Fostamatinib
Fostamatinib is a kinase inhibitor used to treat low platelet counts (thrombocytopenia) in adults with chronic immune thrombocytopenia (ITP) who have not responded well enough to earlier treatments.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fostamatinib (Tavalisse) treats low platelet counts in adults with chronic immune thrombocytopenia (ITP, where the immune system destroys platelets) after an earlier treatment fell short, and it blocks an enzyme called SYK that drives that attack; on the market since about 2018, it is a specialist, later-line option. Most people manage it reasonably well, though diarrhea is common, along with nausea or dizziness at times, and the dose can be lowered or paused if it lingers. The one thing to watch is blood pressure, which can climb, so expect checks every two weeks until it is stable, then monthly, plus monthly blood tests for liver enzymes and white blood cells.
Clinical pearls
- Rifampin can blunt it, and it raises simvastatin, rosuvastatin and digoxin levels, so every prescriber needs your full medicine list.
- Take doses about 12 hours apart, with or without food, and if one is missed, skip it rather than doubling up.
- A pregnancy test comes first, and birth control is needed during treatment and for a month or more after stopping.
- A fever or new infection deserves a prompt call, because it can lower the white cells that fight infection.
Patient information guide A plain-language walkthrough of Fostamatinib, written from its FDA label.
What Fostamatinib is used for
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Fostamatinib is approved for one condition across the currently available product evidence:
- Chronic immune thrombocytopenia (ITP) in adults — Tavalisse tablets are indicated for adults with ITP who have low platelet counts and have not responded sufficiently to at least one previous ITP treatment.
How Fostamatinib works
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Fostamatinib is a prodrug — after you swallow a tablet, your gut converts it into its active form, a molecule called R406. R406 blocks an enzyme called spleen tyrosine kinase (SYK), which plays a key role in the immune signals that trigger the body to destroy platelets. By blocking SYK, R406 disrupts the process by which antibodies tag platelets for destruction, allowing platelet counts to rise.
Fostamatinib dosage
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Tavalisse tablets are taken orally twice daily and can be swallowed with or without food. Treatment is started at a lower dose; if the platelet count hasn't reached the target level after about a month, the dose may be increased. The goal is to use the lowest dose that keeps platelets at a safe level.
- Take doses roughly 12 hours apart, at consistent times each day.
- If you miss a dose, skip it and take your next dose at the regular time — never double up.
- If platelet counts don't improve sufficiently after 12 weeks, your prescriber will likely stop treatment.
Dosing details from the FDA-approved label
From the Fostamatinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (initial)
- Initiate TAVALISSE at a dose of 100 mg taken orally twice daily
- May be taken with or without food
- In the case of a missed dose, take the next dose at its regularly scheduled time
- Dose increase if platelet count has not increased
- After a month, if platelet count has not increased to at least 50 × 10 9 /L, increase to 150 mg twice daily
- Use the lowest dose to achieve and maintain a platelet count at least 50 × 10 9 /L as necessary to reduce the risk of bleeding
- Maximum: 300 mg/day (150 mg twice daily)
- May be taken with or without food
- Dose reduction for adverse reactions (Table 1)
- 300 mg/day (150 mg AM, 150 mg PM) reduces to 200 mg/day (100 mg AM, 100 mg PM)
- Then 150 mg/day (150 mg once daily in the morning)
- Then 100 mg/day (100 mg once daily)
- If further dose reduction below 100 mg/day is required, discontinue TAVALISSE
- Discontinuation for lack of response
- Discontinue TAVALISSE after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding
- Concomitant strong CYP3A4 inhibitor
- Monitor for toxicities that may require TAVALISSE dose modifications (see Table 1)
- Exposure to R406 (the major active metabolite) is increased
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 × 10 9 /L as necessary to reduce the risk of bleeding. ( 2.1 ) Manage adverse reactions using dose reduction, interruption of treatment, or discontinuation. ( 2.3 ) Discontinue TAVALISSE after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding. ( 2.5 ) 2.1 Recommended Dosage Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. After a month, if platelet count has not increased to at least 50 × 10 9 /L, increase TAVALISSE dose to 150 mg twice daily. Use the lowest dose of TAVALISSE to achieve and maintain a platelet count at least 50 × 10 9 /L as necessary to reduce the risk of bleeding. TAVALISSE may be taken with or without food. In the case of a missed dose of TAVALISSE, instruct patients to take their next dose at its regularly scheduled time. 2.2 Monitoring After obtaining baseline assessments: Monitor CBCs, including platelet counts, monthly until a stable platelet count (at least 50 × 10 9 /L) is achieved. Thereafter, continue to monitor CBCs, including neutrophils, regularly. Monitor liver function tests (LFTs) (e.g., ALT, AST, and bilirubin) monthly. Monitor blood pressure every 2 weeks until establishment of a stable dose, then monthly thereafter. 2.3 Dose Modification for Adverse Reactions TAVALISSE dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions may require dose-interruption, reduction, or discontinuation. A dose reduction schedule is provided in Table 1, based on daily dose. For example, if a patient is on the maximum dose at the time of an adverse reaction, the first dose reduction would be from 300 mg/day to 200 mg/day. Table 1: Dose Reduction Schedule Daily Dose Administered as: AM PM 300 mg/day 150 mg 150 mg 200 mg/day 100 mg 100 mg 150 mg/day 150 mg Once daily TAVALISSE should be taken in the morning. --- 100 mg/day If further dose reduction below 100 mg/day is required, discontinue TAVALISSE. 100 mg --- The recommended dose modifications for adverse reactions are provided in Table 2.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fostamatinib side effects
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The most common side effects reported with Tavalisse include:
Common side effects
- Diarrhea or frequent bowel movements
- High blood pressure
- Nausea
- Dizziness
- Elevated liver enzymes (ALT/AST) on blood tests
- Respiratory infections (colds, upper respiratory tract infections)
- Rash
- Fatigue
- Abdominal pain
When to get medical help
- Call your doctor right away if you have a severe headache, vision changes, or a very high blood pressure reading — this could be a hypertensive crisis.
- Get medical help if you have yellowing of the skin or eyes, dark urine, or severe nausea/vomiting — these can be signs of liver injury.
- Tell your doctor promptly if diarrhea becomes severe, with signs of dehydration such as extreme thirst or no urination.
- Contact your prescriber if you develop a fever or unusual signs of infection — fostamatinib can lower your white blood cell count (neutropenia).
- Seek immediate care for chest pain, shortness of breath, or fainting.
Call your doctor right away if you experience severe diarrhea, signs of liver problems (yellowing skin or eyes, dark urine), very high blood pressure, fever with chills, or chest pain — these can become serious and may require a dose change or stopping the medication.
Fostamatinib warnings and precautions
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- High blood pressure: Fostamatinib raises blood pressure in many patients. Hypertensive crisis (dangerously high blood pressure) occurred in 1% of study patients. Blood pressure must be monitored every two weeks until stable, then monthly. Patients with pre-existing high blood pressure are at greater risk.
- Liver injury (hepatotoxicity): Elevated liver enzymes (ALT/AST) occurred in about 9% of patients. Monthly liver function tests are required. Dose reduction or stopping treatment may be needed.
- Diarrhea: Affected about 31% of patients; severe diarrhea occurred in 1%. Stay hydrated and contact your doctor early if diarrhea starts.
- Low white blood cells (neutropenia): Occurred in 6% of patients; febrile neutropenia (fever plus low neutrophils) in 1%. Monthly blood count monitoring is required. Report any fever or signs of infection promptly.
- Fetal harm: Fostamatinib caused birth defects and embryo death in animal studies. Effective contraception is mandatory during treatment and for at least one month after the last dose.
Fostamatinib interactions
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Fostamatinib interacts with several types of medications because of how it is processed in the body and how it affects other drug pathways:
- Strong CYP3A4 inhibitors (e.g., ketoconazole and similar antifungals): Can significantly increase fostamatinib levels, raising the risk of side effects — closer monitoring is required.
- Strong CYP3A4 inducers (e.g., rifampin): Can dramatically reduce fostamatinib's effectiveness — this combination is not recommended.
- Simvastatin and other CYP3A4 substrate statins: Fostamatinib can more than double simvastatin blood levels — watch for muscle pain or statin side effects.
- Rosuvastatin (a BCRP substrate statin): Fostamatinib can nearly double rosuvastatin levels — dose adjustment may be needed.
- Digoxin (a P-gp substrate heart medication): Fostamatinib can raise digoxin levels significantly — toxicity monitoring is important.
- Moderate CYP3A4 inhibitors (e.g., verapamil): Can modestly increase fostamatinib exposure — be aware of increased side effect risk.
Interactions listed in the FDA-approved label
From the Fostamatinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors: Concomitant use increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions. Monitor for toxicities of TAVALISSE that may require dose reduction (see Table 1).
- Strong CYP3A4 inducers: Concomitant use reduces exposure to R406. Concomitant use is not recommended.
- CYP3A4 substrates: TAVALISSE may increase concentrations of some CYP3A4 substrate drugs. Monitor for toxicities of the CYP3A4 substrate drug that may require dosage reduction.
- BCRP substrates (e.g., rosuvastatin): TAVALISSE may increase concentrations of BCRP substrate drugs. Monitor for toxicities of the BCRP substrate drug that may require dosage reduction.
- P-glycoprotein (P-gp) substrates (e.g., digoxin): TAVALISSE may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Concomitant use with a strong CYP3A4 inhibitor increases exposure to R406 (the major active metabolite).( 7 ) Strong CYP3A4 Inducers: Concomitant use is not recommended. ( 7 ) 7.1 Effect of Other Drugs on TAVALISSE Strong CYP3A4 Inhibitors Concomitant use with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions. Monitor for toxicities of TAVALISSE that may require dose reduction (see Table 1 ) when given concurrently with a strong CYP3A4 inhibitor [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . Strong CYP3A4 Inducers Concomitant use with a strong CYP3A4 inducer reduces exposure to R406. Concomitant use of TAVALISSE with strong CYP3A4 inducers is not recommended [see Clinical Pharmacology (12.3) ] . 7.2 Effect of TAVALISSE on Other Drugs CYP3A4 Substrates Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs. Monitor for toxicities of CYP3A4 substrate drug that may require dosage reduction when given concurrently with TAVALISSE [see Clinical Pharmacology (12.3) ] . BCRP Substrates Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (e.g., rosuvastatin). Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with TAVALISSE [see Clinical Pharmacology (12.3) ] . P-Glycoprotein (P-gp) Substrates Concomitant use of TAVALISSE may increase concentrations of P-gp substrates (e.g., digoxin). Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with TAVALISSE [see Clinical Pharmacology (12.3) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fostamatinib
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- High blood pressure: Tell your doctor if you have or have had high blood pressure — you are at higher risk for blood pressure problems on this drug.
- Liver disease: Tell your doctor about any liver problems; liver enzymes will need to be watched closely.
- Pregnancy: Do not use fostamatinib if you are pregnant. Women who can become pregnant must take a pregnancy test before starting and use effective contraception during treatment and for at least one month after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for at least one month after stopping — the active drug passes into milk at high concentrations in animals.
- Children and teenagers: Fostamatinib is not recommended for anyone under 18 — it caused bone growth problems in animal studies.
- Older adults (65+): May experience more serious side effects and are more likely to develop high blood pressure on this medication — careful monitoring is needed.
- All other medications: Especially antifungals, antibiotics, statins, and heart medications — always give your prescriber and pharmacist a full medication list before starting.
Fostamatinib overdose
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There is no specific antidote if too much fostamatinib is taken, and dialysis does not remove meaningful amounts of the active drug from the body. If an overdose is suspected, seek medical attention immediately — treatment focuses on closely monitoring for and managing any side effects that arise with supportive care.
What Fostamatinib does in the body
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Fostamatinib raises blood pressure in many patients — on average, systolic pressure increased by about 3 mmHg and diastolic by about 3.5 mmHg compared to placebo. About 31% of patients on fostamatinib developed blood pressure readings at or above 140/90 mmHg, compared to 15% on placebo. Blood pressure generally returned toward normal within a week of stopping treatment. At twice the maximum recommended dose, fostamatinib did not cause a clinically meaningful change in heart rhythm (QT interval).
How your body processes Fostamatinib
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Fostamatinib is a prodrug — it is converted in the gut into its active form, R406, which reaches peak levels in the blood about 1.5 hours after a dose. R406 is heavily protein-bound and has a half-life of about 15 hours, meaning it takes roughly that long for the body to clear half of the drug. About 80% of R406 is removed through the stool and 20% through urine. Food (especially a high-fat meal) modestly increases the amount absorbed. The drug's processing is not meaningfully affected by age, sex, race, kidney impairment, or liver impairment as studied.
How to store Fostamatinib
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Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fostamatinib
209 supplements and herbal products have documented interactions with Fostamatinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 167
- Minor · 36
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Fostamatinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fostamatinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication for, and why did my doctor prescribe it?
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Does it matter if I take it with food or on an empty stomach?
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What side effects should I actually watch out for?
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I'm a woman of childbearing age — do I need to do anything special before starting?
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Can I take my other medications — including my statin and blood pressure pill — alongside this?
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How will my doctor know if this medication is actually working?
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Is Fostamatinib available over the counter?
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When was Fostamatinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fostamatinib on HelloPharmacist
Fostamatinib forms and strengths (how it comes)
Fostamatinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Tavalisse tablets are used to treat thrombocytopenia (low platelet counts) in adults with chronic immune thrombocytopenia (ITP) who have not responded adequately to a previous ITP treatment.
- Tavalisse tablets are taken by mouth twice daily, with or without food.
- Tavalisse is started at a lower dose and may be increased after one month if your platelet count has not reached the target level — follow your prescriber's dose instructions exactly.
- If you miss a dose of Tavalisse, skip it and take your next dose at the regularly scheduled time; do not take two doses at once.
- Tavalisse should be stopped after 12 weeks if your platelet count has not improved enough to reduce your bleeding risk, as directed by your prescriber.
Fostamatinib on the U.S. market: products, makers and brands
How Fostamatinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Fostamatinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Tavalisse; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Fostamatinib is used (Medicaid data)
A general measure of how commonly Fostamatinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fostamatinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fostamatinib prescribed? Of the 1,601 medications we measure, Fostamatinib ranks #1,380 by Medicaid prescriptions — more than 14% of them.
Utilization by Fostamatinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fostamatinib 100 MG Oral Tablet Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2044922
fostamatinib 150 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2044930
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fostamatinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Fostamatinib NDCs with Medicaid activity.
Compare Fostamatinib products
A representative set of FDA-listed product records for Fostamatinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | Rigel Pharmaceuticals, Inc. | NDA | View NDC → |
| 150 mg | Oral | Rigel Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Fostamatinib NDCs →
Fostamatinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fostamatinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fostamatinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fostamatinib FDA approval history
How Fostamatinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fostamatinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Fostamatinib recalls since July 2021.
✅No Fostamatinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2044896 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2044921In current FDA listings
Look up RxCUI 2044896 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fostamatinib supply and shortage status
Whether Fostamatinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Fostamatinib brand names
Fostamatinib is sold under one brand name in the FDA directory — Tavalisse. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fostamatinib: manufacturers and labelers
One company lists Fostamatinib products with the FDA. By number of product records, the largest are Rigel Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Fostamatinib drug class (RxNorm)
Fostamatinib belongs to the Other systemic hemostatics class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fostamatinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Rigel Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →