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Idelalisib Dosage

Applies to the following strength(s): 100 mg ; 150 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

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.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes a communication plan. For additional information: www.fda.gov/REMS.

US BOXED WARNINGS:
-HEPATOTOXICITY: Serious liver toxicity with fatal outcome has been reported. Monitor hepatic function prior to and during treatment. Withhold and reduce or discontinue this drug as recommended.
-SEVERE DIARRHEA OR COLITIS: Monitor for diarrhea or colitis. Withhold and reduce or discontinue this drug as recommended.
-PNEUMONITIS: Serious pneumonitis with fatal outcomes has been reported. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue this drug as recommended
-INTESTINAL PERFORATION: Intestinal perforation with fatal outcomes has been reported. Discontinue this drug for intestinal perforation.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take with or without food.
-Tablets should be swallowed whole.

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