Tavlesse 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

TAVLESSE 100 mg film-coated tablets

TAVLESSE 150 mg film-coated tablets

fostamatinib disodium hexahydrate

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What TAVLESSE is and what it is used for

What TAVLESSE is

TAVLESSE contains the active substance fostamatinib. It specifically acts on an enzyme called spleen tyrosine kinase, which plays an important role in the destruction of platelets. Thus, TAVLESSE limits the immune system's destruction of platelets and increases their number in the body. This helps reduce the risk of severe bleeding.

What TAVLESSE is used for

TAVLESSE is used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a previous ITP treatment has not been sufficiently effective. ITP is an autoimmune disease in which the body's own immune system attacks and destroys blood platelets. Platelets are necessary to help form clots and stop bleeding.

2. What you need to know before taking TAVLESSE

Do not take TAVLESSE

• if you are allergic to fostamatinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before starting TAVLESSE about all your medical conditions, especially if:

• you have high blood pressure,
• you have liver problems,
• you become pregnant or plan to become pregnant,
• you are breastfeeding or plan to breastfeed.

Immediately inform your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking this medicine:

• if you have high blood pressure (hypertension). High blood pressure may develop or worsen during treatment with TAVLESSE and can be serious. Your doctor will check your blood pressure periodically during treatment with this medicine. If necessary, your doctor may start you on blood pressure medication or change your current blood pressure treatment. Inform your doctor or pharmacist if you have headaches, confusion, dizziness, chest pain, or difficulty breathing.
• if you have yellowing of the skin or eyes (jaundice), or if you experience abdominal pain and swelling, swelling of the legs and ankles, skin itching, abnormally dark urine, pale stools, bloody or tar-like stools, persistent fatigue, stomach discomfort, vomiting, or loss of appetite. Changes in blood tests measuring liver function are common with this medicine. These may be signs of liver problems, which may occur and can be serious. Your doctor will perform periodic blood tests to monitor liver function during treatment with this medicine.
• if you have diarrhoea. This is common in people treated with this medicine and may be severe. Inform your doctor or pharmacist if you develop diarrhoea during treatment with this medicine. Your doctor may recommend dietary changes, increased fluid intake, or prescribe an anti-diarrhoeal medicine to help manage your symptoms.
• if you have high fever (a sign of serious infection), chills, nausea, or a general feeling of being unwell. Your doctor will perform periodic blood tests to monitor your white blood cell count and may inform you that you have a low white blood cell count (neutropenia). Decreased white blood cell counts are common with this medicine and can be serious. This may increase the risk of infections, including serious infections.

Children and adolescents

TAVLESSE must not be used in patients under 18 years of age. TAVLESSE has not been studied in this age group.

Other medicines and TAVLESSE

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

Taking TAVLESSE with certain medicines may affect how the other medicines work, and other medicines may affect how TAVLESSE works. In particular, inform your doctor if you are taking any of the following medicines:

• Ketoconazole, which is commonly used to treat fungal infections.
• Rifampicin, which is commonly used to treat bacterial infections.
• Simvastatin and rosuvastatin, which are commonly used to treat high cholesterol.
• Digoxin, which is commonly used to treat various heart conditions such as atrial fibrillation, atrial flutter, and heart failure.
• Midazolam, which is commonly used for sedation or to treat anxiety.
• Anticoagulants, which are commonly used to prevent blood clots.
• Nelfinavir, which is commonly used to treat HIV infection.
• Verapamil, which is commonly used to treat various heart conditions, such as high blood pressure.
• Ranitidine, which is commonly used to treat heartburn.
• Ethinylestradiol, which is commonly used as a contraceptive.
• Pioglitazone, which is commonly used to treat type 2 diabetes.

Pregnancy, breastfeeding, and fertility

Pregnancy

TAVLESSE must not be used during pregnancy. It may cause harm or birth defects to the unborn baby.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are a woman who can become pregnant, you must use a reliable method of contraception while taking TAVLESSE and continue using it for at least one month after the last dose.

Contact your doctor immediately if you become pregnant while taking this medicine.

Breastfeeding

Use of TAVLESSE is not recommended during breastfeeding. You must not breastfeed during treatment with TAVLESSE or for at least one month after the last dose.

If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine.

Fertility

TAVLESSE may affect a woman's ability to become pregnant and have children. Speak to your doctor if you have concerns about this. There is no effect in men.

TAVLESSE – contains sodium

[TAVLESSE 100 mg film-coated tablets]. This medicine contains 23 mg of sodium (a main component of cooking/table salt) in each tablet. This is equivalent to 1.2% of the maximum daily recommended sodium intake for an adult.

[TAVLESSE 150 mg film-coated tablets]. This medicine contains 34 mg of sodium (a main component of cooking/table salt) in each tablet. This is equivalent to 1.7% of the maximum daily recommended sodium intake for an adult.

3. How to take TAVLESSE

What dose should you take

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will measure your platelet count.

The recommended dose of TAVLESSE is 100 mg twice daily (one 100 mg tablet).

However, your doctor will monitor your platelet count during treatment with TAVLESSE and may adjust your dose if necessary.

Once treatment with TAVLESSE has started, the dose may be increased to 150 mg twice daily (one 150 mg tablet), depending on platelet count and tolerability. A daily dose exceeding 300 mg (two 150 mg tablets) per day should not be exceeded.

If you do not respond to treatment with fostamatinib, your doctor will discontinue treatment.

If you have liver problems or high blood pressure, your doctor may start treatment with a lower dose.

If you experience serious adverse effects (such as high blood pressure, liver problems, diarrhea, or decreased white blood cell count), your doctor may reduce your dose or temporarily or permanently discontinue treatment.

How to take TAVLESSE

Swallow the tablets whole with water.

TAVLESSE may be taken with food or between meals.

If you experience stomach discomfort, take the tablets with food.

If you vomit

If you vomit at any time after taking TAVLESSE, do not take an additional tablet. Take the next dose at the usual time.

If you take more TAVLESSE than you should

If you take too much TAVLESSE, call your doctor or pharmacist immediately or go to the nearest hospital emergency department.

If you forget to take TAVLESSE

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking TAVLESSE

It is important to continue taking TAVLESSE for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

TAVLESSE may cause serious adverse effects. Inform your doctor immediately if you experience any of the following serious adverse effects, either for the first time or if they worsen (see also section 2):

• high fever. Fever has been associated with low white blood cell counts (febrile neutropenia) or infection
• diarrhea
• infection and inflammation of the lungs (pneumonia). Signs include shortness of breath, chest pain, and discolored mucus production
• jaundice, abdominal pain and swelling, swelling of the legs and ankles, skin itching, abnormally dark urine, pale stools, bloody or tarry stools, chronic fatigue, stomach discomfort or vomiting, loss of appetite. These may be symptoms of liver problems.
• severe increase in blood pressure that may lead to stroke (hypertensive crisis). Signs include headache, confusion, dizziness

Other adverse effects

In addition to the serious adverse effects listed above, you may experience other adverse effects.

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

• gastrointestinal disorders, such as diarrhea, stomach discomfort or vomiting, and frequent bowel movements
• high blood pressure
• abnormal blood test results showing liver function abnormalities
• dizziness

Common (may affect up to 1 in 10 people):

• low white blood cell count or neutropenia
• stomach pain
• chest pain
• tiredness (fatigue)
• flu-like symptoms
• nose and throat infections, such as sore throat and common cold
• tracheal infection, such as bronchitis
• changes in taste sensation
• skin rash
• headache

Reporting of adverse effects

If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of TAVLESSE

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture. Keep the bottle tightly closed.

Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of TAVLESSE

• The active substance is fostamatinib disodium hexahydrate.

TAVLESSE 100 mg film-coated tablets

TAVLESSE 150 mg film-coated tablets

• The other components are:
  • Mannitol, sodium bicarbonate, sodium carboxymethyl starch (type A), povidone (K30), magnesium stearate. See section 2.
  • Film coating: poly(vinyl alcohol), titanium dioxide, macrogol (3350), talc, yellow iron oxide, red iron oxide

Appearance of the product and contents of the container

TAVLESSE 100 mg film-coated tablets

The film-coated tablet is round, biconvex, with a dark orange coating. The tablets are marked with the inscription «R» on one side and «100» on the other.

Available in bottles of 30 and 60 film-coated tablets. Each bottle contains 2 desiccants.

Only certain pack sizes may be marketed.

TAVLESSE 150 mg film-coated tablets

The film-coated tablet is oval, biconvex, with a light orange coating. The tablets are marked with the inscription «R» on one side and «150» on the other.

Available in bottles of 30 and 60 film-coated tablets. Each bottle contains 2 desiccants.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona - Spain

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 11/2024

Detailed information on this medicine is available on the website of the European Medicines Agency:

https://www.ema.europa.eu/en