ALOXI

Package leaflet: Information for the user

Aloxi 250 micrograms injectable solution

Palonosetron
Please read this leaflet carefully before receiving this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Aloxi is and what it is used for
2. What you need to know before receiving Aloxi
3. How Aloxi is administered
4. Possible side effects
5. How to store Aloxi
6. Contents of the pack and other information

1. What Aloxi is and what it is used for

Aloxi contains the active substance palonosetron, which belongs to a class of medicines called
"serotonin (5HT ) antagonists".
Aloxi is used in adults, adolescents, and children over one month of age to help prevent the feeling of illness or discomfort (nausea and vomiting) associated with anticancer treatments known as chemotherapy.
It works by blocking the action of a chemical substance called serotonin, which can cause nausea or vomiting.

2. What you should know before receiving Aloxi

Do not take Aloxi if:

• you are allergic to palonosetron or to any of the other ingredients of this medicine (listed in section 6). You will not receive Aloxi if any of the above conditions apply to you. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions
Talk to your doctor or nurse before receiving Aloxi if:

• you have intestinal blockage or have previously had repeated constipation
• you or your family members have had heart problems, such as irregular heartbeats ("QT prolongation")
• you have untreated imbalances of certain minerals in the blood, such as potassium or magnesium.

If any of the above conditions apply to you (or if you are unsure), speak with your doctor or nurse before receiving Aloxi.

Other medicines and Aloxi
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking the following medicines:

Medicines for depression or anxiety
Inform your doctor or nurse if you are taking medicines for depression or anxiety, such as:

• medicines called SSRIs ("selective serotonin reuptake inhibitors"), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• medicines called SNRIs ("serotonin-noradrenaline reuptake inhibitors"), such as venlafaxine, duloxetine (these may lead to the development of serotonin syndrome and should be used with caution).

Medicines that may affect heart rhythm
Inform your doctor or nurse if you are taking medicines that affect heart rhythm, as they could cause heart rhythm problems when taken with Aloxi. These include:

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

If any of the above conditions apply to you (or if you have any doubts), talk to your doctor or nurse before taking Aloxi, as these medicines could cause heart rhythm problems when taken together with Aloxi.

Pregnancy
If you are pregnant or think you might be pregnant, your doctor will not administer Aloxi unless absolutely necessary. This is because it is unknown whether Aloxi could harm the unborn baby.
Please consult your doctor or nurse for advice before receiving this medicine if you are pregnant or think you might be pregnant.

Breast-feeding
It is not known whether Aloxi passes into breast milk.
Please consult your doctor or nurse for advice before receiving this medicine if you are breast-feeding.

Driving and using machines
You may feel dizzy or tired after receiving this medicine. If this occurs, do not drive or operate tools or machinery.

Aloxi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially 'sodium-free'.

3. How Aloxi is administered

Aloxi is normally administered by a doctor or nurse.

• You will receive the medicine approximately 30 minutes before the start of chemotherapy.

Adults

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

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

• The doctor will calculate the correct dose based on body weight.
• The maximum dose is 1,500 micrograms.
• Aloxi is administered as an intravenous infusion (slow infusion into a vein).

Administration of Aloxi on days following chemotherapy is not recommended, unless you are to undergo another cycle of chemotherapy.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:
Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects:

• allergic reaction – signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse, skin rash with swelling and itching (urticaria). This is a very rare side effect: it may affect up to 1 in 10,000 people. Contact your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Contact your doctor if you notice any of the following side effects:
Adults
Common: may affect up to 1 in 10 people

• headache, dizziness,
• constipation, diarrhoea.

Uncommon: may affect up to 1 in 100 people

• change in the colour of a vein and enlargement of veins
• feeling happier than usual or feeling anxious
• drowsiness or difficulty sleeping
• decreased or loss of appetite
• weakness, feeling tired, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling on the skin
• itchy skin rash
• changes in vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, intestinal gas (flatulence), dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain.

Contact your doctor if you notice any of the side effects listed above.
Uncommon side effects observed in tests: may affect up to 1 in 100 people

• low or high blood pressure
• abnormal heart rate or reduced blood flow to the heart
• unusually high or low potassium levels in the blood
• high blood sugar levels or presence of sugar in the urine
• low calcium levels in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• abnormalities in the ECG (electrocardiogram) (“QT prolongation”).

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
• jerky body movements
• irregular heart rate
• cough or shortness of breath
• nosebleeds
• itchy skin rash or hives
• fever
• pain at the infusion site.

Contact your doctor if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aloxi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the vial and carton after "Exp.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• For single use only; any unused solution must be discarded.

6. Pack contents and other information

What Aloxi contains

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

Description of the appearance of Aloxi and pack contents
Aloxi injectable solution is a clear, colourless solution supplied in a pack containing one
type I glass vial with a chlorobutyl rubber stopper and an aluminium cap, containing 5 ml of solution. Each vial contains one dose.
Available in packs of 1 vial containing 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Patient information leaflet

Aloxi 500 microgram capsules

Palonosetron
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Aloxi is and what it is used for
2. What you need to know before taking Aloxi
3. How to take Aloxi
4. Possible side effects
5. How to store Aloxi
6. Contents of the pack and other information

1. What Aloxi is and what it is used for

Aloxi contains the active substance palonosetron, which belongs to a class of medicines called
"serotonin (5HT ) antagonists".
Aloxi is used in adults to help prevent the feeling of illness or discomfort (nausea and
vomiting) associated with anti-cancer treatments known as chemotherapy.
It works by blocking the action of a chemical called serotonin, which can cause nausea or vomiting.

2. What you need to know before taking Aloxi

Do not take Aloxi:

• if you are allergic to palonosetron or to any of the other ingredients of this medicine (listed in section 6). Do not take Aloxi if you fall under any of the conditions listed above. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aloxi if:

• you have intestinal obstruction or have had repeated constipation in the past
• you have had heart problems or your family members have had heart problems, such as irregular heartbeats (“QT prolongation”)
• you have an untreated imbalance of certain minerals in your blood, such as potassium and magnesium.

Children
Do not give this medicine to children.
Other medicines and Aloxi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking the following medicines:
Medicines for depression or anxiety
Inform your doctor or pharmacist if you are taking medicines for depression or anxiety, such as:

• medicines called SSRIs (“selective serotonin reuptake inhibitors”), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• medicines called SNRIs (“serotonin-norepinephrine reuptake inhibitors”), such as venlafaxine, duloxetine (these may lead to the development of serotonin syndrome and should be used with caution).

If you fall under any of the conditions listed above (or if you have any doubts), speak with your doctor or pharmacist before taking Aloxi.
Medicines that may affect heart rhythm
Inform your doctor or pharmacist if you are taking medicines that affect heart rhythm; this is because they could cause a problem with your heartbeat if taken together with Aloxi. These include:

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

If you fall under any of the conditions listed above (or if you have any doubts), talk to your doctor or pharmacist before taking Aloxi, because these medicines could cause a problem with your heartbeat if taken together with Aloxi.
Pregnancy
If you are or think you might be pregnant, your doctor will not use Aloxi unless absolutely necessary. This is because we do not know whether Aloxi could harm the unborn baby.
Ask your doctor or pharmacist for advice before taking this medicine if you are or think you might be pregnant.
Breast-feeding
It is not known whether Aloxi passes into breast milk.
Ask your doctor or pharmacist for advice before using this medicine during breast-feeding.
Driving and using machines
You may feel dizzy or tired after taking this medicine. If this happens, do not drive or operate tools or machinery.
Aloxi contains sorbitol and may contain traces of soya
This medicine contains 7 mg of sorbitol (a type of sugar) per capsule. If your doctor has told you that you are intolerant to certain sugars, talk to your doctor before taking this medicine.
Aloxi may contain traces of lecithin derived from soya. If you are allergic to peanuts or soya, do not take this medicine. Consult your doctor immediately if you notice signs of an allergic reaction.
These signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse; you may also develop a rash with swelling and itching (hives).

3. How to take Aloxi

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one capsule (500 micrograms).
• You should normally take the capsule approximately 60 minutes before the start of chemotherapy.
• This medicine can be taken with or without food.

Administration of Aloxi on days following chemotherapy is not recommended, unless
you are due to undergo another cycle of chemotherapy.
If you take more Aloxi than you should
If you think you have taken more medicine than you should, inform your doctor immediately.
If you forget to take Aloxi
It is unlikely that you will forget to take this medicine. However, if you think you have missed
a dose, inform your doctor immediately.
If you stop taking Aloxi
Do not stop taking this medicine without talking to your doctor. If you decide not to
take Aloxi (or similar medicines), you are likely to experience feeling unwell or illness (nausea and vomiting) during chemotherapy.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine:
Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects:

• allergic reaction – signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse, skin rash with swelling and itching (urticaria). This is a very rare side effect: it may affect up to 1 in 10,000 people. Contact your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Contact your doctor if you notice any of the following side effects:
Common: may affect up to 1 in 10 people

• headache.

Uncommon: may affect up to 1 in 100 people

• difficulty sleeping
• shortness of breath
• eye swelling
• abnormal electrical impulses in the heart
• constipation
• nausea
• high levels of the pigment “bilirubin” (a marker of liver problems) in the blood
• muscle pain. Contact your doctor if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aloxi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

6. Pack contents and other information

What Aloxi contains

• The active substance is palonosetron. Each capsule contains 500 micrograms of palonosetron (as hydrochloride).
• The other components are glycerol monocaprylocaprate (type I), polyglyceryl oleate, glycerol, purified water, butylated hydroxyanisole, gelatin, sorbitol, titanium dioxide.

Description of the appearance of Aloxi and pack contents
Aloxi 500 micrograms soft capsules are smooth, round to oval, opaque, light beige soft capsules containing a clear, yellowish solution. They are supplied in poliamide/aluminum/PVC blisters containing one or five capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Helsinn Birex Pharmaceuticals Ltd.,
Damastown,
Mulhuddart, Dublin 15,
Ireland.

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.