US FDA approved new drug idhifa that contains active pharmaceutical ingredient enasidenib for the treatment of acute myeloid leukemia (AML) in adult patients who have relapsed of AML due to mutation in specific gene. US FDA indicated this drug along with specific assay to identify mutations IDH2 gene before initiating specific therapy.
Leukemia is a group of cancers that usually affect bone marrow. All types of leukemia tend to increase immature white blood cells. Research is still in process to find out exact underlying cause of leukemia but many researchers believe that genetic predisposition and environmental factors are key factors in the pathogenesis of leukemia. These factors include continuous exposure to certain toxic
chemicals in plants and factories, exposure to radiations, smoking, viral infections etc.
There are four major types of leukemia commonly identified in patients. These are acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) and chronic myeloid leukemia (CML). Survival rate of leukemia mainly depends upon patient age and type leukemia.
Idhifa/enasidenib is IDH-2 (isocitrate dehydrogenase-2) inhibitor that blocks enzymes responsible proliferation of immature white blood cells in case of acute myeloid leukemia. This drug must be used in case of detection of IDH2 gene mutations via RealTime IDH2 Assay.
Idhifa/enasidenib side effects
According to health authorities following side effects were reported during clinical trails
- Difficulty in breathing
- Acute respiratory distress
- Inflammation in lungs
- Fluid accumulation in lungs
- Weight gain
- Metabolic changes
- Abdominal pain
- hepatic and renal impairment
US FDA indicated Idhifa/enasidenib for the treatment of acute myeloid leukemia (AML) in adult patients who have relapsed of AML due to mutation in specific gene. US FDA indicated this drug along with specific assay to identify mutations IDH2 gene before initiating specific therapy.
This drug is formulated as tablet form in two potencies 50mg and 100mg. Standard dosing frequency for adult patients is 100mg orally with or without food for up-to 6 months to see significant clinical response. In case of toxicity discontinue drug and consult with your health care provider.