Xospata® (gilteritinib) for FLT3‑Mutated Relapsed or Refractory AML

What Xospata® Is and How It Works

Xospata® (gilteritinib) is an oral tyrosine kinase inhibitor used for adults with relapsed or refractory acute myeloid leukemia (AML) that harbors an FLT3 mutation. Tablets are typically taken once daily. Many patients compare xospata price and xospata cost, including options for xospata without insurance, when planning therapy and ongoing refills. YouDrugstore is a licensed Canadian pharmacy headquartered in Manitoba; prescriptions are reviewed by licensed pharmacists before dispensing. We also work with licensed, vetted international partner pharmacies to supply authentic brand medicines, offering a broad selection at competitive, affordable pricing.

Gilteritinib selectively inhibits FLT3 (FMS-like tyrosine kinase 3), a driver mutation found in a substantial share of AML cases. By blocking FLT3 signaling, the drug slows leukemic cell proliferation and may promote cell death. The usual starting dose is 120 mg once daily, with or without food. The manufacturer is Astellas; you may see references such as Astellas Xospata, xospata gilteritinib, and xospata approval details in official materials. Regulatory bodies have issued the xospata FDA label and EMA approvals; the ADMIRAL trial (often cited as xospata admiral) supports survival benefits compared with salvage chemotherapy.

The medicine’s official documentation includes the full xospata label and xospata PI (prescribing information). These resources provide guidance on dosing, monitoring, and dose adjustments for safety. Some patients and clinicians also review the gilteritinib label across regions to compare recommendations.

Dosage and Usage

• Starting dose: 120 mg orally once daily. Tablets can be taken with or without food and should be swallowed whole.
• Assessment: Continue therapy until disease progression or unacceptable toxicity. Increase to 200 mg once daily if a clinical response is inadequate and tolerated, per the xospata FDA label.
• Monitoring: Baseline and periodic ECGs are recommended due to QT prolongation risk. Monitor electrolytes (potassium, magnesium) and liver enzymes.
• Differentiation syndrome: Recognize signs such as fever, dyspnea, weight gain, or hypotension; the xospata PI outlines management protocols.
• Drug interactions: Avoid strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort). Use caution with strong CYP3A inhibitors and monitor closely. Avoid grapefruit and Seville oranges.
• Missed dose: If a dose is missed, a same-day catch-up dose may be taken; skip if the next day has already started. Do not double doses. If vomiting occurs after a dose, do not re-dose that day.
• Hepatic and renal considerations: The label provides guidance for dose modifications based on adverse reactions and lab abnormalities.

• Store at 20–25°C (68–77°F); brief excursions 15–30°C (59–86°F) are acceptable.
• Keep tablets in the original container with the desiccant to protect from moisture.
• Do not use if the seal is broken or past the expiration date.
• For travel, keep medicine in your carry-on, in original labeled packaging, and away from heat and humidity.
• Carry an updated medication list, and maintain consistent daily dosing times across time zones.

Benefits and Savings

Xospata® offers targeted inhibition of FLT3 mutations in AML. In the phase 3 ADMIRAL trial, gilteritinib improved overall survival versus salvage chemotherapy in relapsed or refractory FLT3-mutated AML. Once-daily oral dosing removes the need for infusion visits, and therapy can continue as long as it is effective and tolerated. The xospata manufacturer (Astellas) provides safety and monitoring guidance to help optimize outcomes.

Ordering through YouDrugstore can reduce the monthly burden. Many customers report 60–80% savings compared with typical US pharmacy prices. That can be helpful for those paying xospata out of pocket or managing xospata without insurance. Multi-month supplies can lower the per‑month cost, and you can turn on reorder reminders to avoid gaps in treatment.

For occasional deals, visit our promotions page for an xospata coupon.

Side Effects and Safety

• Common effects: fatigue, nausea, diarrhea or constipation, decreased appetite, cough, shortness of breath, dizziness, headache, muscle or joint pain, peripheral edema, mouth sores, rash, and elevated liver enzymes.
• Laboratory changes: increases in AST/ALT, bilirubin, creatine phosphokinase, or creatinine; electrolyte shifts may occur.
• Cardiac: QT interval prolongation has been observed; ECG and electrolytes require monitoring.
• Infections: febrile neutropenia and other infections can occur, reflecting disease and treatment effects.
• Gastrointestinal: abdominal pain, vomiting, and, rarely, pancreatitis have been reported.

Serious risks include differentiation syndrome, QT prolongation (potential for torsades de pointes), posterior reversible encephalopathy syndrome (PRES), and pancreatitis. Prompt clinical evaluation is essential if suggestive symptoms arise. Discuss pregnancy avoidance and breastfeeding considerations, as embryo‑fetal harm is a potential risk. The gilteritinib xospata label provides full boxed and warning details.

Onset Time

Laboratory signs of response may start to appear within several weeks as dosing stabilizes. In clinical experience and trials, many patients who respond show improvement within one to two months. The ADMIRAL study reported a median time to first response of about six weeks, though some responses occur earlier or later. Deep responses (such as CR/CRh) can take multiple cycles. Continue therapy as directed while monitoring for efficacy and safety.

Compare With Alternatives

Other FLT3‑targeted options exist in defined settings. Midostaurin (Rydapt) is often used with induction and consolidation in newly diagnosed FLT3‑mutated AML, while gilteritinib is indicated as monotherapy for relapsed or refractory disease. Quizartinib (Vanflyta) targets FLT3‑ITD and is authorized in certain regions; its use depends on the mutation subtype and regional approvals (see xospata EMA guidance for Europe).

Non‑FLT3 targeted strategies for relapsed AML include venetoclax combined with hypomethylating agents (azacitidine or decitabine) depending on patient factors. Treatment selection considers mutation profile, prior therapies, transplant eligibility, and tolerability.

For context on other targeted oncology therapies available through our pharmacy (not AML alternatives), see Bavencio® and Zytiga®.

Combination Therapy

• Xospata® is approved as monotherapy for relapsed or refractory FLT3‑mutated AML.
• Investigational or off‑label combinations (e.g., with azacitidine or venetoclax) are being studied; clinical protocols guide dosing and sequencing.
• When combining agents that can prolong QT or affect CYP3A4 metabolism, clinicians may adjust doses and increase monitoring.
• Concomitant use with strong CYP3A inducers should be avoided; evaluate the full medication list for interactions.

Patient Suitability and Cost-Saving Tips

Xospata® may be appropriate for adults with FLT3‑mutated AML after relapse or refractory disease, confirmed by an approved diagnostic test. It is not intended for pediatric use. Caution is advised with baseline prolonged QTc, electrolyte disturbances, severe hepatic impairment, or a history of PRES. Review all concomitant drugs, including antifungals, anticonvulsants, antibiotics, and herbal products, for CYP3A4 interactions.

To manage costs, consider a multi‑month fill to reduce per‑month expense, and enroll in reorder reminders so you do not run out. Ask about current pharmacy discounts that can lower the xospata cash price. Patients who are uninsured can still access Canadian pricing and compare gilteritinib price options through our store.

Authoritative Sources

Astellas Xospata U.S. Prescribing Information

FDA Label and Medication Guide for Xospata (gilteritinib)

Health Canada Drug Product Database: Gilteritinib

Order Xospata® from YouDrugstore: add to cart, upload your prescription, and we ship with prompt, express, cold-chain handling.

This content is educational and does not replace advice from your healthcare professional. Always follow the guidance of your care team and the official prescribing information.