100 mg and 150 mg film-coated tablets
fostamatinib disodium hexahydrate
What TAVLESSE is and what it is used for
What TAVLESSE is
TAVLESSE contains the active substance fostamatinib. It specifically targets an enzyme called splenic tyrosine kinase, which plays an important role in the breakdown of thrombocytes ( blood platelets ).
TAVLESSE thus limits the immune system’s breakdown of platelets and increases the number of platelets 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 previous treatment for ITP has not worked well enough. ITP is an autoimmune disease, where the body’s immune system attacks and breaks down platelets in the blood. Platelets are needed for the blood to clot and thus stop bleeding.
What you need to know before using 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
Before taking TAVLESSE, talk to your doctor or pharmacist about all your medical conditions, especially if you:
- have high blood pressure,
- have liver problems,
- are pregnant or planning to become pregnant,
- breastfeeding or planning to breastfeed.
Tell your doctor, pharmacist, or nurse immediately if you get any of the following symptoms while taking this medicine:
- if you have high blood pressure ( hypertension ). New or worsening high blood pressure is common in people treated with TAVLESSE and can be serious. Your doctor will regularly check your blood pressure while you are being treated with this medicine. If necessary, the doctor can start giving you a blood pressure-lowering medicine or change your current medicine for the treatment of blood pressure, etc. Tell your doctor or pharmacist if you experience headache, confusion, dizziness, chest pain, or shortness of breath,
- if your skin or eyes appear yellow (jaundice) or if you develop abdominal pain and swollen abdomen, swollen legs and ankles, itchy skin, abnormally dark urine, pale stools or bloody or tar-colored stools, chronic fatigue, feeling sick or vomiting, and loss of appetite. Changes in blood tests for liver function are common with this drug. These may be symptoms of liver problems. Liver problems can occur and can be serious. The doctor will take regular blood tests to check how well your liver is working while you are being treated with this medicine.
- if you get diarrhea. This is common in those receiving this medicine and can be serious. Tell your doctor or pharmacist if you get diarrhea during treatment with this medicine. The doctor may recommend that you change your diet, drink more water, or give you an anti-diarrhea medicine to limit the symptoms.
- if you develop a high fever (a sign of serious infection ), chills, feel sick or feel generally unwell. The doctor will take regular blood tests to check the number of white blood cells, and you may be told that the number of white blood cells has dropped ( neutropenia ). Decreases in the number of white blood cells are common with this drug and can be serious. This can increase your risk of infection, even severe infection.
Children and young people
TAVLESSE must not be used in patients under the age of 18. The drug 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 other medicines can affect how the other medicines work, and other medicines can affect how TAVLESSE works.
In particular, tell your doctor if you take anything from this list:
- Ketoconazole, this medicine is normally used to treat fungal infections.
- Rifampicin, this medicine is normally used to treat bacterial infections.
- Simvastatin and rosuvastatin, these drugs are normally used to treat high cholesterol.
- Digoxin, this drug is normally used to treat various heart diseases such as atrial fibrillation, atrial flutter, and heart failure.
- Midazolam, this drug is normally used for sedation or to treat anxiety.
- Anticoagulants, this drug is normally used to prevent the blood from clotting.
- Nelfinavir, this medicine is normally used to treat HIV infections.
- Verapamil, this drug is normally used to treat various heart diseases such as high blood pressure.
- Ranitidine, this medicine is normally used to treat heartburn.
- Ethinylestradiol, this drug is normally used as a contraceptive.
- Pioglitazone, this drug is normally used to treat type 2 diabetes.
Pregnancy, breastfeeding, and fertility
Pregnancy
TAVLESSE should not be used during pregnancy. It can harm your unborn child or cause birth defects.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are a woman of childbearing potential, you must use reliable contraception while taking TAVLESSE, and you must continue to use reliable contraception for at least 1 month after taking your last dose.
Contact your doctor immediately if you become pregnant while taking this medicine.
Breast-feeding
TAVLESSE is not recommended during breastfeeding. You should not breastfeed during treatment with TAVLESSE and for at least 1 month after your last dose.
If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine.
Fertility
TAVLESSE can affect a woman’s ability to get pregnant and have a baby. Talk to your doctor if you are concerned about this. There is no effect on men.
TAVLESSE contains sodium
TAVLESSE 100 mg film-coated tablets contain 23 mg sodium (the main ingredient in common/table salt) per tablet. This corresponds to 1.2 percent of the maximum recommended daily intake of dietary sodium for adults.
TAVLESSE 150 mg film-coated tablets contain 34 mg sodium (the main ingredient in common salt/table salt) per tablet. This corresponds to 1.7 percent of the maximum recommended daily intake of dietary sodium for adults.
How to take TAVLESSE
Recommended dose
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Before you start the treatment, the doctor will measure the number of platelets in your blood.
The recommended dose of TAVLESSE is 100 mg twice a day (one 100 mg tablet).
However, the doctor will check the platelet count during treatment with TAVLESSE and may change the dose as needed.
After you start treatment with TAVLESSE, the dose can be increased to 150 mg twice a day (one 150 mg tablet) based on the platelet count and how well you tolerate the medicine. A daily dose of 300 mg (two tablets of 150 mg) must not be exceeded.
If you do not get any effect from the treatment with fostamatinib, the doctor will stop the treatment.
If you have liver problems or high blood pressure, your doctor may give you a lower starting dose. If you experience serious side effects (such as high blood pressure, liver problems, diarrhea, or a reduced number of white blood cells ), the doctor may lower your dose or stop treatment temporarily or permanently.
How to take TAVLESSE
Swallow the tablets whole with water.
TAVLESSE can be taken with food or between meals.
In case of stomach upset, take the tablets with food.
If you feel sick
If you ever feel unwell after taking TAVLESSE, do not take another tablet. Take the next dose at the regularly scheduled time.
If you have taken too much TAVLESSE
If you have taken too much TAVLESSE, contact your doctor or pharmacist immediately or go to the nearest emergency department.
If you forget to take TAVLESSE
Do not take a double dose to make up for a forgotten tablet. Take the next dose at the regularly scheduled time
If you stop taking TAVLESSE
It is important to take TAVLESSE for as long as the doctor prescribes it. Do not stop taking TAVLESSE unless your doctor tells you to.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
TAVLESSE can cause serious side effects. Tell your doctor immediately if you get 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 levels of white blood cells (febrile neutropenia ) or infection
- diarrhea
- infection and inflammation of the lungs ( pneumonia ). Symptoms include feeling short of breath, chest pain and production of discolored mucus
- jaundice, abdominal pain and swollen stomach, swollen legs and ankles, itchy skin, abnormally dark urine, pale stools, or bloody or tar-colored stools, chronic fatigue, feeling sick or vomiting, loss of appetite. These may be symptoms of liver problems.
- severe increase in blood pressure that can lead to stroke (hypertensive crisis). The symptoms are headache, confusion, and dizziness.
Other side effects ar
In addition to the serious side effects mentioned above, you may also experience other side effects.
Very common (may affect more than 1 in 10 people):
- problems from the stomach and intestines, such as diarrhea, nausea, vomiting, and frequent bowel movements
- high blood pressure
- abnormal blood test results that show how your liver is working
- dizziness
Common (may affect up to 1 in 10 people):
- low white blood cell count or neutropenia
- stomach ache
- chest pain
- fatigue (exhaustion)
- flu-like symptoms
- infection in your nose and throat, such as sore throat and the common cold
- infection of the airways, such as bronchitis
- taste changes
- rash
- headache
How TAVLESSE should be stored
Keep this medicine out of the sight and reach of children.
No special temperature instructions. Store in the original packaging. Moisture sensitive. Close the jar well.
Use before the expiration date stated on the label after “Exp.” respectively “EXP”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is fostamatinib disodium hexahydrate.
TAVLESSE 100 mg film-coated tablets
TAVLESSE 150 mg film-coated tablets
- Other ingredients are:
- Mannitol, sodium bicarbonate, sodium starch glycolate (type A), povidone (K30), magnesium stearate
- Film coating: poly(vinyl alcohol), titanium dioxide, macrogol (3350), talc, iron oxide yellow, iron oxide red
Appearance and package sizes of the medicine
TAVLESSE 100 mg film-coated tablets
The tablet is round, domed on both sides with a dark orange film coating. The tablets are marked with “R” on one side and “100” on the other.
The tablets are supplied in cans of 30 and 60 film-coated tablets. Each jar contains 2 desiccants.
Not all pack sizes may be marketed.
TAVLESSE 150 mg film-coated tablets
The tablet is oval, domed on both sides with a light orange film coating. The tablets are marked with “R” on one side and “150” on the other.
The tablets are supplied in cans of 30 and 60 film-coated tablets. Each jar contains 2 desiccants.
Not all pack sizes may be marketed.
Instituto Grifols, SA
Can Guasc, 2 – Parets del Vallès 08150 Barcelona – Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
Grifols Nordic AB Tel: +46 8 441 89 50