Duvelisib Application Scope

Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

Duvelisib Characteristics

Ingredients: Duvelisib
Properties: PI3Kδ and PI3Kγ dual inhibitor
Packaging Specification: 15 mg × 56 capsules/box; 25 mg × 56 capsules/box
Storage: Store below 30°C in the original package to protect from light
Expiry Date: As indicated on the package
Executive Standard: FDA approved
Approval Number: NDA 211155
Date of Revision: January 2024
Manufacturer: Secura Bio, Inc.

Guidelines for the Use of COPIKTRA

Dosage and Administration:
- Recommended Dose: 25 mg orally twice daily
- Administration: Take with or without food
- Missed Dose: If a dose is missed by fewer than 6 hours, take it as soon as possible; if more than 6 hours, skip and resume next dose at usual time
Adverse Reactions:
- Common Adverse Reactions (≥20%):
  - Diarrhea or colitis, neutropenia, rash, fatigue, fever, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, anemia
- Serious Adverse Reactions:
  - Neutropenia, thrombocytopenia, sepsis, hypokalemia, increased lipase, pneumonia, pneumonitis
Contraindications: None listed
Precautions:
- - Hypersensitivity Reactions: Monitor patients and discontinue if reactions occur
  - Platelet Count Monitoring: Monitor platelet counts during treatment
  - Pregnancy and Lactation: Advise patients to inform their healthcare provider if pregnant, planning pregnancy, breastfeeding, or planning to breastfeed

Duvelisib Interactions

CYP3A4 Inhibitors: Reduce COPIKTRA dose to 15 mg twice daily
Strong CYP3A4 Inducers: Avoid coadministration
Moderate CYP3A4 Inducers: Avoid if possible; if unavoidable, increase COPIKTRA dose
CYP3A4 Substrates: Monitor for toxicities when co-administering with sensitive CYP3A substrates

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.