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AKYNZEO 300 mg/0.5 mg HARD CAPSULES

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About the medicine

How to use AKYNZEO 300 mg/0.5 mg HARD CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Patient Information: Summary of Product Characteristics

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.

Contents of the pack

  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. Storage of 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 active substances (active ingredients) called:

  • netupitant;
  • palonosetron.

What Akynzeo is used for

Akynzeo is used to help prevent nausea and vomiting in adults with cancer who are receiving chemotherapy.

How Akynzeo works

Chemotherapy medicines can cause the body to release substances called serotonin and substance P. These substances stimulate the vomiting center in the brain, which can make you feel sick or vomit. The active substances in Akynzeo work by blocking the actions of serotonin and substance P on the brain and nervous system. Netupitant (an NK1 receptor antagonist) blocks the actions of substance P, and palonosetron (a 5-HT3 receptor antagonist) blocks certain serotonin receptors. By blocking the actions of substance P and serotonin, the active substances help prevent the stimulation of the vomiting center and the resulting nausea.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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, ask your doctor, pharmacist, or nurse before taking this medicine;
  • if you are pregnant.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before taking Akynzeo:

  • if you have liver problems;
  • if you have a blockage in your intestine or a history of constipation;
  • if you or a close family member have ever had a heart problem called "QT interval prolongation";
  • if you have other heart problems;
  • if you have been told you have an imbalance of certain minerals in your blood, such as potassium and magnesium, that has not been corrected.

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

Children and adolescents

Children and adolescents under 18 years should not take Akynzeo.

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 and 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 medicines:

  • medicines that can cause abnormal heart rhythms, such as amiodarone, nicardipine, quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine, or domperidone;
  • medicines with a narrow therapeutic index that are mainly metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, dihydroergotamine, ergotamine, fentanyl, or quinidine;
  • certain chemotherapy medicines, such as docetaxel or etoposide;
  • erythromycin, for treating bacterial infections;
  • midazolam, a sedative used for treating anxiety;
  • dexamethasone, which may be used for treating nausea and vomiting;
  • ketoconazole, for treating Cushing's syndrome;
  • rifampicin, for treating tuberculosis (TB) and other infections.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 and not using contraceptive methods.

Do not breastfeed 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 tools or machines.

Akynzeo contains sucrose, sorbitol, and sodium, and may contain soy

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

It may contain soy lecithin. If you are allergic to peanuts or soy, seek medical attention immediately if you notice signs of an allergic reaction. Signs may include hives, skin 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

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

How much to take

  • The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
  • Take the capsule about 1 hour before starting the chemotherapy cycle.
  • Akynzeo can be taken with or without food.

Akynzeo is taken before chemotherapy to prevent nausea and vomiting. Do not take Akynzeo on days after chemotherapy, unless you are about to receive another cycle of chemotherapy.

If you take more Akynzeo than you should

The usual dose is 1 capsule. If you think you may have taken more than you should, tell your doctor immediately. Symptoms of an overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoria, and leg pain.

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 help 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 a similar medicine), it is likely that chemotherapy will cause nausea and vomiting.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 immediately 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, swelling of the 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;
  • fatigue.

Uncommon:may affect up to 1 in 100 people

  • hair loss;
  • lack of energy (weakness);
  • decreased appetite;
  • high blood pressure;
  • skin rash with itching and raised bumps (hives);
  • heart muscle problems (cardiomyopathy);
  • feeling of spinning (vertigo), dizziness, or sleep problems (insomnia);
  • stomach problems including stomach upset, feeling bloated, nausea, pain, indigestion, belching, gas, or diarrhea;
  • high levels of certain enzymes, including alkaline phosphatase and liver transaminases (found in blood tests);
  • high levels of creatinine, which measures kidney function (found in blood tests);
  • abnormal electrocardiogram (ECG) ("prolongation of QT and PR intervals", "conduction disorder", "tachycardia", and "first-degree atrioventricular block");
  • low levels of "neutrophils", a type of white blood cell that fights infection (found in blood tests);
  • high levels of white blood cells (found in blood tests).

Rare:may affect up to 1 in 1,000 people

  • back pain, joint pain;
  • feeling of warmth, flushing of the face or other areas of the skin (hot flashes);
  • itchy skin rash;
  • drowsiness;
  • sleep problems;
  • ringing in the ears;
  • vomiting;
  • low blood pressure;
  • chest pain (not related to the heart);
  • numbness, blurred vision;
  • sudden nervous breakdown, mood change;
  • bladder infection and inflammation (cystitis);
  • hemorrhoids;
  • conjunctivitis (a type of eye inflammation);
  • low levels of potassium (found in blood tests);
  • heart rhythm disorders;
  • heart valve problems (mitral insufficiency);
  • coated tongue, difficulty swallowing, dry mouth, belching, unusual taste after taking the medicine;
  • reduced blood flow to the heart muscle (myocardial ischemia);
  • high levels of creatine phosphokinase/creatine phosphokinase MB, indicating a sudden reduction in blood flow to the heart muscle (found in blood tests);
  • high levels of troponin, indicating heart muscle failure (found in blood tests);
  • high levels of bilirubin, indicating liver failure (found in blood tests);
  • high levels of myoglobin, indicating muscle damage (found in blood tests);
  • high levels of urea in the blood, indicating kidney failure (found in blood tests);
  • high levels of "lymphocytes", a type of white blood cell that helps the body fight disease (found in blood tests);
  • low levels of white blood cells (found in blood tests);
  • abnormal electrocardiogram (ECG) ("ST segment depression", "ST-T segment abnormality", "right/left bundle 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month stated.
  • No special storage conditions are required.
  • 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 protect the environment.

6. Contents of the pack and other information

What 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 mg of palonosetron).
  • The other ingredients are microcrystalline cellulose (E460), sucrose esters of fatty acids, povidone K-30, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylate/monoacrylate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), lacquer (partially esterified), yellow, red, and black iron oxide (E172), propylene glycol (E1520).

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

Appearance and packaging

The hard capsules are opaque with a white body and a caramel-colored cap with "HE1" printed on the body. Pack size containing 1 capsule in an aluminum blister or 4 x 1 hard capsules in unit-dose blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

For further information on this medicine, contact the local representative of the marketing authorization holder:

Belgium

Vifor Pharma

Tel: +32(0)32 182070

Lithuania

PharmaSwiss

Tel: +370 5 279 07 62

Bulgaria

Angelini Pharma Bulgaria EOOD

Tel: +359 2 975 13 95

Luxembourg

Vifor Pharma

Tel: +32(0)32 182070

Czech Republic

Angelini Pharma Ceská republika s.r.o.

Tel: (+420) 546 123 111

Hungary

Angelini Pharma Magyarország Kft

Tel: +36 1 336 1614

Denmark

Swedish Orphan Biovitrum A/S

Tel: + 45 32 96 68 69

Malta

Helsinn Birex Pharmaceuticals Ltd.

Tel: + 353 1 822 5404

Germany

RIEMSER Pharma GmbH

Tel: + 49 30 338427-0

Netherlands

Vifor Pharma

Tel: +31(0)88 8484300

Estonia

PharmaSwiss

Tel: +372 6827 400

Norway

Swedish Orphan Biovitrum AS

Tel: +47 66 82 34 00

Greece

Galenica A.E.

Tel: +30 210 52 81 700

Austria

Angelini Pharma Österreich GmbH

Tel: +43-5-9-606-0

Spain

Vifor Pharma España, S.L.

Tel: +34 902 121 111

Poland

Angelini Pharma Polska Sp. z o.o.

Tel: +48 22 70 28 200

France

Vifor France

Tel: +33 (0)1 41 06 58 90

Portugal

OM Pharma

Tel: +351 21 470 85 00

Croatia

PharmaSwiss

Tel: +385 1 6311 833

Romania

Angelini Pharmaceuticals Romania Srl

Tel: +40 21 331 67 67

Ireland

Chugai Pharma France

Tel: +33 1 79 36 36 18

Slovenia

PharmaSwiss

Tel: +386 1 2364 700

Iceland

Swedish Orphan Biovitrum A/S

Tel: + 45 32 96 68 69

Slovakia

Angelini Pharma Slovenská republika s.r.o.

Tel: +421 2 5920 7320

Italy

Italfarmaco

Tel: + 39 02 64431

Finland

Oy Swedish Orphan Biovitrum Ab

Tel: +358 201 558 840

Cyprus

Galenica A.E.

Tel: +30 210 52 81 700

Sweden

Swedish Orphan Biovitrum AB (publ)

Tel: +46 8 697 20 00

Latvia

PharmaSwiss

Tel: +371 6750 2185

United Kingdom

Chugai

Tel: +44 1748 827 276

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Online doctors for AKYNZEO 300 mg/0.5 mg HARD CAPSULES

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General medicine 4 years exp.

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Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Family medicine 24 years exp.

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Cardiology 18 years exp.

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Frequently Asked Questions

Is a prescription required for AKYNZEO 300 mg/0.5 mg HARD CAPSULES?
AKYNZEO 300 mg/0.5 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in AKYNZEO 300 mg/0.5 mg HARD CAPSULES?
The active ingredient in AKYNZEO 300 mg/0.5 mg HARD CAPSULES is palonosetron, combinations. This information helps identify medicines with the same composition but different brand names.
Who manufactures AKYNZEO 300 mg/0.5 mg HARD CAPSULES?
AKYNZEO 300 mg/0.5 mg HARD CAPSULES is manufactured by Helsinn Birex Pharmaceuticals Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AKYNZEO 300 mg/0.5 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AKYNZEO 300 mg/0.5 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to AKYNZEO 300 mg/0.5 mg HARD CAPSULES?
Other medicines with the same active substance (palonosetron, combinations) include AKYNZEO 235 mg/0.25 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, ALOXI 250 micrograms INJECTABLE SOLUTION, FERANT 250 micrograms injectable solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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