Patient leaflet - Palonosetron Hydrochloride 250 micrograms solution for injection
1. What Palonosetron hydrochloride is and what it is used for
Palonosetron 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.
Palonosetron is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
2. What you need to know before you use Palonosetron
Do not use Palonosetron
- If you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before using Palonosetron
- If you have acute bowel obstruction or a history of repeated constipation.
- If you are using Palonosetron 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).
- If you have other heart problems.
- If you have an imbalance of certain minerals in your blood such as potassium and magnesium which has not been treated.
It is not recommended to take Palonosetron in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Other medicines and Palonosetron hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Pregnancy
If you are pregnant or think you might be, your doctor will not administer palonosetron to you unless it is clearly necessary. It is not known whether palonosetron 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 palonosetron is found in breast milk. Ask your doctor or pharmacist for advice before using palonosetron if you are breast-feeding.
Driving and using machines
Palonosetron may cause dizziness or tiredness. If affected, do not drive or use any tools or machines.
Palonosetron hydrochloride contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free’.
3. How to use Palonosetron hydrochloride
A doctor or nurse will normally inject Palonosetron hydrochloride about 30 minutes before the start of chemotherapy.
Adults
The recommended dose of Palonosetron is 250 micrograms given as a rapid injection into a vein.
Children and Adolescents (aged 1 month to 17 years)
The doctor will decide the dose, depending on bodyweight; however the maximum does is 1500 micrograms. Palonosetron will be given as a slow infusion into a vein.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects and their frequencies are listed below:
Adults
Common(may affect up to 1 in 10 people)
- headache, dizziness, constipation and diarrhoea.
Uncommon (may affect up to 1 in 100 people)
- 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 (may affect up to 1 in 10,000 people) Allergic reactions to Palonosetron
The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice itchy, lumpy rash (hives), burning or pain at the site of injection.
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
- abnormal heart rate
- coughing or shortness of breath
- nosebleed
- itchy skin rash or hives
- fever
- pain at the site of infusion
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Palonosetron hydrochloride
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.
Keep the vial in the outer carton in order to protect from light. Single use only, any unused solution should be disposed of.
6. Contents of the pack and other information
What Palonosetron hydrochloride 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, sodium citrate, citric acid monohydrate and water for injections.
What Palonosetron hydrochloride looks like and contents of the pack
Palonosetron hydrochloride solution for injection is a clear, colourless solution and is supplied in a pack of one 6 ml Type I glass vial with brominized butyl rubber stopper and a 20 mm aluminium-plastic seal flip 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 Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40, planta 8, 28046 Madrid,
Spain
Manufacturer
NETPHARMALAB CONSULTING SERVICES
Carretera de Fuencarral, 22 28108 – Alcobendas, Madrid Spain
KYMOS, S.L.
Ronda de Can Fatjó,
7B (Parque Tecnológico del Vallès), Cerdanyola del Vallès, 08290 Barcelona, Spain