TAVLESSE 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

TAVLESSE 100 mg film-coated tablets

TAVLESSE 150 mg film-coated tablets

fostamatinib disodium hexahydrate

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.

Contents of the pack

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

1. What is TAVLESSE and what is it used for

What is TAVLESSE

TAVLESSE contains the active substance fostamatinib. It acts specifically on an enzyme called spleen tyrosine kinase, which plays an important role in the destruction of platelets. In this way, TAVLESSE limits the destruction of platelets by the immune system and increases their number in the body. This helps to 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 previous ITP treatment has not been effective enough. ITP is an autoimmune disease in which the body's immune system attacks and destroys the platelets in the blood. Platelets are needed to help create clots and stop bleeding.

2. What you need to know before you take 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

Tell 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 breast-feeding or plan to breast-feed.

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

• if you have high blood pressure (hypertension). The onset of hypertension or its worsening is common in people treated with TAVLESSE and can be severe. Your doctor will check your blood pressure periodically during treatment with this medicine. If necessary, your doctor may start treating you with blood pressure medications or change the medication you are currently taking to treat high blood pressure. Tell your doctor or pharmacist if you have headaches, confusion, dizziness, chest pain, or difficulty breathing.
• if you have yellowing of the skin and eyes (jaundice) or if you have abdominal pain and swelling, swelling of the legs and ankles, itching of the skin, abnormally dark urine, light-colored stools, or bloody or tarry stools, chronic fatigue, stomach upset, or vomiting and loss of appetite. Changes in blood tests that measure liver function are common with this medicine. They can be symptoms of liver problems. Liver problems can occur and can be severe. Your doctor will perform periodic blood tests to check liver function during treatment with this medicine.
• if you have diarrhea. This is common in people treated with this medicine and can be severe. Tell your doctor or pharmacist if you have diarrhea during treatment with this medicine. Your doctor may recommend changes in your diet or that you drink more water or give you an anti-diarrheal medication to limit your symptoms.
• if you have a high fever (a sign of severe infection), chills, or nausea, or have a general feeling of being unwell. Your doctor will perform periodic blood tests to check your white blood cell count and may tell you that you have a low white blood cell count (neutropenia). Low white blood cell counts are common with this medicine and can be severe. This can increase the risk of infection, including severe infections.

Children and adolescents

TAVLESSE should 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 take any other medicines.

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

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

Pregnancy, breast-feeding, and fertility

Pregnancy

TAVLESSE should 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 to use it for at least one month after taking the last dose.

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

Breast-feeding

TAVLESSE is not recommended during breast-feeding. You should not breast-feed while taking TAVLESSE and for at least one month after the last dose.

If you are breast-feeding or plan to breast-feed, consult your doctor or pharmacist before using this medicine.

Fertility

TAVLESSE may affect a woman's ability to become pregnant and have a child. Talk to your doctor if this concerns you. There is no effect on males.

TAVLESSE contains sodium

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

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

3. How to take TAVLESSE

How much to take

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

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

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

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

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

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

If you experience severe side effects (such as high blood pressure, liver problems, diarrhea, or low white blood cell count), your doctor may reduce your dose or stop treatment temporarily or permanently.

How to take TAVLESSE

Swallow the tablets whole with water.

TAVLESSE can be taken with or without food.

If you have stomach upset, take the tablets with food.

If you vomit

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

If you take more TAVLESSE than you should

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

If you forget to take TAVLESSE

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

If you stop taking TAVLESSE

It is important that you take TAVLESSE while your doctor prescribes it for you. Do not stop taking this medicine unless your doctor tells you to.

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

4. Possible side effects

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

Serious side effects

TAVLESSE can cause serious side effects. Tell your doctor immediately if you experience any of the following serious side effects, either for the first time or if they get worse (see also section 2):

• high fever. Fever has been associated with low white blood cell counts (febrile neutropenia) or with infection
• diarrhea
• infection and inflammation of the lungs (pneumonia). The signs are shortness of breath, chest pain, and coughing up mucus that has changed color
• jaundice, abdominal pain and swelling, swelling of the legs and ankles, itching of the skin, abnormally dark urine, light-colored stools, or bloody or tarry stools, chronic fatigue, stomach upset, or vomiting and loss of appetite. These can be symptoms of liver problems.
• severe increase in blood pressure that can cause a stroke (hypertensive crisis). The signs are headache, confusion, dizziness

Other side effects

In addition to the serious side effects mentioned above, you may experience other side effects.

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

• gastrointestinal disorders, such as diarrhea, stomach upset, or vomiting and frequent bowel movements
• high blood pressure
• abnormal results in blood tests that show liver function
• dizziness

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

• low white blood cell count or neutropenia
• stomach pain
• chest pain
• fatigue
• flu-like symptoms
• nose and throat infections, such as sore throat and common cold
• trachea infection, such as bronchitis
• taste disturbances
• skin rash
• headache

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. Storing TAVLESSE

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

This medicine does not require any special storage conditions. Keep the bottle tightly closed and store in the original package to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What is in TAVLESSE

• The active substance is fostamatinib disodium hexahydrate.

TAVLESSE 100 mg film-coated tablets

TAVLESSE 150 mg film-coated tablets

• The other ingredients are:
• • mannitol, sodium bicarbonate, sodium carboxymethylcellulose (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 and packaging

TAVLESSE 100 mg film-coated tablets

The film-coated tablet is round, curved on both sides, with an orange-brown film coating. The tablets are marked with "R" on one side and "100" on the other.

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

Not all pack sizes may be marketed.

TAVLESSE 150 mg film-coated tablets

The film-coated tablet is oval, curved on both sides, with a light orange film coating. The tablets are marked with "R" on one side and "150" on the other.

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

Not all 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 about this medicine, contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:11/2024

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

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