Moxetumomab Pasudotox-tdfk Injection

Moxetumomab pasudotox-tdfk (marketed as Lumoxiti), from AstraZeneca, is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

It is a CD22-directed antibody-drug conjugate: the antibody portion binds to CD22 on the surface of malignant B-cells, delivering a bacterial toxin (PE38) that is internalized and disrupts protein synthesis, leading to cell death.

• Capillary leak syndrome (CLS) — can be severe or life-threatening; monitor weight, blood pressure, and signs of fluid retention.
• Hemolytic uremic syndrome (HUS) has been reported; monitor renal function, hemoglobin, and platelet counts.
• Requires pre-medication and adequate hydration to reduce infusion-related reactions and renal risk.
• Electrolyte abnormalities and infections are commonly reported.

What documents are required to import Moxetumomab pasudotox-tdfk to India?

It may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered hematologist-oncologist
• Diagnostic report confirming relapsed/refractory hairy cell leukemia and prior treatment history
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is it available in India?

Moxetumomab pasudotox-tdfk (Lumoxiti) is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source Lumoxiti (moxetumomab pasudotox-tdfk) from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA (as Lumoxiti) — September 2018.

What is Moxetumomab pasudotox-tdfk used for?

It treats relapsed or refractory hairy cell leukemia in adults after at least two prior systemic therapies.

Who manufactures it?

It is developed and marketed by AstraZeneca as Lumoxiti.

How is it administered?

By intravenous infusion, on days 1, 3, and 5 of each 28-day cycle, as prescribed by the treating physician.

How much does it cost in India?

Cost depends on treatment cycles required and sourcing logistics — share your prescription with IPN for a quote.