Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.
1. Why am I using XPOVIO?
XPOVIO contains the active ingredient selinexor. XPOVIO is used in combination with dexamethasone, or in combination with dexamethasone and bortezomib, to treat multiple myeloma in adults who have received previous therapy.
For more information, see Section 1. Why am I taking XPOVIO? in the full CMI.
2. What should I know before I use XPOVIO?
Do not use if you have ever had an allergic reaction to XPOVIO or any of the ingredients listed at the end of the CMI. Do not use if you are pregnant or intend to become pregnant or are breastfeeding. Do not use if you are less than 18 years of age.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed. Talk to your doctor if you are male and capable of sexually reproducing.
For more information, see Section 2. What should I know before I use XPOVIO? in the full CMI.
3. What if I am taking other medicines?
Some medicines may reduce the effect of XPOVIO or increase the risk of side effects.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use XPOVIO?
- It is important to use XPOVIO exactly as prescribed by your doctor.
- Swallow the tablets whole with water. Do not crush, chew, break, or divide the tablets. Take the tablets with or without food.
More instructions can be found in Section 4. How do I use XPOVIO? in the full CMI.
5. What should I know while using XPOVIO?
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while taking XPOVIO? in the full CMI.
6. Are there any side effects?
Common side effects of taking XPOVIO are nausea, fatigue, anaemia, decreased appetite. Serious side effects include long or excessive bleeding, infection including symptoms of chills, fever or sore throat, or allergic reactions symptoms including, problems with breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
XPOVIO®(x-poh-vee-oh)
Active ingredient(s): selinexor (seh-lih-nek-sor)
Consumer Medicine Information (CMI)
This leaflet provides important information about taking XPOVIO. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking XPOVIO.
Where to find information in this leaflet:
1. Why am I taking XPOVIO?
2. What should I know before I use XPOVIO?
3. What if I am taking other medicines?
4. How do I use XPOVIO?
5. What should I know while using XPOVIO?
6. Are there any side effects?
7. Product details
1. Why am I using XPOVIO?
XPOVIO contains the active ingredient selinexor. XPOVIO is an anti-cancer medicine.
XPOVIO is used in combination with bortezomib and dexamethasone for the treatment of multiple myeloma (a cancer of the bone marrow) in adults who have received at least one previous treatment.
XPOVIO is used in combination with dexamethasone for the treatment of multiple myeloma that has come back or did not respond to previous treatment, in adults who have received at least three previous treatments and whose disease did not respond to the following treatments:
- at least one proteasome inhibitor,
- at least one immunomodulatory medicine, and
- an anti-CD38 monoclonal antibody
2. What should I know before I use XPOVIO?
Warnings
Do not use XPOVIO if:
- you are allergic to selinexor, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
- have or have had any other medical conditions including the following:
– low levels of platelets in your blood (thrombocytopenia)
– bleeding problems
– low levels of white blood cells (neutropenia)
– serious infections
– low levels of sodium in your blood (hyponatraemia)
– eye problems, such as cataracts
– Tumour Lysis Syndrome
– problems with your liver or kidneys - take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not use XPOVIO if you are pregnant or intend to become pregnant.
If you are capable of bearing children, you should use an effective form of contraception or abstain from sexual intercourse while taking XPOVIO and for at least 1 week after your last dose.
Your doctor will ask you to complete a pregnancy test before you start taking XPOVIO.
Do not use XPOVIO if you are breastfeeding. If you intend to breastfeed, wait at least 1 week after your last dose.
Males
Males who are capable of sexually reproducing should use effective contraception or abstain from sexual intercourse while taking XPOVIO and for at least 1 week after your last dose.
Children
Children younger than 18 years of age should not use XPOVIO.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Medicines that may reduce the effect of XPOVIO include:
- rifampicin
- St. John’s Wort
- carbamazepine
- phenytoin
- phenobarbital
- apalutamide
- enzalutamide
Check with your doctor if you are taking any medicines that may increase the risk of the following side effects:
- drowsiness
- sleepiness
- dizziness
- fainting
- confusion
- hallucinations (seeing or hearing things that are not there)
- problems with thinking clearly
- make you less alert
- make you less aware of things around you (delirious)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect XPOVIO.
4. How do I use XPOVIO?
How much to take
Follow the instructions provided and use XPOVIO until your doctor tells you to stop.
You may experience side effects while taking XPOVIO. These side effects are usually temporary. Your doctor may manage these side effects by asking you to stop taking XPOVIO or prescribing a different dose from the recommended dose below.
If you vomit after taking XPOVIO, do not take an extra dose. Take your next dose when you are next meant to.
XPOVIO taken with bortezomib and dexamethasone
The recommended dose of XPOVIO in combination with bortezomib and dexamethasone is based on a 35-day cycle as follows:
- Take 100 mg (5 XPOVIO 20 mg tablets) by mouth once a week on days 1, 8, 15, 22 and 29.
- Bortezomib will be injected under the skin once a week on days 1, 8, 15 and 22.
- Take 20 mg of dexamethasone by mouth on days 1, 2, 8, 9, 15, 16, 22, 23, 29 and 30.
XPOVIO taken with dexamethasone alone
The recommended starting dose of XPOVIO in combination with dexamethasone is two times a week as follows:
- Take 80 mg (4 XPOVIO 20 mg tablets) by mouth twice a week on days 1 and 3 of each week.
- Take 20 mg of dexamethasone by mouth on days 1 and 3 of each week.
When to take XPOVIO
Take XPOVIO at about the same time on the days you are required to take it.
How to take XPOVIO
Swallow the tablets whole with water. Do not crush, chew, break, or divide the tablets. Take the tablets with or without food.
If you forget to use XPOVIO
If you miss your dose at the usual time, skip the dose you missed and take your next dose when you are next meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much XPOVIO
If you think that you have used too much XPOVIO, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using XPOVIO?
Things you should do
It is important for you to drink enough fluids to help prevent dehydration.
It is important to eat enough calories to help prevent weight loss.
Take all your medicines as prescribed by your doctor. These include dexamethasone and medicines to prevent or treat nausea, vomiting or diarrhoea.
Keep your appointments with your doctor and any blood tests.
Males and women capable of bearing children should abstain from sexual intercourse or use an effective form of contraception while taking this medicine and for at least 1 week after your last dose.
Take precautions against falling, especially if you are elderly. XPOVIO can cause dizziness, fainting, drowsiness, and fatigue.
Remind any doctor, dentist, or pharmacist you visit that you are taking XPOVIO.
Call your doctor straight away if you:
- become pregnant while taking this medicine.
Things you should not do
- Do not breastfeed while using this medicine and for at least 1 week after your last dose.
- Do not stop using this medicine or change the dose unless your doctor tells you to.
- Do not use this medicine for any other complaints unless your doctor tells you to.
- Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how XPOVIO affects you.
XPOVIO may cause fatigue, dizziness, and confusion in some people. Do not drive or use any machines if you experience any of these symptoms.
Looking after your medicine
- Store below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
- do not store it in the bathroom or near a sink, or
- do not store it in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
Nerve-related
Blood test-related
|
Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
Gut or stomach-related
Bleeding-related
Brain-related
Infection-related
Allergy-related
Others
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Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What XPOVIO contains
| Active ingredient (main ingredient) |
Each film-coated tablet contains 20 mg of selinexor |
| Other ingredients (inactive ingredients) |
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| Potential allergens | Not applicable |
Do not take this medicine if you are allergic to any of these ingredients.
What XPOVIO looks like
XPOVIO is a blue, round, curved, film-coated tablet with K20 debossed on one side and blank on the other side (Aust R 346589).
XPOVIO tablets are packed in blister foils in cartons.
Each pack contains 8, 12, 16, 20, 24 or 32 tablets. Not all pack sizes are available.
Who distributes XPOVIO
Antengene (Aus) Pty Ltd
Level 34, 140 William St
Melbourne VIC 3000
Version 2.0
® Registered Trademark
This leaflet was prepared in February 2023.
Published by MIMS May 2023