Fostamatinib disodium

What is Fostamatinib disodium?

• Fostamatinib disodium (Tavalisse) is a kinase inhibitor used to treat thrombocytopenia (low platelet levels) in patients with chronic immune thrombocytopenic purpura (ITP) that did not get better with other treatment.
• ITP is a condition in which platelets are destroyed by the immune system.

Fostamatinib disodium

What are the uses of this medicine?

• Fostamatinib disodium (Tavalisse) is a prescription medicine that is used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough.

How does this medicine work?

• Fostamatinib (fos" ta ma' ti nib) is an orally available, specific inhibitor of spleen tyrosine kinase that is used to treat chronic immune mediated thrombocytopenia.
• The spleen tyrosine kinase (Syk) signaling pathway is important in phagocytosis and specifically the antibody mediated uptake and destruction of platelets by splenic macrophages in patients with immune thrombocytopenia.
• The Syk signaling pathway may also play a role in other immune cell types involved in inflammation and cell damage.
• Fostamatinib inhibits Syk kinase-mediated IgG Fc gamma receptor signaling, resulting in inhibition of the activation of mast cells, macrophages, and B-cells and related inflammatory responses and tissue damage.
• Syk kinase, widely expressed in hematopoietic cells, is a nonreceptor tyrosine kinase that is involved in coupling activated immunoreceptors to signal downstream events that mediate diverse cellular responses, including proliferation, differentiation, and phagocytosis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• clarithromycin (Biaxin, in Prevpac), digoxin (Lanoxin), itraconazole (Onmel, Sporanox), ketoconazole, rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and rosuvastatin (Crestor).

Is this medicine FDA approved?

• Fostamatinib was been shown to raise platelet counts in patients with refractory chronic immune thrombocytopenia and was approved for this use in the United States in 2018.
• Fostamatinib has also been evaluated in patients with rheumatoid arthritis, autoimmune hemolytic anemia and other immune-mediated conditions, but has not been specifically approved for these uses.

How should this medicine be used?

Recommended dosage:

• Initiate Tavalisse at 100 mg orally twice daily with or without food. After 4 weeks, increase to 150 mg twice daily, if needed, to achieve platelet counts of at least 50 × 109/L as necessary to reduce the risk of bleeding.
• Discontinue Tavalisse after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

Administration:

• Take Tavalisse with or without food.
• If you miss a dose of Tavalisse, take your next dose at its regularly scheduled time.
• If you take too much Tavalisse, call your healthcare provider right away or go to the nearest hospital emergency room right away.
• Your healthcare provider will check your platelet count during your treatment with Tavalisse and may change your dose of Tavalisse as needed.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg, 150 mg

This medicine is available in fallowing brand namesː

• Tavalisse

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• dizziness
• respiratory infection
• rash
• tiredness
• chest pain
• stomach (abdomen) pain

Tavalisse can cause serious side effects, including:

• hypertension
• Liver problems
• Diarrhea
• neutropenia

What special precautions should I follow?

• Hypertension can occur with Tavalisse treatment. Monitor blood pressure every 2 weeks until stable, then monthly. Manage hypertension using standard antihypertensive treatment and, if needed, interrupt, reduce or discontinue Tavalisse.
• Fostamatinib is associated with transient and usually mild elevations in serum aminotransferase levels during therapy but has yet to be linked to instances of clinically apparent acute liver injury. Elevated liver function tests (LFTs), mainly ALT and AST, can occur with Tavalisse. Monitor LFTs monthly. If LFT levels are elevated, interrupt, reduce or discontinue Tavalisse.
• Diarrhea occurred in patients treated with Tavalisse. Manage diarrhea with supportive measures. If diarrhea becomes severe, interrupt, reduce or discontinue Tavalisse.
• Neutropenia occurred in patients treated with Tavalisse. Monitor ANC monthly, and for infection. If neutrophil count decreases below 1.0 × 109/L, interrupt, reduce or discontinue Tavalisse.
• Tavalisse can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and the mechanism of action, Tavalisse can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: fostamatinib disodium hexahydrate Inactive ingredients: The tablet core contains mannitol, sodium bicarbonate, sodium starch glycolate, povidone, and magnesium stearate. The film coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow, and iron oxide red.

Who manufactures and distributes this medicine?

• Manufactured for: Rigel Pharmaceuticals, Inc., 1180 Veterans Blvd., South San Francisco, CA USA
• Manufactured by: Patheon, Inc., 111 Consumers Drive, Whitby, Ontario L1N Canada

What should I know about storage and disposal of this medication?

• Store Tavalisse at room temperature between 68°F and 77°F (20°C to 25°C).
• The bottle of Tavalisse contains 2 desiccant canisters that help keep your medicine dry.
• Do not remove the desiccant canisters from the bottle.

• Dailymed label info on Fostamatinib disodium
• FDA Fostamatinib disodium

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