250 micrograms solution for injection. 
palonosetron

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Aloxi is and what it is used for 
2. What you need to know before you get Aloxi 
3. How to get Aloxi 
4. Possible side effects 
5. How to store Aloxi 
6. Contents of the packaging and other information 

1. What Aloxi is and what it is used for

Aloxi contains the active substance palonosetron. It belongs to a group of medicines called ‘serotonin ( 5HT 3 ) antagonists’.

Aloxi is used in adults, adolescents and children over one month of age to prevent nausea and vomiting during so-called chemotherapy treatment (“cytotoxic drugs”) for cancer.

It works by blocking the activity of the chemical serotonin, which can make you feel sick or vomit.

2. What you need to know before you get 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 receive Aloxi if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking this medicine.

Warnings and cautions

Talk to your doctor or nurse before receiving Aloxi if:

  • you have any obstruction in the intestine or have had constipation repeatedly in the past
  • you have had heart problems or if there are heart problems in the family, such as a change in heart rate (“extended QT interval”)
  • you have an imbalance in certain minerals in the blood that has not been treated – e.g. potassium and magnesium.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before getting Aloxi.

Other medicines and Aloxi

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. It is especially important that you 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, for example:

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

Drugs that can affect the heartbeat

Tell your doctor or nurse if you are taking any other medicines that may affect your heart rate – you may have heart problems if you take them with Aloxi. These are:

  • drugs for heart problems, e.g. amiodarone, nicardipine, and quinidine
  • medicines for infection, e.g. moxifloxacin and erythromycin
  • medicines for severe mental problems, e.g. haloperidol, chlorpromazine, quetiapine, and thioridazine
  • medicine for nausea and vomiting called domperidone.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Aloxi – you may have heart problems if you take these medicines with Aloxi.

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not give you Aloxi unless absolutely necessary. The reason is that it is not known whether Aloxi can harm the child.

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

Breast-feeding

It is not known if Aloxi passes into breast milk.

Ask your doctor or nurse for advice before taking Aloxi if you are breast-feeding.

Driving and using machines

You may feel dizzy or tired after taking this medicine. If this happens, do not drive or use any tools or machines.

Aloxy contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’.

3. How to get Aloxi

Aloxi is usually given by a doctor or nurse.

  • You will receive 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 to a friend.

Children and adolescents (aged 1 month to 17 years)

  • The doctor calculates the correct dose based on body weight.
  • The highest dose is 1,500 micrograms.
  • Aloxi is given as a drip (a slow infusion into a vein).

You should not receive Aloxi in the next few days after chemotherapy unless you are given another round of chemotherapy.

If you have any further questions on the use of this product, 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 be caused by this medicine:

Serious side effects are

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

  • allergic reaction – signs of this may be swelling of the lips, face, tongue, or throat, difficulty breathing or collapse, itchy raised rash ( hives ). This is very rare: may affect up to 1 in 10,000 people.

Tell your doctor immediately if you get any of the side effects listed above.

Other side effects ar

Tell your doctor if you get 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

  • color changes and enlargement of the veins
  • you feel happier than usual or more anxious
  • drowsiness or insomnia
  • loss of appetite or loss of appetite
  • weakness, fatigue, fever, or flu-like symptoms
  • numbness, burning, tingling, or ant crawling in the skin
  • skin rash with itching
  • impaired vision or eye irritation
  • motion sickness
  • tinnitus
  • hiccups, flatulence, dry mouth, or indigestion
  • abdominal pain
  • urination difficulties
  • joint pain.

Tell your doctor if you get any of the side effects listed above.

Uncommon side effects were seen on specimens: may affect up to 1 in 100 people

  • high or low blood pressure
  • abnormal heart rate or poor 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
  • low level of calcium in the blood
  • high level of the pigment bilirubin in the blood
  • high levels of certain liver enzymes
  • abnormal 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 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
  • cough or shortness of breath
  • nosebleeds
  • itchy rash or hives
  • fever
  • pain at the infusion site.

Tell your doctor if you get any of the side effects listed above.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month.
  • No special storage instructions.
  • For single use only, any remaining solution should be discarded.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

Aloxi injection solution is a clear, colorless solution and is supplied in a pack with one vial of type I glass with chlorobutyl siliconized rubber stopper and aluminum. The vial contains 5 ml of solution, which is a dose.

Available in packs of 1 vial containing 5 ml solution.

Marketing Authorization Holder and Manufacturer

Helsinn Birex Pharmaceuticals Ltd. 
Damastown 
Mulhuddart 
Dublin 15 
Ireland

Muhammad Nadeem

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