(Ibrutinib)Lokemide®

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Capsule 70 - 140 mg

Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion.

INDICATIONS

LOKEMIDE is a kinase inhibitor indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.

• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).

• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.

• Waldenström’s macroglobulinemia (WM).

• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

• Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

DOSAGE AND ADMINISTRATION

• MCL and MZL: 560 mg taken orally once daily.

• CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily.

WARNINGS AND PRECAUTIONS

• Hemorrhage: Monitor for bleeding and manage.

• Infections: Monitor patients for fever and infections, evaluate promptly, and treat.

• Cytopenias: Check complete blood counts monthly.

• Cardiac arrhythmias: Monitor for symptoms of arrhythmias and manage.

• Hypertension: Monitor blood pressure and treat.

• Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.

• Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

DRUG INTERACTIONS

Some of major drug interactions include:

•CYP3A Inhibitors (Ciprofloxacin, Fluconazole, Voriconazole, Itraconazole, Ketokonazol, …).

•CYP3A Inducers may decrease LOKEMIDE concentrations.

•Drugs that interfere with platelet function or coagulation may potentiate the risk of bleeding complications (Aspirin, Enoxaparin, Heparin, Warfarin, Clopidogrel, Diclofenac, Ibuprofen, …).

Lokemide

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