Eltrombopag Krka

Leaflet accompanying the packaging: patient information

Eltrombopag Krka, 25 mg, coated tablets

Eltrombopag Krka, 50 mg, coated tablets

Eltrombopag Krka, 75 mg, coated tablets

Eltrombopag

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Eltrombopag Krka and what is it used for
• 2. Important information before taking Eltrombopag Krka
• 3. How to take Eltrombopag Krka
• 4. Possible side effects
• 5. How to store Eltrombopag Krka
• 6. Contents of the packaging and other information

1. What is Eltrombopag Krka and what is it used for

Eltrombopag Krka contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. The medicine is used to increase the number of platelets in the patient's blood.
Platelets are blood components that help reduce the risk of bleeding or prevent it.

• Eltrombopag Krka is used to treat a blood clotting disorder called primary immune thrombocytopenia (ITP) in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) and have not responded to them.

Primary immune thrombocytopenia is caused by a low number of platelets in the blood (thrombocytopenia). People with primary immune thrombocytopenia are more prone to bleeding. Symptoms that patients with primary immune thrombocytopenia may notice include petechiae (small, flat, red spots under the skin), bruising, nosebleeds, bleeding from the gums, and difficulty stopping bleeding in case of injury or trauma.

• Eltrombopag Krka may also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had difficulty due to side effects during interferon treatment. Many people with hepatitis C have a low platelet count, not only due to the disease but also as a result of the action of certain antiviral drugs used in treatment. Taking Eltrombopag Krka may help patients complete full treatment with antiviral drugs (peginterferon and ribavirin).

2. Important information before taking Eltrombopag Krka

When not to take Eltrombopag Krka

• If the patient is allergicto eltrombopag or any of the other ingredients of this medicine (listed in section 6 under "What Eltrombopag Krka contains"). ➔ Consult a doctorif the patient thinks they have the above condition.

Warnings and precautions

Before starting treatment with Eltrombopag Krka, the patient should discuss the following with their doctor:

• liver function disorders. Patients with low platelet count and advanced (long-term) liver disease are at higher risk of side effects, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag Krka outweigh the risks, the patient will be closely monitored during treatment.
• risk of blood clots in veins or arteries, or if there have been cases of blood clots in the family.

The risk of blood clots may be increased:

• if the patient is elderly
• if the patient has been immobilized for a long time
• if the patient has cancer
• if the patient is taking oral contraceptives or hormone replacement therapy
• if the patient has recently undergone surgery or had an injury
• if the patient is overweight
• if the patient smokes
• if the patient has advanced chronic liver disease➔ Tell your doctorbefore starting treatment if any of the above conditions apply to the patient. Do not take Eltrombopag Krka unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Krka, the doctor will perform tests to rule out this disease. If the patient has MDS and takes Eltrombopag Krka, MDS may worsen. ➔ Tell your doctor if any of the above situations apply to the patient.

Eye examination

The doctor will recommend an eye examination to detect cataracts. If the patient does not undergo routine eye examinations, the doctor should recommend regular examinations. The occurrence of any bleeding in the retina (layer of light-sensitive cells at the back of the eye) or near it may also be examined.

Regular tests will be necessary

Before starting treatment with Eltrombopag Krka, the doctor will perform blood tests to assess blood cells, including platelets. During treatment, these tests will be repeated at regular intervals.

Blood tests for liver function

Eltrombopag Krka may cause changes in blood test results that may indicate liver damage - increased activity of certain liver enzymes, in particular bilirubin and alanine and aspartate transaminase. If the patient is taking interferon-based treatment with Eltrombopag Krka for low platelet count associated with hepatitis C, some liver diseases may worsen.
Before starting treatment with Eltrombopag Krka and at regular intervals during treatment, the patient will undergo blood tests to assess liver function. It may be necessary to stop taking Eltrombopag Krka if the levels of these substances increase too much or if other symptoms of liver damage occur.
➔
Read the information in section 4 of this leaflet "Liver disorders".

Platelet count test

If the patient stops taking Eltrombopag Krka, there is a likelihood of a recurrence of low platelet count within a few days. The platelet count will be monitored, and the doctor will discuss appropriate precautions with the patient.
A very high platelet count may increase the risk of blood clots. However, blood clots can also occur when the platelet count is normal or too low. The doctor will adjust the dose of Eltrombopag Krka for the patient to avoid excessive increase in platelet count.

Seek immediate medical attentionif the patient experiences any of the following symptoms of a blood clot:

• swelling, painor tenderness of one leg
• sudden shortness of breath, especially with severe chest pain or rapid breathing
• abdominal pain, abdominal enlargement, blood in stool

Bone marrow tests

In patients with bone marrow disorders, medicines like Eltrombopag Krka may worsen these disorders. Changes in bone marrow may be indicated by abnormal blood test results. The doctor may order direct bone marrow tests during treatment with Eltrombopag Krka.

Tests to detect gastrointestinal bleeding

If the patient is taking interferon-based treatment with Eltrombopag Krka, they will be monitored for symptoms of stomach or intestinal bleeding after stopping treatment with Eltrombopag Krka.

Heart tests

The doctor may decide to perform a heart test on the patient during treatment with Eltrombopag Krka and perform an electrocardiogram (ECG).

Elderly patients (65 years and older)

There is limited data on the use of Eltrombopag Krka in patients aged 65 and older. Caution should be exercised when using Eltrombopag Krka in patients aged 65 and older.

Children and adolescents

Eltrombopag Krka is not recommended for children under 1 year of age with primary immune thrombocytopenia. The medicine is also not recommended for patients under 18 years of age with low platelet count associated with hepatitis C virus infection.

Eltrombopag Krka and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag Krka- including both prescription and over-the-counter medicines and mineral supplements. These include:

• antacids used to treat indigestion, heartburn, stomach ulcers(see also "When to take the medicine" in section 3)
• statins, cholesterol-lowering medicines
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplantsor immune system disorders
• mineral products, such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be components of vitamin and mineral supplements(see also "When to take the medicine" in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer. Consult a doctorif the patient is taking any of the above medicines. Some of them should not be taken during treatment with Eltrombopag Krka, while others may require dose adjustment or appropriate timing of administration. The doctor will review the patient's medicines and recommend changes if necessary.

If the patient is taking medicines to prevent blood clots, there is an increased risk of bleeding. The doctor will discuss this with the patient.
If the patient is taking corticosteroids, danazol, and (or) azathioprine, the doses of these medicines may be reduced or their use may be stopped during concurrent use of Eltrombopag Krka.

Taking Eltrombopag Krka with food and drink

Eltrombopag Krka should not be taken with dairy products or drinks, as the calcium in dairy products affects the absorption of the medicine. For more information, see "When to take the medicine" in section 3.

Pregnancy and breastfeeding

Do not take Eltrombopag Krka during pregnancy, unless the doctor recommends it.
The effect of Eltrombopag Krka taken during pregnancy is unknown.

• Tell your doctor if the patient is pregnant, thinks they may be pregnant, or plans to have a baby.
• Use appropriate contraceptionwhile taking Eltrombopag Krka to prevent pregnancy.
• Tell your doctor if the patient becomes pregnantwhile taking Eltrombopag Krka.

Do not breastfeed while taking Eltrombopag Krka.It is not known whether Eltrombopag Krka passes into breast milk.
➔
Tell your doctorif the patient is breastfeeding or plans to breastfeed.

Driving and using machines

Eltrombopag Krka may cause dizzinessand other side effects that reduce attention.
➔
Do not drive or operate machineryunless the patient is sure that these symptoms do not occur.

Eltrombopag Krka contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Eltrombopag Krka

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Krka unless the doctor or pharmacist recommends it. During treatment with Eltrombopag Krka, the patient will remain under the care of a doctor experienced in treating the patient's condition.

How much to take

In the case of primary immune thrombocytopenia

Adults and children(aged 6 to 17) - the usual starting dose for primary immune thrombocytopenia is one 50 mg tabletof Eltrombopag Krka per day.
Patients of East Asian/South-East Asian descent may require a lower starting dose of 25 mg.
Children(aged 1 to 5) - the usual starting dose for primary immune thrombocytopenia is one 25 mg tabletof Eltrombopag Krka per day.

In the case of hepatitis C

Adults- the usual starting dose for hepatitis C is one 25 mg tabletof Eltrombopag Krka per day. In patients of East Asian/South-East Asian descent, treatment should be started with the same dose of 25 mg.
The onset of action of Eltrombopag Krka may occur after 1 to 2 weeks. Depending on the patient's response to treatment with Eltrombopag Krka, the doctor may recommend a change in the daily dose.

How to take the tablets

Swallow the tablets whole with water.

When to take the medicine

Make sure that:

• 4 hours beforetaking Eltrombopag Krka
• and 2 hours aftertaking Eltrombopag Krka

the patient will notconsume the following foods:

• dairy products, such as cheese, butter, yogurt, ice cream
• milkor drinks containing milk, yogurt, or cream
• antacids used to treat indigestion and heartburn
• vitamin and mineral supplementscontaining iron, calcium, magnesium, aluminum, selenium, or zinc

If these recommendations are not followed, Eltrombopag Krka will not be properly absorbed by the body.

Consult a doctor for more information about suitable foods and drinks.

Taking a higher dose of Eltrombopag Krka than recommended

Consult a doctor or pharmacist immediately. If possible, show them the packaging of the medicine or this leaflet. The patient's condition will be monitored for potential side effects and appropriate treatment will be administered promptly.

Missing a dose of Eltrombopag Krka

Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Krka per day.

Stopping treatment with Eltrombopag Krka

Do not stop taking Eltrombopag Krka without consulting a doctor. If the doctor recommends stopping treatment, the patient's platelet count will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for: consult a doctor

In patients taking Eltrombopag Krka for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe side effects may occur. It is essential to inform the doctor about these symptoms.

Increased risk of blood clots

In some patients, there may be an increased risk of blood clots, and medicines like Eltrombopag Krka may worsen this. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may occur in no more than 1 in 100 patients.

Seek immediate medical attention if the patient experiences any symptoms of a blood clot, such as:

• swelling, pain, feeling of heat, rednessor tenderness of one leg
• sudden shortness of breath, especially with severe chest pain or rapid breathing
• abdominal pain, abdominal enlargement, blood in stool

Liver disorders

Eltrombopag Krka may cause changes in blood test results that may indicate liver damage. Liver disorders (increased enzyme activity in blood test results) are common and may occur in no more than 1 in 10 patients. Other liver problems are uncommon and may occur in no more than 1 in 100 patients.
If any of the following symptoms of liver disorders occur:

• yellowingof the skin or whites of the eyes (jaundice)
• abnormally dark urinetell your doctor immediately.

Bleeding or bruising after stopping treatment

Usually, within two weeks of stopping treatment with Eltrombopag Krka, the patient's platelet count returns to pre-treatment levels. A low platelet count may increase the risk of bleeding or bruising. The doctor will monitor the patient's platelet count for at least 4 weeks after stopping treatment with Eltrombopag Krka.
➔
Tell your doctorif the patient experiences bruising or bleeding after stopping treatment with Eltrombopag Krka.
In some patients, gastrointestinal bleedingmay occur after stopping treatment with peginterferon, ribavirin, and Eltrombopag Krka. Symptoms include:

• black, tarry stools (a change in stool color that is an uncommon side effect and may occur in no more than 1 in 100 patients)
• blood in stool
• vomiting blood or coffee grounds-like material ➔ Tell your doctor immediatelyif any of these symptoms occur.

The following side effects have been reported as associated with treatment with Eltrombopag Krka

in adult patients with primary immune thrombocytopenia:

Very common side effects

May occur in more than 1 in 10patients:

• common cold
• nausea
• diarrhea
• cough
• infection of the nose, sinuses, throat, and upper respiratory tract (upper respiratory tract infection)
• back pain

Very common side effects that may be detected in blood tests:

• increased activity of liver enzymes (alanine aminotransferase (ALT))

Common side effects

May occur in no more than 1 in 10patients:

• muscle pain, muscle spasms
• bone pain
• heavy menstrual bleeding
• throat pain and discomfort when swallowing
• eye disorders, including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• herpes simplex
• pneumonia
• sinusitis
• tonsillitis
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, numbness, or prickling sensations
• reduced skin sensation
• drowsiness
• ear pain
• pain, swelling, or tenderness of one leg (usually the calf) with warmth of the skin in the affected area (symptoms of deep vein thrombosis)
• localized swelling filled with blood from a damaged blood vessel (hematoma)
• hot flashes
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function disorders
• skin changes, including excessive sweating, rash, redness, itching, and skin discoloration
• hair loss
• foamy urine with air bubbles (symptoms of protein in the urine)
• high fever
• chest pain
• feeling of weakness
• sleep disturbances, depression
• migraine
• blurred vision
• dizziness
• flatulence

Common side effects that may be detected in blood tests:

• decreased red blood cell count (anemia)
• decreased platelet count (thrombocytopenia)
• decreased white blood cell count
• decreased hemoglobin level
• increased eosinophil count
• increased white blood cell count (leukocytosis)
• increased blood sugar level
• decreased potassium level
• increased creatinine level
• increased alkaline phosphatase activity
• increased liver enzyme activity (aspartate aminotransferase (AST))
• increased bilirubin level in the blood (a substance produced by the liver)
• increased protein levels

Uncommon side effects

May occur in no more than 1 in 100patients:

• allergic reaction
• interrupted blood flow to a part of the heart
• sudden shortness of breath, especially with severe chest pain and (or) rapid breathing, which may be a symptom of a blood clot in the lungs (see "Increased risk of blood clots" above in section 4)
• loss of function of a part of the lung due to blockage of the pulmonary artery
• possible pain, swelling, or redness in the area of the vein, which may be symptoms of a blood clot in the vein
• yellowing of the skin or abdominal pain, which may be symptoms of bile duct obstruction, liver disease, or liver damage due to inflammation (see "Liver disorders" above in section 4)
• liver damage due to the medicine
• rapid heartbeat, irregular heartbeat, blue discoloration of the skin, heart rhythm disorders (QT interval prolongation), which may be symptoms of heart and blood vessel disorders
• blood clot
• redness
• painful swelling of the joints due to uric acid (gout)
• depression, anxiety, sleep disturbances, mood changes
• balance, speech, and nerve function disorders, tremors
• painful or abnormal skin sensations
• paralysis of one side of the body
• migraine with aura
• nerve damage
• expansion or swelling of blood vessels causing headache
• eye disorders, including increased tearing, cataracts, retinal bleeding, dry eyes
• respiratory tract infections, breathing difficulties
• mouth ulcers or blisters, gum inflammation
• loss of appetite
• gastrointestinal disorders, including frequent bowel movements, food poisoning, stomach pain, constipation, bloating, taste disturbances, hemorrhoids, stomach pain or discomfort
• toothache
• liver function disorders, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage due to the medicine (see "Liver disorders" above in section 4)
• skin changes, including discoloration, peeling, redness, itching, and skin lesions
• joint pain, back pain, bone pain, limb pain (legs, arms, hands, or feet), muscle spasms
• irritability, general malaise, skin reaction, such as redness or swelling and pain at the injection site, chest pain or discomfort
• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), bronchitis
• depression, anxiety, sleep disturbances, nervousness

Uncommon side effects that may be detected in blood tests:

• changes in red blood cell shape
• presence of developing white blood cells, which may indicate certain diseases
• increased platelet count
• decreased calcium level
• decreased red blood cell count (anemia) due to excessive destruction of red blood cells (hemolytic anemia)
• increased myelocyte count
• increased neutrophil count
• increased urea level in the blood
• increased protein level in the urine
• increased albumin level in the blood
• increased total protein level
• decreased albumin level in the blood
• increased urine pH
• increased hemoglobin level

The following additional side effects have been reported as associated with treatment with Eltrombopag Krka

in children (aged 1 to 17) with ITP:

If these side effects worsen, tell your doctor, pharmacist, or nurse.

Very common side effects

May occur in more than 1 in 10children:

• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• high fever
• nausea

Common side effects

May occur in no more than 1 in 10children:

• difficulty sleeping (insomnia)
• toothache
• nose and throat pain
• itchy nose, runny nose, or nasal congestion
• throat pain, runny nose, and nasal congestion
• mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers

The following side effects have been reported as associated with treatment with Eltrombopag Krka

in combination with peginterferon and ribavirin in patients with HCV:

Very common side effects

May occur in more than 1 in 10patients:

• headache
• loss of appetite
• cough
• nausea, diarrhea
• muscle pain, muscle weakness
• itching
• fatigue
• fever
• unusual hair loss
• weakness
• flu-like illness
• swelling of the hands or feet
• chills

Very common side effects that may be detected in blood tests:

• decreased red blood cell count (anemia)

Common side effects

May occur in no more than 1 in 10patients:

• urinary tract infections
• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), bronchitis
• weight loss
• sleep disturbances, drowsiness, depression, anxiety
• dizziness, concentration and memory disorders, mood changes
• liver function disorders, including liver damage due to inflammation (see "Liver disorders" above in section 4)
• skin changes, including rash, dry skin, eczema, redness, itching, and sweating
• joint pain, back pain, bone pain, limb pain (legs, arms, hands, or feet), muscle spasms
• irritability, general malaise, skin reaction, such as redness or swelling and pain at the injection site, chest pain or discomfort
• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), bronchitis
• depression, anxiety, sleep disturbances, nervousness

Common side effects that may be detected in blood tests:

• increased blood sugar level
• decreased white blood cell count
• decreased neutrophil count
• decreased albumin level in the blood
• decreased hemoglobin level
• increased bilirubin level in the blood (a substance produced by the liver)
• changes in blood clotting enzymes

Uncommon side effects

May occur in no more than 1 in 100patients:

• pain when urinating
• heart rhythm disorders (QT interval prolongation)
• gastroenteritis (stomach and intestinal inflammation), throat pain
• mouth ulcers or blisters, gastritis
• skin changes, including discoloration, peeling, redness, itching, and skin lesions, and night sweats
• blood clots in the vein that carries blood to the liver (possible liver damage and (or) gastrointestinal disorders)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at the injection site, chest discomfort
• decreased red blood cell count (anemia) due to excessive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• liver failure

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Eltrombopag Krka

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eltrombopag Krka contains

• The active substance of the medicine is eltrombopag. Eltrombopag Krka, 25 mg, coated tablets Each coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. Eltrombopag Krka, 50 mg, coated tablets Each coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag. Eltrombopag Krka, 75 mg, coated tablets Each coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
• Other ingredients are: tablet core: povidone, microcrystalline cellulose, mannitol, hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate. tablet coating: hypromellose, macrogol, talc, titanium dioxide (E 171), iron oxide red (E 172) (only for 50 mg and 75 mg), iron oxide yellow (E 172) (only for 50 mg) and indigo carmine (E 132) (only for 50 mg and 75 mg). See section 2 "Eltrombopag Krka contains sodium".

What Eltrombopag Krka looks like and contents of the pack

Eltrombopag Krka, 25 mg, coated tablets are round, biconvex, white, with "25" embossed on one side.
Eltrombopag Krka, 50 mg, coated tablets are round, biconvex, brown, with "50" embossed on one side.
Eltrombopag Krka, 75 mg, coated tablets are round, biconvex, pink, with "75" embossed on one side.
Eltrombopag Krka is available in a carton containing 14, 28, 56, or 84 coated tablets, in calendar blisters, and in bulk packs containing 84 (3 packs of 28) coated tablets, in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer

Elpen Pharmaceutical Co. Inc.
95 Marathonos Ave.
19009 Pikermi, Attiki
Greece
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Strasse 5
27472 Cuxhaven
Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For more information about this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the leaflet:24.03.2025