Aloxi 250 micrograms solution for injection Hydrochloride - United Kingdom[英国药品]

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Aloxi 250 micrograms solution for injection Hydrochloride

2015-03-13 19:50:20 来源: 作者: 【大中小】浏览:400次评论:0条

For doctors

What is it and how is it used?

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.

What do you have to consider before using it?

Do not take Aloxi

Take special care with Aloxi

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’.

How is it used?

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.

What are possible side effects?

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:

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.

How should it be stored?

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.

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For doctors

What is it?

Aloxi is a medicine that contains the active substance palonosetron. It is available as a solution for injection (250 micrograms in 5 ml) and as beige capsules (500 micrograms).

What is it used for?

Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). The solution for injection is used for chemotherapy that is either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin). The capsules are only used for chemotherapy that is a moderate trigger of nausea and vomiting in adults.

How is it used?

Aloxi should only be given before chemotherapy by a healthcare professional.
The injection is given into a vein over 30 seconds about 30 minutes before the start of chemotherapy, at a dose of 250 micrograms. It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Alternatively, the patients should take one capsule one hour before the start of chemotherapy.

How does it work?

How has it been studied?

Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting. Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type). A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.

All of the studies measured the number of patients who did not vomit after receiving chemotherapy.

What benefits has it shown during the studies?

Aloxi solution for injection was as effective as the comparator medicines. With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the patients receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221). With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the patients receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185). When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of 191).
In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting. However, only the 500-microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500-microgram capsule or the injection did not vomit during this period.

What is the risk associated?

The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache. With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 patients in 100. For the full list of all side effects reported with Aloxi, see the Package Leaflet. Aloxi should not be used in people who may be hypersensitive (allergic) to palonosetron or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi to Helsinn Birex Pharmaceuticals Limited on 22 March 2005. The marketing authorisation is valid for an unlimited period.

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Name

Aloxi 250 micrograms solution for injection

Composition

Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).

For a full list of excipients, see section 6.1.