What are Enasidenib warning

 Warnings

Differentiation syndrome

• In the clinical trial, 14% of patients treated with enasidenib experienced symptoms of differentiation syndrome, which can be fatal if not treated
• Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multiorgan dysfunction
• Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 1 day and at up to 5 months after initiating enasidenib
• If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution
• Taper corticosteroids only after resolution of symptoms; differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids
• If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for >48 hr after initiation of corticosteroids, interrupt enasidenib until signs and symptoms are no longer severe
• Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended

Contraindications

None

Cautions

Differentiation syndrome reported, which can be fatal if not treated

Based on animal embryofetal toxicity studies, can cause embryofetal harm when administered to pregnant women. drugs available for pregnant women 

Drug interaction overview

• OATP1B1, OATP1B3, and BCRP substrates

1. Enasidenib is an OATP1B1, OATP1B3, and BCRP inhibitor
2. Coadministration with OATP1B1, OATP1B3, and BCRP substrates will increase effects and toxicities of these substrates
3. Decrease dose of OATP1B1, OATP1B3, and BCRP substrate(s) as recommended in respective prescribing information, and as clinically indicated

• P-gp substrates

1. Enasidenib is a P-gp inhibitor
2. Coadministration with P-gp substrates will increase effects and toxicities of these substrates
3. For a sensitive P-gp substrate may lead to serious adverse reactions, decrease dose or modify dosing frequency of such a P-gp substrate and monitor for adverse reactions as recommended in respective prescribing information

       

IDHIFA (ENASIDENIB)

DRUG INTERACTIONS IDHIFA

Effect Of IDHIFA On Other Drugs

OATP1B1, OATP1B3, And BCRP Substrates

IDHIFA is an OATP1B1, OATP1B3, and BCRP inhibitor. Coad ministration of IDHIFA increases the exposure of OATP1B1, OATP1B3, and BCRP substrates, which may increase the incidence and severity of adverse reactions of these substrates [see CLINICAL PHARMACOLOGY]. Decrease the dosage of OATP1B1, OATP1B3, and BCRP substrate(s) as recommended in the respective prescribing information, and as clinically indicated.

Certain P-glycoprotein (P-gp) Substrates

IDHIFA is a P-gp inhibitor. Coad ministration of IDHIFA increases the exposure of P-gp substrates, which may increase the incidence and severity of adverse reactions of these substrates [see CLINICAL PHARMACOLOGY]. For a P-gp substrate where small concentration changes may lead to serious adverse reactions, decrease the dose or modify the dosing frequency of such a P-gp substrate and monitor for adverse reactions as recommended in the respective prescribing information.

IDHIFA (ENASIDENIB)

How much take Idhifa Medicine dosage

The Idhifa dosage your doctor prescribes will depend on your condition and whether you have serious side effects from treatment.

Before and during Idhifa treatment, your doctor will test your blood cell counts and other lab values. Based on these results, your doctor will adjust your Idhifa dosage if needed.

The following information describes dosages that are commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. Again, your doctor will determine the best dosage to fit your needs.

Idhifa Medicine

Drug forms and strengths

Idhifa comes as tablets that you’ll take by mouth. It’s available in two strengths:

• 50 milligrams (mg)
• 100 mg

Dosage for AML

The recommended dosage of Idhifa for treating a type of relapsed or refractory acute myeloid leukemia (AML)* is 100 mg once daily.

You’ll take this dosage for at least 6 months, unless:

• your AML gets worse, or
• you have unmanageable, serious side effects from Idhifa

Idhifa side effects | Allevaire India

Like all drugs, Idhifa may cause side effects. The following lists contain some of the key side effects that may occur while taking Idhifa. These lists do not include all possible side effects.

For more information about the possible side effects of Idhifa, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Idhifa, you can do so through MedWatch.

IDHIFA (Enasidenib) is available.

Mild side effects

The mild side effects* of Idhifa, which can rarely become serious, include:

• nausea or vomiting†
• diarrhea†
• decreased appetite†
• changes in blood levels of calcium, potassium, or phosphorus

increased level of bilirubin (a byproduct of red blood cells that are broken down), which can cause jaundice (yellowing of your skin or the whites of your eyes)

These side effects should be manageable or diminish over time while you’re taking Idhifa. But if any of your side effects become severe or don’t go away, tell your doctor right away.

Also, keep in mind that your doctor may order lab tests to check for certain side effects of Idhifa. So, be sure to keep all appointments for labs and other tests during your Idhifa treatment.

* To learn more about this drug’s side effects, talk with your doctor or pharmacist, or view Idhifa’s prescribing information.

† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects with Idhifa treatment are common. Call your doctor right away if you have new or unusual symptoms as they may be serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

Tumor lysis syndrome (a condition that occurs when cancer cells release their contents into your body). Symptoms can include:

• restlessness, irritability, confusion, or delirium (change in mental function)
• extreme tiredness
• nausea, vomiting, or diarrhea
• muscle weakness, cramps, or spasms
• tingling in your extremities or around your mouth
• irregular heartbeat

seizures

• Leukocytosis (high white blood cell count).*
• Allergic reaction.*
• Differentiation syndrome.†

* For more information about this side effect, see “Side effect details” below.

† Idhifa has a boxed warning Trusted Source for differentiation syndrome. This is the most serious warning from the FDA. To learn more, see ”Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Differentiation syndrome

Treatment with Idhifa increases your risk for differentiation syndrome (DS). In fact, Idhifa has a boxed warningTrusted Source for DS. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). These warnings alert doctors and patients about drug effects that may be dangerous.

DS is a common serious side effect of Idhifa. It can happen after your first dose of Idhifa or within the first 5 months of treatment.

DS affects your blood cells. And if it’s not treated, it can lead to severe symptoms including organ failure and possibly, death.

There isn’t one medical test alone that doctors can use to diagnose DS. Instead, they order certain labs tests before and during Idhifa treatment to both:

• check on the condition you’re using Idhifa to treat
• monitor for changes in your body that may result from serious side effects including DS

To learn more about your risk for DS with Idhifa treatment, talk with your doctor.

Possible symptoms of DS

While taking Idhifa, seek emergency medical care right away if you have any new or unusual symptoms. Possible symptoms that may occur with DS include:

fever

cough

trouble breathing or breathing more quickly than usual

feeling dizzy or faint

fast weight gain (more than 10 pounds in 1 week)

swelling in your hands, feet, ankles, or lower legs

bone pain

swollen lymph nodes

In addition, DS may cause other serious symptoms or health problems, too.

Management of DS

If your doctor believes you have DS from taking Idhifa, they’ll treat your condition with a corticosteroid that’s either taken by mouth or given as an injection into your vein. An example of a corticosteroid that may be used is dexamethasone (Decadron).

Your doctor will also monitor you until your DS symptoms improve. And depending on your condition, your doctor may have you stay at a hospital or stop treatment with Idhifa.

High white blood cell count

Idhifa may cause leukocytosis (increased white blood cell count). Having an elevated white blood cell count is a possible serious side effect of Idhifa.

Specifically, the drug may cause non-infectious leukocytosis. It’s called non-infectious because it doesn’t happen in response to an infection in your body. Typically, white blood cells help protect you from infection-causing germs.

Typically, having an increased white blood cell count doesn’t cause symptoms. So, to monitor for this side effect, your doctor will order blood tests to check your blood cell counts. They’ll do this before and during your Idhifa treatment. If your white blood cell counts are too high, your doctor may prescribe a drug called hydroxyurea (Droxia, Hydra, Siklos). Hydroxyurea can help lower your white blood cell count.

If your white blood cell count doesn’t go down with hydroxyurea treatment, your doctor may have you stop taking Idhifa. And they may have you restart treatment with Idhifa once your white blood cell count is within a normal range.

Gastrointestinal side effects

While you’re taking Idhifa, you may have certain gastrointestinal (GI) side effects. (GI side effects are related to your digestive system.) These are common side effects of Idhifa.

GI side effects that may occur with Idhifa include:

nausea

vomiting

diarrhea

decreased appetite

changes in taste

If you have mild GI side effects that bother you, talk with your doctor or pharmacist. They may recommend prescription or over-the-counter drugs to help manage certain side effects like nausea or vomiting. Or, they may recommend non-drug treatments, such as electrolyte drinks or a bland diet. Be sure to check with your doctor before trying any medications for GI side effects.

If you have severe nausea, vomiting, or diarrhea, call your doctor right away. These side effects could be serious, and they may lead to severe dehydration or other health problems. (With dehydration, you have a low level of fluid in your body.)