Copiktra Duvelisib Capsules

1. Indications and Usage
Duvelisib capsules are indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) after at least two systemic therapies.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 25 mg taken orally twice daily (approximately 12 hours apart).
Administration: Capsules should be swallowed whole and should not be opened, crushed, or chewed. It can be taken with or without food.
Duration: Treatment should continue until disease progression or unacceptable toxicity.
3. Mechanism of Action
Duvelisib is a dual inhibitor of phosphoinositide 3-kinases (PI3K)-δ and PI3K-γ. By inhibiting these isoforms, it blocks downstream signaling pathways that regulate cell proliferation, survival, migration, and homing, thereby inhibiting the growth and spread of malignant B-cells.
4. Safety and Warnings
Fatal and Severe Infections: Serious and fatal infections (including bacterial, fungal, viral, and opportunistic infections like Pneumocystis jirovecii pneumonia) can occur. Prophylaxis against Pneumocystis jirovecii pneumonia is required.
Colitis and Diarrhea: Severe or fatal colitis and diarrhea have been reported.
Cutaneous Reactions: Severe dermatologic reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported.
Interstitial Lung Disease/Pneumonitis: Fatal cases have been reported.
Hematologic Toxicity: Severe neutropenia, anemia, and thrombocytopenia are common.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequent adverse reactions (incidence ≥20%) include diarrhea, neutropenia, pneumonia, nausea, rash, fever, cough, upper respiratory tract infection, vomiting, and fatigue.
Clinical Research: Clinical trials demonstrated that duvelisib achieved high objective response rates in patients with heavily pre-treated CLL/SLL.
6. Drug Interactions
Strong CYP3A4 Inhibitors: Co-administration increases duvelisib exposure. The dosage should be reduced to 15 mg twice daily.
Strong CYP3A4 Inducers: Co-administration decreases duvelisib exposure and should be avoided.
P-gp Substrates: Duvelisib is a P-gp inhibitor and may increase the exposure of sensitive P-gp substrates (e.g., dabigatran, digoxin).
7. Pharmaceutical Information
Composition: The active ingredient is duvelisib.
Appearance: The capsules are white to off-white opaque with “duv 25mg” printed in black ink on one side.
Storage: Store at 20°C to 25°C (68°F to 77°F) in the original container to protect from moisture.