Idhifa

• It is used to treat a type of leukemia.

None.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Differentiation Syndrome

Advise patients on the risks of developing differentiation syndrome as early as 10 days and during the first 5 months on treatment. Ask patients to immediately report any symptoms suggestive of differentiation syndrome, such as fever, cough or difficulty breathing, bone pain, rapid weight gain or swelling of their arms or legs, to their healthcare provider for further evaluation [see Boxed Warning and Warnings and Precautions (5.1)].

Tumor Lysis Syndrome

Advise patients on the risks of developing tumor lysis syndrome. Advise patients on the importance of maintaining high fluid intake, and the need for frequent monitoring of blood chemistry values [see Dosage and Administration (2.3) and Adverse Reactions (6.1)].

Gastrointestinal Adverse Reactions

Advise patients on risk of experiencing gastrointestinal reactions such as diarrhea, nausea, vomiting, decreased appetite, and changes in their sense of taste. Ask patients to report these events to their healthcare provider, and advise patients how to manage them [see Adverse Reactions (6.1)].

Elevated Blood Bilirubin

Inform patients that taking IDHIFA may cause elevated blood bilirubin, which is due to its mechanism of action, and not due to liver damage. Advise patients to report any changes to the color of their skin or the whites of their eyes to their healthcare provider for further evaluation [see Adverse Reactions (6.1)].

Embryo-Fetal Toxicity and Use of Contraceptives

Advise female patients with reproductive potential to use effective contraceptive methods while receiving IDHIFA and to avoid pregnancy while on treatment and for 1 month after completion of treatment. Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during IDHIFA treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 1 month after the last dose of IDHIFA. Coadministration of IDHIFA may increase or decrease the concentrations of combined hormonal contraceptives. The clinical significance of this potential drug interaction is unknown at this time [see Warnings and Precautions (5.2) and Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with IDHIFA and for at least 1 month after the final dose [see Use in Specific Populations (8.2)].

Dosing and Storage Instructions

• Advise patients not to chew or split the tablets but swallow whole with a cup of water.
• Instruct patients that if they miss a dose or vomit after a dose of IDHIFA, to take it as soon as possible on the same day and return to normal schedule the following day. Warn patients not to take 2 doses to make up for the missed dose [see Dosage and Administration (2.2)].
• Keep IDHIFA in the original container. Keep the container tightly closed with desiccant canister inside to protect the tablets from moisture [see How Supplied/Storage and Handling (16.2)].

Manufactured for and marketed by:
Celgene Corporation
Summit, NJ 07901

Licensed from:
Agios Pharmaceuticals
Cambridge, MA 02139

Trademarks are the property of their respective owners.

IDHIFA® is a registered trademark of Celgene Corporation.

Pat. www.celgene.com/therapies

© 2016-2017 Celgene Corporation
All Rights Reserved.

IDHPI.002/MG.002   08/17

IDHIFA (enasidenib) works by blocking the function of a certain protein that has become mutated in white blood cells. This mutation keeps the blood cells from growing and functioning normally, and the build-up of these abnormal cells can lead to acute myeloid leukemia.

IDHIFA is used to treat acute myeloid leukemia in adults who have a mutation in the protein that this medicine targets and blocks.

IDHIFA is usually given after other medicines have been tried without success.

IDHIFA can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking this medicine.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction to IDHIFA: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

IDHIFA can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking IDHIFA.

Seek medical help right away if you have symptoms of differentiation syndrome:

• fever, cough, trouble breathing;

• bone pain;

• rapid weight gain; or

• swelling in your arms, legs, underarms, groin, or neck.

Call your doctor at once if you have any of these side effects:

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe or ongoing vomiting or diarrhea; or

• signs of tumor cell breakdown - vomiting, diarrhea; little or no urination; numbness or tingly feeling; muscle weakness or twitching; fast or slow heart rate; confusion, hallucinations, seizure, feeling restless or irritable.

Common IDHIFA side effects may include:

• nausea, vomiting, diarrhea;

• loss of appetite; or

• jaundice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with enasidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Not hungry.
• Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Advise the patient to read the FDA-approved patient labeling.1

Differentiation Syndrome

Advise patients on the risks of developing differentiation syndrome as early as 10 days and during the first 5 months on treatment. Ask patients to immediately report any symptoms suggestive of differentiation syndrome, such as fever, cough or difficulty breathing, bone pain, rapid weight gain or swelling of their arms or legs, to their healthcare provider for further evaluation.1

Tumor Lysis Syndrome

Advise patients on the risks of developing tumor lysis syndrome. Advise patients on the importance of maintaining high fluid intake, and the need for frequent monitoring of blood chemistry values.1

Gastrointestinal Adverse Reactions

Advise patients on risk of experiencing gastrointestinal reactions such as diarrhea, nausea, vomiting, decreased appetite, and changes in their sense of taste. Ask patients to report these events to their healthcare provider, and advise patients how to manage them.1

Elevated Blood Bilirubin

Inform patients that taking enasidenib mesylate may cause elevated blood bilirubin, which is due to its mechanism of action and not due to liver damage. Advise patients to report any changes to the color of their skin or the whites of their eyes to their healthcare provider for further evaluation.1

Embryo-Fetal Toxicity and Use of Contraceptives

Advise female patients with reproductive potential to use effective contraceptive methods while receiving enasidenib mesylate and to avoid pregnancy while on treatment and for 1 month after completion of treatment. Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during enasidenib mesylate treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with enasidenib mesylate and for at least 1 month after the last dose of enasidenib mesylate. Coadministration of enasidenib mesylate may increase or decrease the concentrations of combined hormonal contraceptives. The clinical significance of this potential drug interaction is unknown at this time.1

Lactation

Advise women not to breastfeed during treatment with enasidenib mesylate and for at least 1 month after the final dose.1

Dosing and Storage Instructions

Advise patients not to chew or split the tablets, but to swallow them whole with a cup of water.1

Instruct patients that if they miss a dose or vomit after a dose of enasidenib mesylate, to take it as soon as possible on the same day and return to normal schedule the following day. Warn patients not to take 2 doses to make up for the missed dose. 1

Keep enasidenib mesylate in the original container. Keep the container tightly closed with desiccant canister inside to protect the tablets from moisture. 1

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

In the U.S.

• Idhifa

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent