300 mg / 0.5 mg hard capsules
netupitant / palonosetron
1. What Akynzeo is and what it is used for
What Akynzeo is
Akynzeo contains two drugs (“active substances”) called:
- netupitant
- palonosetron.
What Akynzeo is used for
Akynzeo is used to prevent nausea or vomiting in adults with cancer when they receive cancer treatment called “chemotherapy”.
How Akynzeo works
Drugs for chemotherapy can cause the body to release substances called serotonin and substance P . This stimulates the vomiting center in the brain, which makes you feel sick or vomit. The drugs in Akynzeo attach to receptors in the nervous system where serotonin and substance Pact: 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 effects of the substance Pandserotonin in this way the drugs help to prevent the stimulation of the vomiting center and nausea that results.
2. What you need to know before taking 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.
- if you are pregnant.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Akynzeo:
- if you have liver problems
- if you have a bowel obstruction or have previously had constipation
- if you or any of your close relatives have ever had a heart problem called “prolonged QT interval”
- if you have any other heart problems
- if you have been told that you have an imbalance of minerals in your blood, such as potassium and magnesium, that have 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 young people
Akynzeo should not be taken by children and adolescents under 18 years of age.
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 reuptake inhibitors) – such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, or escitalopram
- medicines for depression or anxiety called SNRIs ( serotonin and norepinephrine reuptake 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 one of these other medicines:
- drugs that can cause abnormal heart rhythms – such as amiodarone, nicardipine, quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine, or domperidone
- drugs with a narrow range of treatment that are primarily metabolized by CYP3A4 – such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergotamine, ergotamine, fentanyl, or quinidine
- certain chemotherapy drugs – such as docetaxel or etoposide
- erythromycin – for the treatment of bacterial infections
- midazolam – a sedative used to treat anxiety
- dexamethasone – can be used to treat nausea and vomiting
- ketoconazole – for the treatment of Cushing’s syndrome
- rifampicin – for the treatment of tuberculosis 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 breastfeeding
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 using this medicine.
Do not take Akynzeo if you are pregnant or if you are of childbearing potential and do not use contraception.
Do not breast-feed if you are taking Akynzeo, as it is not known if this medicine is excreted in human 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 soy
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 sorbitol per hard capsule.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, ie it is essentially ‘sodium-free’.
It may contain traces of lecithin, which comes from soy. If you are allergic to peanuts or soy, consult a doctor immediately if you notice any signs of an allergic reaction. These signs may include hives, rash, itching, difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue, or throat, and sometimes a drop in blood pressure.
3. How to take Akynzeo
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
How much to take
- The recommended dose is one capsule (each capsule contains 300 mg netupitant and 0.5 mg palonosetron).
- Take the capsule about an hour before starting your chemotherapy cycle.
- You can take Akynzeo with or without food.
Akynzeo is taken before chemotherapy to prevent vomiting and nausea. Do not take Akynzeo the days after you receive chemotherapy – unless you are given another chemotherapy cycle.
If you take more Akynzeo than you should
The usual dose is one capsule. If you think you have taken too much, tell your doctor straight away. Symptoms of overdose may include headache, dizziness, constipation, anxiety, rapid heartbeat, elation, and pain in the legs.
If you forget to take Akynzeo
If you think you have forgotten to take your dose, tell your doctor immediately.
If you stop taking Akynzeo
Akynzeo is taken to prevent nausea and vomiting when you receive 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), chemotherapy is likely to cause nausea and vomiting.
If you have any further questions on the use of this product, 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 are
Stop taking Akynzeo and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
Very rare: (may affect up to 1 in 10,000 people)
- severe allergic reaction – signs include hives, rash, itching, difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue, or throat, and sometimes a drop in blood pressure.
Other side effects ar
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 of weakness)
- decreased appetite
- high blood pressure
- raised, itchy rash on the skin (hives)
- heart muscle problems ( cardiomyopathy )
- dizzy feeling (dizziness), dizziness, or difficulty sleeping (insomnia)
- stomach problems such as stomach upset, feeling bloated, nauseous, pain, indigestion, hiccups, gas or diarrhea
- high levels of certain enzymes, such as alkaline phosphatase in the blood and liver transaminases (seen in blood samples)
- high levels of creatinine – which measures kidney function (seen in blood tests)
- ECG ( electrocardiogram ) changes (called “prolonged QT and PR intervals”, “conduction disorders”, “tachycardia” and “first degree atrioventricular block”)
- low levels of neutrophils – a kind of white blood cell that fights infection (seen in blood samples)
- high level of white blood cells (seen in blood samples).
Rare: (may affect up to 1 in 1,000 people)
- back pain, joint pain
- feeling hot, redness on the face or other areas of the skin (feeling of swelling)
- itchy rash
- drowsiness
- sleeping problems
- tinnitus
- vomiting
- low blood pressure
- chest pain (not related to the heart)
- numbness, blurred vision
- sudden nervous breakdowns, mood swings
- infection and inflammation of the bladder ( cystitis )
- hemorrhoids
- conjunctivitis (a kind of eye inflammation)
- low level of potassium (seen in blood samples)
- changes (or disturbances) in the heart rhythm
- heart valve disease (mitral valve insufficiency)
- the coating on the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after taking the drug
- decreased blood flow to the heart muscle (myocardial ischemia)
- high levels of creatine phosphokinase/creatine phosphokinase MB – showing a sudden decrease in blood flow to the heart muscle (seen in blood tests)
- high levels of troponin – showing dysfunction of the heart muscle (seen in blood tests)
- high levels of the pigment bilirubin – which shows dysfunction of the liver (seen in blood samples)
- high levels of myoglobin – showing muscle damage (seen in blood tests)
- high levels of blood urea – showing impaired kidney function (seen in blood tests)
- high levels of lymphocytes – a type of white blood cell that helps the body fight disease (seen in blood tests)
- low level of white blood cells (seen in blood samples)
- ECG ( electrocardiogram ) problems (called “ST-segment lowering”, “abnormal ST-T segment”, “right/left branch block”, and “second-degree atrioventricular block”).
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
- No special storage instructions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are palonosetron and netupitant. Each hard capsule contains three tablets (300 mg netupitant) and one soft capsule (palonosetron hydrochloride equivalent to 0.5 mg 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 mono-capryl caproate (type I), glycerol, butylinol, 20 polycarbonate 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, and sodium and may contain soy – for more information, see section 2.
What the medicine looks like and the contents of the pack
The hard capsules are opaque with a white base and a light brown cap and are marked with “HE1” on the base. Pack size containing one capsule in an aluminum blister or 4 x 1 hard capsules in perforated unit dose blister. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienVifor PharmaTel: +32 (0) 32 182070 | LithuaniaPharmaSwissTel: +370 5 279 07 62 |
| BulgariaAngelini Pharma Bulgaria EOODTel: +359 2 975 13 95 | Luxembourg / LuxemburgVifor PharmaTel: +32 (0) 32 182070 |
| Czech RepublicAngelini Pharma Czech Republic sroTel: (+420) 546 123 111 | HungaryAngelini Pharma Magyarország KftTel .: +36 1 336 1614 |
| MaltaHelsinn Birex Pharmaceuticals Ltd.Tel .: + 353 1 822 5404 | |
| GermanyRIEMSER Pharma GmbHTel: + 49 30 338427-0 | The NetherlandsVifor PharmaTel: +31 (0) 88 8484300 |
| EestiPharmaSwissTel: +372 6827 400 | NorwaySwedish Orphan Biovitrum ASTel: +47 66 82 34 00 |
| GreeceGalenica AE:Ηλ: +30 210 52 81 700 | AustriaAngelini Pharma Österreich GmbHTel: + 43-5-9-606-0 |
| SpainVifor Pharma España, SLTel: +34 902 121 111 | PolandAngelini Pharma Polska Sp. z ooTel: +48 22 70 28 200 |
| FranceVifor FranceTel: +33 (0) 1 41 06 58 90 | PortugalOM PharmaTel: +351 21 470 85 00 |
| CroatiaPharmaSwissTel: +385 1 6311 833 | RomaniaAngelini Pharmaceuticals Romania SrlTel: +40 21 331 67 67 |
| IrelandChugai Pharma FranceTel: +33 1 79 36 36 18 | SloveniaPharmaSwissTel: +386 1 2364 700 |
| IcelandSwedish Orphan Biovitrum A / SPhone: + 45 32 96 68 69 | Slovak RepublicAngelini Pharma Slovenská republika sroTel: +421 2 5920 7320 |
| ItalyItalfarmacoTel: + 39 02 64431 | Finland / FinlandOy Swedish Orphan Biovitrum AbPuh./Tel: +358 201 558 840 |
| ΚύπροςGalenica AE:Ηλ: +30 210 52 81 700 | |
| LatviaPharmaSwissTel: +371 6750 2185 | United KingdomChugaiTel: +44 1748 827 276 |