Ivosidenib

Fact of Medicine
Brand Name: Tibsovo
API: Ivosidenib
Packaging: 60 Tablets
Strength: 250mg
Manufacturer Name: Agios Pharmaceuticals Inc

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Description

Tibsovo (ivosidenib) tablet is an IDH1 (isocitrate dehydrogenase-1) inhibitor used for individuals with a susceptible mutation IDH1 with:
  • Newly Diagnosed Acute Myeloid Leukemia (AML): In conjunction with medicine azacitidine or as monotherapy to treat newly diagnosed AML in adults aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
  • Relapsed or refractory AML: To treat adult patients with relapsed or refractory Acute Myeloid Leukemia.
  • Locally Advanced or Metastatic Cholangiocarcinoma: To treat adults with locally advanced or metastatic cholangiocarcinoma who have taken prior treatment.
Dosage:

Newly Diagnosed Acute Myeloid Leukemia (Combination Regimen): The recommended dosage of Tibsovo tablets is 500 mg (2 tablets) taken orally once daily until disease progression or unacceptable toxicity. Start Tibsovo treatment on Cycle 1 Day 1st in conjunction with medicine azacitidine 75 mg/m2 intravenously or subcutaneously once daily on Days 1st to 7th (or Days 1st to 5th and 8th to 9th) of each 28-day cycle. For those without disease progression or unacceptable toxicity, continue treatment, in conjunction with azacitidine, for a minimum of six months.

Newly Diagnosed Acute Myeloid Leukemia and Relapsed or Refractory Acute Myeloid Leukemia (Monotherapy Regimen): The recommended dose is 500 mg taken orally once daily until the disease is progressive or unacceptable toxicity occurs. For those without disease progression or unacceptable toxicity, continue treatment for a minimum of six months.

Cholangiocarcinoma: The recommended dosage of Tibsovo tablets for locally advanced or metastatic cholangiocarcinoma is 500 mg taken orally once daily until the disease is progressive or unacceptable toxicity occurs.

Administer Tibsovo 250 mg tablets with or without food orally at about the same time each day. Do not administer this medicine with a high-fat meal because of an increase in the concentration of ivosidenib. Splitting, crushing, or chewing Tibsovo tablets is not recommended.

If any dose is vomited, a replacement dose should be administered; wait until the next scheduled dose is due. If any dose is skipped/missed or not taken at a fixed time, take the dose of Tibsovo tablets as quickly as possible and a minimum of 12 hours before the very next scheduled dose. Catch the normal schedule the very next day. Avoid administering a couple of doses within 12 hours.

Treatment Reactions: The most common side effects of Tibsovo when used in conjunction with the drug azacitidine or alone in adult patients with AML include: diarrhea, changes in blood cell counts, swelling of arms or legs, fatigue, increased blood sugar, changes in liver function tests, reduced electrolytes in the blood, nausea, vomiting, decreased appetite, and joint pain.

The most common side effects of Tibsovo in adults with Cholangiocarcinoma include diarrhea, fatigue, nausea, decreased appetite, abdominal pain, and cough.

Warnings and Precautions:

  • In the study patients with newly diagnosed Acute Myeloid Leukemia treated with Ivosidenib tablets plus azacitidine experienced differentiation syndrome. In case this syndrome is suspected, start dexamethasone 10 mg intravenously every 12 hours (or an equivalent dose of a substitute oral or intravenous corticosteroid) and hemodynamic assessment until improvement.
  • Those treated with Ivosidenib can develop QT (QTc) prolongation. Concomitant use of Ivosidenib with medicines known to prolong the QTc interval (e.g., antiarrhythmic drugs, fluoroquinolones, 5-HT3 receptor antagonists, triazole antifungals) and CYP3A4 inhibitors may scale up the risk of QTc interval prolongation. Monitoring of electrolytes and electrocardiograms (ECGs) should be conducted.
  • Evaluate blood counts as well as blood chemistries before initiating Tisovo, at least once weekly for the 1st month, once every other week for the 2nd month, and once a month for the time span of therapy. Blood creatine phosphokinase should be monitored weekly for the first month of treatment.
  • Guillain-Barré (GB) syndrome may develop in those treated with Tibsovo Ivosidenib. Monitor patients for the onset of new manifestations of motor or sensory neuropathy such as unilateral or bilateral weakness, paresthesias, sensory alterations, or breathing complications. Permanently discontinue treatment in those who are diagnosed with GuillainBarré (GB) syndrome.

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Storage: Store the Tibsovo pills at temperatures 20 to 25°C (68 to 77°F); excursions are permitted between 15 to 30°C (59 to 86°F).

Availability in India: The Indian Pharma (TIP) helps connect buyers with suppliers who can ship TIBSOVO at the global level as per the need of buyers. The Indian Pharma provides the guarantee of quality and delivery for the TIBSOVO Tablets.

Buying Procedure: In order to buy TIBSOVO tablets, you can contact us at our TOLL-FREE Number 1800 889 1064 or on WhatsApp Number +919310090915 or Email us at: info@theindianpharma.com along with your Identity Proof, Valid Prescription Letter, and Medical Reports.

Conclusion: Tibsovo is a novel oral inhibitor, demonstrating durable remissions and promising tolerability in adults with relapsed/refractory AML with IDH1 mutation. Tibsovo offers a new therapeutic option for individuals with relapsed or refractory Acute Myeloid Leukemia whose disease is associated with IDH1 mutation.

FAQ

What does Tibsovo contain as an active substance?

The Tibsovo specifically contains the active substance Ivosidenib.

How much does Tibsovo cost in India?

The cost of Tibsovo tablets in India can vary. If you want to buy Tibsovo 250 mg online, then THE INDIAN PHARMA can help you to access this medicinal product at the lowest price through legal channels.

Is Tibsovo Tablet Available In India?

Tibsovo is a pharmaceutical prescription medication that can be only dispensed against a valid medical prescription. THE INDIAN PHARMA can facilitate the import of Tibsovo to all locations after fulfilling the legal requirement (if applicable). Please contact us via +919310090915 | TOLL-FREE: 1800-889-1064 or write us at info@theindianpharma.com to buy Tibsovo tablets online in India.

Can I get Tibsovo even if I am not based in India?

THE INDIAN PHARMA (TIP) helps patients in accessing or importing Tibsovo ivosidenib, not approved in their home country against the valid prescription and in conformity with the local laws and regulations of their respective country.

Where can I get Tibsovo Tablets at the best price?

In order to get the best price of Tibsovo in India and other countries, always buy this medication from a Pharmaceutical Wholesaler Company which is GDP certified. Noida-based The Indian Pharma can offer the best price for Tibsovo Tablets.

Is it safe to buy Tibsovo online in India?

Yes, one can buy Tibsovo in India at the best price from The Indian Pharma (TIP) if Tibsovo has not been launched or is unavailable in the country. We can help facilitate the Import of Tibsovo through legal channels.

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