Lusutrombopag Shionogi

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  • Lusutrombopag Shionogi
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Staðsetning

  • Fáanlegt í:
  • Lusutrombopag Shionogi
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antihemorrhagics,
  • Lækningarsvæði:
  • Thrombocytopenia
  • Ábendingar:
  • Lusutrombopag Shionogi is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/004720
  • Leyfisdagur:
  • 17-02-2019
  • EMEA númer:
  • EMEA/H/C/004720
  • Síðasta uppfærsla:
  • 26-05-2019

Opinber matsskýrsla

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/889817/2018

EMEA/H/C/004720

Lusutrombopag Shionogi (lusutrombopag)

An overview of Lusutrombopag Shionogi and why it is authorised in the EU

What is Lusutrombopag Shionogi and what is it used for?

Lusutrombopag Shionogi is a medicine used to prevent excessive bleeding in adults with

thrombocytopenia due to long-standing liver disease. Patients with thrombocytopenia have reduced

number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.

The medicine is for use in patients having an invasive procedure (a medical procedure that involves

cutting into or puncturing the skin or inserting instruments into the body).

Lusutrombopag Shionogi contains the active substance lusutrombopag.

How is Lusutrombopag Shionogi used?

Lusutrombopag Shionogi is available as 3-mg tablets. The medicine can only be obtained with a

prescription.

Treatment with Lusutrombopag Shionogi should start at least 8 days before the procedure and the

recommended dose is 1 tablet daily for 7 days.

For more information about using Lusutrombopag Shionogi, see the package leaflet or contact your

doctor or pharmacist.

How does Lusutrombopag Shionogi work?

In the body, a hormone called thrombopoietin stimulates the production of platelets by attaching to

receptors (targets) in the bone marrow. The active substance in Lusutrombopag Shionogi,

lusutrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet

count.

What benefits of Lusutrombopag Shionogi have been shown in studies?

In two main studies involving adults with low levels of platelets due to long-standing liver disease,

Lusutrombopag Shionogi increased platelet count before an invasive procedure and reduced the need

for transfusions.

The first study, involving 96 adults, found that 79% of patients who took Lusutrombopag Shionogi did

not require a transfusion of platelets before their procedure, compared with 13% of patients who

received placebo (a dummy treatment). The second study involving 215 adults found that 65% of

patients who took Lusutrombopag Shionogi did not require platelet transfusion before their procedure,

compared with 29% of patients who received placebo.

What are the risks associated with Lusutrombopag Shionogi?

Unwanted effects that occurred in studies involving patients taking Lusutrombopag Shionogi were

headache, nausea (feeling sick), portal vein thrombosis (a blockage in the blood vessel that carries

blood from the intestines to the liver) and rash. Similar effects occurred in patients receiving placebo.

For more information on the side effects and restrictions of Lusutrombopag Shionogi, see the package

leaflet.

Why is Lusutrombopag Shionogi authorised in the EU?

Studies have found that Lusutrombopag Shionogi increases platelet count, thereby lowering the risk of

excessive bleeding during or after an invasive procedure and reducing the need for transfusing

platelets. Unwanted effects that occurred in studies are thought to result from patients’ medical

condition and the nature of the invasive procedure for which Lusutrombopag Shionogi was used.

The European Medicines Agency decided that Lusutrombopag Shionogi’s benefits are greater than its

risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

Lusutrombopag Shionogi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Lusutrombopag Shionogi have been included in the summary of product

characteristics and the package leaflet.

As for all medicines, data on the use of Lusutrombopag Shionogi are continuously monitored. Side

effects reported with Lusutrombopag Shionogi are carefully evaluated and any necessary action taken

to protect patients.

Other information about Lusutrombopag Shionogi

Lusutrombopag Shionogi received a marketing authorisation valid throughout the EU on 18 February

2019.

Further information on Lusutrombopag Shionogi can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/lusutrombopag-shionogi

This overview was last updated in 03-2019.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Lusutrombopag Shionogi 3 mg film-coated tablets

lusutrombopag

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. 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, pharmacist, or nurse.

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, pharmacist, or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Lusutrombopag Shionogi is and what it is used for

What you need to know before you take Lusutrombopag Shionogi

How to take Lusutrombopag Shionogi

Possible side effects

How to store Lusutrombopag Shionogi

Contents of the pack and other information

1.

What Lusutrombopag Shionogi is and what it is used for

Lusutrombopag Shionogi contains the active substance lusutrombopag, which belongs to a group of

medicines called thrombopoietin receptor agonists. The medicine helps to increase the number of

platelets

in your blood. Platelets are blood components that help the blood to clot and so prevent

bleeding.

Lusutrombopag Shionogi is used to

reduce the risk of bleeding during surgery and other

procedures (

including tooth extractions and endoscopy). It is given to adults who have low numbers

of platelets because of chronic liver disease.

2.

What you need to know before you take Lusutrombopag Shionogi

Do not take Lusutrombopag Shionogi:

-

if you are allergic

to lusutrombopag or any of the other ingredients of this medicine (listed in

section 6 under ‘

What Lusutrombopag Shionogi contains

’).

Check with your doctor

if this applies to you before you take Lusutrombopag Shionogi

Warnings and precautions

Talk to your doctor:

-

if you are at risk of blood clots

in your veins or arteries, or if you previously have had blood

clots

-

if you have severe liver disease

-

if your spleen has been removed

-

if you are having interferon treatment.

Talk to your doctor

before taking Lusutrombopag Shionogi, if any of these applies.

Signs of a blood clot:

look out for any of the signs

below

:

swelling, pain, heat, redness,

or tenderness in

your leg

sudden shortness of breath

, especially with sharp pain in the chest or rapid breathing

pain in the abdomen

(tummy), swollen abdomen, blood in your stools.

Get medical help immediately

if you notice any of these.

Children and adolescents

Do not give this medicine to children or adolescents under the age of 18 years, because the medicine

has not been studied in children and adolescents.

Other medicines and Lusutrombopag Shionogi

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

Pregnancy and breast-feeding

Do not take Lusutrombopag Shionogi

if you are pregnant unless your doctor specifically

recommends it. The effect of Lusutrombopag Shionogi during pregnancy is not known.

Tell your doctor

if you are pregnant, think you may be pregnant, or are planning to have

a baby.

Use reliable methods of contraception

while

you are taking Lusutrombopag Shionogi.

If you do become pregnant

during treatment with Lusutrombopag Shionogi, tell your

doctor

immediately

Do not breast-feed during treatment

with Lusutrombopag Shionogi, as it is not known if the

medicine passes into milk.

→ If you are already breast-feeding,

talk to your doctor immediately.

Driving and using machines

Lusutrombopag Shionogi has no known effects on your ability to drive or to use machines.

Lusutrombopag Shionogi contains sodium

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

free’.

3.

How to take Lusutrombopag Shionogi

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Recommended dose

: take one tablet once a day, at the same time each day, for seven days only. Take

the tablet with a liquid and swallow it whole. Do not chew, break, or crush the tablet. You can take it

with food or between meals.

Your treatment will start at least 8 days before your surgery or procedure. Do not change the dose or

schedule for taking Lusutrombopag Shionogi unless your doctor or pharmacist tells you to.

If you have severe liver disease,

tell your doctor before taking Lusutrombopag Shionogi.

If you take more than you should

If you have taken more Lusutrombopag Shionogi than you should, talk to your doctor or go to the

hospital. If possible, show them the pack, or this leaflet. You may be monitored for side effects

associated with excessive platelets such as blood clots (see section 2, ‘

Warnings and precautions’

, and

section 4, ‘

Possible side effects

’).

If you forget to take a tablet

If you miss a tablet of Lusutrombopag Shionogi, take it as soon as you remember on the same day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lusutrombopag Shionogi

Do not stop taking Lusutrombopag Shionogi without talking to your doctor and do not take

Lusutrombopag Shionogi for more than 7 days.

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.

Higher risk of blood clots

Certain people may have a higher risk of blood clots, including people with liver disease, and

medicines like Lusutrombopag Shionogi could make this problem worse.

Signs of a blood clot:

look out for any of the signs below:

swelling, pain, heat, redness,

or tenderness in

your leg

sudden shortness of breath

, especially with sharp pain in the chest or rapid breathing

pain in the abdomen

(tummy), swollen abdomen, blood in your stools.

Get medical help immediately

if you notice any of these.

Common

side effects

(may affect up to 1 in 10 people)

Headache

Nausea

Blood clot in the liver (portal vein thrombosis)

Rash.

Reporting of side effects

If you get any side effects, talk to your doctor, 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 in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Lusutrombopag Shionogi

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 blisters after EXP. The

expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

This medicine does not require any special temperature storage conditions.

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 Lusutrombopag Shionogi contains

The active substance is lusutrombopag. Each film-coated tablet contains 3 mg lusutrombopag.

The other ingredients are:

Tablet core:

mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate,

hydroxypropylcellulose, carmellose calcium and magnesium stearate

Film coating:

hypromellose, titanium dioxide, triethyl citrate, talc and red-ferric oxide (E172)

What Lusutrombopag Shionogi looks like and contents of the pack

Lusutrombopag Shionogi 3 mg film-coated tablets are light red, 7 mm, round, film-coated tablets

debossed with the Shionogi trademark above the identifier code “551” on one side and debossed with

the strength “3” on the other side.

Lusutrombopag Shionogi is supplied in aluminium blisters in a carton containing 7 film-coated tablets.

Marketing Authorisation Holder

Shionogi B.V.

Kingsfordweg 151,

1043GR Amsterdam

The Netherlands

Manufacturer

Manufacturing Packaging Farmaca (MPF) B.V.

Appelhof 13

Oudehaske

8465RX

The Netherlands

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

Authorisation Holder:

AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT,

LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK

Shionogi B.V. Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:

+31 (0) 207038327

contact@shionogi.eu

DE

Shionogi GmbH

Tel: +49 (0)89 2109 3049

kontakt@shionogi.eu

ES

Shionogi SLU

Tel: +34 911 239 258

contacta@shionogi.eu

IT

Shionogi Srl

Tel: +39 06 94 805 118

contattaci@shionogi.eu

UK

Shionogi Limited

Tel: +44 (0)20 3053 4190

contact@shionogi.eu

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu.