Package Insert: Information for the Patient

TAVLESSE 100 mg Film-Coated Tablets

TAVLESSE 150 mg Film-Coated Tablets

fostamatinib disodium hexahydrate

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

What is TAVLESSE

TAVLESSE contains the active ingredient 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 is TAVLESSE used for

TAVLESSE is used for the treatment of 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 the platelets in the blood. Platelets are necessary to help create clots and stop bleeding.

Do not take TAVLESSE

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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.

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

• if you have high blood pressure (hypertension). The appearance of hypertension or its worsening are frequent in people treated with TAVLESSE and can be serious. Your doctor will check your blood pressure periodically during treatment with this medication. If necessary, your doctor may start treating you with blood pressure medications or change the medication you are currently taking to treat blood pressure. Inform your doctor or pharmacist if you have headaches, confusion, dizziness, chest pain, or difficulty breathing.
• if you have yellow skin and eyes (jaundice) or if you experience abdominal pain, swelling, leg and ankle swelling, skin itching, abnormally dark urine, light-colored or bloody stools, or black stools, chronic fatigue, stomach discomfort, or vomiting, and loss of appetite. Changes in blood tests that measure liver function are frequent with this medication. They may be symptoms of liver problems. They may appear and be serious. Your doctor will perform blood tests periodically to check liver function during treatment with this medication.
• if you have diarrhea. This is something frequent in people treated with this medication and can be serious. Inform your doctor or pharmacist if you experience diarrhea during treatment with this medication. Your doctor may recommend changes to your diet or that you drink more water or give you an antidiarrheal medication to limit your symptoms.
• if you have high fever (a sign of severe infection), chills, or nausea, or have a general feeling of discomfort. Your doctor will perform blood tests periodically to check white blood cell counts and may tell you that you have a decrease in white blood cell count (neutropenia). Decreases in white blood cell counts are frequent with this medication and can be serious. This may increase the risk of infection, including severe infections.

Children and adolescents

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

Other medications and TAVLESSE

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The use of TAVLESSE with certain medications may affect the mechanism of action of other medications, and other medications may affect the mechanism of action of TAVLESSE. In particular, inform your doctor if you are taking any of the following medications:

• 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 clot formation.
• 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, breastfeeding, and fertility

Pregnancy

TAVLESSE should not be used during pregnancy. It may cause damage or congenital defects to the fetus.

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

If you are a woman and may become pregnant, you should use a reliable contraceptive method 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 medication.

Breastfeeding

It is not recommended to use TAVLESSE during breastfeeding. Do 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 medication.

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 men.

TAVLESSE - contains sodium

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

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

How much to take

Follow exactly the administration instructions for this medication as indicated 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 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 begun, the dose may be increased to 150 mg twice a day (one 150 mg tablet) based on platelet count and tolerability. Do not exceed a daily dose of 300 mg (two 150 mg tablets) per day.

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 severe side effects (such as high blood pressure, liver problems, diarrhea, or a decrease in 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 can be taken with food or between meals.

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

What to do 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.

What to do if you take too much TAVLESSE

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

What to do if you miss a dose

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

What to do if you stop taking TAVLESSE

It is essential to take TAVLESSE as long as your doctor prescribes it. Do not stop taking this medication unless your doctor tells you to.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

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

Severe side effects

TAVLESSE can cause severe side effects. Inform your doctor immediately if you experience any of the following severe side 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
• lung infection and inflammation (pneumonia). Signs are shortness of breath, chest pain, and mucus secretion that has changed color
• jaundice, abdominal pain and swelling, leg and ankle swelling, skin itching, dark urine, light-colored or bloody stools, or tar-like stools, chronic fatigue, stomach discomfort or vomiting, loss of appetite. They may be symptoms of liver problems.
• severe high blood pressure that can cause a stroke (hypertensive crisis). Signs are headache, confusion, dizziness

Other side effects

In addition to the severe side effects mentioned earlier, you may experience other side 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
• dizziness

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

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

Reporting side effects

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date refers to the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of TAVLESSE

• The active ingredient is fostamatinib disodium hexahydrate.

TAVLESSE 100 mg film-coated tablets

TAVLESSE 150 mg film-coated tablets

• The other components are:
• • Manitol, sodium bicarbonate, sodium carboxymethylcellulose (type A), povidone (K30), magnesium stearate. See section 2.
  • Film-coating: polyvinyl alcohol, titanium dioxide, macrogol (3350), talc, yellow iron oxide, red iron oxide

Appearance of the product and contents of the pack

TAVLESSE 100 mg film-coated tablets

The film-coated tablet is round, curved on both sides, with a dark orange film. The tablets bear 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 some 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. The tablets bear 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 some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona - Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:11/2024

For detailed information about this medicine, please visit the website of the European Medicines Agency:

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