Acalanib 100
Form: Tablet
Strength: 100mg
Generic Name: Acalabrutinib
Company: Drug International Ltd.
MRP:৳ 1200.0 (Box=60)
Per Piece: ৳ 20.00
Is Antibiotic: No
Indications
Acalanib 100 is indicated for the treatment of adult patients with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval may depend on confirmatory trials.
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Pharmacology
Acalanib 100 is a small-molecule inhibitor of BTK. Acalanib 100 and its active metabolite, ACP-5862, form 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. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, Acalanib 100 inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and malignant B-cell proliferation, and tumor growth in mouse xenograft models.
Dosage & Administration
The recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food. Advise patients not to break, open, or chew capsules. Manage toxicities using treatment interruption, dose reduction, or discontinuation. Avoid Acalanib 100 in patients with severe hepatic impairment.
Interaction
- CYP3A Inhibitors: Avoid co-administration with strong CYP3A inhibitors. Dose adjustments may be recommended.
- CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Dose adjustments may be recommended.
- Gastric Acid Reducing Agents: Avoid co-administration with proton pump inhibitors.
Contraindications
Not available.
Side Effects
The most common adverse reactions (incidence ≥30%) include:
- Anemia
- Neutropenia
- Upper respiratory tract infection
- Thrombocytopenia
- Headache
- Diarrhea
- Musculoskeletal pain
Precautions & Warnings
- Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly.
- Hemorrhage: Monitor for bleeding and manage appropriately.
- Cytopenias: Monitor complete blood counts regularly.
- Second Primary Malignancies: Other malignancies, including skin cancers and solid tumors, have occurred. Advise patients to use sun protection.
- Atrial Fibrillation and Flutter: Monitor for symptoms of arrhythmias and manage.
Overdose Effects
Not available.
Therapeutic Class
Tyrosine Kinase Inhibitor
Storage Conditions
Do not store above 30⁰C. Keep away from light and out of the reach of children.