ZYDELIG Rx

Indications for ZYDELIG:

Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate due to other co-morbidities. Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least 2 prior systemic therapies. Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies.

Limitations Of use:

Not recommended for first-line treatment of CLL, FL, SLL, or in combination with bendamustine and/or rituximab for FL.

Adult:

Swallow whole. ≥18yrs: initially 150mg twice daily (max); continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

<18yrs: not established.

Contraindications:

History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis.

Boxed Warning:

Fatal and serious toxicities: hepatic, severe diarrhea, colitis, pneumonitis, infections, and intestinal perforation.

Warnings/Precautions:

Risk of fatal/serious hepatotoxicity: monitor ALT/AST every 2 weeks for the first 3 months, every 4 weeks for the next 3 months, then every 1–3 months thereafter; if ALT/AST >3xULN, monitor weekly until resolved; if ALT/AST >5xULN, withhold and continue monitoring weekly until resolved; if ALT/AST >20xULN or bilirubin >10xULN, discontinue permanently. Monitor for diarrhea or colitis; withhold if severe or hospitalization; discontinue permanently if life-threatening. Risk of fatal/serious pneumonitis; monitor for pulmonary symptoms or a decline by >5% in oxygen saturation; if diagnosed, treat and discontinue permanently. Risk of fatal/serious infections; monitor for signs/symptoms and interrupt if Grade ≥3. Treat infections before starting. Provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis during treatment; interrupt if PJP infection is suspected and permanently discontinue if confirmed. Monitor patients with history of CMV infection or (+) baseline CMV serology; interrupt if CMV PCR (+) until resolved; if resumed, monitor for reactivation at least monthly. Risk of fatal/serious intestinal perforation; discontinue permanently if occurs. Monitor for severe cutaneous or serious allergic reactions; discontinue if occur. Monitor CBCs at least every 2 weeks for the first 6 months, and at least weekly if neutrophils <1.0Gi/L. Hepatic impairment; monitor. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during and for at least 1 month (females) or 3 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for 1 month after last dose).

Pharmacological Class:

Phosphatidylinositol 3-kinase inhibitor.

Interactions:

Avoid concomitant drugs that can cause hepatotoxicity or diarrhea. May be potentiated by strong CYP3A inhibitors (eg, ketoconazole); use alternatives or monitor frequently for idelalisib toxicity. May be antagonized by strong CYP3A inducers (eg, rifampin); avoid. May potentiate CYP3A substrates (eg, oral midazolam); avoid.

Adverse Reactions:

Diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, rash, neutropenia, ALT/AST elevations.

REMS:

YES

How Supplied:

Tabs—60