ALOXI 250 micrograms INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Aloxi 250 micrograms solution for injection

Palonosetron

Read all of this leaflet carefully before you are given 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Aloxi and what is it used for
2. What you need to know before you are given Aloxi
3. How Aloxi will be given to you
4. Possible side effects
5. Storage of Aloxi
6. Contents of the pack and further information

1. What is Aloxi and what is it used for

Aloxi contains the active substance palonosetron, which belongs to a group of medicines called 'serotonin (5HT3) antagonists'.

Aloxi is used in adults, adolescents, and children over 1 month of age to prevent nausea and vomiting when they receive cancer treatments called chemotherapy.

This medicine works by blocking the action of a chemical called serotonin, which can cause nausea or vomiting.

2. What you need to know before you are given Aloxi

Do not take Aloxi if:

• you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).

Aloxi will not be given to you if any of the above applies to you. If you are unsure, consult your doctor or nurse before you are given this medicine.

Warnings and precautions

Tell your doctor or nurse before you are given Aloxi if:

• you have a blockage in your intestine or have had repeated constipation in the past;
• you have had heart problems or have a family history of heart problems, such as changes in your heartbeat ('prolonged QT interval');
• you have an imbalance of certain minerals in your blood that have not been treated, such as potassium and magnesium.

If any of the above applies to you (or if you are unsure), consult your doctor or nurse before you are given this medicine.

Other medicines and Aloxi

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, tell them if you are taking:

Medicines for depression or anxiety

Tell your doctor or nurse if you are taking any medicine for depression or anxiety, including:

• medicines called SSRIs ('selective serotonin reuptake inhibitors'), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• medicines called SNRIs ('serotonin and noradrenaline reuptake inhibitors'), such as venlafaxine and duloxetine (may cause serotonin syndrome and should be used with caution).

Medicines that may affect your heartbeat

Tell your doctor or nurse if you are taking any medicine that affects your heartbeat. This is because these medicines may cause problems with your heartbeat when taken with Aloxi. These medicines include:

• medicines for heart problems, such as amiodarone, nicardipine, and quinidine;
• medicines for infections, such as moxifloxacin and erythromycin;
• medicines for severe mental health problems, such as haloperidol, chlorpromazine, quetiapine, and thioridazine;
• a medicine for nausea and vomiting called domperidone.

If any of the above applies to you (or if you are unsure), consult your doctor or nurse before you are given Aloxi. This is because these medicines may cause problems with your heartbeat when taken with Aloxi.

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not give you Aloxi unless it is clearly necessary. This is because we do not know if Aloxi is harmful to the baby.

Consult your doctor or nurse before you are given this medicine if you are pregnant or think you may be pregnant.

Breast-feeding

It is not known if Aloxi is found in breast milk.

Consult your doctor or nurse before you are given this medicine if you are breast-feeding.

Driving and using machines

You may feel dizzy or tired after you are given this medicine. If this happens, do not drive or use tools or machines.

Aloxi contains sodium

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

3. How Aloxi will be given to you

Aloxi will usually be given to you by a doctor or nurse.

• You will be given the medicine about 30 minutes before the start of chemotherapy.

Adults

• The recommended dose of Aloxi is 250 micrograms.
• It is given as an injection into a vein.

Children and adolescents (from 1 month to 17 years of age)

• Your doctor will calculate the correct dose based on your weight.
• The maximum dose is 1500 micrograms.
• Aloxi will be given as a drip (a slow infusion into a vein).

Aloxi should not be given to you on the days following chemotherapy unless you are going to receive another cycle of chemotherapy.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

The following side effects may happen with this medicine:

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects:

• allergic reaction: the signs may include swelling of the lips, face, tongue, or throat, difficulty breathing or fainting, itchy rash, or hives (urticaria). This reaction is very rare: it may affect up to 1 in 10,000 people.

Tell your doctor immediately if you notice any of the serious side effects mentioned above.

Other side effects

Tell your doctor if you notice any of the following side effects:

Adults

Common:may affect up to 1 in 10 people

• headache, dizziness;
• constipation, diarrhea.

Uncommon:may affect up to 1 in 100 people

• change in the color of the vein and enlarged veins;
• feeling unusually happy or feeling anxious;
• drowsiness or sleep problems;
• decreased or loss of appetite;
• weakness, tiredness, fever, or flu-like symptoms;
• numbness, burning, itching, or tingling sensation in the skin;
• itchy rash;
• vision changes or eye irritation;
• movement disorder;
• ringing in the ears;
• hiccups, gas (flatulence), dry mouth, or indigestion;
• abdominal pain (stomach pain);
• difficulty urinating;
• joint pain.

Tell your doctor if you notice any of the side effects mentioned above.

Uncommon side effects seen in trials:may affect up to 1 in 100 people

• high or low blood pressure;
• abnormal heartbeat or lack of blood flow to the heart;
• high or low levels of potassium in the blood;
• high levels of sugar in the blood or sugar in the urine;
• low levels of calcium in the blood;
• high levels of bilirubin in the blood;
• high levels of certain liver enzymes;
• abnormalities in the electrocardiogram ('prolonged QT interval').

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

• burning, pain, or redness at the injection site.

Children and adolescents

Common:may affect up to 1 in 10 people

• headache.

Uncommon:may affect up to 1 in 100 people

• dizziness;
• spasmodic movements;
• abnormal heartbeat;
• cough or shortness of breath;
• nosebleeds;
• itchy rash or hives;
• fever;
• pain at the infusion site.

Tell your doctor if you notice any of the side effects mentioned above.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are 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 Aloxi

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 and carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

For single use, any unused solution should be discarded.

6. Contents of the pack and further information

What Aloxi contains

• The active substance is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms of palonosetron. Each 5 ml vial contains 250 micrograms of palonosetron.
• The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, and hydrochloric acid.

Appearance and pack contents

Aloxi solution for injection is a clear and colorless solution and is presented in a Type I glass vial with a chlorobutyl rubber stopper and an aluminum cap, containing 5 ml of the solution. Each vial contains a single dose.

It is presented in packs of 1 vial containing 5 ml of solution.

Marketing authorization holder and manufacturer

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

Date of last revision of this leaflet:

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