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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:208716Orig1s000 OTHER REVIEW(S)Clinical Inspection Summary NDA 208716 (abemaciclib)Page 2for disease progression for three subjects. Two

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How to fill out idhifa enasidenib tablets

01

Take idhifa enasidenib tablets exactly as prescribed by your doctor.

02

Swallow the tablets whole with a glass of water. Do not crush, chew, or break the tablets.

03

Take idhifa with or without food, as directed by your doctor.

04

It is important to take idhifa at the same time every day to maintain a consistent level of the medication in your body.

05

If you miss a dose of idhifa, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.

06

Do not stop taking idhifa without first consulting your doctor, even if you feel well.

07

Keep idhifa tablets in their original container, tightly closed, and out of reach of children.

Who needs idhifa enasidenib tablets?

01

Idhifa enasidenib tablets are generally prescribed for adults with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation.

02

This medication is used when other treatments have not been effective or have stopped working.

03

It is important to consult with a doctor or healthcare professional to determine if idhifa is appropriate for your specific condition.

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What is idhifa enasidenib tablets?

Idhifa enasidenib tablets is a medication used to treat certain types of acute myelogenous leukemia (AML).

Who is required to file idhifa enasidenib tablets?

Healthcare providers or pharmacies that dispense idhifa enasidenib tablets are required to report the usage.

How to fill out idhifa enasidenib tablets?

Idhifa enasidenib tablets should be filled out with the patient's information, dosage instructions, and any relevant medical history.

What is the purpose of idhifa enasidenib tablets?

The purpose of idhifa enasidenib tablets is to help treat AML by targeting specific genetic mutations.

What information must be reported on idhifa enasidenib tablets?

Information such as patient name, prescribed dosage, date dispensed, and treating physician must be reported on idhifa enasidenib tablets.

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