Aloxi 250 micrograms solution for injection

Aloxi belongs to a group of medicines known as serotonin 5HT3 antagonists.

These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting.

Aloxi is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adult patients.

Do not take Aloxi

• If you are allergic to the active ingredient or any of the other ingredients of Aloxi.

Take special care with Aloxi

• If you have acute bowel obstruction or a history of repeated constipation.
• If you are taking Aloxi in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
• If you have a personal or family history of alterations in heart rhythm (QT prolongation).

It is not recommended to take Aloxi in the days following chemotherapy unless you are receiving another chemotherapy cycle.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy

If you are pregnant or think you might be, your doctor will not administer Aloxi to you unless it is clearly necessary.
It is not known whether Aloxi will cause any harmful effects when used during pregnancy.

Ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be.

Breast-feeding

It is not known if Aloxi is found in breast milk.
Ask your doctor or pharmacist for advice before using Aloxi if you are breast-feeding.

Driving and using machines

Aloxi may cause dizziness or tiredness. If affected, do not drive or use any tools or machines.

Important information about some of the ingredients of Aloxi

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

A doctor or nurse will normally inject Aloxi about 30 minutes before the start of chemotherapy. The usual dose of Aloxi is 250 micrograms given as a rapid injection into a vein.

If you have any further questions on the use of this product, ask your doctor.

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).

Common side effects:
headache, dizziness, constipation and diarrhoea.

Uncommon side effects:

• high or low blood pressure
• abnormal heart rate or lack of blood flow to the heart
• change in the color of the vein and/or veins becoming larger
• abnormally 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 the pigment bilirubin in the blood
• high levels of certain liver enzymes
• elevated moods or feelings of anxiousness
• sleepiness or trouble sleeping
• decrease or loss of appetite
• weakness, tiredness, fever or flu like symptoms
• numbness, burning, prickling or tingling sensations on the skin
• itchy skin rash
• impaired vision or eye irritation
• motion sickness
• ringing in the ear
• hiccups, flatulence, dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• electrocardiogram abnormalities (QT prolongation)

Very rare side effects:
Allergic reactions to Aloxi (The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives)), burning or pain at the site of injection.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.
Do not use 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.
Single use only, any unused solution should be disposed of.

What Aloxi contains

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

What Aloxi looks like and the contents of the pack

Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap, which contains 5 ml of the solution. Each vial contains one dose.

Available in packs of 1 vial containing 5 ml of solution.

Marketing Authorisation Holder and ManufacturerHelsinn Birex Pharmaceuticals Ltd.,
Damastown,
Mulhuddart,
Dublin 15,
Ireland.This leaflet was last approved in