasigna is supplied as hard capsules.

Tasigna 50mg: White to yellowish

powder in hard gelatin capsule with red

opaque cap and light yellow opague body,

size 4 with black radial imprint

“NVR/ABL” on cap.

Tasigna 150mg: White to yellowish

powder in red opaque hard gelatin

capsules, size 1 with black axial imprint

“NVR/BCR”.

Tasigna 200mg: White to yellowish

powder in light yellow opaque hard

gelatin capsules, size 0 with red axial

imprint “NVR/TKI”.

Pack size

50mg: available in Duplex blister packs

(PVC/PVDC with aluminium backing) of

120 capsules

150mg and 200mg: available in Duplex

blister packs (PVC/PVDC with

aluminium backing) or Aluminium blister

packs (PA/AL/PVC with aluminium

backing) of 28 or 112 capsules

Ingredients

Active ingredients

The active substance is nilotinib. Each

hard capsule contains nilotinib (as

hydrochloride monohydrate).

Inactive ingredients

Capsule content:

lactose monohydrate,

crospovidone, poloxamer, colloidal

anhydrous, magnesium stearate;

Capsule shell: 50mg:

gelatin, titanium

dioxide (E171), red iron oxide (E172),

yellow iron oxide (E172);

150mg:

titanium dioxide (E171), red iron oxide

(E172), yellow iron oxide (E172);

200mg:

gelatin, titanium dioxide (E171),

yellow iron oxide (E172)

Printing ink: 50mg:

shellac, black iron

oxide (E172), propylene glycol,

ammonium hydroxide

; 150mg:

shellac,

black iron oxide (E172), industrial

methylated spirit;

200mg:

shellac,

dehydrated alcohol, isopropyl alcohol,

butyl alcohol, propylene gycol, strong

ammonia solution, potassium hydroxide,

red iron oxide (E172)

MAL Number

Tasigna 50mg: MAL19106015ARZ

Tasigna 150mg: MAL11105040ARZ

Tasigna 200mg: MAL20081780ARZ

Manufacturer

Novartis Pharma Stein AG,

Schaffhauserstrasse, CH-4332, Stein,

Switzerland.

Product Registration Holder

Novartis Corporation (Malaysia) Sdn.

Bhd.

Level 22, Tower B, Plaza 33,

No. 1, Jalan Kemajuan, Seksyen 13,

46200 Petaling Jaya

Information Issued

25/03/2019

Date of revision

27/12/2019

Serial Number

NPRA (R1/2) 26122019/289

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