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Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Xospata (gilteritinib) is a kinase inhibitor approved by the FDA for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test.
Xospata selectively inhibits FLT3 receptor tyrosine kinase, blocking abnormal signaling from FLT3 mutations (including both ITD and TKD variants) that drive leukemic cell growth and survival in a significant subset of AML patients.
Xospata is intended for patients with relapsed or refractory AML confirmed to carry a FLT3 mutation, a genetic alteration associated with a higher risk of relapse and generally poorer outcomes with standard chemotherapy alone.
The recommended starting dose of Xospata is 120 mg (three 40 mg tablets) taken orally once daily, with or without food, continued until disease progression or unacceptable toxicity.
Boxed Warning — Xospata: Patients treated with Xospata have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, pleural or pericardial effusion, pulmonary infiltrates, and rapid weight gain. If differentiation syndrome is suspected, corticosteroid therapy should be initiated and hemodynamic monitoring instituted until symptoms resolve.
Cases of PRES have been reported. If PRES is suspected, Xospata should be discontinued and antihypertensive treatment provided as needed.
Xospata can prolong the QT interval. ECG monitoring and electrolyte correction are recommended during treatment.
Cases of pancreatitis have been reported. Patients should be monitored for signs and symptoms.
Xospata may cause fetal harm. Effective contraception should be used during treatment and for a period after the final dose, as advised by the treating physician.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Xospata is manufactured and marketed by Astellas Pharma US, Inc. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating hematologist-oncologist confirming relapsed or refractory AML diagnosis and FLT3 mutation testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for FLT3-mutated relapsed or refractory AML, Xospata is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Xospata directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Xospata should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, protected from light and moisture, and this condition is maintained throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile logistics to the patient's city.
Patients across India can access Xospata through NPP's regulated import pathway, with hematology-oncology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support hematology-oncology care coordination and documentation for Xospata access.
Delhi's major hospitals assist patients with prescription support and documentation for Xospata.
Bangalore's specialist network offers access coordination for eligible FLT3-mutated AML patients seeking Xospata.
Chennai-based hematology specialists coordinate Xospata access alongside comprehensive AML care.
Hyderabad's care institutions support patients pursuing Xospata therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Xospata.
Pune-based specialists assist with prescription support and Xospata treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Xospata.
Kochi's specialist units assist patients with the documentation needed for Xospata access.
Chandigarh's care centers support Xospata treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Xospata access process.
Lucknow-based centers assist patients pursuing Xospata therapy.
Bhubaneswar's institutions support access to Xospata for eligible patients.
Guwahati's specialists help coordinate Xospata access for patients across the Northeast.
Patients in other cities across India can also access Xospata through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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