TRISENOX 2 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

concentrate fo

r solution for infusion

arsenic trioxide

Read all of this leaflet cai given this medicine becai information for you.

refully before you are use it contains important

The effect of these medicines on

your heartbeat can

• – Keep this leaflet. You may need to read it again.

• – If you have further questions, please ask your doctor, pharmacist or nurse.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

be made worse by TRISENOX. You must be sure to tell your doctor about all medicines you are taking.

– if you are taking or have recently

taken any medicine

which may affect your liver. If you are not sure, show

effects not listed in this

What is in this leaflet:

leaflet. See section 4.

1.

2.

What TRISENOX is and what it is used for

the bottle or pack to your doctor.

TRISENOX with food and drink

There are no restrictions on your fooi are receiving TRISENOX.

Pregnancy

d or drink while you

• 3.

• 4.

• 5.

What you need to know given TRISENOX

How TRISENOX is giver

Possible side effects How to store TRISENOX

before you are

isk your doctor or pharmacist for advice before taking my medicine.

RISENOX may cause harm to the foetus when used by iregnant women.

ai

Pi

11 you are able to become pregnant, you must use

6. Contents of the pack ar d other information

■ffective birth control during treatment with TRISENOX.

el

11 you are pregnant or you become pregnant during the

TRISENOX is used in adult oatients with newly diagnosed low-to-intermeciate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease

has not responded to other type of myeloid leukaemia, abnormal white blood cells and bruising occur.

therapies. APL is a unique a disease in which and abnormal bleeding

treatment with TRISENOX, you must for advice.

Men should also use effective contra; treatment with TRISENOX.

Breast-feeding

ask your doctor

ception during

TRISENOX must be given ui a physician experienced in 1 leukaemias.

You must not receive TRI:

mder the supervision of the treatment of acute

SENOX

If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You must talk to your doctor or nurse before you are given TRISENOX, if

– you have impaired kidney function.

– you have any liver problems.

Your doctor will take the following precautions:

– Tests will be performed potassium, magnesium,

to check the amount of calcium and creatinine in

your blood before your first dose of TRISENOX.

– You should have an el ectri cal recording of the heart

(electrocardiogram ECGj first dose.

– Blood tests (potassium,

performed before your

calcium, magnesium and liver

function) should be repeated during your treatment with TRISENOX.

In addition, you will receive electrocardiograms twice weekly.

If you are at risk for a certain type of abnormal heart

rhythm (e.g. torsade de

pointes or QTc prolongation),

your heart will be monitored continuously.

– Your doctor may monitcr your health during and after treatment, since arsenii: trioxide, the active

substance in TRISENOX, You should report any m

, may cause other cancers, ew and exceptional

symptoms and circumstances whenever you see your doctor.

– Follow-up of your cognitive and mobility functions if you are at risk for vitamin Bl deficiency.

Children and adolescent;;

TRISENOX is not recommended in children and adolescents below 18 years of age.

Other medicines and TRISENOX ________________

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines, including medicines obtain ?d without a prescription.

In particular tell your doctor

– if you are taking any of

various types of medicines

which could cause a change in the rhythm of your

• heartbeat. These include some types of antia

e:

rhythmics (medicines used

to correct irregular heart beats, e.g. quinidine,

amiodarone, sotalol, medicines to treat p

, dofetilide)

।sychosis (loss of contact

with reality, e.g. thioridazine)

medicines for depression (e.g. amitriptyline) some types of medicines to treat bacterial infections (e.g. erythromycin and sparfloxacin) some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole)

any medicines that cause a decrease in

magnesium or potassium in your blood

(e.g. amphotericin B)

cisapride (a medicine used to relieve certain stomach problems).

The following information is intended for medical or healthcare professionals only:

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESEN".

Dilution of TRISENOX

TRISENOX must be diluted

before administration.

Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.

CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)

isk your doctor or pharmacist for advice before taking my medicine.

he arsenic in TRISENOX passes intc breast milk.

iecause TRISENOX can harm nursing infants, do not

ai

breast-feed while on TRISENOX.

C riving and using machines

TRISENOX is expected to have no or

m your ability to drive and use machines.

01

negligible influence

11 you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms

g'

o away before driving or using machines.

RISENOX contains sodium

RISENOX contains less than 1 mmol sodium (23 mg)

ler dose. This means that the medic

P'

‚sodium-free‘.

ne is essentially

. How TRISENOX is given

Curation and frequency of treatnn

ent

’atients with newly diagnosed acute iromyelocytic leukaemia

Ei

B!

Your doctor will give you TRISENOX once every day as

in infusion. In your first treatment cycle, you may be

treated every day up to 60 days at most or until your

loctor determines that your disease

di

is better. If your

disease responds to TRISENOX, you will be given

4

21

additional treatment cycles. Each cycle consists of 0 doses given 5 days per week (followed by 2 days

interruption) for 4 weeks followed by 4 weeks interruption. Your doctor will decide exactly how long

rou must continue on therapy with TRISENOX.

yi

Ei

’atients with acute promyelocytic lei

'ukaemia, whose

disease has not responded to other therapies

Your doctor will give you TRISENOX once every day as

in infusion. In your first treatment cycle, you may be

treated every day up to 50 days at most or until your

loctor determines that your disease

di

is better. If your

disease responds to TRISENOX, you will be given a

.econd treatment cycle of 25 doses given 5 days per

week (followed by 2 days interrupticn) for 5 weeks. Your doctor will decide exactly how long you must continue on therapy with TRISENOX.

Method and route of administration

TRISENOX must be diluted with a so glucose or a solution containing sodi

। ution containing ium chloride.

TRISENOX is normally given by a dor lor or a nurse. Il is given as a drip (infusion) into a vein over 1–2 hours, but

the infusion may last longer if side el

ai

md dizziness occur.

effects like flushing

TRISENOX must not be mixed with, or infused through the same tube with other medicines.

If your doctor or nurse gives you more TRISENOX

t ian he/she should

You may experience convulsions, mu

isde weakness and

confusion. If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.

11 you have any further question on the use of this medicine, ask your doctor, pharmacist or nurse.

Dilution: Carefully insert the needle of a syringe into the

'ial and withdraw the required volume. TRISENOX must

vi

then be diluted immediately with 101 glucose 50 mg/ml (5 %) solution for ciloride 9 mg/ml (0.9 %) solution for

Oto 250 ml of njection or sodium injection.

Li

C; at

nused portions of each vial must be discarded properly.

:o not save any unused portions for idministration.

later

Ise of TRISENOX

TRISENOX is for single use only. It mi

lust not be mixed

with or concomitantly administered in the same intravenous line with other medicinal products.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse

straight away if you notice

the following side effects, as these may be signs of

a severe condition called syndrome", which might

• – difficulty in breathing

• – coughing

• – chest pain

• – fever

Tell your doctor or nurse

"differentiation be fatal:

straight away if you notice

one or more of the follov/ing side effects, as these may be signs of allergic reaction:

• – difficulty in breathing

• – fever

• – sudden weight gain

• – water retention

• – fainting

• – palpitations (strong her rtbeat you can feel in your chest)

While on treatment with TRISENOX, you may experience some of the following reactions:

Very common (may affect more than 1 in 10 people):

– fatigue (weariness), pai

in, fever, headache

– nausea, vomiting, diarrhoea

– dizziness, muscle pain, numbness or tingling

– rash or itching, increase! (swelling due to excess

d blood sugar, oedema fluid)

• – shortness of breath, fast heart beat, abnormal ECG heart tracing

• – reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glut amyltransferase in the blood

Common (may affect up to

1 in 10 people):

– reduction in blood cell counts (platelets, red and/or

white blood cells), incre: – chills, increased weight

rased white blood cells

• – a fever due to an infect on and low levels of white blood cells, herpes zoster infection

• – chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluic around the heart or the lung, low blood pressure, abnormal heart rhythm

• – fit, joint or bone pain, irflammation of the

blood vessels

increased sodium or ma;

ignesium, ketones in the

blood and urine (ketoac dosis), renal function tests abnormal, kidney failure

• – stomach (abdominal) ache

• - redness of the skin, swollen face, blurred vision

available data):

– lung infection, infection

– inflammation of the lun(

and breathlessness, cardiac failure

1 in the blood

igs which causes chest pain

– dehydration, confusion

– Cerebral disease (Encepl encephalopathy) with vr including difficulties to i disorders and confusion

Reporting of side effects

If you get any side effects,1

ihalopathy, Wernicke 'arious manifestations use arms and legs, speech

talk to your doctor,

pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

United Kingdom

The Yellow Card Scheme at:

or search for MHRA Yellow Card in the Google Flay or Apple App Store.

Ireland

HPRA Pharmacovigilance, Website: By reporting side effects you can help provide more information on the safety of this medicine.

What TRISENOX contains

– The active substance is arsenic trioxide. Each ml of concentrate contains 2 mg of arsenic trioxide. Each

vial of 6 ml contains 12 mg of ars। – The other ingredients are sodium

enic trioxide, hydroxide,

hydrochloric acid and water for injections. See section 2 „TRISENOX contains sodium“.

solution. Each carton contains 10 glass vials.

single-use

Marketing Authorisation Holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer

Teva Pharmaceuticals Europe B.V., Swensweg 5,

2i

Tl

C

Ei

031 GA Haarlem, The Netherlands

his leaflet was last revised in 11,

./2019.

etailed information on this medicin 5 is available on the uropean Medicines Agency web site:

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here are also links to other website1

diseases and treatments.

s about rare

uire any special storage

'ironment.

Do not throw away any mei household waste. Ask your away medicines you no loni

After dilution, if not used immediately, storage times and conditions before use are the responsibility of your doctor, pharmacist or nurse and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has

This medicine does not req conditions.

taken place in a sterile env This medicine must not be particulate matter or if the

used if you notice foreign solution is discoloured.

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 vial label anc the carton.

help to protect the environment.

■dicines via wastewater or

1 pharmacist how to throw iger use. These measures will

TRISENOX must be administered intravenously over 1–2 hours. The infusion duration may be extended up to

responsibiIity of the user and would

4 hours if vasomotor reacti

ions are observed. A central

venous catheter is not required.

The diluted solution must be clear and colourless. All parenteral solutions must tie inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if foreign particulate matter is present.

After dilution in intravenou: chemically and physically st and 72 hours at refrigerate।

s solutions, TRISENOX is :able for 24 hours at 15–30 °C d (2–8 °C) temperatures.

From a microbiological poirt of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the

teva

H61852

318797.02-UKIEHR

EAS3793b

normally not be

longer than 24 hours at 2–8 °C, unless dilution has taken place in controlled and validated aseitic conditions.

Procedure for proper disposal

Any unused product, any items that with the product and waste material

of in accordance with local requirements.

come into contact must be disposed

teva

H61852

318797.02-UKIEHR

EAS3793b