• Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received 2 prior therapies.
• Relapsed or refractory follicular lymphoma (FL) in patients who have received 2 prior systemic therapies.

Contraindicated in:

• Concurrent use with strong CYP3A inducers
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: edema.

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

F and E: hyperkalemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia.

GI: colitis, diarrhea, HEPATOTOXICITY, abdominal pain, constipation, hypoalbuminemia, ↑amylase, ↑lipase, ↑liver enzymes, mucositis, nausea, vomiting, hyperbilirubinemia.

GU: ↓fertility (men), ↑serum creatinine.

Hemat: neutropenia, anemia, leukopenia, lymphocytosis, lymphopenia, thrombocytopenia.

Metab: ↓appetite, ↓weight.

MS: arthralgia, pain.

Neuro: fatigue, headache.

Resp: PNEUMONITIS, cough, dyspnea.

Misc: INFECTION, fever.

Drug-Drug:

• Strong CYP3A inducers, including rifampin, may ↓ levels and effectiveness; avoid concurrent use.
• Strong CYP3A inhibitors, including ketoconazole, may ↑ levels and risk of toxicity; ↓ duvelisib dose.
• May ↑ levels and risk of toxicity of CYP3A substrates.

• Capsules: 15 mg; 25 mg;

• PO (Adults): 25 mg twice daily. Concurrent use of strong CYP3A inhibitor — 15 mg twice daily.

Copiktra

• Inhibits phosphatidylinositol-3-kinase (PI3K) in malignant B cells which leads to apoptosis and inhibition of proliferation of primary malignant B cell lines and primary CLL tumor cells.

• Decreased progression of CLL, SLL, and FL.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: phosphatidylinositol-3-kinase inhibitors

Absorption: 42% absorbed after oral administration.

Distribution: Extensively distributed to tissues.

Protein Binding: 98%.

Metabolism/Excretion: Primarily metabolized by the liver by the CYP3A4 isoenzyme. 79% of drug excreted in feces (11% as unchanged drug), 14% in urine (<1% as unchanged drug).

Half-life: 4.7 hr.

(plasma concentrations)

• Instruct patient to take duvelisib as directed. Take missed doses as soon as remembered if within 6 hrs of missed dose and take next dose as usual. If >6 hrs, skip dose and take next dose as scheduled. 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 signs and symptoms of infections, diarrhea (any new or worsening diarrhea, stool with mucus or blood, abdominal pain), new or worsening skin rash (painful sores or ulcers on skin, lips, or in mouth; severe rash with blisters or peeling skin; rash with itching; rash with fever), lung inflammation occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 1 mo after last dose of duvelisib. Advise patient to notify health care professional immediately if pregnancy is suspected. May impair male fertility.

DOO-ve-LIS-ib

NDC Code^*

• 71779- Verastem, Inc.
  • 71779-115- Copiktra
    • 71779-115-01- 56 CAPSULE in 1 BOTTLE (71779-115-01)

• 71779- Verastem, Inc.
  • 71779-115- Copiktra
    • 71779-115-02- 2 PACKAGE in 1 CARTON (71779-115-02) > 28 BLISTER PACK in 1 PACKAGE (71779-115-03) > 1 CAPSULE in 1 BLISTER PACK

• 71779- Verastem, Inc.
  • 71779-125- Copiktra
    • 71779-125-01- 56 CAPSULE in 1 BOTTLE (71779-125-01)

• 71779- Verastem, Inc.
  • 71779-125- Copiktra
    • 71779-125-02- 1 PACKAGE in 1 CARTON (71779-125-02) > 28 BLISTER PACK in 1 PACKAGE (71779-125-04) > 1 CAPSULE in 1 BLISTER PACK