duvelisib

Contraindicated in:

OB: Pregnancy;
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.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema

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

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

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

GU: ↓fertility (men), ↑serum creatinine

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

Metab: ↓appetite, weight loss

MS: arthralgia, pain

Neuro: fatigue, headache

Resp: cough, dyspnea, PNEUMONITIS

Misc: fever, DEATH, INFECTION

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A inducers, including rifampin, and moderate CYP3A inducers, including etravirine, may ↓ levels and effectiveness; avoid concurrent use. If concurrent use with moderate CYP3A inducer unavoidable, ↑ duvelisib dose on Day 12 of coadministration with moderate CYP3A inducer.
Strong CYP3A inhibitors, including ketoconazole, may ↑ levels and risk of toxicity; ↓ duvelisib dose.
May ↑ levels and risk of toxicity of CYP3A substrates.

Availability ⬆ ⬇

Capsules: 15 mg; 25 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 25 mg twice daily. Concurrent use of strong CYP3A inhibitor: 15 mg twice daily; Concurrent use of moderate CYP3A inducer and receiving dose of 25 mg twice daily: 40 mg twice daily; Concurrent use of moderate CYP3A inducer and receiving dose of 15 mg twice daily: 25 mg twice daily

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

Decreased progression of CLL and small lymphocytic lymphoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: phosphatidylinositol-3-kinase inhibitors

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–2 hr	12 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Instruct patient to take duvelisib as directed. Take missed doses as soon as remembered if within 6 hr of missed dose and take next dose as usual. If >6 hr, skip dose and take next dose as scheduled.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed.
Advise patient to notify health care provider 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), or lung inflammation occur.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking any new medications.
Advise patient to report signs or symptoms of decline in liver function (fatigue, swelling, nausea, vomiting, dark urine, clay-colored stools, jaundice).
Rep: May cause fetal harm. Advise women of reproductive potential and men with female partners of reproductive potential to use effective contraception and avoid breastfeeding during and for ≥1 mo after last dose of duvelisib. Advise patient to notify health care provider immediately if pregnancy is suspected. May impair male fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

11014- Catalent Pharma Solutions, LLC
- 11014-0347-
  - 11014-0347-2- 1 BAG in 1 DRUM (11014-0347-2) / 83350 CAPSULE in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0348-
  - 11014-0348-2- 1 BAG in 1 DRUM (11014-0348-2) / 100000 CAPSULE in 1 BAG

73116- Secura Bio, Inc
- 73116-215- COPIKTRA
  - 73116-215-28- 28 CAPSULE in 1 PACKAGE (73116-215-28)

73116- Secura Bio, Inc
- 73116-215- COPIKTRA
  - 73116-215-56- 56 CAPSULE in 1 PACKAGE (73116-215-56)

73116- Secura Bio, Inc
- 73116-225- COPIKTRA
  - 73116-225-28- 28 CAPSULE in 1 PACKAGE (73116-225-28)

73116- Secura Bio, Inc
- 73116-225- COPIKTRA
  - 73116-225-56- 56 CAPSULE in 1 PACKAGE (73116-225-56)

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Indications ⬇

Contraind./Precautions ⬆ ⬇