Product image of Enasidenib 100mg (Enasidenib) 100mg Tablet supplied by GNH India

Enasidenib 100mg

Active Ingredient:
Enasidenib
Form:
Tablet
Brand:
IDHIFA
Origin:
USA

Enasidenib 100mg (Enasidenib Tablet) 100mg

Enasidenib, the active ingredient in IDHIFA, is an IDH2 inhibitor presented as a 100mg tablet for oral use. It is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation detected by an FDA-approved test.

GNH India supplies IDHIFA as a licensed, GDP-compliant international pharmaceutical supplier serving oncology centers worldwide.

Strength

100mg

Pack Size

30s

Storage

Ambient

Manufacturer / TM Owner

Celgene

1
Pack/s
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Indications & Clinical Uses

IDHIFA is an IDH2 inhibitor used in the treatment of specific types of leukemia. It is indicated for the following conditions:

  • Relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation: IDHIFA is used to treat adult patients with AML who have a specific mutation in the IDH2 gene, as detected by an FDA-approved test. It helps to reduce the levels of 2-hydroxyglutarate (2-HG), which is associated with the proliferation of leukemia cells.
  • AML with mutated IDH2: In patients with AML and an IDH2 mutation, IDHIFA decreases 2-HG levels, reduces blast counts, and increases the percentage of mature myeloid cells, promoting differentiation and inhibiting the proliferation of leukemia cells.

How It Works

  • IDHIFA works by selectively inhibiting the mutant isocitrate dehydrogenase 2 (IDH2) enzyme. This inhibition reduces the production of the oncogenic metabolite 2-hydroxyglutarate (2-HG), which is associated with the proliferation of leukemia cells. By reducing 2-HG levels, IDHIFA promotes the differentiation of leukemic cells and inhibits their proliferation, thereby helping to control the disease.

Side Effects

IDHIFA, like all medications, can cause side effects. Common side effects include:

Common Side Effects

  • Nausea
  • Fatigue
  • Diarrhea
  • Decreased appetite
  • Constipation
  • Vomiting
  • Abdominal pain
  • Dyspnea

Serious or Rare Side Effects

  • Differentiation syndrome: This is a condition that can occur when leukemia cells differentiate and proliferate rapidly. Symptoms include acute respiratory distress, pulmonary infiltrates, pleural effusion, renal impairment, fever, lymphadenopathy, bone pain, peripheral edema, and pericardial effusion.
  • Hepatic and renal dysfunction: IDHIFA can cause liver and kidney problems, which can be serious in some cases.

Precautions & Warnings

IDHIFA should be used with caution and under the supervision of a healthcare professional. Important precautions include:

  • Monitoring for differentiation syndrome: Patients should be monitored for signs and symptoms of differentiation syndrome, and appropriate treatment should be initiated if necessary.
  • Hepatic and renal function: Regular monitoring of liver and kidney function is recommended during treatment with IDHIFA.
  • Pregnancy and breastfeeding: The safety of IDHIFA in pregnancy and breastfeeding has not been established. Women of childbearing potential should use effective contraception during treatment.
  • Drug interactions: IDHIFA may interact with other medications, so patients should inform their healthcare provider about all medications they are taking.
  • Store at 20°C to 25°C: Keep the bottle tightly closed and store in the original bottle containing a desiccant canister to protect from moisture.

Avoid Interactions

IDHIFA may interact with other medications, which can affect its efficacy or increase the risk of side effects. Major and moderate interactions include:

Major Interactions (Avoid)

  • Strong CYP3A4 inducers: These medications can decrease the concentration of IDHIFA in the blood, potentially reducing its effectiveness.
  • Strong CYP3A4 inhibitors: These medications can increase the concentration of IDHIFA in the blood, potentially increasing the risk of side effects.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers: These medications can decrease the concentration of IDHIFA in the blood, potentially reducing its effectiveness.
  • Moderate CYP3A4 inhibitors: These medications can increase the concentration of IDHIFA in the blood, potentially increasing the risk of side effects.
  • UGT1A1 inhibitors: These medications can increase the concentration of IDHIFA in the blood, potentially increasing the risk of side effects.

Frequently Asked Questions

IDHIFA is used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation detected by an FDA-approved test. It helps to reduce the levels of 2-hydroxyglutarate (2-HG), which is associated with the proliferation of leukemia cells.

Enasidenib works by selectively inhibiting the mutant isocitrate dehydrogenase 2 (IDH2) enzyme. This inhibition reduces the production of the oncogenic metabolite 2-hydroxyglutarate (2-HG), which is associated with the proliferation of leukemia cells. By reducing 2-HG levels, Enasidenib promotes the differentiation of leukemic cells and inhibits their proliferation, thereby helping to control the disease.

The recommended dose of IDHIFA is 100 mg orally once daily, with or without food. Treatment should be continued until disease progression or unacceptable toxicity occurs. The prescriber will determine the appropriate dose and duration of treatment based on the patient's individual needs and response to the medication.

The safety of IDHIFA in pregnancy and breastfeeding has not been established. Women of childbearing potential should use effective contraception during treatment with IDHIFA. Patients should consult their healthcare provider for personalized advice regarding the use of IDHIFA during pregnancy or breastfeeding.

To order IDHIFA from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask the buyer to confirm trade or institutional credentials and will reply with pricing, availability, shipping, and the import paperwork.

IDHIFA is specifically indicated for patients with AML who have an IDH2 mutation. It works by targeting the mutant IDH2 enzyme, reducing the production of 2-HG, and promoting the differentiation of leukemic cells. Other treatments for AML may target different pathways or mechanisms, and the choice of treatment depends on the specific characteristics of the patient's disease and their individual needs.

IDHIFA should be stored at 20°C to 25°C, with excursions permitted to 15°C to 30°C for short-term transportation. The bottle should be kept tightly closed and stored in the original bottle containing a desiccant canister to protect from moisture. Patients should follow the storage instructions provided with the medication to ensure its effectiveness and safety.

IDHIFA is administered orally as a 100 mg tablet, once daily, with or without food. Patients should follow the dosing instructions provided by their healthcare provider and take the medication exactly as prescribed. It is important to continue treatment until disease progression or unacceptable toxicity occurs, as determined by the healthcare provider.

The most serious risks associated with IDHIFA include differentiation syndrome, which can cause acute respiratory distress, pulmonary infiltrates, pleural effusion, renal impairment, fever, lymphadenopathy, bone pain, peripheral edema, and pericardial effusion. Patients should be monitored for signs and symptoms of differentiation syndrome, and appropriate treatment should be initiated if necessary.

IDHIFA is not suitable for everyone. Patients with a known hypersensitivity to Enasidenib or any of the excipients in the formulation should not use IDHIFA. Additionally, the safety of IDHIFA in children and adolescents has not been established. Patients should consult their healthcare provider to determine if IDHIFA is appropriate for their individual needs and medical history.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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