Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Aloxi 250 micrograms solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Palonosetron hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Aloxi contains the active substance palonosetron. This belongs to a group of medicines called 'serotonin (5HT3) antagonists'. Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy. It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit.
2.
What you need to know before you take it
Aloxi
Do not take Aloxi if:
- you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). You will not be given Aloxi if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. Warnings and precautions Talk to your doctor or nurse before you are given Aloxi if:
- you have a blocked bowel or have had repeated constipation in the past
- you have had heart problems or heart problems run in your family, such as changes in your heart beat ('QT prolongation')
- you have an imbalance of certain minerals in your blood which has not been treated – such as potassium and magnesium. If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Aloxi.
1
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 the following medicines: Medicines for depression or anxiety Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including:
- 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 (can lead to the development of serotonin syndrome and should be used with caution). Medicines that can affect your heart beat Tell your doctor or nurse if you are taking any medicines that affect your heart beat – this is because they could cause a heart beat problem when taken with Aloxi. This includes:
- medicines for heart problems such as amiodarone, nicardipine, quinidine
- medicines for infections such as moxifloxacin, erythromycin
- medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine, thioridazine
- a medicine for feeling or being sick (nausea and vomiting) called domperidone. If any of the above applies to you (or you are not sure), talk to your doctor or nurse before taking Aloxi – this is because these medicines could cause a heart beat problem when taken with Aloxi. Pregnancy If you are pregnant or think you might be pregnant, your doctor will not give you Aloxi unless it is clearly necessary. This is because we do not know if Aloxi may harm the baby. Ask your doctor or nurse for advice before being given this 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 nurse for advice before being given this medicine if you are breast-feeding. Driving and using machines You may feel dizzy or tired after being given this medicine. If this happens, do not drive or use any tools or machines. Aloxi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodiumfree'.
3.
How to take it
Aloxi
Aloxi is normally given 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 young people (aged 1 month to 17 years)
- The doctor will work out the right dose based on bodyweight. 2
• •
The maximum dose is 1500 micrograms. Aloxi will be given as a drip (a slow infusion into a vein).
It is not recommended you are given Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle. If you have any further questions on 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 straight away if you notice any of the following serious side effects:
- allergic reaction – the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, an itchy, lumpy rash (hives). This is very rare: may affect up to 1 in 10,000 people. Tell your doctor straight away if you notice any of the serious side effects listed 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, feeling dizzy,
- constipation, diarrhoea. Uncommon: may affect up to 1 in 100 people
- change in the colour of the vein and veins becoming larger
- feeling happier than usual or feeling anxious
- feeling sleepy or trouble sleeping
- decrease or loss of appetite
- weakness, feeling tired, 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, passing wind (flatulence), dry mouth or indigestion
- abdominal (stomach) pain
- difficulty passing water (urinating)
- joint pain. Tell your doctor if you notice any of the side effects listed above. Uncommon side effects shown in tests: may affect up to 1 in 100 people
- high or low blood pressure
- abnormal heart rate or lack of blood flow to the heart
- abnormally high or low levels of potassium in the blood
- high levels of sugar in the blood or sugar in the urine 3
• • • •
low levels of calcium in the blood high levels of the pigment bilirubin in the blood high levels of certain liver enzymes ECG (electrocardiogram) abnormalities ('QT prolongation').
Very rare: may affect up to 1 in 10,000 people
- Burning, pain or redness at the injection site Children and young people Common: may affect up to 1 in 10 people
- headache. Uncommon: may affect up to 1 in 100 people
- dizziness
- jerky body movements
- abnormal heart rate
- coughing or shortness of breath
- nosebleed
- itchy skin rash or hives
- fever
- pain at the site of infusion. Tell your doctor if you notice any of the side effects listed above. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. • • • •
6.
How to store it
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 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.
Contents of the pack and other information
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, water for injections, sodium hydroxide and hydrochloric acid.
4
What Aloxi looks like and 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 Manufacturer Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland. This leaflet was last revised in 11/2021
5
Frequently asked questions about Aloxi 250 micrograms solution for injection
How do I take Aloxi 250 micrograms solution for injection?
Aloxi 250 micrograms solution for injection comes as injection containing 250mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Aloxi 250 micrograms solution for injection?
The active substance in Aloxi 250 micrograms solution for injection is palonosetron hydrochloride.
Are there equivalent medicines to Aloxi 250 micrograms solution for injection?
Medicines with the same active substance, strength and form include: Palonosetron 250 micrograms solution for injection, Palonosetron 250 micrograms solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Aloxi 250 micrograms solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Aloxi 250 micrograms solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: palonosetron hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Aloxi is indicated in adults for:
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
• the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Aloxi is indicated in paediatric patients 1 month of age and older for:
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
4.2. Posology and method of administration
Aloxi should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Posology
Adults
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Aloxi should be injected over 30 seconds.
The efficacy of Aloxi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Elderly people
No dose adjustment is necessary for the elderly.
Paediatric population
Children and Adolescents (aged 1 month to 17 years):
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
The safety and efficacy of Aloxi in children aged less than 1 month have not been established. No data are available. There are limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.
Hepatic impairment
No dose adjustment is necessary for patients with impaired hepatic function.
Renal impairment
No dose adjustment is necessary for patients with impaired renal function.
No data are available for patients with end stage renal disease undergoing haemodialysis.
Method of administration
For intravenous use.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval. A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1).
However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval. These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti- arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities. Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.
There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Aloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium- free'.
4.5. Interaction with other medicinal products and other forms of interaction
Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes. Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Chemotherapeutic agents
In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Metoclopramide
In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
CYP2D6 inducers and inhibitors
In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Corticosteroids
Palonosetron has been administered safely with corticosteroids.
Serotonergic Drugs (e.g. SSRIs and SNRIs)
There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Other medicinal products
Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
4.6. Fertility, pregnancy and lactation
Pregnancy
For Palonosetron no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
There is no experience of palonosetron in human pregnancy. Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Breast-feeding
As there are no data concerning palonosetron excretion in breast milk, breast- feeding should be discontinued during therapy.
Fertility
There are no data concerning the effect of palonosetron on fertility.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
4.8. Undesirable effects
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9 %) and constipation (5 %).
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi. These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100). Very rare (<1/10,000) adverse reactions were reported post-marketing.
Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness.
System organ class
Common ARs
(≥1/100 to<1/10)
Uncommon ARs
(≥1/1,000 to <1/100)
Very rare ARs°
(<1/10,000)
Immune system disorders
Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Metabolism and nutrition disorders
Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Psychiatric disorders
Anxiety, euphoric mood
Nervous system disorders
Headache
Dizziness
Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
Eye disorders
Eye irritation, amblyopia
Ear and labyrinth disorders
Motion sickness, tinnitus
Cardiac disorders
Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Vascular disorders
Hypotension, hypertension, vein discolouration, vein distended
Respiratory, thoracic and mediastinal disorders
Hiccups
Gastrointestinal disorders
Constipation
Diarrhoea
Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Hepatobiliary disorders
Hyperbilirubinaemia
Skin and subcutaneous tissue disorders
Dermatitis allergic, pruritic rash
Musculoskeletal and connective tissue disorders
Arthralgia
Renal and urinary disorders
Urinary retention, glycosuria
General disorders and administration site conditions
Asthenia, pyrexia, fatigue, feeling hot, influenza like illness
Injection site reaction*
Investigations
Elevated transaminases-, electrocardiogram QT prolonged
° From post-marketing experience
* Includes the following: burning, induration, discomfort and pain
Paediatric population
In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg). The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
System organ class
Common ARs
(≥1/100 to<1/10)
Uncommon ARs
(≥1/1,000 to <1/100)
Nervous system disorders
Headache
Dizziness, dyskinesia
Cardiac disorders
Electrocardiogram QT prolonged
conduction disorder, sinus tachycardia
Respiratory, thoracic and mediastinal disorders
Cough, dyspnoea, epistaxis
Skin and subcutaneous tissue disorders
Dermatitis allergic, pruritus, skin disorder, urticaria
General disorders and administration site conditions
Pyrexia, infusion site pain, infusion site reaction, pain
Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9. Overdose
No case of overdose has been reported.
Doses of up to 6 mg have been used in adult clinical studies. The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed. In the unlikely event of overdose with Aloxi, this should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose.
Paediatric population
No case of overdose has been reported in paediatric clinical studies.
💬 Ask about this leaflet
Ask anything about Aloxi 250 micrograms solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.