Active ingredient
- irinotecan sucrosofate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/16/1130/001 .
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
Package leaflet: Information for the user
onivyde® pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
Irinotecan
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What ONIVYDE pegylated liposomal is and what it is used for
2. What you need to know before you use ONIVYDE pegylated liposomal
3. How ONIVYDE pegylated liposomal is used
4. Possible side effects
5. How to store ONIVYDE pegylated liposomal
6. Contents of the pack and other information
1. What ONIVYDE pegylated liposomal is and what it is used for
What ONIVYDE pegylated liposomal is and how it works
ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan. This active substance is held in tiny lipid (fatty) particles called liposomes.
Irinotecan belongs to a group of cancer medicines called `topoisomerase inhibitors'. It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA. This prevents the cancer cells from multiplying and growing, and they eventually die.
The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer.
What ONIVYDE pegylated liposomal is used for
ONIVYDE pegylated liposomal is used to treat adult patients with metastatic pancreatic cancer (cancer of the pancreas that has already spread elsewhere in the body) whose previous cancer treatment included a medicine called gemcitabine. ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin.
If you have any questions about how ONIVYDE pegylated liposomal works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you use ONIVYDE pegylated liposomal
Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.
Do not use ONIVYDE pegylated liposomal:
Warnings and precautions
Talk to your doctor or nurse before you are given ONIVYDE pegylated liposomal
Talk to your doctor or nurse immediately during treatment with ONIVYDE pegylated liposomal
What to do in case of diarrhoea
As soon as the first liquid stool occurs, start drinking large volumes of rehydration fluids (e.g. water, soda water, fizzy drinks, soup) to avoid losing too much liquid and salts from your body. Contact your doctor immediately to give you a suitable treatment. Your doctor may give you a medicine which contains loperamide to begin treatment at home but it must not be used for longer than 48 consecutive hours. If loose stools persist, contact your doctor.
Blood tests and medical examinations
Before you start treatment with ONIVYDE pegylated liposomal, your doctor will perform blood tests (or other medical examinations) to determine the best starting dose for you. You will need to have further (blood or other) tests during treatment so that your doctor can monitor your blood cells and assess how you are responding to the treatment. Your doctor may need to adjust the dose or stop treatment.
Children and adolescents
ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years.
Other medicines and ONIVYDE pegylated liposomal
Tell your doctor if you are taking, have recently taken or might take any other medicines.
It is especially important that you tell your doctor if you have been given irinotecan in any form earlier.
ONIVYDE pegylated liposomal must not be used instead of other medicines containing irinotecan because it behaves differently when it is contained in the liposomes than when it is given in its free form.
It is also especially important that you tell your doctor if you are also taking the following medicines, since they reduce the availability of irinotecan in your body:
It is especially important that you tell your doctor if you are also taking the following medicines, since they increase the availability of irinotecan in your body:
ONIVYDE pegylated liposomal with food and drink
Avoid eating grapefruits and drinking grapefruit juice while you are receiving ONIVYDE pegylated liposomal as it may increase the availability of the active substance of ONIVYDE pegylated liposomal in your body.
Pregnancy and breast-feeding
You should not be given ONIVYDE pegylated liposomal if you are pregnant as it may harm the baby. Tell your doctor if you are or think you may be pregnant. Ask your doctor for advice if you are planning to have a baby. If you are given ONIVYDE pegylated liposomal you should not breast-feed until one month after the last dose.
During your ONIVYDE pegylated liposomal treatment and one month after you should choose an effective birth control method which suits you, to prevent pregnancy in this period of time. Males should use condoms during ONIVYDE pegylated liposomal treatment and 4 months thereafter.
Tell your doctor if you are breast-feeding. You must not be given ONIVYDE pegylated liposomal if you are breast-feeding as this may be harmful to your baby.
Driving and using machines
ONIVYDE pegylated liposomal may influence your ability to drive and use machines (as you may be sleepy, dizzy and exhausted with the use of ONIVYDE pegylated liposomal). You should avoid driving, using machines or performing other tasks that need full attention if you feel sleepy, dizzy and exhausted.
ONIVYDE pegylated liposomal contains sodium
One millilitre of this medicine contains 0.144 mmol (3.31 mg) sodium—keep this in mind if you are on a controlled sodium diet.
3. How ONIVYDE pegylated liposomal is used
ONIVYDE pegylated liposomal must only be given by healthcare professionals trained in giving anticancer medicines.
Carefully follow all instructions given to you by your doctor or nurse.
Your doctor will decide upon the doses you will receive.
ONIVYDE pegylated liposomal is given as a drip (infusion) into a vein, which should take at least 90 minutes and should be given as a single dose.
After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
The treatment will be repeated every two weeks.
In certain cases, lower doses or longer dosing intervals may be required.
You may receive pre-medication against nausea and vomiting. If you have experienced sweating, abdominal cramping and salivation together with early frequent and liquid stools in previous treatments with ONIVYDE pegylated liposomal, you may receive additional medicines before ONIVYDE pegylated liposomal to prevent or reduce this in the following treatment cycles.
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. It is important that you are aware of what these side effects may be.
Your doctor may also prescribe other medicines to help control your side effects.
Tell your doctor or nurse about any of the following serious side effects straight away:
The following side effects may occur:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store ONIVYDE pegylated liposomal
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 carton and vial after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Once the concentrate has been diluted for infusion with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection, the dispersion should be used as soon as possible, but may be stored at ambient temperature (15°C to 25°C) for up to 6 hours. The diluted dispersion for infusion can be stored in the refrigerator (2°C - 8°C) for no more than 24 hours prior to use. It must be protected from light, and it must not be frozen.
Do not throw away this medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What ONIVYDE pegylated liposomal contains
What ONIVYDE pegylated liposomal looks like and contents of the pack
ONIVYDE pegylated liposomal is supplied as a white to slightly yellow opaque isotonic liposomal dispersion in a glass vial.
Each pack contains one vial with 10 ml of concentrate.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in 08/2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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