AKYNZEO 300 MG / 0.5 MG HARD CAPSULES - patient leaflet, side effects, dosage

Akynzeo

Akynzeo 300 mg/0.5 mg hard capsules

netupitant/pa­lonosetron

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.

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

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

• 3. How to take Akynzeo

• 4. Possible side effects

• 5. How to store Akynzeo

• 6. Contents of the pack and other information

1. what akynzeo is and what it is used for

What Akynzeo is

• Akynzeo contains two medicines (‘active 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 NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5-HT3 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 akynzeodo 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 metabolized 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 sucrose, sorbitol, sodium and may contain traces of soya.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 7 mg of sorbitol in each hard capsule.

This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

It may contain traces of lecithin – which comes from soya. If you are allergic to peanut or soya, see your doctor straight away if you notice any signs of an allergic reaction. The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.

3. How to take Akynzeo

4. Possible side effects

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

• headache
• constipation
• feeling tired.

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

• hairloss
• 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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

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:

United Kingdom

Chugai

Tel: +44 1748 827 276

This leaflet was last revised in 11/2021

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 blister 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 informationwhat akynzeo contains the active substances are palonosetron and netupitant. each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).

• The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).

This medicine contains sucrose, sorbitol, sodium and may contain soya – see section 2 for more information.

What Akynzeo looks like and contents of the pack

The hard capsules are opaque with a white body and a caramel cap with ‘HET printed on the body. Pack size containing 1 capsule in an aluminium blister or 4 × 1 hard capsules in aluminium perforated unit dose blisters. Not all pack sizes may be marketed.

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