Generic Name: Idelalisib Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Idelalisib used for?

Idelalisib is used to treat certain types of cancer (such as chronic lymphocytic leukemia-CLL, follicular B-cell non-Hodgkin’s lymphoma, small lymphocytic lymphoma-SLL). Idelalisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How should I take Idelalisib?

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Swallow the tablets whole. Do not chew or crush the tablets.

The dosage is based on your medical condition and response to treatment.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

How do I store Idelalisib?

Idelalisib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Idelalisib in the bathroom or the freezer. There may be different brands of Idelalisib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Idelalisib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Idelalisib?

Before taking idelalisib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung problems, stomach/intestinal ulcers, current serious infection.

Idelalisib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking idelalisib. Idelalisib may harm an unborn baby. Women should ask about reliable forms of birth control while taking this medication and for 1 month after stopping treatment. Men should ask about reliable forms of birth control while taking this medication and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 month after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Idelalisib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Idelalisib. Idelalisib is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Idelalisib?

Before taking idelalisib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung problems, stomach/intestinal ulcers, current serious infection.

Idelalisib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking idelalisib. Idelalisib may harm an unborn baby. Women should ask about reliable forms of birth control while taking this medication and for 1 month after stopping treatment. Men should ask about reliable forms of birth control while taking this medication and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 month after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Idelalisib?

Some products that may interact with this drug are: bendamustine, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

Other medications can affect the removal of idelalisib from your body, which may affect how idelalisib works. Examples include rifampin, phenytoin, carbamazepine, St. John’s wort, among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include domperidone, midazolam, among others.

Idelalisib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Idelalisib?

Idelalisib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Idelalisib?

Idelalisib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Idelalisib.

What is the dose of Idelalisib for an adult?

Usual Adult Dose for non-Hodgkin’s Lymphoma

150 mg orally twice a day

Duration of therapy: Continue treatment until disease progression or unacceptable toxicity

Uses:

-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities

-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies

-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

Usual Adult Dose for Chronic Lymphocytic Leukemia

150 mg orally twice a day

Duration of therapy: Continue treatment until disease progression or unacceptable toxicity

Uses:

-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities

-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies

-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

Usual Adult Dose for Lymphoma

150 mg orally twice a day

Duration of therapy: Continue treatment until disease progression or unacceptable toxicity

Uses:

-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities

-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies

-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

Renal Dose Adjustments

No dose adjustment is necessary for patients with a CrCl greater than or equal to 15 mL/min.

Liver Dose Adjustments

If hepatotoxicity develops during treatment

-AST and/or ALT greater than 3 to 5 times the upper limit of normal (3 to 5 x ULN): Maintain dose, monitor at least weekly until less than or equal to ULN.

-AST and/or ALT greater than 5 to 20 x ULN: Withhold drug, monitor at least weekly until less than or equal to ULN, may resume at 100 mg twice a day.

-AST and/or ALT greater than 20 x ULN: Discontinue drug permanently.

-Bilirubin greater than 1.5 to 3 x ULN: Maintain dose, monitor at least weekly until less than or equal to ULN.

-Bilirubin greater than 3 to 10 x ULN: Withhold drug, monitor at least weekly until less than or equal to ULN, may resume at 100 mg twice a day.

-Bilirubin greater than 10 x ULN: Discontinue drug permanently.

Dose Adjustments

Dose Modifications for Adverse Reactions:

Diarrhea:

-If moderate diarrhea develops during treatment (increase of 4 to 6 stools per day over baseline), maintain dose and monitor at least weekly until resolved.

-If severe diarrhea develops during treatment (increase of 7 or more stools per day over baseline), withhold drug and monitor at least weekly until resolved. May resume at 100 mg twice a day.

-If life-threatening diarrhea develops during treatment, discontinue drug permanently.

Neutropenia:

-If neutropenia develops during treatment (ANC 0.5 to less than 1.0 Gi/L), maintain dose and monitor at least weekly.

-If neutropenia develops during treatment (ANC less than 0.5 Gi/L), interrupt drug and monitor at least weekly until ANC is greater than or equal to 0.5 Gi/L. May resume at 100 mg twice a day.

Thrombocytopenia:

-If thrombocytopenia develops during treatment (platelets 25 to less than 50 Gi/L), maintain dose and monitor at least weekly.

-If thrombocytopenia develops during treatment (platelets less than 25 Gi/L), withhold drug and monitor at least weekly. May resume at 100 mg twice a day when platelets are greater than or equal to 25 Gi/L.

Other Severe or Life-Threatening Toxicities:

-Withhold drug until toxicity is resolved.

-May resume at 100 mg twice a day.

-Recurrence of severe or life-threatening toxicity upon rechallenge should result in permanent discontinuation of the drug.

What is the dose of Idelalisib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Idelalisib available?

Idelalisib is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Idelalisib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 14, 2018 | Last Modified: August 14, 2018

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