Nexpovio - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

NEXPOVIO 20 mg film-coated tablets selinexor

This medicinal product 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. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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.

What is in this leaflet

• 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

1. What NEXPOVIO is and what it is used for

NEXPOVIO contains the active substance selinexor. Selinexor is a cancer medicine known as an XPO1 inhibitor. It blocks the action of a substance called XPO1 that transports proteins from the cell nucleus into the cell cytoplasm. Some cell proteins must be in the nucleus in order to function properly.

By blocking XPO1 function, selinexor prevents the exit of certain proteins out of the nucleus, and interfering with the continued growth of cancer cells, and leading to the death of cancer cells.

What NEXPOVIO is used for

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

2. What you need to know before you take NEXPOVIO

Do not take NEXPOVIO

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

Warnings and precautions

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).

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.

Children and adolescents

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

Other medicines and NEXPOVIO

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

Pregnancy

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.

Breast -feeding

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.

Fertility

NEXPOVIO may impair fertility in females and males.

Contraception

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.

Driving and using machines

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.

NEXPOVIO contains sodium

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

3. How to take NEXPOVIO

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is: 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.

Method of use

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

Duration of use

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

If you take more NEXPOVIO than you should

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

If you forget to take NEXPOVIO

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.

If you stop taking NEXPOVIO

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you notice any of the following side effects.

NEXPOVIO may cause the following serious side effects :

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

• reduced number of blood platelets

Your doctor will carry out blood tests before you start taking NEXPOVIO, and as needed during and after treatment. These tests will be more frequent during the first two months of treatment to monitor your blood platelet counts. Your doctor may stop treatment or adjust the dose based on your platelet counts. Tell your doctor immediately if you have signs of reduced number of blood platelets such as: – easy or excessive bruising

• – skin changes that appear as a rash of pinpoint-sized reddish-purple spots

• – prolonged bleeding from cuts

• – bleeding from your gums or nose

• – blood in your urine or stools

• reduced number of red and white blood cells, including neutrophils and lymphocytes Your

doctor will carry out blood tests to monitor your red and white blood cell counts before you start taking NEXPOVIO and as needed during and after treatment. These tests will be more frequent during the first two months of treatment. Your doctor may stop treatment or adjust the dose based on your blood cell counts or may treat you with other medicines to increase cell counts. Tell your doctor immediately if you have signs of reduced neutrophils such as a fever.

• fatigue

Inform your doctor if you experience new or worsening fatigue. Your doctor may adjust the dose in case of persistent or worsening fatigue.

• nausea, vomiting, diarrhoea

Inform your doctor immediately if you develop nausea, vomiting or diarrhoea. Your doctor may adjust the dose or stop treatment based on the severity of your symptoms. In addition, your doctor may prescribe you medicines to take before or during NEXPOVIO treatment to prevent and treat nausea and/or vomiting and/or diarrhoea.

• decreased appetite and/or weight

Your doctor will weigh you before you start taking NEXPOVIO and as needed during and after treatment. This will be more frequent during the first two months of treatment. Tell your doctor if you lose your appetite and if you lose weight. Your doctor may adjust the dose in case of reduced appetite and weight and/or prescribe medicines to increase your appetite. Maintain adequate fluid and caloric intake throughout your treatment.

• reduced sodium level

Your doctor will carry out blood tests to check your sodium level before you start taking NEXPOVIO, and as necessary during and after treatment. These tests will be more frequent during the first two months of treatment. Your doctor may adjust the dose and/or prescribe salt tablets or fluids based on your sodium level.

• confusional state and dizziness

Inform your doctor if you experience confusion. Avoid situations where dizziness or confusional state may be a problem and do not take other medications that may cause dizziness or confusional state without talking to your doctor. Do not drive or operate machines if you experience any confusion or dizziness until it resolves. Your doctor may adjust the dose to reduce these symptoms.

Tell your doctor or nurse immediately if you notice any of the other following side effects as listed below.

Other possible side effects are:

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

• Pneumonia
• Upper respiratory tract infection
• Bleeding from nose
• Headache
• Dehydration
• Increased blood sugar level
• Decreased potassium level
• Loss of sleep (insomnia)
• Dizziness
• Impaired sense of taste
• Blurred vision
• Shortness of breath
• Cough
• Diarrhoea
• 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)
• Damage to nerves in the hands and feet that can cause tingling and numbness (peripheral

neuropathy)

• Fainting (syncope)
• Increase in heart rate (tachycardia)
• Low vision
• Loss of taste
• Taste disorder
• Balance disorder
• Cognitive disorder
• Disturbance in attention
• Memory impairment
• Cataract
• Low blood pressure (hypotension)
• 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
• Increase in muscle enzyme called creatine
• Loss of hair
• Night sweats

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)

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 national reporting system listed iny reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEXPOVIO

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 blister pack, the inner carton, and the outer carton after “EXP:” The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any damage or signs of tampering.

Do not throw away any medicines 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 NEXPOVIO contains

• 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”.

What NEXPOVIO looks like and contents of the pack

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 3, 4, 5, or 8 tablets, providing a total of 12, 16, 20, or 32 tablets.

Marketing Authorisation Holder and Manufacturer

Karyopharm Europe

GmbH 80339 München

Germany

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

Norge

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Österreich

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Polska

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Portugal

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

România

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Slovenija

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Slovenská republika

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Suomi/Finland

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

Sverige

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

United Kingdom (Northern Ireland)

Karyopharm Europe GmbH

Tel: +49 (0) 89 54 84 86 101

This leaflet was last revised in mm/yyyy.

This medicine has been given ‘conditional approval’.

This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency web site:

ANNEX IV

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

• Conditional marketing authorisation

The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.

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