LuciDela Idelalisib tablets 150mg

Idelalisib (Trade Name: Zydelig) Detailed Product Information

Product Name: Idelalisib Tablets

English Name: Idelalisib Tablets

Trade Name: Zydelig / LuciDela

Specification: 150 mg × 60 tablets per box

Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.

Laos National Drug Approval Number: 03 L 1312/25

I. Indications

1. Relapsed Chronic Lymphocytic Leukemia (CLL)

Used in combination with rituximab for the treatment of patients with relapsed CLL; indicated for patients for whom rituximab monotherapy is appropriate due to comorbidities. Not recommended as a first-line treatment.

2. Relapsed Follicular Non-Hodgkin Lymphoma (FL)

Indicated for patients with relapsed FL who have received at least two prior systemic therapies. Approved under an accelerated approval program; continued approval is contingent upon verification of clinical benefit in confirmatory trials.

3. Relapsed Small Lymphocytic Lymphoma (SLL)

Indicated for patients with relapsed SLL who have received at least two prior systemic therapies; similarly requires support from subsequent clinical data.

II. Dosage and Administration

1. Recommended Dosage

150 mg orally, twice daily. May be taken with or without food. Tablets should be swallowed whole. Continue treatment until disease progression or until unacceptable toxicity occurs.

2. Dosage Adjustments

Hepatotoxicity: Suspend treatment if ALT/AST levels exceed 5 times the upper limit of normal (ULN). Upon recovery, resume treatment at a reduced dose of 100 mg twice daily.

Diarrhea: Moderate diarrhea (an increase of 4–6 bowel movements per day) requires monitoring; severe diarrhea (≥ 7 bowel movements per day) requires suspension of treatment followed by dose reduction.

Neutropenia: Suspend treatment if the absolute neutrophil count (ANC) falls below 0.5 Gi/L. Upon recovery, resume treatment at a reduced dose.

Other Severe Toxicities: Suspend treatment until resolution; subsequently, resume treatment at a reduced dose or permanently discontinue the drug.

III. Adverse Reactions

1. Common Reactions (≥ 20%)

Diarrhea, fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills, rash. 2. Laboratory Abnormalities (≥30%)

Neutropenia, hypertriglyceridemia, hyperglycemia, elevated liver enzymes.

3. Serious Adverse Reactions

Hepatotoxicity, severe diarrhea/colitis, pneumonia, intestinal perforation, hypersensitivity reactions, neutropenia.

IV. Contraindications

History of severe hypersensitivity reactions (e.g., anaphylaxis, toxic epidermal necrolysis).

V. Precautions

1. Hepatotoxicity

Monitor ALT/AST every two weeks during the first 3 months of treatment, and periodically thereafter; discontinue the drug if ALT/AST levels exceed 5 times the upper limit of normal.

2. Pneumonia

Discontinue the drug and initiate corticosteroid treatment if cough, dyspnea, or decreased oxygen saturation occurs.

3. Intestinal Perforation

Maintain vigilance, particularly in the presence of moderate to severe diarrhea; patients must promptly report symptoms such as abdominal pain or fever.

4. Embryo-Fetal Toxicity

Contraindicated in pregnant women; women of childbearing potential must use effective contraception, continuing for 1 month after discontinuing the drug.

VI. Drug Interactions

CYP3A Inducers (e.g., rifampin): Decrease Idelalisib plasma concentrations; co-administration should be avoided.

CYP3A Inhibitors (e.g., ketoconazole): Increase the risk of toxicity; monitoring and dose adjustment are required.

CYP3A Substrates (e.g., midazolam): Idelalisib inhibits their metabolism, increasing exposure; co-administration should be avoided.

VII. Pharmacological Mechanism

Target: Selectively inhibits PI3Kδ kinase, thereby blocking the B-cell receptor signaling pathway and inducing apoptosis in malignant B cells.

Molecular Formula: C22H18FN7O; Molecular Weight: 415.42.

VIII. Storage Instructions

Storage: Store in a tightly sealed container, protected from light, at 20–30°C; excursions between 15–30°C are permitted for short periods.