Gilternib 40 MG (Gilteritinib)
Product Name: Gilternib
Manufacturer: Everest Pharmaceuticals
Category: Oncology/Leukemia Treatment
Product Information
Gilternib (Gilteritinib) 40mg is an oral FLT3/AXL dual kinase inhibitor used to treat adults with relapsed or refractory Acute Myeloid Leukaemia (AML) carrying a FLT3 mutation. It works by selectively inhibiting the FLT3 receptor, including both the ITD and TKD mutation subtypes, alongside the related AXL kinase, blocking the abnormal signalling that drives leukaemic blast proliferation and survival in FLT3-mutated AML. In the pivotal ADMIRAL trial, Gilternib was associated with meaningfully longer overall survival compared with salvage chemotherapy in this setting. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Gilternib (Gilteritinib) 40mg
| Brand Name | Gilternib (Gilteritinib) |
| Generic Name | Gilteritinib (as Gilteritinib Fumarate) INN |
| Drug Class | FLT3/AXL Dual Kinase Inhibitor |
| Available Strength | 40mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 30 Tablets per Pack |
| Primary Indication | Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukaemia |
| Regulatory Approvals | USFDA Approved (Relapsed/Refractory FLT3-Mutated AML). Carries an FDA Boxed Warning for differentiation syndrome. |
| Originator Brand | Xospata by Astellas Pharma |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Category | Oncology / Leukaemia Treatment |
| Storage Conditions | Store below 30 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children. |
How Gilternib (Gilteritinib) Works
Gilternib contains Gilteritinib, a small-molecule dual inhibitor of FLT3 (FMS-like tyrosine kinase 3) and AXL. In approximately a third of AML cases, mutations in the FLT3 gene, either internal tandem duplication (FLT3-ITD) mutations or tyrosine kinase domain (FLT3-TKD) mutations, produce a continuously active receptor that drives uncontrolled proliferation and survival of leukaemic blast cells.
Gilternib selectively inhibits both FLT3 mutation subtypes, distinguishing it from some earlier FLT3 inhibitors that were only active against FLT3-ITD. Its additional activity against AXL, a kinase implicated in resistance to FLT3-targeted therapy, is thought to contribute to its effectiveness even in previously treated, resistant AML. In the pivotal ADMIRAL trial, patients with relapsed or refractory FLT3-mutated AML treated with Gilteritinib achieved a median overall survival of approximately 9 months, compared with 6 months for those receiving salvage chemotherapy.
Gilternib is taken as a once-daily oral tablet, and treatment is only appropriate for patients whose AML has been confirmed to carry a susceptible FLT3 mutation, using an approved diagnostic test.
Indication for Gilternib (Gilteritinib)
Gilternib (Gilteritinib) is indicated for the following condition:
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Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukaemia For the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation (ITD or TKD), as detected by an approved test. |
Benefits of Gilternib (Gilteritinib) 40mg
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Survival Benefit Over Salvage Chemotherapy The ADMIRAL trial demonstrated significantly longer median overall survival with Gilteritinib compared to standard salvage chemotherapy in relapsed/refractory FLT3-mutated AML. |
Coverage of Both FLT3 Mutation Types Gilternib is active against both FLT3-ITD and FLT3-TKD mutations, offering broader coverage than some earlier-generation FLT3 inhibitors. |
Oral Alternative to Salvage Chemotherapy As an oral, targeted therapy, Gilternib offers an outpatient-friendly option in a treatment setting historically dominated by intensive, hospital-based chemotherapy. |
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Affordable Alternative to Xospata Gilternib contains the same active ingredient as Xospata by Astellas Pharma, at a significantly lower cost, making this precision therapy more financially accessible. |
Convenient Once-Daily Dosing Gilternib is taken as a single oral tablet once daily, with or without food, supporting long-term outpatient management. |
WHO-GMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under WHO-GMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Gilternib tablets. |
How to Take Gilternib (Gilteritinib)
Route: Oral, with or without food, at approximately the same time each day. Tablets should be swallowed whole.
Standard dose: 120mg (three 40mg tablets) taken orally once daily, exactly as directed by the prescribing haemato-oncologist.
Treatment duration: Treatment is generally continued for a minimum of 6 months, in the absence of disease progression or unacceptable toxicity, to allow adequate time for a clinical response.
Missed dose: If a dose is missed, contact your oncology team for guidance on the correct next step, rather than adjusting the dose independently.
Dose modification for toxicity: Dose interruption and/or reduction may be required to manage differentiation syndrome, QT prolongation, pancreatitis, or other adverse reactions, as directed by the prescribing physician.
Paediatric use: The safety and efficacy of Gilternib in paediatric patients have not been established. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Gilternib treatment, particularly during the first 3 months. Your oncology team will monitor closely for signs and symptoms of differentiation syndrome, and will check ECG and electrolytes for QT interval prolongation, lipase and amylase if pancreatitis is suspected, and periodic complete blood counts and liver function tests. Report any fever, breathlessness, rapid weight gain, swelling, severe abdominal pain, dizziness, palpitations, or fainting to your oncology team immediately.
Drug Interactions and Important Information
Avoid concomitant use of Gilternib with strong CYP3A inducers, as these may decrease Gilteritinib exposure and reduce effectiveness; use caution with strong CYP3A inhibitors, which may increase exposure. Gilteritinib is an inhibitor of P-glycoprotein (P-gp), BCRP, and OCT1; coadministration may increase the exposure of sensitive substrate medications, and for those where small concentration changes could cause serious adverse reactions, the substrate medication’s dose or frequency may need to be adjusted.
Avoid concomitant use of Gilternib with drugs that target the 5HT2B receptor or sigma nonspecific receptor, such as certain antidepressants (escitalopram, fluoxetine, sertraline), unless considered essential, as Gilteritinib may reduce their effectiveness. Breastfeeding is not recommended during treatment or for 2 months after the final dose. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Gilternib.
Side Effects and Precautions
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Common Side Effects Fatigue and weakness Fever Diarrhoea and nausea Elevated liver enzymes Muscle and joint pain Oedema (swelling) and constipation |
Serious Warnings and Precautions Differentiation syndrome, potentially fatal. See boxed warning. QT interval prolongation, requiring ECG and electrolyte monitoring. Posterior reversible encephalopathy syndrome (PRES), a rare neurological condition. Pancreatitis and anaphylactic/hypersensitivity reactions. Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Gilternib (Gilteritinib)?
Gilternib is suitable for adult patients with relapsed or refractory Acute Myeloid Leukaemia confirmed to carry a FLT3 mutation (ITD or TKD subtype) by an approved diagnostic test. It is prescribed by haemato-oncologists experienced in managing AML and in recognising differentiation syndrome. A thorough medical assessment including FLT3 mutation testing, baseline ECG and electrolytes, and blood counts is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, focused on complex, technology-driven specialty medicines across oncology, nephrology, and virology. Operating under Bangladesh’s TRIPS/Doha Declaration exemption for least-developed countries, Everest manufactures advanced generics such as Gilternib under WHO-GMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Gilternib is one of Everest’s specialty precision-oncology products, offering a bioequivalent alternative to Xospata by Astellas Pharma at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty and oncology medications. We ensure Gilternib (Gilteritinib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Gilternib (Gilteritinib) from Mediaid Pharmacy?
Gilternib represents a precision-targeted, evidence-backed option for relapsed or refractory FLT3-mutated AML, a setting with historically poor outcomes on chemotherapy alone. As the generic equivalent of Xospata by Astellas Pharma, it delivers the same active ingredient, Gilteritinib, with the same proven FLT3/AXL dual-inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP-compliant standards and distributed globally by Mediaid Pharmacy, Gilternib gives patients worldwide access to advanced leukaemia therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Gilteritinib option with worldwide delivery, Gilternib from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Gilternib (Gilteritinib)
What is Gilternib (Gilteritinib) used for?
Gilternib (Gilteritinib) is used to treat adult patients with relapsed or refractory Acute Myeloid Leukaemia carrying a FLT3 mutation (ITD or TKD). It works by blocking the abnormal FLT3 signalling that drives leukaemic cell growth, and has been shown to extend survival compared with standard salvage chemotherapy in this setting.
How should I take Gilternib (Gilteritinib)?
Gilternib is taken orally, once daily, with or without food. The standard dose is 120mg (three 40mg tablets) once daily. Treatment is generally continued for at least 6 months, in the absence of progression or unacceptable side effects, to allow enough time for a response. Always follow your haemato-oncologist’s exact instructions.
What strength is Gilternib available in?
Gilternib is available in a 40mg tablet, supplied in a pack of 30 tablets. The standard 120mg daily dose is achieved by taking three tablets together, exactly as prescribed by your oncologist.
Is Gilternib the same as Xospata (Gilteritinib by Astellas)?
Yes. Gilternib is the generic equivalent of Xospata. Both contain the same active ingredient, Gilteritinib, and work through the same FLT3/AXL inhibition mechanism. Gilternib is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offers the same clinical mechanism as Xospata at a significantly lower cost.
What are the side effects of Gilternib (Gilteritinib)?
Common side effects include fatigue, fever, diarrhoea, nausea, and elevated liver enzymes. Gilternib carries a boxed warning for differentiation syndrome, a potentially fatal reaction requiring immediate medical attention, most often occurring within the first 3 months of treatment. Always consult your oncology team for a complete assessment of your individual risks and benefits before starting treatment.
Can Gilternib be used with other medications?
Avoid strong CYP3A inducers, and use caution with strong CYP3A inhibitors. Gilternib may increase the levels of certain other medications and should not be combined with some antidepressants (such as escitalopram, fluoxetine, or sertraline) unless essential. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Gilternib.
Is Gilternib (Gilteritinib) safe during pregnancy or breastfeeding?
No. Gilternib is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Breastfeeding should be avoided during treatment and for at least 2 months after the final dose. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Gilternib (Gilteritinib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Gilternib (Gilteritinib) 40mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Gilternib (Gilteritinib) 40mg with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
