• Relapsed chronic lymphocytic leukemia (CLL) (in combination with rituximab).

Contraindicated in:

• History of serious allergic reactions including anaphylaxis or toxic epidermal necrolysis
• Concurrent use of strong CYP3A inducers or substrates
• Concurrent use of other hepatotoxic drugs
• Concurrent use of drugs that cause diarrhea
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment (CCr ≤15 mL/min)
• Underlying hepatic impairment (monitor for toxicity; safety and effectiveness in patients with baseline ALT or AST values >2.5 x upper limit of normal [ULN] or bilirubin >1.5 x ULN not established)
• Strong CYP3A inhibitors
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may be more sensitive to drug effects.

CV: peripheral edema.

Derm: rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

EENT: nasal congestion.

Endo: hyperglycemia, hypoglycemia.

F and E: hyponatremia.

GI: ↑ liver enzymes, abdominal pain, colitis/diarrhea, hepatotoxicity, nausea, vomiting, INTESTINAL PERFORATION, stomatitis.

Hemat: anemia, neutropenia, thrombocytopenia.

Metab: hypertriglyceridemia.

MS: arthralgia, pain.

Neuro: fatigue, headache, insomnia, weakness.

Resp: cough, dyspnea, PNEUMONITIS.

Misc: chills, fever, infection(pneumonia, sepsis, febrile neutropenia, Pneumocystis jiroveci pneumonia, and Cytomegalovirus infection), night sweats, ANAPHYLAXIS.

Drug-Drug:

• Strong CYP3A inducers, including carbamazepine,, phenytoin or rifampin, may ↓ levels and effectiveness; avoid concurrent use.
• Concurrent use of strong CYP3A inhibitors, including ketoconazole, may ↑ levels and risk of toxicity; careful monitoring recommended.
• May ↑ levels of CYP3A substrates, including midazolam; avoid concurrent use.

• Tablets: 100 mg; 150 mg;

• PO (Adults): 150 mg twice daily until disease progression or unacceptable toxicity.

Zydelig

• Acts as an inhibitor of phosphatidylinositol 3–kinase; induces apoptosis and inhibits cell proliferation in malignant B-cell and tumor cells, also inhibits come cell-signaling pathways, chemotaxis, adhesion and cell viability.

• Decreased progression of CLL.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A isoenzymes. Metabolites are excreted in feces (78%) and urine (14%).

Half-life: 8.2 hr.

(↑ in progression-free survival†)

† Noted for CLL.

• Instruct patient to take idelalisib as directed. If a dose is missed by less than 6 hr take as soon as remembered; if missed by more than 6 hr wait and take next scheduled dose at usual time. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional immediately if diarrhea (bowel movements increase by six or more/day), severe abdominal pain, severe skin reactions (painful sores or ulcers on skin, lips, or mouth; severe rash with blisters or peeling skin), signs and symptoms of anaphylaxis, DRESS, fever or signs of infection occur, or if signs and symptoms of liver toxicity (yellowing of skin or whites of eyes, dark or brown urine, bruising, abdominal pain in upper right side, bleeding), pneumonitis (cough, dyspnea), occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 1 mo after last dose of idelalisib. Advise patient to notify health care professional promptly if pregnancy is suspected. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose.

EYE-dela-li-sib

NDC Code^*

• 61958- Gilead Sciences, Inc.
  • 61958-1701- Zydelig
    • 61958-1701-1- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)

• 61958- Gilead Sciences, Inc.
  • 61958-1702- Zydelig
    • 61958-1702-1- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)