Generic name: IDELALISIB 100mg
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on Oct 22, 2018.
The recommended maximum starting dose of Zydelig is 150 mg administered orally twice daily.
Zydelig can be taken with or without food. Tablets should be swallowed whole.
Continue treatment until disease progression or unacceptable toxicity. The optimal and safe dosing regimen for patients who receive treatment longer than several months is unknown.
See Table 1 for dose modification instructions for specific toxicities related to Zydelig. For other severe or life-threatening toxicities related to Zydelig, withhold drug until toxicity is resolved. If resuming Zydelig after interruption for other severe or life-threatening toxicities, reduce the dose to 100 mg twice daily. Discontinue Zydelig permanently for recurrence of other severe or life-threatening Zydelig-related toxicity upon rechallenge.
|Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; ULN, upper limit of normal; CMV, cytomegalovirus; PCR: polymerase chain reaction; PJP: Pneumocystis jirovecii pneumonia|
|Pneumonitis||Any symptomatic pneumonitis|
|Discontinue Zydelig in patients with any severity of symptomatic pneumonitis|
|ALT/AST||>3–5 × ULN||>5–20 × ULN||>20 × ULN|
|Maintain Zydelig dose. Monitor at least weekly until ≤1 × ULN.||Withhold Zydelig.
Monitor at least weekly until ALT/AST are ≤1 × ULN, then may resume Zydelig at 100 mg BID.
|Discontinue Zydelig permanently.|
|Bilirubin||>1.5–3 × ULN||>3–10 × ULN||>10 × ULN|
|Maintain Zydelig dose. Monitor at least weekly until ≤1 × ULN.||Withhold Zydelig. Monitor at least weekly until bilirubin is ≤1 × ULN, then may resume Zydelig at 100 mg BID.||Discontinue Zydelig permanently.|
|Diarrhea*||Moderate diarrhea||Severe diarrhea or hospitalization||Life-threatening diarrhea|
|Maintain Zydelig dose. Monitor at least weekly until resolved.||Withhold Zydelig. Monitor at least weekly until resolved, then may resume Zydelig at 100 mg BID.||Discontinue Zydelig permanently.|
|Neutropenia||ANC 1.0 to <1.5 Gi/L||ANC 0.5 to <1.0 Gi/L||ANC <0.5 Gi/L|
|Maintain Zydelig dose.||Maintain Zydelig dose. Monitor ANC at least weekly.||Interrupt Zydelig. Monitor ANC at least weekly until ANC ≥0.5 Gi/L, then may resume Zydelig at 100 mg BID.|
|Thrombocytopenia||Platelets 50 to <75 Gi/L||Platelets 25 to <50 Gi/L||Platelets <25 Gi/L|
|Maintain Zydelig dose.||Maintain Zydelig dose. Monitor platelet counts at least weekly.||Interrupt Zydelig. Monitor platelet count at least weekly. May resume Zydelig at 100 mg BID when platelets ≥25 Gi/L.|
|Infections||Grade 3 or higher sepsis or pneumonia|
|Interrupt Zydelig until infection has resolved.|
|Evidence of CMV infection or viremia|
|Interrupt Zydelig in patients with evidence of active CMV infection of any grade or viremia (positive PCR or antigen test) until the viremia has resolved. If Zydelig is resumed, monitor patients by PCR or antigen test for CMV reactivation at least monthly.|
|Evidence of PJP infection|
|Interrupt Zydelig in patients with suspected PJP infection of any grade. Permanently discontinue Zydelig if PJP infection is confirmed.|
No dose modification is required for lymphocytosis, which has been observed in some patients taking Zydelig. This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
More about Zydelig (idelalisib)
- Side Effects
- During Pregnancy
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 1 Review
- Drug class: PI3K inhibitors
- FDA Approval History