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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: PLGB 05815/0111.
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
onivyde® pegylated liposomal 4.3 mg/mI
concentrate for dispersion for infusion
Irinotecan
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
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.
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.
Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.
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 your treatment.
ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years.
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.
Tell your doctor, pharmacist or nurse if you are already having, or have recently had chemotherapy and/or radiotherapy or treatment with the antifungal medicine flucytosine.
It is also especially important that you tell your doctor if you are also taking the following medicines, since they reduce the level 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 level of irinotecan in your body:
Avoid eating grapefruits and drinking grapefruit juice while you are receiving ONIVYDE pegylated liposomal as it may increase the level of irinotecan in your body.
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.
Prior to taking this medicine talk with your doctor about the possible risk with this medicine and the options that may preserve your ability to have children.
During your ONIVYDE pegylated liposomal treatment and for seven months 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 for 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.
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.
This medicine contains 33.1 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.65% of the recommended maximum daily dietary intake of sodium for an adult.
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.
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:
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)
Not known (frequency cannot be estimated from the available data)
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.
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.
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.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in 09/2022