Acaluxen 100 mg Capsule contains Acalabrutinib, a highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor. It is used in the management of specific B-cell malignancies by targeting abnormal signaling pathways that promote the growth and survival of malignant B cells. Acaluxen is designed for long-term oral therapy and offers targeted action with a well-established safety and efficacy profile.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

Tyrosine Kinase Inhibitor

Indications

Acaluxen is indicated for the treatment of adult patients with B-cell malignancies where inhibition of Bruton’s Tyrosine Kinase (BTK) is clinically appropriate, as prescribed by a qualified healthcare professional.

Pharmacology

Acalabrutinib is a small-molecule, irreversible inhibitor of Bruton’s Tyrosine Kinase (BTK). Both Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the active site of BTK, resulting in sustained inhibition of BTK enzymatic activity.

BTK plays a crucial role in B-cell antigen receptor (BCR) and cytokine receptor signaling pathways. Inhibition of BTK disrupts downstream signaling involved in B-cell proliferation, survival, adhesion, trafficking, and chemotaxis. Nonclinical studies have demonstrated that Acalabrutinib suppresses BTK-mediated activation of signaling proteins such as CD86 and CD69, leading to reduced malignant B-cell proliferation and tumor growth in xenograft models.

Dosage & Administration

• The recommended dose is 100 mg orally every 12 hours until disease progression or unacceptable toxicity.

• Capsules should be swallowed whole with water.

• Do not open, break, or chew the capsules.

• Acaluxen may be taken with or without food.

• If a dose is missed by more than 3 hours, skip the missed dose and take the next dose at the scheduled time.

• Do not take extra capsules to make up for a missed dose.

• Dose reduction to 100 mg once daily may be considered after resolution of toxicity to Grade 1 or baseline.

• Discontinue therapy if severe adverse reactions recur more than four times.

Drug Interactions

• Strong CYP3A inhibitors (e.g., itraconazole) significantly increase Acaluxen exposure.

• Moderate CYP3A inhibitors may increase drug levels up to three-fold.

• Strong CYP3A inducers (e.g., rifampin) markedly reduce Acaluxen exposure.

• Antacids and proton pump inhibitors reduce Acaluxen absorption due to increased gastric pH.

• Acaluxen is a substrate of P-glycoprotein (P-gp) and BCRP transporters and may increase exposure of BCRP substrates such as methotrexate.

• Based on in vitro and pharmacokinetic modeling, clinically significant interactions with CYP substrates are unlikely at recommended doses.

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Side Effects

Common adverse reactions (≥30%) include:

• Anemia

• Neutropenia

• Thrombocytopenia

• Upper respiratory tract infection

• Headache

• Diarrhea

• Musculoskeletal pain

Pregnancy & Lactation

• Acalabrutinib may cause fetal harm based on animal studies. Pregnant women should be advised of potential risks.

• There are no adequate data in pregnant women.

• Breastfeeding is not recommended during treatment and for at least 2 weeks after the final dose due to potential adverse effects on the infant.

Precautions & Warnings

• Serious and sometimes fatal hemorrhagic events have been reported. Monitor patients, especially those on antiplatelet or anticoagulant therapy.

• Serious infections, including opportunistic infections, HBV reactivation, and progressive multifocal leukoencephalopathy (PML), may occur.

• Monitor complete blood counts regularly due to the risk of cytopenias.

• Second primary malignancies, including skin cancer, have been reported; advise sun protection.

• Atrial fibrillation and atrial flutter have occurred; monitor patients with cardiac risk factors.

Use in Special Populations

• Renal impairment: No dose adjustment is required in mild to moderate renal impairment; not studied in severe renal impairment or dialysis.

• Hepatic impairment: Mild to moderate hepatic impairment may increase exposure; not studied in severe hepatic impairment.

• Pediatric use: Safety and efficacy have not been established.

• Geriatric use: No clinically relevant differences in safety or efficacy compared to younger adults.

Storage Conditions

Store below 30°C.
Protect from light.
Keep out of the reach of children.