InfoCons Consumer Protection informs you – Akynzeo – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Akynzeo is and what it is used for

What Akynzeo is

Akynzeo contains two act

ive substances called:

• netupitant
• palonosetron.

What Akynzeo is used for

Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called ‘chemotherapy’.

How Akynzeo works

Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick. The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK 1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5- HT 3 receptor antagonist) blocks certain receptors for serotonin. By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.

⚠️ 2. What you need to know before you take Akynzeo

Do not take Akynzeo if

• you are allergic to netupitant or palonosetron, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
• you are pregnant.

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Akynzeo if:

• you have liver problems
• you have a blockage in your gut, or you have had constipation in the past
• you or one of your close relatives has ever had a heart problem called ‘QT interval prolongation’
• you have any other heart problems
• you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.

Children and adolescents

Akynzeo should not be taken by children and adolescents under 18 years.

Other medicines and Akynzeo

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines :

• medicines for depression or anxiety called SSRIs (selective serotonin re- uptake inhibitors) – such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
• medicines for depression or anxiety called SNRIs (serotonin noradrenaline re- uptake inhibitors)
• such as venlafaxine or duloxetine.

Also tell your doctor, pharmacist or nurse if you are taking any of the following medicines as your doctor may need to change the dose of these other medicines:

• medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone
• medicines with a narrow therapeutic range that are primarily metaboli sed by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, or quinidine
• some chemotherapy medicines – such as docetaxel or etoposide
• erythromycin – to treat bacterial infections
• midazolam – a sedative used to treat anxiety
• dexamethasone – can be used to treat feeling and being sick
• ketoconazole – to treat Cushing’s syndrome
• rifampicin – to treat tuberculosis (TB) and other infections.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.

Pregnancy and breast -feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.

Do not breast-feed if you are taking Akynzeo. This is because it is not known whether the medicine passes into breast milk.

Driving and using machines

You may feel dizzy or tired after taking Akynzeo. If this happens, do not drive or use any tools or machines.

Akynzeo contains sorbitol (E420), sodium an d potassium

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine contains 32.2 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 1.6 1% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 2.60 mg potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

💊 3. How to take Akynzeo

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

• The recommended dose is one sachet (each sachet contains 300 mg of netupitant and 0.5 mg of palonosetron ).
• Take the sachet about 1 hour before you start your chemotherapy cycle.
• You can take Akynzeo with or without food.
• Squeeze the entire contents of the sachet directly into the mouth.

Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing. Do not take Akynzeo in the days after you have chemotherapy – unless you are about to have another chemotherapy cycle.

If you take more Akynzeo than you should

The usual dose is 1 sachet . If you think you may have taken more than you should, tell your doctor straight away. The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.

If you forget to take Akynzeo

If you think you have forgotten to take your dose, tell your doctor straight away.

If you stop taking Akynzeo

Akynzeo is taken to help prevent you feeling and being sick when you are having chemotherapy. If you do not want to take Akynzeo, discuss this with your doctor. If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.

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

❗ 4. Possible side effects

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

Serious side effects

Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effect – you may need urgent medical treatment:

Very rare: (may affect up to 1 in 10 000 people)

• severe allergic reaction signs include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common: (may affect up to 1 in 10 people)

• headache
• constipation
• feeling tired.

Uncommon: (may affect up to 1 in 100 people)

• hair loss
• lack of energy (feeling weak)
• decreased appetite
• high blood pressure
• raised, itchy rash on the skin (hives)
• problems with the muscles in your heart (cardiomyopathy)
• spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)
• stomach problems including stomach discomfort, feeling bloated, nausea, pain, indigestion, hiccups, wind or diarrhoea
• high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases (shown in blood tests)
• high levels of creatinine – which measures kidney function (shown in blood tests)
• ECG (electrocardiogram) problems (called ‘QT and PR interval prolongation’, ‘conduction disorder’, ‘tachycardia’ and ‘atrioventricular block first degree’)
• low levels of ‘neutrophils’ – a kind of white blood cell which fight infections (shown in blood tests)
• high level of white blood cells (shown in blood tests).

Rare: (may affect up to 1 in 1 000 people)

• back pain, joint pain
• feeling hot, reddening of the face or other areas of the skin (feeling flushed)
• itchy skin rash
• feeling drowsy
• sleep problems
• ring in the ear
• vomiting
• low blood pressure
• chest pain (not related to the heart)
• numbness, blurred vision
• sudden nervous breakdown, change in mood
• infection and inflammation in the bladder (cystitis)
• haemorrhoids
• conjunctivitis (a type of eye inflammation)
• low level of potassium (shown in blood tests )
• modifications (or disturbances) in heart rhythm
• heart valve disorder (mitral valve incompetence)
• coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake
• decreased blood flow to the heart muscle (myocardial ischemia)
• high levels of creatine phosphokinase/ creatine phosphokinase MB – which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
• high levels of troponin – which indicates heart muscle dysfunction (shown in blood tests )
• high levels of the pigment bilirubin – which indicates liver dysfunction (shown in blood tests )
• high levels of myoglobin – which indicates muscle injury (shown in blood tests)
• high levels of blood urea – which indicates kidney dysfunction (shown in blood tests )
• high level of ‘lymphocytes’– type of white blood cell which help the body fight disease (shown in blood tests )
• low level of white blood cells (shown in blood tests)
• ECG (electrocardiogram) problems (called ‘ST segment depression’, ‘ST -T segment abnormal’ ‘bundle branch block right/left’, and ‘atrioventricular block second degree’)

Reporting of side effects

If you get any side effects, 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 via the national reporting system listed in Appendix V B y reporting side effects, you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Akynzeo

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 sachet after ‘EXP’.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

📦 6. Contents of the pack and other information

What Akynzeo contains

• The active substances are palonosetron and netupitant. Each sachet contains 300 mg of netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
• The other ingredients are glycerol (E422), xanthan gum, citric acid, sodium citrate dihydrate, potassium sorbate and sorbitol liquid (non- crystallising) (E420).

This medicine contains sodium, potassium and sorbitol (E420), see section 2 for more information.

What Akynzeo looks like and contents of the pack

White to off -white homogeneous suspension.

Pack size containing 1 or 4 PET/ALU/PE ( polye ster /aluminium/ polyethylene) sachet (s) in a single outer carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Helsinn Birex Pharmaceuticals Ltd.

Damastown Mulhuddart Dublin 15 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Immedica Pharma AB Tél/Tel: + 46(0)8 533 39 500 Lietuva Farma Mondo Tel: + 370 689 36600 България Angelini Pharma Bulgaria EOOD Luxembourg/Luxemburg Immedica Pharma AB Teл.: +359 2 975 13 95 Tél/Tel: + 46(0)8 533 39 500 Česká republika MagnaPharm CZ s.r.o.

Tel: +420 234 076 049 Magyarország MagnaPharm Hungary Kft.

Tel.: +36 1 354 1840 Danmark Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 69 Malta Helsinn Birex Pharmaceuticals Ltd.

Tel.: + 353 1 822 5404 Deutschland Esteve Pharmaceuticals GmbH Tel: + 49 30 338427-0 Nederland Immedica Pharma AB Tel: + 46(0)8 533 39 500 Eesti Farma Mondo Tel: + 370 698 36600 Norge Swedish Orphan Biovitrum AS Tlf: +47 66 82 34 00 Ελλάδα Galenica A.E.

Τηλ: +30 210 52 81 700 Österreich Esteve Pharmaceuticals GmbH Tel: 0800560044 España Immedica Pharma AB Tel: +34(0)9 373 70 164 Polska MagnaPharm Poland sp. z o.o.

Tel: +48 22 570 27 00 France Immedica Pharma France SARL Tél: + 33(0)148 014 711 Portugal Immedica Pharma AB Tel: + 46(0)8 533 39 500 Hrvatska Bausch Health Poland sp. z.o.o. P odružnica Zagreb Tel: +385 1 670 0750 România MagnaPharm Marketing & Sales Romania SRL Tel: +40 372 502 221 Ireland Chugai Pharma France Tel: +33 1 79 36 36 18 Slovenija PharmaSwiss Tel: +386 1 2364 700 Ísland Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 69 Slovenská republika MagnaPharm SK s.r.o.

Tel: +421 917 532 065 Italia Italfarmaco Tel: + 39 02 64431 Suomi/Finland Oy Swedish Orphan Biovitrum Ab Puh./Tel: +358 201 558 840 Κύπρος Galenica A.E.

Τηλ: +30 210 52 81 700 Sverige Swedish Orphan Biovitrum AB (publ) Tel: +46 8 697 20 00 Latvija Farma Mondo Tel: + 370 698 36600

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Akynzeo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1001).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.