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 may cause hepatotoxicity or diarrhea. Avoid concomitant strong CYP3A inducers (eg, rifampin, phenytoin, St. John’s wort, carbamazepine) or CYP3A substrates (eg, oral midazolam). Concomitant strong CYP3A inhibitors (eg, ketoconazole); monitor for idelalisib toxicity.

Adverse Reactions:

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

REMS:

YES

How Supplied:

Tabs—60