• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What NEXPOVIO is and what it is used for
2. What you need to know before you take NEXPOVIO
3. How to take NEXPOVIO
4. Possible side effects
5. How to store NEXPOVIO
6. Contents of the pack and other information

NEXPOVIO is used to treat adult patients with multiple myeloma that has come back after treatment. NEXPOVIO is used

• together with two other medicines called bortezomib and dexamethasone in people who had at least one other prior treatment.
  OR
• together with dexamethasone in patients who have received at least four previous types of myeloma treatment and whose disease cannot be controlled with prior medicines used to treat multiple myeloma.

Multiple myeloma is a cancer which affects a type of blood cell called the plasma cell. A plasma cell normally produces proteins to fight infections. People with multiple myeloma have cancerous plasma cells, also called myeloma cells, which can damage bones and kidneys and increase the risk of infection. Treatment with NEXPOVIO kills myeloma cells and reduces symptoms of the disease.

If you are allergic to selinexor or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking NEXPOVIO and during treatment if you:

• have or have had bleeding problems.
• have had a recent infection or get an infection.
• have nausea, vomiting or diarrhoea.
• lose your appetite or lose weight.
• have confusion and dizziness.
• have a decrease in your blood sodium levels (hyponatraemia).
• have a new or worsening cataract.

Your doctor will examine you and you will be monitored closely during treatment. Before starting NEXPOVIO and during treatment, you will have blood tests to check that you have enough blood cells.

NEXPOVIO should not be given to children and adolescents under 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

A pregnancy test is recommended before NEXPOVIO treatment for women able to have children.

Do not use NEXPOVIO during pregnancy as it can harm the unborn child. Women who become pregnant while taking NEXPOVIO must immediately stop treatment and inform the doctor.

Do not breast-feed during treatment with NEXPOVIO or 1 week after the last dose, as it is unknown whether selinexor or its metabolites are excreted in human milk and cause harm to the breast-fed children.

NEXPOVIO may impair fertility in females and males.

Women who can become pregnant must use effective contraception during treatment and for at least 1 week after the last dose.

Men are recommended to use effective contraceptive measures or avoid sexual intercourse with women able to have children during treatment and for at least 1 week after the last dose.

NEXPOVIO can cause fatigue, confusion and dizziness. Do not drive or use machines if you get such a reaction while being treated with this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 20 mg tablet, that is to say essentially ‘sodium-free’.

• when used together with bortezomib and dexamethasone: 100 mg (5 tablets) once daily, on day 1 of each week, or as directed by your doctor.
• when used with dexamethasone: 80 mg (4 tablets) once daily, on days 1 and 3 of each week, or as directed by your doctor.

Your doctor may alter your dose if side effects occur.

It is important to take this medicine exactly as your doctor has told you to avoid dosing errors.

Swallow NEXPOVIO tablets whole with a glassful of water, either with food or between meals. Do not chew, crush, divide or break the tablets in order to prevent risk of skin irritation from the active substance.

Your doctor will let you know the duration of treatment based on how you are responding to treatment and side effects.

Call your doctor or go to the nearest hospital emergency room right away. Take your box of NEXPOVIO tablets with you.

Do not take a double dose to make up for a forgotten dose. Also, do not take an extra dose if you vomit after taking NEXPOVIO. Take your next dose when scheduled.

Do not stop taking or change your dose of NEXPOVIO without your doctor’s approval. However, if you become pregnant while taking NEXPOVIO, you must immediately stop treatment and inform your doctor.

Very common (may affect more than 1 in 10 people):

• Pneumonia
• Upper respiratory tract infection
• Bronchitis
• Viral infection of the nose and throat (Nasopharyngitis)
• Damage to nerves in the hands and feet that can cause tingling and numbness (peripheral neuropathy)
• Bleeding from nose
• Headache
• Dehydration
• Increased blood sugar level
• Decreased potassium level
• Loss of sleep (insomnia)
• Impaired sense of taste
• Blurred vision
• Shortness of breath
• Cough
• Abdominal pain
• Constipation
• Loss of energy
• Fever

Common (may affect more than 1 in 100 people)

• Bacterial infection in the blood
• The body normally releases chemicals into the blood stream to fight an infection, when the body’s response to these chemicals is out of balance, triggering changes that can damage multiple organ systems (sepsis)
• Reduced number of neutrophils with fever
• Decreased phosphate level
• Increase potassium level
• Decreased calcium level
• Decreased magnesium level
• Mental confusion (hallucination)
• Increased amylase and lipase level
• Increased uric acid level
• Confusing thinking (delirium)
• Fainting (syncope)
• Increase in heart rate (tachycardia)
• Low vision
• Loss of taste
• Taste disorder
• Balance disorder
• Cognitive disorder
• Disturbance in attention
• Memory impairment
• Low blood pressure (hypotension)
• Spinning sensation (vertigo)
• Indigestion, dry mouth, abdominal discomfort
• Flatulence or bloating
• Skin itchiness
• Muscle spasm
• Kidney problems
• General physical health deterioration, gait disturbance, malaise, chills
• Increased levels of liver enzymes (alanine aminotransferase, aspartate amino transferase, and alkaline phosphatase)
• Fall
• Memory impairment, including amnesia
• Increase in muscle enzyme called creatine
• Loss of hair
• Night sweats including excessive sweating
• Lower respiratory tract infection
• Bruise

Uncommon (may affect up to 1 in 100 people):

• rapid break down of tumour cells that could be potentially life-threatening and cause the symptoms as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath (tumour lysis syndrome)
• inflammation of brain that could cause confusion, headache, seizures (encephalopathy)

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 MHRA 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.

• The active substance is selinexor. Each film-coated tablet contains 20 mg selinexor.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone K30, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate. For the tablet coating the ingredients are talc, poly(vinyl alcohol) partially hydrolysed, glyceryl monostearate, polysorbate 80, titanium dioxide, macrogol, indigo carmine aluminium lake and brilliant blue FCF aluminium lake. See section 2 “NEXPOVIO contains sodium”.

NEXPOVIO film-coated tablets are blue, round, with “K20” debossed on one side.

Each outer carton contains four child-resistant inner packs. Each inner pack contains one plastic blister with 2, 3, 4, 5, or 8 tablets, providing a total of 8, 12, 16, 20, or 32 tablets.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: