Product Information
Ivosenib (Ivosidenib) 250mg is an oral, targeted inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme, used to treat IDH1-mutated Acute Myeloid Leukaemia (AML), IDH1-mutated myelodysplastic syndrome (MDS), and IDH1-mutated cholangiocarcinoma (bile duct cancer). It works by blocking the mutant IDH1 enzyme, dramatically reducing levels of the oncometabolite 2-hydroxyglutarate (2-HG), which accumulates in IDH1-mutated cancer cells and blocks normal cell differentiation. Ivosenib is a precision, biomarker-guided therapy and should only be used after confirmed IDH1 mutation testing. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Ivosenib (Ivosidenib) 250mg
| Brand Name | Ivosenib (Ivosidenib) |
| Generic Name | Ivosidenib INN |
| Drug Class | Isocitrate Dehydrogenase-1 (IDH1) Inhibitor |
| Available Strength | 250mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 1 Bottle of 60 Tablets per Box (Approximately a 30-Day Supply) |
| Primary Indication | IDH1-Mutated Acute Myeloid Leukaemia, Myelodysplastic Syndrome, and Cholangiocarcinoma |
| Regulatory Approvals | USFDA Approved (AML, MDS, Cholangiocarcinoma). Carries an FDA Boxed Warning for differentiation syndrome. |
| Originator Brand | Tibsovo by Servier Pharmaceuticals |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration | Registered in Bangladesh |
| Storage Conditions | Store between 20 and 25 degrees Celsius. Protect from light and moisture. Keep in the original container with the lid tightly closed. Keep out of the reach of children. |
How Ivosenib (Ivosidenib) Works
Ivosenib contains Ivosidenib, a small-molecule inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme. In certain cancers, mutations in the IDH1 gene cause the enzyme to produce abnormally high levels of an oncometabolite called 2-hydroxyglutarate (2-HG). Accumulated 2-HG interferes with normal cellular processes, blocking the healthy differentiation of blood-forming or tumour cells and contributing to the malignant, poorly differentiated state seen in IDH1-mutated cancers.
By inhibiting the mutant IDH1 enzyme, Ivosenib substantially reduces 2-HG levels, restoring more normal cellular differentiation. In clinical studies, repeated dosing of Ivosidenib reduced 2-HG concentrations in bone marrow to levels similar to those seen in healthy individuals, and produced a comparable reduction in tumour tissue from patients with cholangiocarcinoma.
Ivosenib is taken as a once-daily oral tablet, and treatment is only appropriate for patients whose cancer has been confirmed to carry a susceptible IDH1 mutation, using an approved diagnostic test.
Indications for Ivosenib (Ivosidenib)
Ivosenib (Ivosidenib) is indicated for patients with a susceptible IDH1 mutation, as detected by an approved test, for the following conditions:
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Newly Diagnosed AML In combination with azacitidine, or as monotherapy, for adults 75 years of age or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
Relapsed or Refractory AML and MDS As monotherapy, for adult patients with relapsed or refractory acute myeloid leukaemia or relapsed or refractory myelodysplastic syndrome. |
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Cholangiocarcinoma As monotherapy, for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma (bile duct cancer). |
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Benefits of Ivosenib (Ivosidenib) 250mg
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Precision, Biomarker-Guided Therapy Ivosenib is used based on confirmed IDH1 mutation status, allowing oncologists to match therapy precisely to the genetic driver of the malignancy. |
Option for Older, Less Fit AML Patients For newly diagnosed AML, Ivosenib offers a targeted, non-intensive treatment option for older patients or those with comorbidities that rule out intensive induction chemotherapy. |
Multi-Cancer Coverage Approved across AML, MDS, and cholangiocarcinoma, Ivosenib supports patients across several distinct IDH1-mutated cancer types. |
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Affordable Alternative to Tibsovo Ivosenib contains the same active ingredient as Tibsovo, at a dramatically lower cost, making this precision therapy more financially accessible to patients worldwide. |
Convenient Once-Daily Dosing Ivosenib is taken as an oral tablet once daily, with or without food, offering a manageable outpatient regimen compared to intravenous chemotherapy. |
cGMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under cGMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Ivosenib tablets. |
How to Take Ivosenib (Ivosidenib)
Route: Oral, with or without food, at approximately the same time each day. Tablets should be swallowed whole.
Standard dose: 500mg (two 250mg tablets) taken orally once daily, continued until disease progression or unacceptable toxicity, exactly as directed by the prescribing haemato-oncologist.
Treatment duration for AML/MDS: For patients with AML or MDS who are not experiencing disease progression or unacceptable toxicity, treatment is generally continued for a minimum of 6 months, to allow adequate time for a clinical response.
Missed dose: If a dose is missed, take it as soon as possible on the same day, and resume the normal schedule the next day; do not take two doses on the same day to make up for a missed dose.
Dose modification for QTc prolongation: If QTc interval prolongation occurs, the dose is reduced or withheld, with treatment then resumed at a lower dose or permanently discontinued, depending on severity, as directed by the prescribing physician.
Strong CYP3A4 inhibitors: If coadministration cannot be avoided, reduce the Ivosenib dose to 250mg once daily. If the strong CYP3A4 inhibitor is later discontinued, the dose can be increased back to 500mg once daily after at least 5 half-lives of the inhibitor have passed.
Paediatric use: The safety and efficacy of Ivosenib in paediatric patients have not been established. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Ivosenib treatment, particularly in the first weeks. Your oncology team will monitor closely for signs and symptoms of differentiation syndrome, including unexplained fever, breathlessness, rapid weight gain, or swelling. Monitoring also includes electrocardiograms (ECG) and electrolytes, given the risk of QTc interval prolongation, and periodic complete blood counts and liver function tests. Report any breathlessness, fever, rapid weight gain, swelling of the legs, dizziness, palpitations, or fainting to your oncology team immediately.
Drug Interactions and Important Information
Coadministration of Ivosenib with strong or moderate CYP3A4 inhibitors increases Ivosidenib plasma concentrations and the risk of QTc interval prolongation; alternative therapies that are not strong or moderate CYP3A4 inhibitors should be considered where possible, and a dose reduction is required if coadministration cannot be avoided, as detailed in the dosing section above. Coadministration with strong or moderate CYP3A4 inducers decreases Ivosidenib exposure and may reduce effectiveness; avoid where possible.
Avoid concomitant use of Ivosenib with other medicines known to prolong the QTc interval; if unavoidable, monitor patients closely for increased risk of QTc prolongation. Breastfeeding is not recommended during treatment. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Ivosenib.
Side Effects and Precautions
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Common Side Effects Diarrhoea Nausea and vomiting Abdominal pain and constipation Mouth sores Decreased appetite Fatigue |
Serious Warnings and Precautions Differentiation syndrome, which can be fatal. See boxed warning. QTc interval prolongation, requiring ECG and electrolyte monitoring. Guillain-Barré syndrome (rare). Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Ivosenib (Ivosidenib)?
Ivosenib is suitable for adult patients with IDH1-mutated newly diagnosed AML (aged 75 or older, or with comorbidities precluding intensive chemotherapy), IDH1-mutated relapsed or refractory AML or MDS, or IDH1-mutated previously treated cholangiocarcinoma, confirmed by an approved IDH1 mutation test. It is prescribed by haemato-oncologists and medical oncologists experienced in biomarker-guided cancer therapy and in recognising differentiation syndrome. A thorough medical assessment including IDH1 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 Ivosenib under cGMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Ivosenib is one of Everest’s specialty precision-oncology products, offering a bioequivalent alternative to Tibsovo by Servier Pharmaceuticals 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 Ivosenib (Ivosidenib) 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 Ivosenib (Ivosidenib) from Mediaid Pharmacy?
Ivosenib represents one of the most precise treatment options available for IDH1-mutated blood cancers and cholangiocarcinoma, targeting the exact metabolic driver behind the disease. As the generic equivalent of Tibsovo, it delivers the same active ingredient, Ivosidenib, with the same proven IDH1-inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under cGMP-compliant standards and distributed globally by Mediaid Pharmacy, Ivosenib gives patients worldwide access to precision-targeted cancer therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Ivosidenib option with worldwide delivery, Ivosenib from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Ivosenib (Ivosidenib)
What is Ivosenib (Ivosidenib) used for?
Ivosenib (Ivosidenib) is used to treat adult patients with IDH1-mutated newly diagnosed AML (in combination with azacitidine or alone, for older or less fit patients), IDH1-mutated relapsed or refractory AML or MDS, and IDH1-mutated previously treated cholangiocarcinoma. It works by blocking a mutant enzyme that would otherwise block normal cell maturation in these cancers.
How should I take Ivosenib (Ivosidenib)?
Ivosenib is taken orally, once daily, with or without food. The standard dose is 500mg (two 250mg tablets) once daily. For AML or MDS, treatment is generally continued for a minimum of 6 months if there is no progression or unacceptable toxicity, to allow time for a response. Always follow your oncologist’s exact instructions.
What strength is Ivosenib available in?
Ivosenib is available in a 250mg film-coated tablet, supplied as a bottle of 60 tablets in each box, which generally provides a full 30-day supply at the standard 500mg-once-daily dose (two tablets per day).
Is Ivosenib the same as Tibsovo (Ivosidenib by Servier)?
Yes. Ivosenib is the generic equivalent of Tibsovo. Both contain the same active ingredient, Ivosidenib, and work through the same IDH1-inhibition mechanism. Ivosenib is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offers the same clinical mechanism as Tibsovo at a significantly lower cost.
What are the side effects of Ivosenib (Ivosidenib)?
Common side effects include diarrhoea, nausea, abdominal pain, mouth sores, decreased appetite, and fatigue. The most important risk is differentiation syndrome, a potentially fatal reaction requiring immediate medical attention, alongside QTc interval prolongation, which requires ECG monitoring. Always consult your oncology team for a complete assessment of your individual risks and benefits before starting treatment.
Can Ivosenib be used with other medications?
Strong or moderate CYP3A4 inhibitors increase Ivosidenib levels and QTc prolongation risk, requiring a dose reduction if unavoidable. Strong or moderate CYP3A4 inducers reduce effectiveness and should be avoided. Avoid other medicines that prolong the QTc interval where possible. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Ivosenib.
Is Ivosenib (Ivosidenib) safe during pregnancy or breastfeeding?
No. Ivosenib is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Ivosenib (Ivosidenib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Ivosenib (Ivosidenib) 250mg 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 Ivosenib (Ivosidenib) 250mg with Worldwide Shipping
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