Zydelig(idelalisib)

Zydelig is a kinase inhibitor indicated for the treatment of the following patients:
⑴ Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients who would be considered for appropriate treatment with rituximab alone due to other comorbidities.
⑵ Patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least 2 prior systemic therapies.
⑶ Patients with relapsed small lymphocytic lymphoma (SLL) who have received at least 2 prior systemic therapies.
Accelerated approval is authorized for FL and SLL based on overall response rate. No improvement in patient survival or disease-related symptoms has been established. Continued approval for these indications is contingent on confirmation of clinical benefit in confirmatory trials.
Dosage and administration
Recommended starting dose: 150 mg orally, twice daily.
Dosage form and strength
Tablets: 150 mg, 100 mg.
Contraindications
History of severe allergic reactions including anaphylaxis and toxic epidermal necrosis.
WARNINGS AND PRECAUTIONS
⑴ Severe skin reactions: Monitor and discontinue Zydelig for the development of severe skin reactions in patients.
⑵ Allergic reactions: Monitor and discontinue Zydelig in patients for allergic reactions.
⑶ Neutropenia: Monitor blood cell counts.
⑷ Embryo-fetal toxicity: May cause fetal harm. Advise women of the potential risk to the fetus and to avoid pregnancy while taking Zydelig.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20%) are diarrhea, fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash.
The most common laboratory abnormalities (incidence ≥30%) are neutropenia, hypertriglyceridemia, hyperglycemia, ALT elevation, and AST elevation.
DRUG INTERACTIONS
CYP3A inducers: Avoid coadministration of strong CYP3A inducers with Zydelig.
CYP3A substrates: Avoid coadministration of CYP3A substrates with Zydelig.
USE IN SPECIFIC POPULATIONS
Breastfeeding mothers: Discontinue drug or breastfeeding.