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Tibsovo (ivosidenib)

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CHEMMEDIX

$27,600.00

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Description

What is Tibsovo (ivosidenib) for?

Tibsovo (ivosidenib) is indicated for the treatment of:

  • Acute myeloid leukemia (AML) with an IDH1 mutation in:
    • Adults with newly diagnosed AML who are ≥75 years of age or who have health problems that prevent the use of certain chemotherapy treatments.
    • Adults with AML when the disease has come back (relapsed) or has not improved after previous treatment (refractory).
  • Adults with bile duct cancer (cholangiocarcinoma) that has spread:
    • Who have already received previous treatment(s) and
    • Whose tumor has a certain type of abnormal IDH1 mutation.

How does Tibsovo (ivosidenib) work?

Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme.

Susceptible IDH1 mutations are defined as those leading to increased levels of 2-hydroxyglutarate (2-HG) in the leukemia cells and where efficacy is predicted by 1) clinically meaningful remissions with the recommended dose of ivosidenib and/or 2) inhibition of mutant IDH1 enzymatic activity at concentrations of ivosidenib sustainable at the recommended dosage according to validated methods. The most common of such mutations are R132H and R132C substitutions[1].

Ivosidenib was shown to inhibit selected IDH1 R132 mutants at much lower concentrations than wild-type IDH1 in vitro. Inhibition of the mutant IDH1 enzyme by ivosidenib led to decreased 2- HG levels and induced myeloid differentiation in vitro and in vivo in mouse xenograft models of IDH1-mutated AML. In blood samples from patients with AML with mutated IDH1, ivosidenib decreased 2-HG levels ex-vivo, reduced blast counts, and increased percentages of mature myeloid cells[1].

Where has Tibsovo (ivosidenib) been approved?

Tibsovo (ivosidenib) was approved based on the results of study AG-120-C-001 (see ‘Clinical Trials’) by:

  •  Food and Drug Administration (FDA), USA
    • July 20, 2018, for relapsed and refractory acute myeloid leukemia (AML) with IDH1 mutation[2];
    • May 02, 2019, for newly-diagnosed adult patients with IDH1 mutant acute myeloid leukemia (AML) not eligible for intensive chemotherapy[3].

The FDA previously granted Priority Review and Orphan Drug Designation to Tibsovo (ivosidenib)[4].

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free tocontact our support team.

Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.

How is Tibsovo (ivosidenib) taken?

The recommended dosage of Tibsovo (ivosidenib) is[1]:

  • 500 mg taken orally, once daily with or without food, until disease progression or unacceptable toxicity.

For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Please note: take Tibsovo (ivosidenib) tablets orally about the same time each day. Do not administer Tibsovo (ivosidenib) with a high-fat meal because of an increase in ivosidenib concentration. Do not split or crush Tibsovo (ivosidenib) tablets.

Complete information about Tibsovo (ivosidenib) dosage and administration can be found in the official prescribing information listed in our resources section[1].

Note: Please consult with your treating doctor for personalised dosing. 

Are there any known side effects or adverse reactions of Tibsovo (ivosidenib)?

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include[1]:

  • QTc prolongation (a change in heart’s electrical activities that can cause irregular heartbeats)
  • Guillain-Barré syndrome (signs and symptoms include: weakness or tingling feeling in legs, arms, or upper body; numbness and pain in body; difficulty breathing)

Common adverse reactions

The common adverse reactions listed in the prescribing information include[1]:

  • fatigue
  • rash
  • joint pain
  • muscle pain
  • cough
  • diarrhea
  • nausea

Use in specific populations

Tibsovo (ivosidenib) can be fatal for a fetus, it is advised to avoid pregnancy and breastfeeding[1].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[1].

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