TAVLESSE
Generic Name/API: fostamatinib disodium hexahydrate
Manufacturer: Instituto Grifols, S.A.
Dosage Forms & Strength & Pack Size:
Tablets: 100 mg and 150 mg, 60’s
Storage:
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package to protect from moisture. Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What TAVLESSE is
TAVLESSE contains the active substance fostamatinib. It specifically targets an enzyme called spleen tyrosine kinase, that plays an important part in the destruction of platelets. In this way TAVLESSE limits platelet destruction by the immune system and increases platelet count 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 an earlier treatment
for ITP has not worked well enough. ITP is an autoimmune disease, in which the body’s own immune system attacks and
destroys platelets in the blood. Platelets are needed to help create clots and stop bleeding.
Do not take TAVLESSE
• if you are allergic to fostamatinib or any of the other ingredients in this medicine (listed in section 6).
• if you are pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before taking TAVLESSE, about all of your medical conditions, particularly if you:
• have high blood pressure,
• have liver problems,
• are pregnant or plan to become pregnant,
• are breastfeeding or plan to breastfeed.
Tell your doctor, pharmacist or nurse immediately if you get any of the following symptoms while you are 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 severe. Your doctor will check your blood pressure regularly during treatment with this medicine. If
needed, your doctor may start you on blood pressure medicine or change your current medicine to treat your blood pressure.
Tell your doctor or pharmacist if you get headaches, confusion, dizziness, chest pain or shortness of breath.
• if your skin and eyes appear yellowish (jaundice) or if you get abdominal pain and swelling, swelling in your legs and ankles, itchy skin, abnormal dark urine, pale stool colour or bloody or tar-coloured stool, chronic fatigue, feeling or being sick in the stomach, and loss of appetite. Changes in liver function blood tests are common with this medicine. These may be symptoms of liver problems. Liver problems may occur and can be severe.
Your doctor will regularly carry out blood tests to check how well your liver is working during treatment with this medicine.
• if you get diarrhoea. This is common in people treated with this medicine and can be severe. Tell your doctor or pharmacist if you get diarrhoea during treatment with this medicine.
Your doctor may recommend changes in your diet, drinking more water, or give an antidiarrhoeal medicine to limit your symptoms.
• if you get a high fever (a sign of serious infection), chills, feel sick, or have a general feeling of being unwell. Your doctor will regularly do blood tests to check your white blood cell counts, and you may be told about a decrease in your white blood cell counts (neutropenia). Decreases in your white blood cell count
are common with this medicine and can be severe. This may increase your risk of infection, including serious infections.
Children and adolescents
TAVLESSE should not be used in patients less than 18 years of age. This medicine 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 may affect how the other medicines work and other medicines may affect how
TAVLESSE works.
In particular, tell your doctor if you are taking anything in this list:
• Ketoconazole, this medicine is typically used to treat fungal infections.
• Rifampicin, this medicine is typically used to treated bacterial infections.
• Simvastatin and rosuvastatin, these medicines are typically used to treat high cholesterol.
• Digoxin, this medicine is typically used to treat various heart conditions such as atrial fibrillation, atrial flutter and heart failure.
• Midazolam, this medicine is typically used for sedation or to treat anxiety.
• Anticoagulants, this medicine is typically used to prevent blood clotting.
• Nelfinavir, this medicine is typically used to treat HIV infection.
• Verapamil, this medicine it typically used to treat various heart conditions such as high blood pressure.
• Ranitidine, this medicine is typically used to treat heart burn.
• Ethinylestradiol, this medicine is typically used for birth control.
• Pioglitazone, this medicine is typically used to treat type 2 diabetes.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
